Additive Manufacturing in Orthopedics and ...

SAMINT-MILI 20057

Master’s Thesis 30 credits

September 2020

Additive Manufacturing in Orthopedics and

Craniomaxillofacial Surgery for the Develop-

ment of High-risk Custom-made Implants

A Qualitative Study of Implementation Factors from a

Multi-stakeholder Perspective

Antonia Evgenia Nioti

Master’s Programme in Industrial Management and Innovation

Masterprogram i industriell ledning och innovation

I

Abstract

Additive manufacturing in orthopedics and craniomaxil-

lofacial surgery for the development of high-risk cus-

tom-made implants: A qualitative study of implementa-

tion factors from a multi-stakeholder perspective


Additive manufacturing (AM) has enabled the possibility for the hospitals to

become their own implant producers developing implants that are tailored to

patient’s anatomy. Despite the enormous potential of custom-made implants

there are challenges that complicate the implementation of them into clinical

practice. The aim of this research is to (1) identify the main driving forces and

barriers for the delivery of custom-made implants; (2) explore staff stakeholder

views and practices related to the implementation of AM in surgery for the

development of custom-made implants; (3) formulate recommendations on

how to cope with the implementation challenges. The research method was an

explorative qualitative study consisted of a literature review on the challenges

of custom-made implants in clinical applications coupled with the collection and

inductive analysis of empirical data. The latter was based on ten semi-struc-

tured interviews conducted among both domestic and international hospital

managers medical doctors and research engineers. The consolidated frame-

work for implementation research (CFIR) was utilized for data collection. Using

the five domains of CFIR, the following results were obtained: (1) Characteris-

tics of individuals: Most research participants indicated a positive attitude to-

wards the intervention expressing self-efficacy to its use; (2) Intervention char-

acteristics: Custom-made implants were perceived to have a relative advantage

in surgical practice due to their high degree of observability and geometrical

adaptability providing increased surgical quality, perfect patient fit and better

understanding of the pathologies. However, high implementation costs, low

degree of trialability and high degree of complexity in the development process

were regarded as drawbacks of the innovation; (3) Outer setting: the regula-

tory uncertainty and lack of reimbursement limit the accessibility of custom-

made implants to low income populations; (4) Inner setting: scarcity of re-

sources, staff resistance to change, insufficient management support, commu-

nication difficulties, limited access to educational materials and training oppor-

tunities as well as lack of time and innovative capacity were regarded by the

majority of participants as implementation barriers; (5) Process: central for the

success of implementation is the need for a coherent implementation plan and

evaluation process as well as the engagement of key stakeholders such as hos-

pital managers, payers, regulatory and implementation advisors. This disserta-

tion proffers a deeper understanding of the implementation issues related to

custom-made implants and offers preliminary recommendations on how to

cope with implementation impediments through the use of Rogers diffusion of

innovation coupled with concepts from the field of organizational change and

innovation management including Clayton’s disruptive innovation.

Keywords: Implementation, CFIR, custom-made implants, barriers, surgery,

disruptive innovation, facilitators.

Supervisor: Marcus Lindahl

Subject reader: David Sköld

Examiner: Åse Linné

SAMINT-MILI 20057

Printed by: Uppsala University

Faculty of Science and Technology

Visiting address: Ångströmlaboratoriet Lägerhyddsvägen 1 House 4, Level 0

Postal address: Box 536 751 21 Uppsala

Telephone: +46 (0)18 – 471 30 03

Telefax: +46 (0)18 – 471 30 00

Web page: http://www.teknik.uu.se/student-en/

II

POPULAR SCIENCE SUMMARY

INTRODUCTION Additive manufacturing, also called tree dimensional printing (3DP), is

a process of creating, easy and very fast physical objects with complex shapes from models

designed in a computer. The last couple of years, additive manufacturing has been applied in

surgery enabling the possibility for the hospitals to provide custom-made implants on-site. A

custom-made implant is a medical device that is designed specifically to fit a particular pa-

tient’s bone structure. In craniomaxillofacial and orthopaedic surgery these devices are placed

surgically into the patient to improve functions such as face deformities and hip and knee frac-

tures. With the use of additive manufacturing a custom-made implant can be fabricated within

48 hours making it possible for the hospitals to become their own manufacturers. However,

producing custom-made implants in a hospital setting is not an easy case because the set of

activities required to design and fabricate the implants comes with many challenges. Therefore,

the aim of this research is to understand the factors that hinder or facilitate the use of additive

manufacturing in surgery for the delivery of custom-made implants and thereby create the

foundation that will help hospitals becoming implant producers.

METHODOLOGY The research begun with a literature review in which previous scientific

articles in applications of custom-made implants in surgery were studied with the purpose of

identifying what drives or hampers the delivery of custom-made implants in the market. Then

a step further was taken by interviewing involved individuals in the process of developing cus-

tom-made implants, namely hospital managers and medical doctors from three hospitals lo-

cated in Switzerland, Netherland and Sweden, and research engineers from two 3D Printing

Labs located in Sweden. The empirical investigation was focus on participants’ opinion regard-

ing the efforts of the hospital to introduce custom-made implants into the daily practice of

clinicians. The collected empirical data were analyzed afterwards inductively and compared

with the findings from the literature review.

FINDINGS The empirical research showed that the research participants had in general a

positive attitude towards the use and potential of additive manufacturing for the development

of custom-made implants in a hospital setting. One of the major advantages of custom-made

implants was that they can be easily adapted to patient needs requiring minimum to no modi-

fication of the patient’s bone structure. This means that the patient will spend less time in sur-

gery leading to less anesthesia exposure, less blood loss, better surgical outcome and faster

rehabilitation. However, developing custom-made implants in a hospital setting was regarded

as a complex procedure. The main barriers were associated with (1) not having enough re-

sources for the implementation, (2) resistance to change from clinicians and management, (3)

lack of innovative capacity, namely lack of interest to explore and exploit the potential of the

technology, (4) communication difficulties between doctors and engineers, (5) insufficient

management support, (6) absence of monetary reward systems, (7) scarcity of training oppor-

tunities, (8) lack of guidelines on how to successfully establish an effective workflow for the

development of custom-made implants, (9) (10) and other external factors such as uncertainty

on how to apply the medical device regulations (MDR) into the development process of the

implants and the lack of compensation for implants produced inside the hospital. The key fa-

cilitators identified involved (1) having a strong coalition team that met regularly, (2) engaging

III

clinicians into the development process to see the benefits of the technology, (3) consulting

implementation and MDR experts (4) providing management support in terms of premises,

empowerment and funding (5) establishing an independent 3D Printing unit and (6) promoting

an entrepreneurial culture. Examining the results methodically led to the identification of 48

barriers and 38 facilitators which were classified into seven main themes: regulatory, strategic,

procedural, financial, structural, contextual, and competence related barriers.

CONCLUSION The main conclusion drawn from this study is that resistance to change is

correlated with the implementation climate and the organizational commitment. Communica-

tion difficulties rise due to the diversity in professional culture and unrealistic expectations of

what it is possible to be achieved during work tasks. Not having enough resources for the im-

plementation indicated shortage in qualified manpower and the need for developing new

strategies for funding and resource allocation. Lack of guidelines on how to establish an ef-

fective workflow for custom-made implants suggested the need for implementation advisors

while regulatory uncertainty denoted the necessity for hiring MDR-experts and simplifying

regulatory procedures. Perceived insufficient management support was due to the limited in-

sight into local and clinicians’ needs as well as the use of unsuitable business models to intro-

duce a new medical technology. Finally, the lack of reimbursement for in-house developed

implants denoted the need for clear remuneration criteria and accurate costing information

that the innovation is profitable enough to generate savings.

RECOMMENDATIONS To cope with the implementation barriers, it is necessary to pro-

vide regulatory support for administrative simplification and develop economic frameworks

to assess the financial impact of the technology. There is also the need for standardized pro-

cedures and proper design frameworks to accommodate the development process as well as

policies and tools to monitor implementation procedures. This research also argues for an im-

plementation plan that takes the local needs into account and leads to routinization through an

iterative cycle of restructuring, clarifying, and evaluating process. Routinization is achieved

through the mutual adaptation of organizational structure and innovation (restructuring) fol-

lowed by economical, educational, physical and phycological support (clarifying) completing

the cycle of innovation change through reflection of implementation strategies and regular

adjustment of implementation plans.

Keywords: Additive manufacturing, patient specific, custom-made implants, barriers, facili-

tators, medical device regulation, orthopedics, craniomaxillofacial.

IV

ACKNOWLEGMENTS

There are three things that I need each day; one is something to look up to, another is

something to look forward to and another is someone to chase. I would like to thank

God because He is the one, I look up to. He has graced my life with opportunities that

I know are not of my hand or any other human hand. To the ones I look forward to

which is my family (…) and to the person I chase – my hero. That person is me in ten

years.

Matthew McConaughey (March 2014)

I would also like to thank those who helped to bring this project to birth starting first with Dr.

Jan-Michaél Hirsch, Professor Emeritus, Department of Surgical Sciences, Oral and maxillo-

facial Surgery at Uppsala University, who provided access to an international healthcare net-

work and offered me encouragement when it was needed the most. Thank you for your

availability and significant support. Your contribution substantially improved the quality of

the empirical research.

I would also like to thank Jan Erik Vollebregt, Specialist in Life Sciences Regulation at Axon

Lawyers in Netherlands, for his guidance and expertise in understanding the medical device

regulation.

A special thanks goes to all hospital managers, medical doctors and engineers who allowed

me to have a glimpse into their working life disclosing valuable knowledge and experience.

Without your participation and contribution, the empirical study would have never been com-

pleted.

My gratitude also extends to David Sköld, Thesis Subject Reader and associate Professor at

the Department of Civil and Industrial Engineering at Uppsala University, for his support to-

wards ethical concerns occurred during this research project and for coming up with helpful

comments after reviewing the thesis.

I am also thankful to Åse Linné, Thesis Examiner and Director of Master’s Programme in In-

dustrial Management and Innovation at Uppsala University, for her constructive comments at

the VIVA.

Last but not least, I would also like to thank AddLife and Marcus Lindahl, Thesis Supervisor

and Head of the Division Industrial Engineering and Management at Uppsala University, for

initiating the project 3D Printing in Healthcare from which the topic of this dissertation was

derived.


Uppsala, October 2020

V

TABLE OF CONTENTS

CHAPTER 1. INTRODUCTION ........................................................................................... 1

1.1 BACKGROUND ................................................................................................................... 1

1.2 RESEARCH FOCUS .............................................................................................................. 2

1.3 RESEARCH AIM AND QUESTIONS ........................................................................................ 3

1.4 DELIMITATIONS ................................................................................................................. 4

CHAPTER 2. LITERATURE REVIEW ............................................................................... 5

2.1 DRIVING FORCES OF CUSTOM-MADE MEDICAL DEVICE INDUSTRY ..................................... 5

2.2 RESTRAINING FORCES OF CUSTOM-MADE MEDICAL DEVICE INDUSTRY .............................. 6

2.2.1 The development process of custom-made implants ................................................. 6

2.2.2 Medical Device Regulation ....................................................................................... 9

2.2.3 Economic challenges ............................................................................................... 13

2.2.4 Organizational challenges ........................................................................................ 14

2.2.5 Technological challenges ........................................................................................ 15

2.3 SUMMARY OF LITERATURE REVIEW FINDINGS ................................................................. 16

CHAPTER 3. THEORETICAL FRAMEWORK .............................................................. 18

3.1 THE FIELD OF IMPLEMENTATION SCIENCE ....................................................................... 18

3.2 IMPLEMENTATION DETERMINANTS FRAMEWORKS AND THEORIES ................................... 21

3.2.1 Consolidated Framework for Implementation Research ......................................... 22

3.2.2 Rogers’ Diffusion of Innovation Theory ................................................................. 24

CHAPTER 4. INTRODUCTION TO METHODOLOGY ................................................ 29

4.1 RESEARCH STRATEGY ...................................................................................................... 29

4.2 RESEARCH DESIGN ........................................................................................................... 30

4.3 SITE AND SAMPLE SELECTION .......................................................................................... 30

4.3.1 Research participants ............................................................................................... 31

4.4 DATA COLLECTION METHODS .......................................................................................... 32

4.4.1 Literature review ...................................................................................................... 32

4.4.2 Interviews ................................................................................................................ 33

4.4.3 CFIR as an interview guide ..................................................................................... 34

4.4.4 Triangulation ........................................................................................................... 36

4.5 THEORETICAL FRAMEWORK FOR DATA ANALYSIS ........................................................... 37

4.6 ETHICAL CONSIDERATIONS .............................................................................................. 37

4.7 LIMITATIONS AND POTENTIAL PROBLEMS ........................................................................ 38

CHAPTER 5: FINDINGS OF EMPIRICAL RESEARCH ............................................... 40

5.1 HOSPITAL MANAGERS’ CHARACTERISTICS AND PERSPECTIVES ........................................ 40

5.1.1 Intervention Characteristics ..................................................................................... 42

5.1.2 Outer Setting ............................................................................................................ 48

5.1.3 Inner Setting ............................................................................................................ 51

5.1.4 Implementation Process ........................................................................................... 60

VI

5.2 MEDICAL DOCTORS’ CHARACTERISTICS AND PERSPECTIVES ............................................ 62


5.2.2 Outer Setting ............................................................................................................ 67

5.2.3 Inner Setting ............................................................................................................ 67

5.3 RESEARCH ENGINEERS’ CHARACTERISTICS AND PERSPECTIVES ....................................... 72


5.3.2 Outer Setting ............................................................................................................ 77

5.3.3 Inner Setting ............................................................................................................ 78

5.4 SUMMARY OF RESULTS .................................................................................................... 81

CHAPTER 6. ANALYSIS ..................................................................................................... 84

6.1 CHARACTERISTICS OF INVOLVED STAKEHOLDERS ........................................................... 84

6.2 OUTER SETTING ............................................................................................................... 85

6.2.1 Regulatory impediments .......................................................................................... 85

6.2.2 Lack of reimbursement ............................................................................................ 87

6.3 PERCEIVED ATTRIBUTES OF INNOVATION ........................................................................ 88

6.3.1 Trialability ............................................................................................................... 88

6.3.2 Relative advantage ................................................................................................... 90

6.3.3 Complexity .............................................................................................................. 90

6.3.4 Observability ........................................................................................................... 91

6.3.5 Insufficient evidence of cost-effectiveness .............................................................. 92

6.4 INNER SETTING ................................................................................................................ 93

6.4.1 Lack of business model innovation ......................................................................... 93

6.4.2 Management support ............................................................................................... 94

6.4.3 Resistance to change ................................................................................................ 96

6.4.4 Lack of time ............................................................................................................. 97

6.4.5 Skill shortage ........................................................................................................... 98

6.4.6 Communication difficulties ..................................................................................... 99

6.4.7 Location of 3D printing facility ............................................................................... 99

6.4.8 Scarcity of resources .............................................................................................. 100

6.4.9 Lack of innovative capacity ................................................................................... 101

6.5 IMPLEMENTATION PROCESS ........................................................................................... 102

6.5.1 Lack of implementation plans and evaluation procedures .................................... 102

6.5.2 Key implementation actors .................................................................................... 102

6.6 SUMMARY OF ANALYSIS ................................................................................................ 105

CHAPTER 7. DISCUSSION AND CONCLUSION ......................................................... 109

7.1 IMPLEMENTATION DRIVERS ........................................................................................... 109

7.2 IMPLEMENTATION BARRIERS ......................................................................................... 109

7.2.1 Regulatory complications ...................................................................................... 110

7.2.2 Financial complications ......................................................................................... 112

7.2.3 Contextual and competence complications ........................................................... 113

7.2.4 Procedural complications ...................................................................................... 114

7.2.5 Strategic complications .......................................................................................... 115

VII

7.2.6 Structural complications ........................................................................................ 116

7.3 RECOMMENDATIONS FOR OVERCOMING IMPLEMENTATION BARRIERS ........................... 116

7.3.1 Regulatory support and administrative simplification ........................................... 117

7.3.2 Funding .................................................................................................................. 117

7.3.3 Overcoming resistance to change .......................................................................... 117

7.3.4 Skills and medical education ................................................................................. 118

7.3.5 Management support and business models innovation ......................................... 120

7.3.6 3D Printing facility ................................................................................................ 121

7.3.7 Implementation and process standardization ......................................................... 122

7.4 FINAL CONCLUSIONS ..................................................................................................... 123

7.5 STUDY LIMITATIONS ..................................................................................................... 126

7.6 FUTURE RESEARCH ........................................................................................................ 127

REFERENCES ..................................................................................................................... 129

APPENDIX A: LITERATURE REVIEW

APPENDIX B: INTERVIEW QUESTIONS

APPENDIX C: CFIR CONSTRUCTS

APPENDIX D: INFORMED CONSENT

APPENDIX E: COMPREHENSIVE OVERVIEW OF EMPIRICAL RESULTS

VIII

TABLE OF FIGURES Figure 1: A summary of the clinical workflow of PSIMs from image acquisition to post-

processing produced implant. ............................................................................................. 9

Figure 2: Taxonomy of theoretical models and frameworks in IS. The picture is adapted from

Nilsen P 2015; 10(1):13. ................................................................................................... 19

Figure 3: A simple illustration of the five domains included in CFIR. The figure is adapted

from Zingg, (2017). .......................................................................................................... 23

Figure 4: The five main domains of CFIR and their respective constructs. ............................ 24

Figure 5: The five stages of innovation decision process. ....................................................... 25

Figure 6: The factors affecting individual’s adoption decision process. ................................. 27

Figure 7: The innovation adoption process in an organization. Picture is adapted from Everett

Rogers, Diffusion of innovations, Figure 10-2 (1995, p. 392). ........................................ 28

Figure 8: Methodological approach to conduct the empirical study ........................................ 30

Figure 9: Data collection methods utilized to answer the research questions. ........................ 33

Figure 10: Selected constructs of CFIR utilized to build the interview guide. ........................ 34

Figure 11: The iterative framework of qualitative analysis. .................................................... 37

Figure 12: Main stakeholders involved in the implementation of 3D Printing Lab. ............. 105

Figure 13: 18 themes and six driving forces organized under the five domains of CFIR. .... 106

Figure 14: A diagram showing the hierarchical correlation between barriers caused by

regulatory uncertainty at macro (industrial) level and at meso (hospital) level. ............ 111

Figure 15: Hierarchical correlation between the factors causing financial uncertainty. ........ 112

Figure 16: The correlation between staff resistance to change and factors related to

implementation climate. ................................................................................................. 114

Figure 17: Procedural complications in the development and implementation of PSIMs. ... 115

Figure 18: Correlation among factors that cause strategic complications. ............................ 116

Figure 19: Suggested framework for prioritizing recommendations. .................................... 125

IX

LIST OF TABLES Table 1: Regulatory impediments (-) and facilitators (+). ....................................................... 12

Table 2: Financial barriers. ...................................................................................................... 14

Table 3: Organizational barriers. ............................................................................................. 15

Table 4: A review of the technological challenges. ................................................................. 16

Table 5: A review of the different criteria encountered in two online webtools and one

scientific article on reviewing implementation frameworks. ........................................... 20

Table 6: Criteria for selecting theoretical implementation framework. ................................... 21

Table 7: A comparative overview of CFIR and Greenhalgh’s conceptual model. .................. 22

Table 8: Participants’ code name, gender, medical discipline, organization and country. ...... 32

Table 9: Managers’ characteristics and incentives. ................................................................. 42

Table 10: Perceived relative advantages of patient specific implants. .................................... 44

Table 11: The complexity of implementing patient specific implants. ................................... 46

Table 12: Main implementation costs and cost-effectiveness of PSIMs. ................................ 48

Table 13: The impact of MDR on the implementation of PSIMs............................................ 51

Table 14: The required structural changes to facilitate implementation of PSIMs. ................ 54

Table 15: Statements regarding internal communication. ....................................................... 55

Table 16: Statements related to the construct “tension for change”. ....................................... 57

Table 17: Statements related to the construct “organizational incentives and rewards”. ........ 58

Table 18: A synopsis of how leadership engagement affects implementation of PSIMs. ....... 59

Table 19: Statements related to knowledge and information accessibility. ............................. 60

Table 20: Statements regarding the implementation process of PSIMs. ................................. 62

Table 21: Medical doctors’ individual characteristics. ............................................................ 64

Table 22: Advantages and disadvantages of PSIMs. ............................................................... 65

Table 23: Complexity of developing 3D printed patient specific implants. ............................ 66

Table 24: Cost-efficiency of patient specific implants. ........................................................... 66

Table 25: The impact of MDR in the development process of implants. ................................ 67

Table 26: The required structure to facilitate implementation of PSIMs. ............................... 68

Table 27: Factors affecting internal communication. .............................................................. 69

Table 28: Factors that hinder or facilitate change. ................................................................... 70

Table 29: Incentives that facilitate or hinder implementation of 3D printed implants. ........... 71

Table 30: Statements related to management support and implementation. ........................... 72

Table 31: Statements related to the construct “access to knowledge and information”. ......... 72

Table 32: Engineering researchers’ individual characteristics. ............................................... 73

Table 33: PSIMs relative advantages in terms of manufacturing technique and aiding tools. 75

Table 34: Perceived complexity of developing patient specific implants. .............................. 76

Table 35: Main implementation costs and cost-efficiency of PSIMs. ..................................... 77

Table 36: External factors affecting the implementation of 3D printed implants. .................. 78

Table 37: Required organizational structural changes to facilitate implementation. ............... 78

Table 38: Statements regarding communication between physicians and engineers. ............. 80

Table 39: Type of education-training and support that facilitates implementation. ................ 81

Table 40: A synopsis of the results from empirical investigation. .......................................... 83

Table 41: Regulatory barriers and facilitators acting at macro, meso and micro level. .......... 87

Table 42: Barriers and facilitators related to reimbursement of PSIMs. ................................. 88

Table 43: Implementation barriers and facilitators related to low degree of trialability. ........ 89

Table 44: Perceived barriers and facilitators due to high degree of complexity. .................... 91

X

Table 45: Implementation barriers and facilitators related to PSIMs’ cost-effectiveness. ...... 93

Table 46: Implementation barriers and facilitators related to lack of business model

innovation. ........................................................................................................................ 94

Table 47: Implementation barriers and facilitators related to management support. .............. 96

Table 48: Staff resistance to change and implementation. ...................................................... 97

Table 49: Factors affecting implementation of PSIMs due to lack of time. ............................ 98

Table 50: Implementation barriers and facilitators related to the theme “skill shortage”. ...... 98

Table 51: Main implementation costs. ................................................................................... 100

Table 52: Lack of innovative capacity and implementation. ................................................. 102

Table 53: Implementation impediments classified into regulatory, financial, contextual,

structural, procedural, strategic and competence barriers. ............................................. 107

Table 54: Implementation catalysts classified into regulatory, financial, strategic, structural,

contextual, procedural and competence facilitators. ...................................................... 108

XI

ABBREVIATIONS

2D Two-dimensional

3D Three-dimensional

3DP Three-dimensional printing

AM Additive manufacturing

CAD Computer-aided design

CAGR Compound annual growth rate

CAM Computer-aided manufacturing

CFIR Consolidated framework for implementation research

CMF Cranio-maxillofacial

CMI Custom-made implant

DI Disruptive innovation

DICOM Digital imaging and communication

DOI Diffusion of innovation theory

EBP Evidence-based practices

EU European

FEA Finite element analysis

FDM Fused deposition modelling

IS Implementation science

MD Medical device

MDCT Multidetector computed tomography

MDD Medical device directive

MDR Medical device regulation

MedTech Medical technology

MRA Mutual recognition agreement

MRI Magnetic resonance image

NIH National Institutes of Health

PIP Poly Implant Prostheses

PM Polyjet modelling

POC Point of care

PSI Patient specific instrument

PSIM Patient specific implant

ROI Region of interest

SFF Solid freeform fabrication

SIM Standard implant

SLA Stereolithography

SLS Selective laser sintering

SMA Swedish medical association

SMPA Swedish medical products agency

UDI Unique device identification

INTRODUCTION

1

Chapter 1. Introduction This chapter initiates with preliminary background information about the potential of additive

manufacturing (AM) and custom-made implants in orthopedics and craniomaxillofacial sur-

gery. The area of the research is discussed highlighting the rationale of this study and the over-

all aim and research questions are specified. A small section regarding the study delimitations

is also included.

1.1 Background Before technology revolutionized the practice of surgery, pre-modern surgery was undevel-

oped, unpredictable, and extremely dangerous. As Scottish anatomist and surgeon John Hunter

described in 1750, surgery was ‘a humiliating spectacle of the futility of science’ and the sur-

geon was ‘a savage armed with a knife’ who learned through experience and experimentation

(Atul, 2012). The patient could rarely question the recommended treatment and was subject to

an unsanitary operation without anesthesia, blood transfusions or sterile equipment. Because

of that, the main issues during surgery were how to relieve pain, reduce blood lose, prevent

infection, and reduce operation time – since it was known that the patient was unlikely to sur-

vive a long operation, speed was of the essence (Medicin through time, 2017).

Today, thanks to technological and scientific breakthroughs great progress has been made in

medical technologies that has led to the revolution of surgical techniques. The modern surgeon

has a variety of innovations in his hands to tackle easier major surgical issues (Malik, et al.,

2015). For example, pain is controlled today via anesthetics and drugs; exploratory operations

are performed using digital imaging techniques such as X-Rays, computed tomography (CT)

scan and Magnetic resonance imaging (MRI) scan, without the need to open patient’s body;

infection issues have been dealt with sterilization, aseptic surgery and rubber gloves (Patila,

2019).

One of the latest innovations is the advent of additive manufacturing (AM), also called 3D

Printing (3DP), which is a manufacturing process that builds up objects from a three-dimen-

sional (3D) digital model (Malik, et al., 2015). In the surgical field 3DP has been coupled with

CT-scan and MRI to produce 3D anatomical models that are tailored to the patient’s anatomy

(Aima, et al., 2019). Using patient specific anatomical models, physicians can better visualize

the complex morphology of the patient, identify the potential challenges of the pathology, an-

ticipate their solution and practice potentially effective treatment before even entering the op-

erating theatre (Aima, et al., 2019; Wong, et al., 2017). Good preoperative preparation in turn

optimizes the surgical procedure decreasing the operation time and the time the patient is on

the operating table which means ‘less anesthesia exposure, decrease blood loss, and improved

surgical outcome’ (Hoang, et al., 2016).

Patient specific models are also used for designing and validating implants tailored to the pa-

tient’s anatomy (Ortho Baltic Implants, 2019). In surgery, an implant is a medical ‘device or

tissue that is inserted inside or on the surface of the body’ (Implants and Prosthetics, 2019) to

‘preserve or maintain a function, or to enhance or alter a contour e.g. a breast or chin implant’

(Segen's Medical Dictionary, 2012). With the utilization of 3DP and CAD/CAM software, im-

plants can be created from scratch to fit specifically a patient’s anatomical structure. 3D printed

INTRODUCTION

2

implants specifically tailored to the patient are known as custom-made implants (CMIs) or

patient specific implants (PSIMs).

The conventional implant treatment comprises the application of standard implants (SIM).

SIMs have limited range of sizes and shapes and therefore they are often insufficient to match

patient’s anatomy, especially in cases with irregular bone defects such as cranial and spinal

implants wherein structures have complex shape (Zuhao, et al., 2018). In these cases, either the

implant or the patient’s bone structure must be modified to ensure accurate fit. Other problems

that remain unsolved with traditional implants are the long manufacturing processes which lead

to delivery delays and high cost for health care providers; ‘bonding strength’ issues that occur

when the implant mismatches with the bone leading to bone atrophy followed by instability

and loosening causing failure of the implant and resulting to additional surgery (Zuhao, et al.,

2018).

By contrast, 3D printed patient specific implants (PSIMs) offer ‘good bone defect matching

and quick and safe joint functional rehabilitation’ (Zuhao, et al., 2018). In addition, PSIMs

require minimum to no modification of the patient’s bone structure reducing thus healthcare

costs ‘since patients will spend less time in longer or additional surgeries or filing for malprac-

tice lawsuits’ (Asanova, et al., 2017). From a manufacturing perspective, implants with very

complex geometry can be produced quickly and at a low-cost reducing lead time and overall

expenses to healthcare providers.

Two major market applications of 3D printed implants are within reconstructive orthopedic

and cranio-maxillofacial surgery (Medgadget, 2019). The complexity of reconstructive surgi-

cal practice is increasing every year due the growing number of fracture cases by trauma tumor,

infections and diseases (Asanova, et al., 2017; Mason, et al., 2019). This means that the need

for PSIMs is growing since they allow for personalized healthcare ensuring that each patient

gets the very best treatment. In fact, the global market of 3D printed medical implants is ex-

pected to grow at a compound annual growth rate (CAGR) of 18% during the forecast period

from 2020 to 2024 (Medgadget, 2019). Considering the pressure caused by the scarcity of re-

sources and the increased demand for personalized healthcare, the emergence of AM opens a

strategic window for healthcare providers by enabling the production of implants on site, also

known as point-of-care (POC) manufacturing of CMIs in which 3D printed applications are

‘created at the place of patient care’ (PR Newswire, 2018).

1.2 Research focus Despite the enormous potential and benefits of 3DP in surgery, implementing the technology

into regular clinical use for developing CMIs entails several challenges (Ramola, et al., 2019;

Willemsen, et al., 2019). For example, there have been concerns over the lack of comprehen-

sive guidelines regarding the integration of medical device regulations (MDR) into the devel-

opment workflow of CMIs (Aima, et al., 2019), the lack of detailed cost analysis that will

confirm that CMIs are cost-effective (Ramola, et al., 2019), and the difficulties in establishing

efficient collaboration between multidisciplinary fields (Willemsen, et al., 2019).

Fixsen et al. (2005) define implementation as ‘a set of specific activities designed to put into

practice’ something new. However, implementing an innovation in a health care system is

INTRODUCTION

3

considered difficult and requires extensive work. Nilsen (2010) describes health care as a com-

plex organization with great variation in terms of structure and political governance. A large

number of individuals and professionals with different culture and expertise work together

which can create certain contradictions when new technologies are introduced. To be able to

tackle the implementation challenges of 3DP into surgical practice for the development of

PSIMs, requires the support and collaboration of the involved stakeholders in the implementa-

tion process such as engineers, physicians, government administrators, hospital management,

and legal representatives (Willemsen, et al., 2019). A major factor in gaining staff support is

the need to prepare them to be able to meet the challenges of 3DP technology. Laura Dam-

schroder (2018), an international leader in advancing the science of implementation, supports

that physicians do not get the support they need to implement new practices. The random con-

trol trials (RCT) in healthcare journals that test the safety and the effectiveness of an interven-

tion, provide only information on whether the intervention works or not, rather than clarifying

what works, where and why. May (2013) highlights also that scientific evidence are not enough

to promote change and complements that implementation research is at its core a social phe-

nomenon and therefore knowledge from social science is required to understand how to apply

evidence in daily practice. It is exactly these kinds of perspectives we need to understand in

order to be able to build implementation strategies that will support physicians (University of

Calgary, 2018). Rogers (1995) underlines that the nature of a social system in which clinicians

are members should be considered when implementing an innovation. Therefore, it is requisite

to understand how to adapt change programs differently within different settings. Understand-

ing the factors that affecting adoption and implementation will help predict potential adoption

patterns of the individual and hence develop implementation strategies that would be suitable

for different settings.

Given that conventional implants have prevailed for centuries and that 3D printed implants

encourages a different, more collaborative relationship between different stakeholders, then it

would be irrational to assume that such a significant shift in clinical practice will occur natu-

rally in a hospital environment. Critical to the value and logic of the research in this study is to

understand the type of support required to prepare health care staff for the adaptation to the

technology demands. Gaining an advance understanding of the various issues associated with

implementing 3D printed implants and preparing the health care staff to cope with the chal-

lenges, is a first step towards the successful implementation of the 3D printed PSIMs in

healthcare.

1.3 Research aim and questions This study aims to identify factors that influence implementation of 3D printing in surgery for

the development of custom-made implants and thereby create the preliminary conditions for

succeeding even better with future adoption. From this, the resources of health care can be

utilized in a more sustainable way to meet the future care needs. Therefore, the research is

based on the following questions:

1. What are the main driving forces and barriers for the delivery of custom-made im-

plants?

INTRODUCTION

4

2. What are staff stakeholder views and practices regarding the implementation of 3DP in

surgery for the development of custom-made implants?

3. How may this knowledge be utilized to prepare healthcare practitioners for future in-

troduction of custom-made implants in surgery?

1.4 Delimitations This study focuses on high-risk medical devices within orthopedic (i.e. spine, hip and knee

joint), cranial and maxillofacial (i.e. scull, mandibula and orbit) surgery. High-risk medical

devices are at the center of this research because ‘they constitute the highest potential risks for

the patient and are often the most expensive for the payer’ (Vinck, et al., 2018). In this report,

the term implant is defined as a non-electronic medical device that is placed permanently,

through surgery, into the patient’s body. Ergo, biomedical implants, prosthetics, patient spe-

cific instruments (PSI), anatomical models, and active medical devices such as peacemakers

are excluded from the scope of this study.

LITERATURE REVIEW

5

Chapter 2. Literature review This chapter provides a brief literature review on high risk 3D printed patient specific implant

and the factors affecting their implementation in orthopedic and maxillofacial surgery. The

chapter initiates with simplified definitions of AM and custom-made implants followed by a

brief description of their applications and benefits in the two medical disciplines: orthopedic

and craniomaxillofacial surgery. Major impediments and drivers are also provided been in-

cluded. A summary of the main literature findings is offered at the end of this section.

2.1 Driving forces of custom-made medical device industry Additive manufacturing (AM) also referred to as three-dimensional printing (3DP), rapid pro-

totyping (RP) and solid freeform fabrication (SFF) (Matias, et al., 2017), is a manufacturing

process that creates a three-dimensional object from a 3D digital model by adding layers of

raw material forming a 3D volumetric structure (Ghai, et al., 2018). In contrast to traditional

manufacturing methods such as cutting, drilling, or machining and computer numerical control

(CNC) that subtract material, 3DP creates object without the need of an initial raw material.

Basically, it creates something out of nothing or to be more precise: 3DP creates objects out of

digital data.

3DP technology has been characterized as one of the most disruptive innovations changing the

way healthcare institutions provide care services (Aima, et al., 2019). The concept of disruptive

innovation (DI) was coined by Clayton Christensen, and is defined as a process by which an

innovation (product or service) that is regarded at the beginning of its life cycle as inferior

appealing to the needs of an untapped customer segment, becomes over time, through incre-

mental improvements, more and more appealing to mainstream customers (Christensen, et al.,

2015). Disruption occurs when the innovation offers sufficient quality that fulfils the standards

of the mainstream customers (Christensen, et al., 2015; Hwang & Christensen, 2008). The def-

inition of Christensen’s indicates that the main drivers of a disruptive innovation is partly the

technological advancements and partly the innovation gap in the market which consists of new

or existing customers whose needs are not met yet. Reflecting over the trajectory of AM based

on Christensen’s definition, it becomes apparent that AM at the beginning of its life cycle, was

regarded limited due to the low quality of 3D printed objects and the high costs per unit in

comparison to conventional production. From 1990 to 2000, AM technology was involved in

terms of quality and cost; and, for the first time, it became available to the vast majority having

a decentralized effect in the manufacturing industry (Smith, 2015). Since then, the technology

has penetrated, among other industries, the medical device industry and in combination with

digitalization enabled the production of custom-made implants on site.

The marketing environment of medical device industry consists of external forces that directly

or indirectly affect the delivery of PSIMs in the mainstream market. According to Sally et al.

(2016, p. 74) there are environmental forces, also known as ‘macro forces’ which affect all

organizations operating in a specific market and are classified into six categories: political,

legal, regulatory, societal, technological and economic. To understand the implementation fac-

tors of PSIMs it is necessary first to scrutinize these forces and investigate whether they have

a driving or restraining effect towards the delivery of custom-made implants (CMI) in the mar-

ket. Usually, the analysis of a marketing environment is conducted in two different socio-

LITERATURE REVIEW

6

ecological levels: macro and micro level. In the field of implementation science however, the

factors that affect implementation are analysed at three socio-ecological levels: macro, meso

and micro. This research will follow the latter approach wherein the macro forces are the en-

vironmental forces affecting all organizations operating in the market of medical devices in-

dustry; the meso forces are elements affecting the hospitals’ internal environment and micro

forces are factors that affect the individuals involved in the implementation process of PSIMs.

The anticipation here is throughout the course of this research explore how the macro forces

affect hospitals (meso level) and the individual (micro level) and hence the delivery of PSIMs

As it was mentioned in the introduction chapter, two major market applications of PSIMs are

within orthopedic and cranio-maxillofacial implants (Medgadget, 2019; Tiwari, 2019). In cra-

nial and maxillofacial (CMF) implants, the untapped customer segment are patients with com-

plex skeletal defects in the face, for example post-traumatic skeletal deformities and congenital

disorders which affect patient’s primary functions i.e. vision, breathing, speech; and physical

appearance (Matias, et al., 2017). In orthopedics, the unmet needs include spinal pathologies,

hip and knee fractures due to trauma cases or osteoporosis, osteoarthritis and musculoskeletal

diseases (Javaid & Haleem, 2018). 20-25% of these operations lead to re-surgery while 10-

15% of them lead to infection (Anderkrans & Forssel, 2020). In both CMF and orthopedics the

cost of corrective or bone reconstructive surgery is high and often is not covered by the insurers

(Anderkrans & Forssel, 2020). The hospitals must cover the expenses by themselves. The re-

ported benefits of PSIMs are good mechanical stability, precise fit, low rates of infection and

complications (Anderkrans & Forssel, 2020), enhanced accuracy and increased patient satis-

faction (Alasseri & Alasraj, 2020).

It seems that the major factors in the market promoting the adoption of PSIMs are the techno-

logical advancement in digitalization i.e. medical imaging, CAD software, 3D techniques; the

increase in the geriatric population; the growing number of brain cancer, trauma and fracture

cases and the demand for personalized patient care (Transparency Market Research, 2020).

2.2 Restraining forces of custom-made medical device industry Reviewing 14 scientific articles published the last five years within orthopaedic and cranio-

maxillofacial surgical disciplines showed that the main challenge related to in-house PSIMs

lies in how to integrate the development process into a hospital. There are regulatory, eco-

nomic, organizational – which falls under the category of societal forces – and technological

factors that complicate the development process and have a restricting effect on the delivery of

PSIMs. Before reviewing these factors, it is noteworthy to outline the main steps in develop-

ment process of PSIMs followed in a clinical setting. This will help the reader gain a better

understanding of the implementation issues since most of the challenges presented in the fol-

lowing sections are closely related to the implementation of PSIM-workflow. Appendix A pro-

vides a summary of how the journal articles were reviewed and the themes generated during

their study.

2.2.1 The development process of custom-made implants

Before reviewing the implementation barriers of 3DP for the development of PSIMs it was

considered noteworthy to outline the main steps in development process of PSIMs in a clinical

LITERATURE REVIEW

7

setting. This will help the reader gain a better understanding of the implementation issues since

most of the challenges presented in the following sections are closely related to the integration

of PSIM-workflow. The fabrication of PSIMs can be described in six stages: image acquisition;

image processing; implant design and evaluation; STL model generation and control; additive

manufacturing and post-processing. Figure 1 illustrates the main steps in the development pro-

cess of an additive manufactured PSIM.

I. Image acquisition

In medical practice, the process of printing a PSIM initiates with image acquisition requested

by the medical doctor. Primary images are usually being obtained by a radiologist using a Mul-

tidetector Computed Tomography (MDCT), Computed Tomography (CT) or Magnetic Reso-

nance Imaging (MRI) (Ganguli, et al., 2018). Once the images are acquired, they are recon-

structed in the Data Imaging and Communications in Medicine (DICOM) file format which is

a standard data format to store, anonymize and transmit medical images (Surovas, 2019; Wong,

2016). Alessandro et al. (2016) highlight the importance of acquiring a high-resolution digital

imaging because it affects the accuracy of the 3D printed object. Low-resolution images ‘can

result in discrepancy between the generated printed model and actual anatomy’ (Marro, et al.,

2016). Therefore, it is recommended before proceeding to the next step of the development

process to inspect the DICOM-file for possible errors in the parameters (i.e. slice thickness,

gantry angle, the used protocol) utilized during image acquisition (Surovas, 2019).

II. Image processing

Image processing includes bone tissue segmentation, mesh generation and virtual production

of the implant model usually conducted by a radiologist (Chen & Gariel, 2016). During this

stage, the data from the DICOM file is extracted and processed in a 3D modelling software to

generate a 3D anatomical patient specific model. Initially, bone tissue segmentation is per-

formed to isolate the anatomical region(s) of interest (ROI) withing the data set. Once the ROI

is isolated, a ‘surface mesh’ of that area is extracted and a surface model is generated which is

converted into a seamless 3D anatomic model (Marro, et al., 2016). The anatomic model is

used afterwards to shape the implant prior to surgery and to plan the surgical operation (surgical

planning), refer to Figure 1.

It has been reported that the final 3D model may deviate from the original DICOM data after

segmentation and mesh generation (George, et al., 2017; Huotilainen, et al., 2013; Marro, et

al., 2016). This is because there are different segmentation methods for MR and CT images,

each with its own image related drawbacks (George, et al., 2017; van Eijnatten, et al., 2018).

The selection of segmentation methods and ‘the way various image related problems are han-

dled is a matter of anatomy knowledge and working experience’ (Surovas, 2019). To ensure

and maintain an accurate anatomical representation of the patient’s bone tissue, the ROI from

the processed data is compared with the original unprocessed DICOM data at every step of the

image process (George, et al., 2017; Marro, et al., 2016).

At this stage, a technician engages in the process considering the selection of available additive

manufacturing techniques and other factors necessary to be taken into account, such as how

the product should be oriented, whether it needs any support during manufacturing or whether

LITERATURE REVIEW

8

it has very thin sections (van Eijnatten, et al., 2018). Answering these questions requires expe-

rience.

III. Implant design and evaluation

The design phase is a collaboration between the technician and the medical doctor. Based on

the generated anatomical model, the implant is designed in accordance with the surgeon’s in-

structions by reconstructing the ROI wherein the fracture is located. For example, in cranial

and maxillofacial surgery the most commonly design technique for fracture reconstruction is

mirroring the non-defect side to the injured side (Ghai, et al., 2018). Then this mirrored image

can be used as a template to generate the implant. It is worth mentioning that simultaneously

patient specific instruments (PSI) are also designed during this stage. PSIs are tools that meant

to accommodate the position and alignment of the implant. PSIs are not in the scope of this

research and therefore they are not going to be analyzed further.

After the design process, the implant undergoes evaluation by virtually testing the implant

model. This may include Finite Element Analysis (FEA) and biomechanical compression tests

to ensure the mechanical sustainability of the implant (Willemsen, et al., 2019). If the virtual

implant does not pass the safety tests, then it must be redesigned and re-evaluated (Figure 1).

IV. STL model generation and control

After evaluation, the CAD data that carry the virtual implant-model are converted to the Stand-

ard Tessellation Language (STL) file which is recognized by the printer. Then the STL file is

transferred to 3D printing machines (Ganguli, et al., 2018). However, during this stage, various

errors can occur and therefore before 3D printing the implant, the STL file is scanned for errors.

These errors may have occurred either in the creation of the CAD drawing or in the conversion

of CAD data into STL file (George, et al., 2017; Huotilainen, et al., 2013). Once the file is error

free, the STL model is sliced into thin two-dimensional (2D) sections and sent to the 3D printer

(Zuhao, et al., 2018). This stage is conducted by the technician.

V. Additive Manufacturing

The 3D printer reconstitutes each digital 2D slice by adding material to them creating 3D sur-

faces. Each time new material is being added to the surface of existing material creating even-

tually a compact 3D model (Burnard, et al., 2020). The construction process is fully automated

and the production time depends on the size and complexity of the object as well as the additive

manufacturing method such as stereolithography (SLA), polyjet modelling (PM), selective la-

ser sintering (SLS), binder jet technique, and fused deposition modelling (FDM) (Matias, et

al., 2017).

VI. Post-processing

Once the 3D printed implant is produced, it is subjected into a series of post processing such

as polishing and sterilization (Zuhao, et al., 2018). This is a critical step because it is performed

manually and must be done with great care so that the accuracy of the object is not affected.

The final step involves removing any remaining materials and parts that have served as support

during the construction process, but which should not be included in the final product. Then

special measures may need to be taken, for example, the objects are sometimes built with cav-

ities and if they are filled with unprocessed building materials they must be emptied. Then, the

LITERATURE REVIEW

9

implant undergoes sterilization via dry heat, chemical substances or radiation (Willemsen, et

al., 2019). Lastly, the implant is subjected once more to another quality control to check for

eventual damages or alteration that may have occurred due to decontamination before it trans-

fers to the operating theatre (Zuhao, et al., 2018).

Figure 1: A summary of the clinical workflow of PSIMs from image acquisition to post-processing produced implant.

In the next section we are going to explore how regulatory impediments and economic, organ-

izational and technological factors acting at macro level affect the implementation of PSIMs

development process into hospitals.

2.2.2 Medical Device Regulation

One of the main barriers for the development and implementation of disruptive innovation in

healthcare is the inertia of regulations (Christensen, et al., 2000; Christensen, et al., 2017). A

custom-made 3D printed implant is a medical device and therefore falls under the European

Medical Device Directive 93/42/EEC (MDD) which was scheduled to be replaced by the Eu-

ropean Medical Device Regulation EU/2017/45 (MDR) on May 26th 2020 but due to the out-

break of COVID-19 the deadline of transition period has extended for another year (European

Commission, 2020; Wildi & Sieber, 2020).

MDR makes a distinction between custom-made and mass-produced medical devices. Accord-

ing to paragraph 3, article 2 of the MDR, a custom-made medical device is legally defined as

any device that is created from scratch with the written prescription of ‘any person authorized

by national law,…and is intended for the sole use of a particular patient exclusively to meet

their individual conditions and needs’. However, medical devices which ‘need to be adapted to

meet the specific requirements … and devices which are mass-produced by means of industrial

manufacturing processes … shall not be considered to be custom-made devices’ (European

Parliament, Council of the European Union, 2017). The above definitions make a distinction

between three types of medical devices: custom-made, customized and standard medical de-

vices. Custom-made MDs cannot be mass-produced while customized MDs together with the

LITERATURE REVIEW

10

standard MDs are considered mass-produced MDs and are not belong to the category of cus-

tom-made MDs. The distinction between custom-made and mass-produced MDs is an im-

portant one because different legislations are applied to each group. For example, the regula-

tory impediments for custom-made MD are low, namely they do not require CE-marking nor

a prior conformity assessment by a notified body nor a Unique Device Identification system

(UDI) to be implemented (Aima, et al., 2019). Furthermore, they ‘may only be used in the

hospital in which they were designed and manufactured’ (Pajot, et al., 2019). They must, nev-

ertheless, depending on their classification, meet the requirements in terms of safety and per-

formance in the essential Annex I. Such requirements involve risk management, analysis and

assessment, performance evaluation, vigilance and traceability; all of them provided in the

form of a technical file (Pajot, et al., 2019).

The classification of MDs depends on how much impact the use of them can have on the human

body and on the hazardous situations arising during their life cycle. Ranging from low risk to

high, MDs are segmented into four classes: Class I, IIa, IIb and III. Since the scope of this study

focuses on high risk 3D printed custom-made orthopaedic and cranio-maxillofacial implants

then only MDs of class III are considered relevant. According to annex 9 of the European

Directive 93/42/EEC, high-risk MDs are defined as surgical invasive MDs for immanent use,

that affect central nervous and cardiovascular system. Examples of high-risk implants are hip,

joint, shoulder, spinal cranial implant etc.

The MDR also encompasses legislations regarding 3D printing of MDs in health institutions

and any health care provider such as private practitioners. Health care institutions ‘have the

possibility of manufacturing, modifying and using’ in-house 3D printed MDs without having

to fulfil the same requirements as an industrial manufacturer, except only the requirements

regarding ‘the general safety and performance of MDs in Annex I’ (Vinck, et al., 2018). How-

ever, in order for this exception to apply, the in-house production must not be ‘on industrial

scale’, namely the MDs produced by the hospital ‘cannot be transferred to another legal entity,

but also that the volume and process of production is not routine-based’ (Vinck, et al., 2018).

Furthermore, the hospital must justify the use of custom-made approach to meet the needs of a

specific targeted patient group while there are equivalent treatment methods available (Vinck,

et al., 2018).

Regulatory impediments

Before MDR was reformed the EU regulations process for medical devices varied between

countries and the EU Medical Device system was criticized for the inability to collect data and

monitor the trade of medical devices (Vasiljeva, et al., 2020). The new regulation of MDs is

aiming to increase patient safety, data transparency and bring safer and more efficient equip-

ment to the market (Prineetha, et al., 2020). In contrast to MDD, the legislations in MDR are

not just guidelines or recommendation that can be tailored to national laws by each EU member

states, rather they have a binding force which must be obeyed. Consequently, this regulatory

homogeneity reduces the risk for interpretation discrepancies in the of MDR creating ‘a single

market, where the trade barriers of medical devices between EU countries are lifted’ (Vasiljeva,

et al., 2020). Theoretically, reduced regulatory heterogeneity will increase the number of

LITERATURE REVIEW

11

exporting companies and the diversity of MD services across EU-market (Dahlberg, 2015; Kox

& Lejour, 2005).

In practice however, guidance or strategy on how to implement the MDR remains uncertain.

Martinez‐Marquez et al. (2020) support that this is because ‘long‐term product quality and

performance standards for PSIMs are not yet established’. This leaves medical regulatory bod-

ies confronted with the challenge of updating product safety standards to ensure long‐term

patient safety and secure product performance. Martinez‐Marquez et al. (2020) argues that the

lack of product quality and performance leads to the introduction of defective PSIMs into the

market jeopardizing patient safety. Vasiljeva et al. (2020) complement that the regulatory un-

certainty is also related to the fact that ‘there are either enough notified bodies to perform a

conformity assessment’ nor established approval and assessment procedures. The Swedish

Medical Association (SMA, Sveriges läkarförbud) underlines that despite a long transition pe-

riod neither the European commission nor Sweden is ready for the change that MDR brings in

the medical device industry (Stensmyren, et al., 2019). Medical device manufacturers warn of

certain risks such as withdrawal of existing devices and a decrease in new medical device in-

novation since their main focus will be on how to make existing devices be compliant with the

new regulations (Vasiljeva, et al., 2020).

The changes in the regulations of MDs also affect countries that have trade relations with EU

such as Switzerland. Switzerland is not an EU or EEA member; however, the country is al-

lowed to access part of the EU’s single market due to the Mutual Recognition Agreement

(MRA) which ensures that Swiss medical device manufacturers have the same access to the

EU market as their EU or EEA competitors (Rehmann & Bernert, 2020). With the MDR com-

ing into force the MRA becomes invalid and consequently the Swiss medical device manufac-

turers will not have the permission to export products to the EU single market unless they fulfil

the requirements of a third country in accordance with the new EU-MDR which require ‘CE

certification issued by a Notified Body within the EU, an authorized representative in the EU

and fulfilment of the obligations under Article 11 MDR’ (Rehmann & Bernert, 2020). This

creates higher administrative barriers to export to EU-market in terms of cost; the required re-

organization is estimated to reach a cost of one billion Swiss francs for all Swiss MedTech

companies (Rehmann & Bernert, 2020). For some manufacturers this means a delayed market

entry up to two years. Others estimate that ‘the re-certification will only be worthwhile for

devices with well performance in the market’(Rehmann and Bernert 2020). To ensure that

Switzerland continues to be regarded as an equivalent trading partner within EU market, the

country will have to not only adapt its national laws to the requirements of MDR but also

update the framework agreement EU-Switzerland (Di Marco & Méance, 2019).

At a hospital level, the limited MDR certification capacity, absence of a comprehensive MDR

implementation guide and withdrawal of manufacturing professionals may lead to cancelled

treatments, growing care queues and restricted access to medical devices including PSIMs.

Especially for the health care institutions that are interested in becoming their own manufac-

turers, the main concern is how to operationalize the requirements of MDR into the develop-

ment workflow of custom-made 3D printed MDs. There are few studies that discuss in detail

on how to practically navigate the regulatory requirements tailored to the development of

LITERATURE REVIEW

12

PSIMs. As a result, health care practitioners are hesitant in using 3D printing (Aima, et al.,

2019). Zuhao et al. (2018) report that the regulatory implementation framework for 3D printing

medical applications including implants is lacking. Aimar et al. (2019) studying the latest ap-

plications in terms of 3D printed metal implants in orthopaedics end up in the same conclusion

and complement that the regulatory procedure is often unclear, bureaucratic and time-consum-

ing ‘making surgeons to opt more convenient medical solutions than the optimal ones’.

Koen Willemsen et al. (2019) describe in their article the legal challenges associated with the

development of custom-made 3D-printed implants to treat spinal instabilities. What makes

their research exceptional and worth of mentioning is that they provide detailed description on

how they operationalized the regulatory requirements into their workflow. The study takes

place at Medical Centre Utrecht, in Netherlands where two patients with severe destruction of

the spine are treated successfully by designing personalized implants for each patient using

computer-aided design and additive manufacturing. In both cases the authors describe the ex-

tensive quality control procedures and regulatory framework required to ensure safety and sus-

tainability of implants. The completion of the regulatory requirements took 6 months in the

first case while in the second case, due to the experience of the team acquired from the first

case, was completed within six weeks (Willemsen, et al., 2019). Despite the restrictive and

time-consuming procedures which included extensive mechanical tests, detailed documenta-

tion and repeated finite element analysis (FEA), the authors support that the regulatory proce-

dure improved the quality of their work, minimizing the risks and ensuring implant sustaina-

bility and patient safety (Willemsen, et al., 2019).

Another concern is the transfer restriction of MDs to another legal entity. This restriction pro-

hibits hospitals from sharing their resources through the formation of strategic alliances – for

example in a case of a joint venture investment (joint 3D Printing Lab) – to provide printing

services to other hospitals or care institutions, ‘unless one of them becomes a legal manufac-

turer’ (Vinck, et al., 2018, p. 64). This restriction may be considered a factor that slows down

the adoption and diffusion of 3DP since strategic alliances facilitate the exchange and dissem-

ination of knowledge between involved parties providing to the partners a faster entry into the

market (Schilling, 2017, p. 165). Table 1 provides a summary of this section. The “+” sign

indicates that MDR promotes change towards PSIMs while the “-” sign denotes the restraining

force of MDR to the adoption and implementation of PSIMs an implementation barrier.

Table 1: Regulatory impediments (-) and facilitators (+).

Facilitators Barriers

+ Regulatory homogeneity creates a single mar-

ket where the trade barrier between EU coun-

tries are lifted, and limits discrepancies in inter-

pretation of MDR.

- Shortage of notified bodies.

- Transfer restrictions of PSIMs to other legal entities.

+ Promotes and enhances patient safety. - Lack of established approval and assessment procedures

to bring the MD to the patient.

+ Allows health care institutions to produce in-

house PSIMs.

- Lack of guidelines on how to integrate MDR into the

workflow of PSIMs.

+ PSIMs have lower regulatory requirements;

no CE marking is required.

- Slows down innovation in medical devices due to in-

creased entry barriers.

LITERATURE REVIEW

13

2.2.3 Economic challenges

Financial issues are related to reimbursement policies and the cost-effectiveness of PSIMs. 3D

printed medical devices produced in-house are not yet reimbursed; currently ‘there are no spe-

cific rules for the reimbursement of 3D printed medical devices’, instead “they are reimbursed

as other devices that are fabricated in a traditional way” followed by an extra cost (Vinck, et

al., 2018, p. 127). Reimbursement for medical devices is not governed at the European level.

The member states can thus decide autonomously which medical devices are reimbursed by

their health insurance, and under what conditions. Vinck et al. (2018) support that lack of re-

imbursement does not constitute impediments to physicians from using the 3D printed devices;

consequently leading to ‘a large scale distribution of high-risk devices to the market but also

to limited accessibility of 3D printed MDs to patients with low income’. Absence of remuner-

ation may also imply the high bargaining power of medical device suppliers or manufacturers

since they are free to decide the price and cost of implants (Vinck, et al., 2018, p. 133). In

Europe the price of a CMF-PSIMs may vary from USD 5,165 to USD 10,130 depending on

the size and design complexity of implant (Anderkrans & Forssel, 2020).

Reimbursement decisions are determined by whether the innovation is more cost-effective than

existing alternatives. Hence, this leaves the question of whether the use of 3D-printed custom-

made implants are more cost-effective than standard ones. Vicks, et. al (2018) underline that

health institutions interested in becoming their own MD-manufacturers should consider

‘whether it will ever be cost efficient for a hospital to invest in 3D printing equipment’ since

MDR clearly indicates that in-house manufacturing is not allowed on an industrial scale and

therefore the hospital will not be able to produce large quantities.

Few data can be found regarding the cost-effectiveness of PSIMs. It is difficult to draw firm

conclusions regarding the cost-effectiveness of the technology in comparison to standard im-

plants by studying the outcomes of case study articles due to their lack of transparency as well

as the heterogeneity of results, methods and content (Ramola, et al., 2019; Tack, et al., 2016).

What seems to be consistent in the literature is that the technology requires a high initial capital,

and that the unit production is considered to be relatively low (Malik, et al., 2015). Martelli et

al. (2016) complement that a huge part of the cost for PSIMs comes from the equipment of

3DP techniques such as computer-aided design software, camera, or materials. A 2016 system-

atic reviewed of 227 studies on clinical and economic outcomes of 3DP in surgical application

noted that the overall cost of the surgical procedure was depended on the cost for printing and

scans (Tack, et al., 2016). Overall, the literature indicates the need for a proper analysis of the

technology’s cost effectiveness (Boyajian, et al., 2019; Ramola, et al., 2019). Table 2 provides

a summary of what was discussed in section 2.2.3.

LITERATURE REVIEW

14

Table 2: Financial barriers.

Barriers

- Inconclusive statement regarding the cost-effectiveness of PSIMs due to high heterogeneity of clinical stud-

ies and lack of transparency of their methods

- Low cost-effectiveness for hospitals due to limited manufacturing scale.

- Suppliers have higher bargaining power

- PSIMs require high initial capital

- Lack of reimbursement system for 3D printed patient specific solutions

2.2.4 Organizational challenges

Organizational challenges are related to ‘workflow changes in the hospital and competency

changes for personnel’ (Jensen, et al., 2019). Christensen supports that most innovations that

has been implemented in healthcare are sustaining innovations rather than disruptive

(Christensen, et al., 2017) and therefore very little is known on how to develop DIs and how to

establish them into existing business models. The author explain that DI is unpredictable in

nature and the fact that it requires change in the business model of a firm which in turn means

cannibalization of existing organizational structures and product portfolios, threatens the status

quo of established market stakeholders and powerful institutional forces. Hence the introduc-

tion of it will be encountered with resistance (Christensen, et al., 2000). The EXPH-group (Ex-

pert Panel on effective ways of investing in health) conducted a study on implementation im-

pediments of DIs in healthcare in Europe. The group uncovered that cultural hindrances, lack

of training and incentives, communication difficulties, improper business model, lack of reim-

bursement, conservative organizational models, lack of political support and evaluation tech-

niques were the main barriers for implementing DIs in healthcare (Barros, et al., 2016).

‘People is the major factor impeding the implementation of disruptive innovation in

healthcare’ – a statement that was noted by health care representatives and entrepreneurs from

Sweden, Netherlands and Switzerland in a seminar arranged by Forum for Health Policy on

March 2018 (Barkman & Forsberg, 2018). More specifically, resistance to change is the main

factor that makes implementation difficult. The resistance mechanisms usually are expressed

in various forms such as ‘avoidance of taking responsibility’, ‘reduced work’, ‘total indiffer-

ence of the management directives’, ‘increased amount of sick days’ or even ‘resignation’

(Nilsen, et al., 2019).

In a qualitative study investigating the attitudes of healthcare professionals (physicians, regis-

tered nurses and assistant nurses) towards the adoption of evidence-based practices at a Swe-

dish hospital, it was found that changes initiated from the top management, lack of management

support and lack of knowledge regarding the benefits of an innovation were discouraging em-

ployees engagement into the organizational change (Nilsen, et al., 2019). Especially for physi-

cians is the ‘increased workload in combination with reduced autonomy' that makes them re-

luctant to engage in quality improvements initiated by the management (Nilsen, et al., 2019).

Physicians do not support a top-down management initiative nor an innovation that does not

make a difference in their daily work (Cabitza, et al., 2018; Nilsen, et al., 2019).

LITERATURE REVIEW

15

In another case study, Cabitza et al. (2018) investigate the willingness of clinicians (orthope-

dists and radiologists, neurologists, cardiologists and odontologists etc.) to acquire the neces-

sary skills to create 3D printed objects. The study was conducted at the Orthopedic Institute

Galeazzi in Milan, one of the largest research hospital groups in Europe. The general results

showed that the preference of senior orthopaedists and traumatology clinicians was to delegate

the task of operating 3DP to other experts. The reasons to that were fear of the potential failure

due to lack of competence in the specific field and lack of time due to other demanding clinical

tasks that left no room for learning new skills. On the other hand, the group that were more

willing to acquire a ‘do-it-yourself’ attitude were the younger clinicians who expressed curios-

ity and excitement for technological novelties and felt that the new tech would improve their

holistic view of medical knowledge and practice (Cabitza, et al., 2018).

Martelli et al. (2016) in their systematic review searching for the advantages and disadvantages

of 3DP in orthopaedic and maxillofacial surgery, found out that the main advantages of 3DP

regarding PSIMs was the generation of precise implant tailored to patient’s anatomy. This con-

sequently increased the accuracy of the surgery. The main limitations were the time it required

for imaging and data processing during pre-surgical planning which makes PSIMs unsuitable

for urgent cases. Louvrier et al. (2017) clarifies that the pre-surgical planning was considered

time-consuming because it demanded the involvement of the surgeon to supervise the design

of the implant. Furthermore, developing implants was a collaboration between many stake-

holders and required skills in 3D software that most surgeons did not have (Martelli, et al.,

2016). As a consequence surgeons experienced ‘a fear of losing control over the decisions that

affected their patients’ (Martelli, et al., 2016) and hence they felt that their leadership was un-

dermined. Another issue is the ‘weak cooperation between doctor and engineer’ (Zuhao, et al.,

2018) and the conventional opinion that 3DP should be operated ‘not by the surgeons but…by

engineers, radiologists or others who have experience and knowledge in the technology’

(Västra Götalandsregionen, 2018). Table 3 is a synopsis of the reviewed organizational barri-

ers.

Table 3: Organizational barriers.

Barriers

- Time consuming pre-surgical planning

- Requires the collaboration between many stakeholder

- Requires skills that most surgeons do not have

- Resistance to change due to lack of time for personal development, communication difficulties

- Lack of management support

- Top-down management initiative is experienced problematic

2.2.5 Technological challenges

The development of PSIMs as described in a previous chapter seems to be a straight-forward

process. In practice, however, inaccuracy errors may occur during image acquisition or seg-

mentation, printing and post-processing. These errors may be related to the limitation of 3D

printing techniques. The three most common 3D printing techniques used in surgical applica-

tions are Fused Deposition Modeling (FDM), Selective Laser Sintering (SLS), and Stereo-

lithography (SLA) (Tong, et al., 2020). Each technology has its own limitations. For example,

LITERATURE REVIEW

16

SLA is adequate for use in the preoperative and intraoperative setting but is regarded expensive

and time consuming (Ramola, et al., 2019). FDM, on the other hand, although faster and inex-

pensive than SLA, should not be used intraoperatively due to low accuracy and presurgical

sterilization issues (Garg & Mehta, 2018). Finally, SLS allows the utilization of a wide range

of material; however, the final product requires extensive post-processing. Variations in the

accuracy of the 3D printing technology leads to the production of anatomical models that are

not a true representation of the actual object (Ramola, et al., 2019). Errors in the development

process indicate the need for standardization of quality management systems. Peel & Eggbeer

(2016) in their study on how to routinize the design process of maxillofacial PSIMs refer to the

necessity of a comprehensive design specification that quantifies product needs such as mate-

rial strength, surface finish, appropriate fit, etc. This will accelerate the workflow since the

designer will focus on the appropriate modelling activities mitigating failures and facilitating

routine (Peel & Eggbeer, 2016). Table 4 provides a summary of PSIMs technological chal-

lenges.

Table 4: A review of the technological challenges.

Barriers

- Risk for inaccuracy errors during development process of PSIMs

- Each 3D printing technique has its own limitations

- Lack of standardize procedure, quality management systems and comprehensive design specification

2.3 Summary of literature review findings The literature review indicates that there are several implementation factors at three different

socio-ecological levels: macro, meso and micro. At macrolevel, the lack of reimbursement and

regulatory framework for 3D printed patient specific solutions seems to be the major barriers

for the hospitals to invest in PSIMs. There are few articles investigating how to operationalize

MDR into the development process of PSIMs. The only available articles that provided details

on how to cope with the regulatory challenges regarding the design of PSIMs were only two;

the one was in orthopedics and the other was in patient specific instruments. The latter is not

in the scope of this study. Therefore, two areas that would be interested to investigate would

be on how hospitals that have adopted 3DP technology are coping with the remuneration and

regulatory challenges.

At organizational level, there are challenges in terms of communication among medical doctors

and engineers, management support, internal resistance, product workflow and availability of

resources. The development process of PSIMs involves the collaboration of several stakehold-

ers with different expertise in each stage of the product’s development stage such as knowledge

in material science, manufacturing and imaging techniques etc. The literature review revealed

that the majority of studies regarding 3DP implementation focus more on the views of practi-

tioners rather than the views of, for instance, hospital managers responsible for the formulation

of implementation strategies, technicians involved in the development process of PSIMs,

MDR-experts, hospital administration and AM-experts. Interviewing key stakeholders will al-

low different perspectives of the same issue to emerge, leading to a better understanding of the

various implementation issues. It was also mentioned that the implementation of a PSIM-

workflow in a hospital setting would require changes in the organizational structure but more

information regarding this could not be found, indicating another area for further investigation.

LITERATURE REVIEW

17

At individual level, it seems that the reluctance of physicians to use PSIMs is associated with

the training and personal beliefs on the technology’s efficacy and cost-effectiveness.

Lastly, little research has been done regarding the implementation of 3D printed patient specific

implants in a hospital setting. The existing studies are focusing more on the clinical challenges

rather than analyzing and interpreting the phenomenon based on philosophical models and

frameworks related to innovation management, classical and implementation theories. Conse-

quently, this leads to the question of what available theoretical models and frameworks exist

that would be suitable for identifying implementation factors and indicate coping strategies that

will accommodate the integration of PSIMs into clinicians’ daily work.

THEORETICAL FRAMEWORK

18

Chapter 3. Theoretical Framework In the previous chapter the literature review indicated that the translation of 3D Printed PSIMs

into clinical practice has been a challenge for the health sector due to various challenges at

micro (individual), macro (system, society) and meso (organizational) level. Therefore, the

next step of this research is to specify potential conceptual frameworks and theories that iden-

tify factors facilitating and hindering the implementation of PSIMs and explain the correlation

among these factors in order to gain a better understanding on the mechanisms of change (im-

plementation strategies). This chapter provides an introduction in the field of Implementation

Science followed by an outline of the most widely used theoretical frameworks and a discus-

sion of the rationale for the selection of theoretical frameworks ending with a synopsis of the

chosen frameworks and theories underlining and guiding the collection and interpretation of

data in this research.

3.1 The field of Implementation Science Centuries of experience have proved that it takes years to integrate clinical innovations, also

called evidence-based practices (EBP), into practice. Although that there are various innova-

tions with evidence of effectiveness, fewer than 50% of them are incorporated into routine

health care practice (Bauer, et al., 2015). Previous studies refer to the existence of a knowledge-

practice gap namely a long gap in between the discovery of clinical innovations and the imple-

mentation of them into daily clinical usage (Bauer & Kirchner, 2020; Brekke, et al., 2009;

Morris, et al., 2011). To bridge this research-practice gap in healthcare, the field of Implemen-

tation Science (IS) was born. IS is a relatively new field (Damschroder, 2020) and has been

defined as

The scientific study of methods to promote the systematic uptake of research findings and other

evidence-based practices into routine practice, and, hence, to improve the quality and effectiveness

of health services. (Eccles & Mittman, 2006)

The National Institutes of Health (NIH), (2020), provides a similar definition underlining that

the aim of IS is to promote ‘the adoption and integration’ of EBPs and their scale up at a

populational level. The above definitions denote that the aim of SI is two-folded: To contribute

with knowledge in the development of implementation by forming, with practical recommen-

dations, how to apply EBPs and to produce knowledge that will improve the health of popula-

tions. The body of implementation knowledge comprises a plethora of frameworks, models

and theories which rely to the reasoning that successful implementation derives from the com-

bination of innovation coupled with context and implementation strategy. Per Nilsen (2015)

provides a clarifying taxonomy (Figure 2) of the various theories, models and frameworks used

in IS that classifies them in three categories:

1. Process models which are utilized to translate research into practice.

2. Theoretical approaches which specify or explain the factors that influence implementation

outcomes. This category includes three subcategories: determinant frameworks, classic the-

ories and implementation theories.

3. Evaluation frameworks which are used to evaluate implementation.


19

Figure 2: Taxonomy of theoretical models and frameworks in IS. The picture is adapted from Nilsen P 2015; 10(1):13.

Since the purpose of this research is to identify which factors are acting as barriers and facili-

tators in the implementation of 3DP PSIMs, the category that is perceived as relevant to this

study is the second one namely, theoretical approaches that are describing what key compo-

nents are influencing implementation.

Assessing and selecting a framework for an implementation study is important but also dizzy-

ing due to the abundance and diversity of available theoretical frameworks and models for

implementation and diffusion analysis (Damschroder, 2020; Nilsen, 2015). To cope with this

challenge, researchers in implementation use various criteria for assessing the models. For in-

stance, Moullin et al. (2015) used in his research criteria related to comprehensiveness,

coherence, applicability and implementation stage. There are also online tools created by re-

searchers to guide the selection of implementation models and frameworks. These online

webtools provide additional assessment criteria such as construct flexibility, levels of the socio-

ecological framework, number of citations according to Google Scholar statistical data since

2016, field of origin (Rabin, et al., 2020) usability, applicability and testability (Birken, et al.,

2018). However, Damschroder, (2020) warns that the online resources ‘do not cover the full

range of theories but rather provide a starting point’. Table 5 provides a summary of the differ-

ent criteria gathered from two online webtools and Moullin’s and peers (2015) study.


20

Table 5: A review of the different criteria encountered in two online webtools and one scientific article on reviewing imple-

mentation frameworks.

Title Reference Criteria Description/measurement

A systematic re-

view of imple-

mentation frame-

works of innova-

tions in

healthcare and

resulting generic

implementation

framework

Moullin et al. 2015 Comprehensiveness Appliable to intervention or innovation

that has been or could be developed

Coherence Similar level of specificity to all con-

structs. Well-defined constructs. in-

clude core implementation concepts

Applicability Reliability, ease of use, ease of com-

munication, ability to explain out-

comes, and ability to predict effective-

ness of interventions

The type of the frame-

work

Descriptive, prescriptive, explanatory,

or predictive

Phases of implementation Exploration, preparation, implementa-

tion, and sustainment

Dissemination

and Implementa-

tion Models in

Health Research

and Practice

webtool

Tabak et al. 2012

Mitchell et al. 2010

http://www.dissemination-

implementation.org/

Construct flexibility Scale of 1 to 5 - the number 1 indicates

that constructs are broadly outlined

while the number 5 indicates that the

constructs are described in detailed.

There is a step by step guide on how to

apply the model.

Focus of the framework Implementation or Diffusion or both

Levels of the socio-eco-

logical framework

Individual

Organizational

System

Community Policy

Number of times cited

Field of origin

Previous applications

Theory, Model,

and Framework

Comparison and

Selection Tool

(T-CaST)

Birken et al. 2018

https://impsci.tracs.unc.edu/

tcast/

Usability

Step-by-step approach

Relevant constructs

Able to be understood, apply by non-

scientists

Applicability Addresses a relevant analytic level

(e.g., individual; organizational; com-

munity

Has been used in a relevant population

Generalizable to other disciplines

Can be used with any research methods

Testability Includes meaningful, valid explana-

tions of proposed relationships.

Acceptability Familiar to key stakeholders (e.g., re-

searchers, clinicians, funders).

Comes from a particular discipline

(e.g., education; health services; social

work).

http://www.dissemination-implementation.org/

http://www.dissemination-implementation.org/

https://impsci.tracs.unc.edu/tcast/

https://impsci.tracs.unc.edu/tcast/


21

The selection criteria for this research can be studied in Table 6. The potential implementation

framework should focus only on implementation of an innovation or intervention and since the

literature review indicated implementation challenges at different socio-ecological level then

the selected framework has to be multi-level determinant also. It is also a pre-requisite to have

well-defined constructs relevant to this research, has a high number of citations and been ap-

plied in healthcare.

Table 6: Criteria for selecting theoretical implementation framework.

Categories Object of

implementa-

tion

Construct

flexibility or

Coherence

Implementa-

tion (I) or

Diffusion (D)

Socio-Ecolog-

ical Levels

Nr of

Times

Cited

Field

of

origin

Previous

applications

Criteria Innovation/

intervention

Well-defined

constructs

Relevant to

the generated

data from the

literature re-

view

Only I for

frameworks and

models

Both I and D for

theories

Individual

Organizational

System

Community

Policy

>1000 Health

care pref-

erably

surgical

practice

Qualitative

studies

(i.e. Multi-

case study or

workshops)

Multiple

stakeholders

from various

research

sites

3.2 Implementation determinants frameworks and theories Determinant frameworks are defined by Nilsen (2015) as a structure or an outline, also called

a checklist which consists of various constructs that are associated with implementation out-

comes. Analyzing each construct will typically lead to a number of barriers and facilitators

which are regarded as uncorrelated factors affecting implementation. Therefore, the purpose of

determinant frameworks is mainly to describe a phenomenon by first highlighting the potential

influential factors related to the phenomenon and then classifying them into specific domains

providing in that way a multi-level implementation analysis such as the individual and organi-

zational level. Since the correlation of factors is not considered in the determinant frameworks

the main limitation of determinant frameworks is that they “do not provide explanations or

specify the mechanism of change” (Nilsen, 2015).

According to Nilsen (2015), the eight most commonly cited determinant frameworks in imple-

mentation science are PARIHS (Kitson, et al., 1998), Greenhalgh Diffusion of Innovations in

Service Organizations (Greenhalgh, et al., 2004), the framework of Grol et al. (2005), the

framework of Nutley et al. (2007), the framework of Cochrane et al. (2007), Ecological Frame-

work (Durlak & DuPre, 2008), Consolidated Framework for Implementation Research (CFIR)

(Damschroder, et al., 2009) and the framework of Gurses et al. (2010). Among them, only the

Conceptual Model, Ecological Framework and CFIR include the characteristics of the inter-

vention or innovation as a determinant. However, the Ecological framework focuses mainly on

behavioural changes and its main field of application is within promoting or preventing imple-

mentation programs (Durlak & DuPre, 2008) which is not consistent with the purpose of this

study.


22

Greenhalgh’s conceptual model focuses on “constructs related to diffusion and dissemination,

system antecedents for innovation, system readiness for innovation, implementation and rou-

tinization” while CFIR focuses only on implementation and routinization (Damschroder, et al.,

2009). Furthermore, CFIR is highly cited and provides a detailed construct definition as well

as a step by step online guide1 on how to conduct the implementation research. Table 7 give an

overview of the two frameworks.

Table 7: A comparative overview of CFIR and Greenhalgh’s conceptual model.

Framework/model Object of im-

plementation

Construct flexibility Implementation (I)

or Diffusion (D)

Socio-Ecologi-

cal Levels

Nr of

Times

Cited

Field of

origin

Greenhalgh’s

Conceptual model

Innovation

Well-defined con-

structs

Both I and D

Individual

Organizational

System

Community Pol-

icy

3 0182 Health ser-

vice re-

search

CFIR Intervention/

innovation

Well-defined con-

structs providing a

step by step guide

Only I Individual

Organizational

System

Community Pol-

icy

4 1933 Health ser-

vices

3.2.1 Consolidated Framework for Implementation Research

The Consolidated Framework for Implementation Research (CFIR) was the outcome of a sys-

tematic review on implementation theories that was initiated after the notion that scientific

evidence was not enough to promote organizational change. After its publication 2009 it is

regarded as a roadmap on implementation for both scientists and non-scientists. In fact, CFIR

has been cited over than 3000 times over placing it among ‘the most widely used frameworks’

(BMC Implementation Science, 2020). Damschroder (2009), the lead author of CFIR, supports

that the various factors affecting implementation of an intervention in a hospital setting can be

found by searching in five domains: the intervention characteristics, outer setting, inner setting,

the characteristics of involved individuals and the implementation process (Figure 3). Each

domain is composed by various constructs that affect the implementation of a specific inter-

vention in an organization. In total CFIR includes 39 different constructs as it is depicted in

Figure 4.

Domain 1: Intervention characteristics

The intervention characteristics domain relates to stakeholders' perceptions of the legitimacy

of the intervention. It includes the attributes of innovation presented by Rogers (relative ad-

vantage, complexity, trialability, compatibility and observability) and adds four extra factors

in Rogers theory. These are the quality and validity of the evidence supporting the intervention,

the source of intervention (whether the intervention is locally or externally developed), the

design quality and packaging as well as the cost included in the implementation of the inter-

vention.

1 Online CFRI guide: https://cfirguide.org/. 2 Source: https://scholar.google.com/citations?hl=en&user=8KQwEGcAAAAJ&view_op=list_works. 3 Source: https://scholar.google.com/citations?hl=en&user=-M-d-GYAAAAJ&view_op=list_works.


23

Figure 3: A simple illustration of the five domains included in CFIR. The figure is adapted from Zingg, (2017).

Domain 2: Outer setting

This domain focuses on the wider environment identifying factors which often affect imple-

mentation by changing the internal environment of the hospital through complex and dynamic

interactions (Bergmark, 2017). These external factors are difficult to be changed by the hospital

and are associated with the political, economic and social context surrounding the organization.

For example, regulations can be a factor that enables or disables innovation. Sometimes it

might be necessary to form new regulations in order to facilitate the introduction of competitive

technologies into the market (Fried, 2017). Implementation of innovation programs can be

challenging in highly regulated industries such as health care and more specifically in medical

device industry. Stern, (2017) supports that the entry of new medical device into the market is

strongly affected by the regulatory process which is characterized by uncertainty. This regula-

tory uncertainty is divided into ‘technological uncertainty’ and ‘content and format uncertainty’

(Stern, 2017). Technological uncertainty is related to the lack of technological understanding

of how the new product works and its consequences on the human body as well as knowledge

regarding the data required to confirm the effectiveness and safety of the product. The content

and formal uncertainty is associated with the absence of standard procedures and guidelines to

evaluate the product.

Domain 3: Inner setting

The internal factors are related to the structural, political and cultural context of the organiza-

tion (i.e. size of the organization, the level of staff turnover, collaboration, norms, values, im-

plementation climate).

Domain 4: Characteristics of individuals involved

This domain relates to the characteristic features of the individuals involved in the implemen-

tation of the intervention. This includes theoretical concepts such as motivation, learning style,

perceived self-efficacy, and identification with the organization.

Domain 5: Process

This domain provides the factors that need to be assessed to accomplish an active change in

established processes at both individual and organizational level. It consists of four main


24

subdomains: planning, engaging, executing, as well as reflecting and evaluating. Each subdo-

main contains a set of determinants which assess implementation process based on the exist-

ence of an implementation plan, whether the right key stakeholders (i.e. opinion leaders, cham-

pions and change agents) are engaged in the implementation of innovation and whether ade-

quate strategies for planning, executing and receiving feedback have been adopted (CFIR

Research Team-Center for Clinical Management Research, 2020).

Figure 4: The five main domains of CFIR and their respective constructs.

CFIR has been used to guid data collection and analysis to find out which constructs was re-

sponsible for the variations of outcomes in a management program implementation

(Damschroder & Lowery, 2013; Fletcher, et al., 2011). Alexis et al. (2016), after reviewing the

application of CFIR, recommend how to comprehensively operationalize CFIR in a research

project. In their list of recommendations they have included that the researcher should inform

the stage of implementation that CFIR is applied on e.g. prior-, during- or post-implementation,

explain the selection and use of each construct, and integrate CFIR into the research process

e.g. data collection. Valéry et al. (2020) complements that ‘CFIR should be adapted to context

and research needs’. CFIR accommodates gaining an understanding of which factors contribute

towards successful implementation and which ones reduce the effectiveness of implementation

efforts. The framework, however, neither explains how these factors correlate with each other

– they may relate differently depending on the context in which the framework is applied – nor

explains how change takes place.

3.2.2 Rogers’ Diffusion of Innovation Theory

CFIR is built on various disciplines such as organizational theories, psychology, and sociology.

One classic theory integrated in CFIR is Rogers diffusion of innovation theory (DOI) which

has been widely applied in implementation research for studying how innovations are taken up

and disseminated in organizations (Marak, et al., 2018; Nielsen, (red.) 2014). Although the

conventional thinking classifies DOI as a theory focusing on diffusion it is relevant in this study

partly because it is a part of CFIR and partly because it highlights the factors of adoption which

is a prerequisite step to achieve implementation. And while CFIR will be used to identify the

adoption factors, Rogers theory will provide the correlation among these factors revealing po-

tential coping mechanisms. Rogers supports that implementation cannot be achieved without

adoption first. One of the challenging aspects of implementing an innovation into a social sys-

tem is to persuade individuals to get involve in the change that the new technology brings into

the social system. Research shows that implementation is fostered by initially focusing on users


25

who will be easier to change so that they can in turn affect their colleagues (Nutley, et al., 2007,

p. 23).

According to Rogers (1995), the process an individual follows to decide on an innovation com-

prises five steps which are knowledge, persuasion, decision, implementation and confirmation

(Figure 5). First the individual becomes aware of the innovation’s existence creating in this

way an understanding of the innovation’s functions. Once the individual gains an understand-

ing of how the innovation works, then (s)he acquires a favourable or an unfavourable attitude

towards the innovation leading her to decide on whether to adopt or reject the innovation. Im-

plementation takes place when the individual deploys the innovation while confirmation is the

process where the individual seeks information that will verify whether the decision on the

innovation was correct or incorrect (Rogers, 1995, p. 181). How the individual decides to adopt

or not an innovation, depends on individual’s characteristics, communication channels, the per-

ceived attributes of innovation, and social system (Rogers, 1995, p. 207).

Figure 5: The five stages of innovation decision process.

Individual characteristics

Rogers segments the potential adopters based on their innovativeness into five groups: innova-

tors, early adopter, early majority, late majority and laggards. Each adoptive group has a spe-

cific phycological profile that reveals their general behaviour as consumers explaining why

some groups accept a new idea while others reject it.

The innovators are risk takers and obsessed with technological properties, actively looking to

adopt new ideas and (Rogers, 1995, p. 263). The early adopters are visionaries and enjoying

embracing emerging technologies to align them to a strategic opportunity (Rogers, 1995, p.

264). They do not require the information to convince them to do the change and are willing to

take risks to achieve a competitive advantage. The early majority, however, are pragmatists

and will require a little bit of convincing. They are risk averse and need evidence that the in-

novation works before they are willing to start adopting it (Rogers, 1995, pp. 264-265). There-

fore, providing references and success stories can be effective, particularly in getting this group

on board.

The late majority are much more demanding and sceptical (Rogers, 1995, p. 265). They prefer

to wait for the technology to become well established within the market before adopting it.

Providing them with numbers and statistics showing them how many people have adopted this

innovation can bring this group on board. Last, are the laggards. The laggards are the hardest

group to convince to change. They are very conservative and not willing to adopt the technol-

ogy until it is a necessity (Rogers, 1995, pp. 265-266).

Communication channels

‘A communication channel is the means by which a message gets from the source to the re-

ceiver’ (Rogers, 1995, p. 18). Each stage of the innovation decision process requires different

communication channels. The inappropriate use of communication channel will lead to a


26

delayed adoption (Rogers, 1995, p. 195). Overall, communication channels are segmented into

interpersonal and mass media (Rogers, 1995, p. 194). While mass media channels are a good

means to reach a large audience rapidly creating awareness and knowledge, interpersonal chan-

nels are important to persuade an individual to adopt an innovation. The more complex the

technology is perceived the more interpersonal contact it requires (Rogers, 1995, p. 207). Usu-

ally, the first adopters are informed about the innovation through mass media, while late

adopters require interpersonal communication (Rogers, 1995, p. 197).

Attributes of innovation

Creating rapidly awareness about the innovation is not enough to lead to adoption of innova-

tion. To speed up the adoption rate requires to shorten the time it takes to decide at the decision

stage (Rogers, 1995, p. 206). A factor that speeds up the adoption rate is the characteristics of

an innovation which are relative advantage, complexity, trialability, compatibility, observabil-

ity (Rogers, 1995, p. 206). Relative advantage is associated with the perception of the individ-

ual that the innovation is advantageous and better in relation to technologies or process it re-

places (Rogers, 1995, p. 212). Complexity relates to whether the innovation is perceived as too

complicated or difficult to use. If it does, it will face additional barriers to acceptance (Rogers,

1995, p. 242). Trialability measures how easily an innovation may be tested (Rogers, 1995, p.

243). Compatibility indicates how consistent the innovation is with the values, expectations

and needs of users in order to be integrated assimilated into their day-to-day life (Rogers, 1995,

p. 224). And lastly, observability is the extent to which the results from the innovation are

visible to others (Rogers, 1995, p. 244).

Social system

Roger underlines that the decision to adopt an innovation does not necessary mean that the

individual will start using it. This is because the decision process to implement an innovation

at an organizational setting is much more complex than the decision process followed by an

individual. According to Rogers, implementation ‘involves behavior change as the new idea or

knowledge translates into practice’ and therefore there are additional factors that affects imple-

mentation which are related to ‘the nature of the social system in which the individuals are

members’ (Rogers, 1995, pp. 26, 173). To illustrate this issue, Green and Seifert (2005) gives

an example of a physician who has read about a new guideline regarding an acute treatment for

heart failure. The physician is aware about the new practice and has decided to use it. Despite

the acceptance of the new practice the physician may still be unable to integrate it into her daily

practice because the new guidelines are not consistent with the hospital policies that guides the

decision and actions of the physician (Green & Seifert, 2005). The physician in this case has

to figure out on her own how to incorporate the new guideline into daily practice, when it is

appropriate the new guideline to be used and how to handle inconsistencies when the new

method does not work. Consequently, the context of the hospital in which the physician works

will either act as a catalyst or as an impediment to implementation. Rogers specifies that the

determinants of the hospital’s internal context depends on organizational and structural char-

acteristics such as centralization, complexity, formalization, interconnectedness, organiza-

tional slack and size (Rogers, 1995, p. 380). Formalization and centralization may encourage

implementation once the innovation is adopted while complexity, interconnectedness and


27

organizational slack and size promotes innovativeness (Rogers, 1995, p. 380). Figure 6 shows

how individual characteristics, communication channels, adopters characteristics and social

system affect the adoption decision process of an individual.

Figure 6: The factors affecting individual’s adoption decision process.

In an organization, there are often individuals who can influence the attitudes and behaviour of

other individuals. In the diffusion of innovation theory, two of the disseminators of knowledge

is mentioned as opinion leaders and change agents (Rogers, 1995, pp. 335, 354). Opinion lead-

ers have technical competence, a higher social status and are more exposed to external forms

of communication. Their role is to convey new impulses to the rest of the population in the

social groups or maintain the norms of the system depending on whether the system is promot-

ing changes or preventing them (Rogers, 1995, p. 354). The change agent is a person or organ-

ization who links the external and internal network of the organization by influencing their

clients to take decisions the agent considers desirable (Rogers, 1995, pp. 335-336).

The innovation process in an organization comprises two main steps: initiation and implemen-

tation. Initiation consists of agenda-setting and matching (Rogers, 1995, p. 391). In the agenda

setting step, problem, issues and needs are defined while at the same time the organization is

seeking an innovation within its environment to cope with the problems. Once the problem and

the innovation are defined, the next step is, matching, to plan and design the match between

the problem and the innovation with the purpose to determine how well theinnovation solves

the problem. This step requires to consider the consequences of implementing the innovation.

The second step in the innovation process is implementation which consists of redefining, clar-

ifying and routinizing (Rogers, 1995, p. 394). In the redefined stage the innovation is modified

and adapts to organizational and industrial requirements. This adaptation of innovation has an

impact on the organization since it transforms the environmental structure of the organization

(Rogers, 1995, pp. 394-395). This mutual adaptation between organization and innovation fa-

cilitates the process of diffusion of innovation in the organization and the innovation starts

having meaning to organizational members (clarifying step). Gradually through a process of


28

human interaction, members of the organization start understanding how the innovation works,

its benefits, its effects on the members and therefore the misunderstandings are decreasing. In

the final step, routinizing, the innovation has become a part of the organization’s daily activities

and it is not perceived anymore as something new, outside of the company (Rogers, 1995, pp.

399-400). Figure 7 depicts a summary of the innovation adoption process in an organization.

Figure 7: The innovation adoption process in an organization. Picture is adapted from Everett Rogers, Diffusion of innova-

tions, Figure 10-2 (1995, p. 392).

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Chapter 4. Introduction to methodology This chapter elaborates the methodological approach to gather and analyze empirical data. As

it was mentioned in the introduction, the aim of this dissertation is to gain an advance under-

standing of the various factors affecting the implementation of 3D printed custom-made im-

plants in surgery and prepare health care practitioners to cope with the implementation chal-

lenges. The first part of this chapter provides details of the adopted research strategy and design

followed by an outline of the research techniques and theoretical framework used to collect

and analyze empirical data. The final part of this chapter elucidates the limitations and potential

problems with the chosen methodological approach as well as the strategies adopted to tackle

these issues.

4.1 Research strategy When conducting a research, there are three things that needs to be specified: the research

strategy, research design and the research methods (Bell, et al., 2019, p. 45). Selecting research

strategy and design depends on the nature of the research question or objective (Bell, et al.,

2019, p. 39; Sekaran & Bougie, 2017, p. 96) and research philosophy (Mukhles M., 2020). In

this case, the research question that relates to the collection of empirical data is the second one

– what are stakeholder views and practices regarding the implementation of 3D printed PSIMs

in surgical practice? While research question one highlighted the main issues emerged from

previous applications of PSIMs, research question two will take this research one step further

by studying the implementation of PSIMs in a real life setting i.e. hospital. Research question

two implies conducting an in-depth explorative study within a real hospital setting to investi-

gate how practitioners are preparing for the implementation of 3DP in surgical practice to de-

velop custom-made implants and what are their views regarding the approaches of the hospital

to the implementation of the technology into their daily practice. It is also desirable to include

the views of staff who are in positions of authority and are involved in the implementation

process as well as people who provide support to medical doctors in the development process

such as technicians or design engineers. Since research question two focuses on studying re-

search participants in their natural settings, with the intention to understand phenomena based

on the participants point of view (Denzin & Lincoln, 2005, p. 3), then the empirical research is

fundamentally qualitative in nature. Compared to quantitative studies in which the main focus

is to ‘measure and/or count social phenomena and the relationships between them’ (Bell, et al.,

2019, p. 163), qualitative studies focus on ‘how participants interpret their social world’ (Bell,

et al., 2019, p. 40). However, the researcher’s philosophical views of the world will determine

the type of qualitative research strategy. For this study the researcher has acquired an interpre-

tive worldview. Interpretivism is based on a social constructionist ontology which asserts that

there are multiple realities which are time and context dependent deriving as an outcome from

human interaction (Bell, et al., 2019, p. 31). The epistemological stance is that reality needs to

be interpreted to discover the underline meaning. Mertens (1998, p. 161) supports that acquir-

ing an interpretative perspective will require to use qualitative methods to ‘gain an understand-

ing of the constructions held by people in that context’. The interpretative perspective of the

world is consistent with researcher’s aim of gathering stakeholders’ perspectives to understand

the implementation issues [constructions] held by practitioners related to PSIMs in the context

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of a hospital environment. However, qualitative studies in implementation science ‘tend to be

targeted towards multiple stakeholders (e.g., providers, administrators) in multiple, diverse set-

tings (e.g., several health clinics)’ (Cohen, et al., 2015). Therefore, the chosen stakeholders for

this research were from diverse hospitals located in different countries with the intention of

acquiring a multinational perspective of the implementation issues related to PSIMs.

4.2 Research design The type of research strategy does not provide information regarding the design of the empiri-

cal research. A research design is ‘a plan that guides the investigator in the process of collect-

ing, analyzing and interpreting observations’ (Nachmias & Frankfort-Nachmias, 1996, p. 77).

It is the ‘framework’ that provides information ‘on how the research will be conducted and the

data analyzed’ (Bell, et al., 2019, p. 45). In our case the chosen research design has to facilitate

the exploration of a contemporary problem or a phenomenon which takes place in a complex

real-life setting (i.e. a hospital) and support the concept of obtaining different stakeholder per-

spectives from multiple levels of the organization in different contexts (multiple hospitals) to

gain a richer understanding of the phenomenon. An exploratory research design would be ad-

equate for the purpose of this research. Saunders et al. (2012, p. 171) elucidates that an

exploratory research intends to provide a better understanding of a complex problem without

offering conclusive statement on how the problem will be resolved. ‘Exploratory research de-

sign simply explores the research questions, leaving room for further research’ (Dudovskiy,

2018). Conducting an exploratory research study includes ‘in-depth individual interviews,

focus group interviews or a literature search’ (Saunders, et al., 2012, p. 171). The complex

problem in this study is the implementation issues of PSIMs within different hospital settings

and the understanding of the implementation barriers and facilitator will be achieved by map-

ping stakeholders’ perceptions using a series of in-depth individual semi-structured interviews.

In-depth individual interviews are consistent with the interpretive philosophical assumption

that reality can be understood through the social constructions and interactions. The collected

data from the interviews was analyzed inductively to understand the dynamic correlation

among implementation factors. Figure 8 depicts the methodological approach followed to con-

duct the empirical study.

4.3 Site and sample selection The initial intension of this research was to conduct a qualitative case study at the hospital of

Södertälje in Stockholm where a 3D printing innovation center is established. Unfortunately,

due to Covid-19 access to the Hospital was not possible and therefore a broader approach was

adopted. To increase the chances of accessing research participants, 39 interview invitations

were sent to different hospitals and 3D Printing Labs in Europe. The identification of research

Ontology

•Constructionism

Epistemology

•Interpretivism

Research strategy

•Qualitative research

Research design

•Explorative

•Semi-structured indepth interviews

•Inductive analysis

Figure 8: Methodological approach to conduct the empirical study

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participants was performed through purposive snowball sampling aiming for a maximum het-

erogeneity sample. It is purposive because the choice of research site and the participants was

based on their relevance to the second research question which focuses on exploring staff stake-

holders’ views regarding the 3DP implementation issues. The literature review revealed that

the majority of studies regarding 3DP implementation focus more on the views of practitioners

rather than the views of for instance managers or even research engineers. Therefore, the an-

ticipation of the researcher was to include the views of different stakeholders who were using

3DP technology to develop PSIMs or giving a strategic perspective to implementation activities

related to PSIMs. Furthermore, two surgical disciplines formed the focal point of staff inter-

views. Since the focus of this dissertation is 3D printed implants in orthopedics and cranio-

maxillofacial surgery, the chosen participants were related to these medical sectors. The reason

for including stakeholders from different organizational level and context was because it was

desirable to capture a three-dimensional perspective of 3DP implementation issues. In sum-

mary, the criteria used to sample research participants were the following:

1. Have experience in 3D printing.

2. Are either working in orthopedics or cranio-maxillofacial department or working in a

3D Printing Lab providing (or has provided) 3DP support to orthopedic or cranio-max-

illofacial surgeons.

3. Are involved in the implementation or development process of PSIMs or at least have

collaborated with orthopedics or cranio-maxillofacial surgeons to develop a PSIM.

Regarding the sample size, Morse (2000) supports that 30 interviews is enough to reach a the-

oretical saturation when using semi-structured interviews approach. Considering the practical

constraints of this dissertation i.e. time constraints, the degree of difficulty to access research

participants, the complexity of the topic, the expected workload and available support from the

faculty, the estimated sample size for this study was initially set to 15 interviews.

4.3.1 Research participants

Three hospitals and two 3D Printing Labs were responded to interview invitation. A total of 10

face-to-face interviews were performed between April 2020 and May 2020 with five hospital

managers, three medical doctors and two research engineers (Table 8). Two interviews were

conducted on Skype, five interviews on the videotelephony application Zoom and three inter-

views were done over the phone. The duration of each interview ranged from 45 to 60 minutes.

To protect confidentiality and anonymity, participants names and their organizations have been

replaced with codes i.e. Manager A from Hospital 1, Medical doctor B from Hospital 2, Engi-

neer B from 3D Printing Lab 1 etc., while the position of each participant is presented in ag-

gregated form in chapter 5.

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Table 8: Participants’ code name, gender, medical discipline, organization and country.

Research participants

code name

Gender Medical Discipline Organization Country

Manager A (MA) Male Cranial and maxillofacial Hospital 1 Switzerland

Manager B (MB) Male Radiology Hospital 1 Switzerland

Manager C (MC) Male Oral and maxillofacial Hospital 1 Switzerland

Manager D (MD) Male Oral and maxillofacial Hospital 2 Sweden

Manager E (ME) Male Orthopedics Hospital 3 Netherlands

Medical Doctor A (MDA) Male Orthopedics and traumatology Hospital 1 Switzerland

Medical Doctor B (MDB) Male Neurology Hospital 2 Sweden

Medical Doctor C (MDC) Male Oral and maxillofacial Hospital 2 Sweden

Engineer A (ENGA) Male Worked with orthopedics & CMF 3D Printing Lab 1 Sweden

Engineer B (ENGB) Male Worked with orthopedics & CMF 3D Printing Lab 2 Sweden

4.4 Data collection methods The methods used to collect data comprise a literature review, interviews and triangulation of

processed data. The collection of data initiated with a review on previous applications of patient

specific implants (PSIMs) in orthopedic and cranio-maxillofacial surgery. Theoretical frame-

works and models were also reviewed to build the theoretical background of the research. Fi-

nally, personal interviews were conducted for collecting primary qualitative data while trian-

gulation was utilized to synthesize the primary and secondary data.

4.4.1 Literature review

Figure 9 provides a synopsis of the methods utilized to collect both primary and secondary

data. The literature review consisted of secondary data which were utilized to answer the first

research question (RQ1) - what are the main driving forces and barriers for the delivery of

custom-made implants? The inquiry was tackled by studying previous implementations of 3D

printed implants applications with the purpose of identifying opportunities and various issues

regarding the implementation of the technology in healthcare. The literature review focused

largely on journal articles, course books, dissertations, published reports and websites (Figure

9). Google Scholar and library databases such as PubMed, DIVA and Discovery were utilized

to support the literature search process. The search was conducted in both English and Swedish

utilizing keywords such as implementation OR adoption, health care OR hospital, 3D printed

implants in surgery, 3D printing and implementation barriers OR challenges OR impediments

OR facilitators OR enablers, patient specific implant in maxillofacial OR orthopaedics OR

craniofacial, additive manufacturing OR 3D printing AND patient specific implants OR cus-

tom-made implants, patient specifika implantat AND implementerings förtjänster OR fördelar

OR hinder OR nackdelar, etc. Secondary data was also used to examine and evaluate existing

theoretical models and frameworks within the field of implementation, innovation diffusion,

management innovation and organizational change with the aim of finding frameworks that

will guide empirical research and analysis. The finding from the literature review guided the

collection and interpretation of primary data.

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4.4.2 Interviews

The primary data for this study was gathered through interviews and were used to answer the

second research question (RQ2) - What are staff stakeholder views and practices regarding the

implementation of 3DP in surgical practice for the development of custom-made implants?

(Figure 9). A research interview is an ‘interpersonal situation, a conversation between two par-

ticipants about a topic of common interest’ (Kvale & Brinkmann, 2009, p. 139). Bell et al.

(2019, p. 434) outlines two main types of interiviews used in qualitative research: unstructured

and semi-structured interviews.

Figure 9: Data collection methods utilized to answer the research questions.

In a qualitative research approach, interviews are a frequently used and well-suited research

method (Bell, et al., 2019, p. 435). Unstructured interviews have no prepared questions rather

the researcher introduces a theme or a topic and lets the interviewee speak his mind

(Denscombe, 2016, p. 267). Follow-up questions are created completely spontaneously. Alt-

hough this method is simple, it comes with the shortcoming of missing many important areas

relevant to the research objectives. On the contrary, in a semi-structured interview, there is a

list of open questions as well as supplementary questions that depend on the respondent's an-

swer. This type of interview is flexible allowing for comparisons between different stakehold-

ers' views on the same issues. The benefit of semi-structured interviews in comparison with

other previously described types of interviews is that it provides, through an interview guide,

an established framework around the interviews focusing on specific issues while at the same

time allows the researcher to pursue other emerging issues that may arise unexpectedly during

the interview process (Bell, et al., 2019, p. 436). Furthermore, ‘semi-structured interview as a

method is suitable for studying people’s perceptions and opinions… allowing diverse

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perceptions to be expressed’ (Kallio, et al., 2016). Semi-structured face-to-face interviews was

the main technique for primary data collection because it captured in detailed the input from

participants regarding their views on 3DP implementation and at the same time ‘respecting

how the participants frame and structure the responses’ (Rossman & Rallis, 2016). The topics

included in the interview guide was formulated based on the consolidated framework for im-

plementation research (CFIR) and on the findings from the literature review.

4.4.3 CFIR as an interview guide

To facilitate the interview-process a template was developed based on the Consolidate Frame-

work for Implementation Science (CFIR). The advantage of utilizing CFIR is that it allows the

researcher to decide which constructs from the CFIR are relevant to her research and which

ones require adaptation to meet the research objectives (Damschroder, et al., 2009). For this

study, 18 constructs of the CFIR were used to formulate open-ended questions. Figure 10 il-

lustrates which constructs were included in the interview guide. The boxes filled with blue

colour are the constructs that were used in the interview guide.

Figure 10: Selected constructs of CFIR utilized to build the interview guide.

Using open-ended questions with some degree of structure helps not only maintain focus on

specific issues but also allows room for the emergence of other issues important to the inter-

viewee (Bell, et al., 2019, p. 436). The interview guide consisted of introductory questions to

acquire demographic information; main questions and one closing question. The purpose of

the closing question was to get insight on other views or perceptions that the research partici-

pant might had, and the previous questions could not reveal (Bell, et al., 2019, p. 442). The

interview guide can be studied in Appendix B.

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35

Due to time constraints it was not possible to investigate all constructs in the CFIR framework

rather only specific categories in each domain. Furthermore, not all the constructs were con-

sidered relevant for this research. The choice of constructs was made based on the information

gathered from the literature review and theoretical background. The rationale for selecting each

construct is provided below. Appendix C gives an overview of the selected CFIR constructs

and their definitions as well as how these definitions were adapted.

Domain 1: Individual characteristics of the involved stakeholders

This domain included introductory questions to identify stakeholders’ demographic and pro-

fessional characteristics such as years of working experience in 3D printed medical device

applications, their role in the organization, etc. There were also questions aiming to identify

each stakeholder group’s motives in getting involved with 3D printing and their beliefs towards

3D printed PSIMs. For example:

1. What motivated you to get involved with 3D printing and patient specific implants?

(motives)

2. How 3D printing changed your role as a doctor or engineer? (personal beliefs on the

tech)

Domain 2: Innovation or intervention characteristics

In this domain, stakeholder’s perception of the innovation was explored. The purpose was to

find out the key attributes of 3D printed PSIMs that influence adoption and implementation.

Of the eight constructs included in this domain only five of them were investigated: relative

advantage, complexity, trialability, adaptability and cost. The choice of the three first con-

structs was based on the innovation attributes described in Rogers’ innovation diffusion theory;

relative advantage, compatibility, complexity, trialability and observability. However, compat-

ibility according to CFIR framework is an attribute placed under the domain Inner Setting while

observability is incorporated in the construct relative advantage with the justification that the

benefits of the innovation must be visible (observable) to stakeholders in order to be regarded

as advantages (CFIR Research Team-Center for Clinical Management Research, 2020). In this

study it was decided to follow the structure and reasoning of CFIR. Lastly, cost was regarded

important to be included since the literature review indicated the need for a proper detailed cost

analysis. The intension here was to find out why it is difficult to prove the cost-efficiency of

the innovation and identify the main costs included in the development of PSIMs. A sample of

the questions belonging in this domain are presented. Further information on the questions that

were used in each construct is provided in Appendix B.

1. What are the main relative advantages of 3D printed patient specific implants in com-

parison to standard ones? (relative advantage)

2. What kind of capabilities and skills do you need to develop 3D printed patient specific

implants? (complexity)

3. What are the main costs that are considered when deciding to implement the 3D printed

custom-made implants? (cost)

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Domain 3: Inner Setting

The selected constructs in this domain were structural characteristics, networks and communi-

cation, implementation climate and readiness for implementation. Due to the complexity of

implants development process presented in the literature review chapter, it was considered sig-

nificant to specify the structural changes required to implement the development workflow of

PSIMs in the hospital setting and identify the challenges surrounding the process. Implemen-

tation climate was an indicator of the organizational commitment towards PSIMs investigating

management support and resource availability. Networks and communication were also in-

cluded to mainly investigate the communication difficulties between medical doctors and en-

gineers. A sample of the questions that were formulated in this domain were:

1. What kinds of infrastructure changes will be needed to accommodate the implementa-

tion of 3D printed PSIMs?

2. How is the communication with the engineers (alternatively doctors)?

3. What do you think would encourage practitioners to engage with patient specific im-

plants?

4. What kind of support or actions can you expect from leaders/managers in your organi-

zation to help make implementation successful?

5. Does the hospital in general have training plans for its practitioners?

Domain 4: Outer Setting

In this domain focus was set on external policies and incentives affecting implementation. This

construct was added in the interview guide due to the regulatory challenges the medical indus-

try is facing according to the findings in the literature review.

1. Are there any external forces that can influence implementation? What kind of financial

or other incentives influenced the decision to implement the intervention?

Domain 5: Implementation Process

This domain was initially not included in the interview guide rather it came up during the first

interview with a hospital that had an in-house 3D Printing Lab. Establishing a 3D Printing Lab

in the hospital is the first step towards in-house development of PSIMs. Therefore, it was con-

sidered relevant to investigate how the 3D Printing Lab was built, who were the key stakehold-

ers responsible for its implementation and whether or not stakeholders were using a method or

strategy to coordinate implementation of 3D Printing Lab and evaluate the process.

1. Who were the key stakeholders in the implementation of 3D Printing Lab?

2. Do you have an implementation plan? What can be improved?

3. Who are involved in the development process of patient specific implants?

When it comes to the transcription of data, audio recording was adopted, after permission from

the research participants, to facilitate the transcribing procedure and ensure capturing the exact

wording of the interviewees (Bell, et al., 2019, p. 445).

4.4.4 Triangulation

The third research question (RQ3) – how this knowledge can be used to prepare healthcare

practitioners for future introduction of custom-made implants in surgery? – was answered via

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37

triangulation of the findings from the literature review and the analyzed empirical data allowing

theory and practice to be compared (Figure 9). This provided a rich picture of the implementa-

tion barriers and led to the formulation of suggestions on how to facilitate the implementation

of 3D printed implants in healthcare.

4.5 Theoretical framework for data analysis Empirical data led to 98 pages of transcribed material which were review first before analysis.

Figure 11 depicts a summary of the framework that was adopted to analyze the transcripts. The

framework consists of four stages: Collection of empirical data, description, analysis and in-

terpretation (Wolcott, 1996). The collected empirical data were thematically analyzed as out-

lined by Braun and Clarke. After generating the transcripts from the interviews and summariz-

ing them, the perspectives of different stakeholder groups were compared with each other. In-

itially, all transcripts, were read carefully, making notes about first impressions. Then prelim-

inary codes were generated following an inductive approach initiated by open coding. The

transcripts were examined line-by-line in which words, phrases and sentences that seemed rel-

evant were labeled with codes. Labels were generated based on statements, views, activities,

and processes that repeated in several transcripts or was important for the interviewee or were

theory-related (Clarke & Braun, 2013). Afterwards the initial codes that were relevant with the

research question were brought together, creating preliminary themes which were labelled too.

The constructs in CFIR was also used as a cross-checking for spotting additional codes that

needed to be explored further. Finally, the themes were studied and analyzed to find whether

there were overlaps or correlations between different themes (Clarke & Braun, 2013). Once the

final themes were created, they were compared with the findings from the literature review.

This process was conducted during collection of empirical data and repeated iteratively for

each stakeholder group until all empirical data were analyzed.

Figure 11: The iterative framework of qualitative analysis.

4.6 Ethical considerations Consideration on how to conduct the empirical research without jeopardizing the physical and

intellectual integrity of the researcher and the research participants is central when designing

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this study. To avoid any ethical issues the empirical study was conducted by following the four

main ethical values: ‘avoidance of harm, informed consent, privacy and preventing deception’

(Bell, et al., 2019, p. 114). To meet the ethical requirements the interviewees were informed

about the purpose of the research and their role in it. They were also informed that participation

to the interviews was confidential, voluntary and could be terminated without any reason at

any time (Bell, et al., 2019, p. 118). Before any interview was conducted the interviewees were

provided with an informed consent and an interview guide. The main purpose with the in-

formed consent was to inform research participants about their rights and the purpose of the

research, as well as to confirm their participation to the study. The informed consent can be

studied in Appendix D. To fulfil the confidentiality requirements, it was decided to anonymize

all research participants in the dissertation unless prior permission was given. Furthermore, any

records and transcriptions were stored safely to protect it from unauthorized individuals.

4.7 Limitations and potential problems The main limitation with this study is that external validity will be limited due to lack of prob-

ability sampling methods, small sample size and selected research design. According to the

conventional view, studies that cannot be generalized to the wider research community cannot

contribute to scientific development (Flyvbjerg, 2013). The researcher holds the view that the

external validity or transferability of a qualitative study is week since it focuses on particular-

ization more than generalization. However, ‘knowledge that cannot be formally generalized

does not mean that it cannot enter into the collective process of knowledge accumulation in a

given field or in a society’ (Flyvbjerg, 2013). Bassey (1981) supports that what is more im-

portant in a qualitative study is not its generalizability but its relatability. Thus, this study ap-

peals to the concept of relatability; meaning that the findings of this research may be of interest

and benefit any hospital that has encountered similar issues described in this work or is keen

on implementing 3DP. It is expected that the synthesis from the empirical analysis and the

findings from the literature review will incrementally add knowledge to the field of 3DP and

implementation science.

Another critical limitation is the reliability of the research strategy. Reliability issues are related

to lack of transparency in how a qualitative study was applied and how the conclusions derived

from the study (Bell, et al., 2019, p. 375) which in turn leads to difficulties in replicating the

study. A way of dealing with reliability issues is to ‘make as many steps as operational as

possible and to conduct the research as if someone were looking over your shoulder’ (Yin,

2003, p. 38). To remove any reliability accusations, detailed information regarding the appro-

priateness of research strategy and design, the data collection techniques, the sampling meth-

ods, interview questions and data analysis techniques were provided in previous chapters. Re-

liability has also been ensured by using a research strategy and data collection methods that are

acknowledged and validated by the research community.

Next was the issue of using interviews as the main source of data which also relates to reliability

issues. The data collection technique is based mainly on personal views and opinions and there-

fore is open to bias (Bell, et al., 2019, p. 375). To minimized potential bias and misinformation

several stakeholder views from different contexts and organizational levels were collected on

the same issues. For example, the views of health care staff regarding the implementation

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39

barriers were compared with the views of hospital management. In this way the research is not

dependent on the opinion of one or two respondents. Furthermore, the interview answers were

also compared with secondary data such as literature review.

Another factor that affected the implementation of the empirical research was the difficulty of

gaining access to research participants. Although early access to healthcare practitioners was

requested the outbreak of Covid-19 significantly limited the possibility to conduct face to face

interviews at a hospital setting. In this case the alternative was to interview by telephone or

using online video calls via Zoom. However, these alternative techniques had their own limi-

tations for example technical problems occurred during the empirical research and three of the

interviews had to be conducted by phone.

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40

Chapter 5: Findings of empirical research This chapter presents the results of the qualitative study described in chapter 4. As it was stated

before the purpose of the empirical research was to explore the views of involved stakeholders

in the implementation process on the barriers and facilitators of implementing 3D printing for

the development of custom-made implants. The presentation initiates with the hospital manag-

ers’ views followed by the responses of medical doctors and ending with engineers’ perspec-

tives regarding the implementation issues of PSIMs in a hospital setting. The description of

collected data from each stakeholder group follows the structure of the interview guide which

was based on the themes taken from the CFIR model. These themes are individual character-

istics, attributes of intervention, outer setting, inner setting, and implementation process. At the

end of every section there is a table that works as a synopsis of the main points discussed in

the text.

5.1 Hospital managers’ characteristics and perspectives Hospital managers’ individual characteristics were specified by investigating research partici-

pants’ competencies, incentives and attitude related to the intervention (Damschroder, et al.,

2009). Table 9 provides a synopsis of hospital managers’ characteristics starting with their

skills presented in an aggregated form. All managers had between five to eighteen years of

experience in additive manufacturing technologies. Three of them are coordinating 3D Printing

Labs located inside the hospital while two of them are focusing more on leading and developing

medical units within oral and cranio-maxillofacial surgery.

From managers’ point of view getting involved with 3DP is an effort to improve the quality of

surgical procedures and healthcare services. One manager mentioned that the introduction of

the technology into his work was an initiation from his boss who was a pioneer in 3DP and

demonstrated for him the benefits of the technology in surgical planning and in the production

of patient specific implants. Two managers stated that they were fascinated by the possibility

of creating patient specific solutions because it promoted personalized medicine providing the

best treatment to patient. Investing in patient specific solutions was also an effort of making

their organization more competitive.

From my perspective, we are here to help people by providing the best treatment. So, we

always scan the market to find the technology that would make us at least as good as the

best clinics in Europe… 3D printing seemed to be the technology that would give us a

competitive edge. (MD – Hospital 3, 2020)

Respondents further explained that hospitals operate in a competitive landscape and in order to

maintain competitive advantage they need to provide the best and highest quality treatment for

patients. 3D printing was considered an innovation that partly could be used to improve the

patients treatment through additive manufacturing and partly to drive the costs down at some

degree by shortening operation time and enhancing the surgical accuracy using patient specific

surgical guides etc.


41

It is more like a general thinking about how the healthcare landscape and hospitals are devel-

oping… On one hand it is the increasing pressure on the costs and on the other hand is the

increasing specialization which drives costs. So how can we somehow help the system to be

more cost effective and at the same time improve treatment… 3D printing appears to be one of

the many possible solutions. (MB – Hospital 1, 2020)

Another reason for engaging with 3DP was to increase or maintain high levels of specialization

while reducing the costs. It was highlighted that 3D printed anatomical models produced during

the development process of PSIMs can be used to train and educate doctors at a low cost. This

solution is regarded as beneficial, especially for hospitals that do not have the resources to

organize training events.

It is about staying relevant in medicine… There are hospitals that do not have the capacity to

provide very specialized training for interventional neuroradiology or vascular surgeons, or

simply they do not have the caseload… So, one of the possible solutions that 3DP is creating is

through the use 3D printed models on which you can train surgeons at a low cost, instead of

doing their training on the patient. (MB – Hospital 1, 2020)

3DP was also characterized as an aid for surgeons to gain more confidence especially in com-

plex surgical cases. Knowing exactly what and where the problem is, has given the possibility

to doctors to plan the surgical procedure and foresee beforehand the best course of action that

will produce the optimal outcome for the patient.

I think, not only for me as a surgeon but also for others, using 3DP helps you become a better

doctor or better surgeon. For example, when you have fractures and you need to operate, it is

much easier to understand the morphology of fractures with a printed model in your own hands

than based only on three dimensional images on the computer screen or two dimensional images

and CT scan. (MA – Hospital 1, 2020)

Another manager stated that 3DP has added extra value to his work because it gave him the

means to illustrate more effectively the result of his work.

I thought it would be a nice addition to the working experience. Just the act of creating

something tangible out of imaging data is a very rewarding experience. It is a different

way of working which I really find immensely valuable to my work. (MB – Hospital 1,

2020)

There was also one manager who started using 3D printing as part of his master thesis which

focused on the acquisition of patient specific instruments to improve the accuracy of total hip

replacement. He was also interested in complementing his medical skills with technical com-

petencies.

I wanted to investigate whether patient specific instruments can help guide surgeons get

more reliable results regarding bone resection, implant alignment-position and make sur-

gery more predictable than it is nowadays. (ME – Hospital 2, 2020)


42

Table 9: Managers’ characteristics and incentives.

Hospital Managers individual characteristics

Skills

Radiology, cranial, oral, maxillofacial, and orthopaedic surgery.

3D printing, image analysis and data processing, surgical planning, implementa-

tion, smart implants, patient specific implants, anatomical models and patient spe-

cific instruments, leading the development of medical units.

Years of 3D printing

experience

5-18

Incentives

➢ Inspired by supervisor after demonstration of the technology’s the benefits in

surgical planning and production of patient specific implants.

➢ To improve visualization of imaging data

➢ To enable potential for personalized medicine

➢ To gain competitive advantage

➢ To improve healthcare service

➢ To complement medical skills with technical

➢ To make surgery more predictable.

➢ To establish a better and more stable position in the market

➢ Maintain high levels of specialization

➢ Reduce treatment costs

Personal beliefs about

the technology

➢ Enhances self-confidence

➢ Makes better doctors

➢ Adds extra value to the work

➢ Promotes personalized health care

➢ Provides optimal solution for the patient

➢ Enhances surgical accuracy

5.1.1 Intervention Characteristics

In this section we will investigate the attributes of patient specific implants that influence the

success of implementation. Issues that was raised here were associated to the constructs relative

advantage, complexity, trialability and cost.

Relative advantage

Relative advantage is associated with individual’s perception that the intervention is better or

worse than an alternative solution (Damschroder, et al., 2009). In this case, custom-made im-

plants (CMI) were compared with standard implants (SIM) which are the alternative and es-

tablished method in reconstructive surgery. One of the main advantages of CIMs compared to

SIMs is that CIMs can be easily adapted and tailored to patient needs. Depending on the re-

quirements of individual case, the implant can be easily produced in complex shapes with dif-

ferent material. Four hospital managers confirmed that the main advantages of using 3D print-

ing for the development of custom-made implants are the improvement in surgical precision,

reduction of surgical time and better preoperative planning. In comparison to standard im-

plants, developing patient specific implants (PSIMs) leads to a much better fit to the patient

which in turn leads to faster rehabilitation.

3D printed implants can be easily adapted (…) to the anatomical morphology of the pa-

tient. There is also the flexibility in utilizing different materials of various properties and

produce a smart implant. On the contrary, with a standard implant this possibility is lim-

ited; you have to make repeated adjustments until a “best fit” is achieved. (MC – Hospital

1, 2020)


43

High degree of adaptability means less adjustment during surgery which in turn leads to

shorter operational time. (MD – Hospital 3, 2020)

Less repeated adjustments lead to shorter operational time which was regarded as another ad-

vantage. The reduction of surgical time was also due to the tools produced during the develop-

ment process such as anatomical models used to shape the implants and surgical guides used

to install the implant. The utilization of patient specific tools help surgeons during pre-opera-

tive planning to visualize complex anatomical problems, plan the operation beforehand and

simulate the surgical procedure enhancing surgical predictability and precision.

…anatomical models for preoperative surgery of implants are reducing the operating time

because the surgeon has the opportunity to properly prepare. Complex cases are being

simplified since they become more predictable. …sometimes the stock implants can be

very rigid especially for mandibular reconstruction and therefore you can be very fast and

precise during surgery with patient specific anatomical models and guides. (MA – Hospital

1, 2020)

One manager referred to the impact of the PSIMs on the patient and to the hospital. The fact

that the patient specific implant fits the bone structure defects of the human body decreases

postoperative complications and therefore accelerates the rehabilitation process and reduces

the need for hospitalization. Shorter hospitalisation means fewer expenses.

We do not have complications with the placement of the implant after surgery and so there

is no need to operate the patient again and readjust the implant which is something that we

sometimes have to do with conventional implants... We noticed that the patient recovers

faster and that of course is beneficial for the hospital as well in terms of the costs. (MD –

Hospital 3, 2020)

Another manager highlighted the enhancement of hospital reputation when having an innova-

tion laboratory providing patient specific treatment.

And of course, the perception of the community is also very good because the hospital has

a high-tech fancy lab which does something very futuristic and increase the popularity/rep-

utation of the hospital; a modern hospital that uses the latest technology to provide high

quality health care services tailored to the patient. (MA – Hospital 1, 2020)

Regarding the limitations of PSIMs in comparison with standard implants, there were two kinds

that were mentioned. The first one was about the consequences of a mismatched implant. Once

it is decided to implant a PSIM then the whole operational approach becomes individualized.

This means that the tools used in the operation are tailored to the specific approach. Therefore,

if the implant does not fit or cutting guide breaks then the whole system will be affected. In

this case a standard implant might need to be used leading to longer operational time and higher

costs.

If the implant does not fit, then you run into a problem. That is one of the often-cited

disadvantages of the whole very individualized system. Perhaps your cutting blade is not

the one that you wanted to use or the cutting guides break or you find an unexpected situ-

ation inter-operatively (…) then the whole system might burst and you cannot use the

guides anymore. And if it is the patient specific implant then you will need to have a plan

B (…) which might also drive the costs (…) because in the end you will need to take one

of the standard implants. (MB – Hospital 1, 2020)


44

The second limitation has to do with the uncertainty related to the evidence of the mechanical

strength and quality of PSIMs. PSIMs have to be designed in a way so that they are mechani-

cally sufficient to withstand the forces. A manager emphasized that a custom-made implant

“cannot be tested as thoroughly as a standard one” to ensure sustainable stability.

No matter how thoroughly a PSIM is tested, it is still a patient specific one. It is custom-

made and cannot be tested as much as a standard one. (…) so how certain are you that this

model will really last and withstand the forces that will encounter? That certainly is another

technological problem which might be able to be solved by virtual simulation, by Finite

Element Analysis (FEA) etc… (MB – Hospital 1, 2020)

Another manager explains that it is difficult to predict the forces that will act on a PSIM because

it depends on the individual. He confirms that this challenge can be solved using FEA. As an

example, he describes a case where a patient specific titanium scaffold was tested in FEA anal-

ysis to find out what sort of loads the device had to carry. The software proved to be very useful

in developing a formula for calculating the forces that the implant had to withstand to avoid

future mechanical failures.

Making sure that the implant can cope with the forces that will act upon them is a chal-

lenging task which can be solved if you find out the right formula to calculate the mechan-

ical requirement… We noticed in our studies that using finite element analysis (FEA), we

could predict the failure of the implant. (MD – Hospital 3, 2020)

Table 10 provides an overview of the perceived advantages of PSIMs from managers’ point of

view. The “+” sign indicates a positive perception while the “-” sign denotes the opposite.

Table 10: Perceived relative advantages of patient specific implants.

Relative advantage of 3D patient specific implants

+ Easily adapted in terms of design and material.

+ Reduced surgical operation time.

+ Enhanced surgical accuracy.

+ Increased surgical predictability.

+ Complex cases are simplified.

+ Better anatomic fit.

+ Faster rehabilitation.

+ Shorter hospitalization.

+ Higher social status.

- Limited contingency – one chance to get it right.

- Cannot be tested as thoroughly as a standard one.

+ Use of FEA to predict the mechanical forces.

Complexity

Complexity of PSIMs was related to the required skill set to understand and develop a PSIM

and to the degree to which PSIMs will alter central work processes. All managers supported

that implementing 3D printed patient specific implants in-house is a technically demanding

process, which requires time and skills in materials and advanced computer design. Because

the development of PSIMs requires time, they are not regarded suitable for urgent cases rather

more suitable for tumor cases which can take from seven to ten days.


45

You always have to think about the surgery, plan it beforehand, produce the implant and

oversee the whole procedure including the sterilization of implants. It also requires exper-

tise in materials; you have to know about biomechanics and always be aware of the risk

that the designed implant might not be physically stable and eventually it might fail. (MC

– Hospital 1, 2020)

One manager emphasized that the skill set required for the development of PSIMs is not cur-

rently available on the market: “at the moment there is still not a profession which covers all

the topics of medical 3D printing” (MA – Hospital 1, 2020). Another manager focused more

on the design of custom-made implant stressing that it requires good knowledge in anatomy,

imaging techniques and informatics. Especially the segmentation of medical images in which

the anatomy of interest is isolated, might be difficult for someone without experience. It was

explained that the accuracy of segmentation depends on the quality of medical images. For

example, in complicated cases such as kidney tumor, the diagnosis is made by using a mul-

tiparametric MRI approach, in which the physician reviews several sequences to form the im-

pression and diagnosis. During this stage there may be a certain degree of uncertainty regarding

the diagnostic accuracy which is difficult to reflect in a 3D printed model.

The acquisition of MRI images is a tradeoff between imaging quality and acquisition time

through different parameters such as slice thickness or field of view. ...you can only represent

what you really see in those image sequences and the difficulty or the danger is that as soon as it

gets translated into a real model, this model is taken as the reality which is not the case. It is still

the model generated based on the imaging data that has been acquired, so here we have another

level of abstraction that the surgeons must be aware of. (MB – Hospital 1, 2020)

Lastly, presenting the anatomical structure in a meaningful way can be onerous because some-

times the structure might be covered by soft tissue or the primary organ making the visualiza-

tion of the structure difficult. In this case, using transparent material or hollowing the structure

are possible alternatives.

…you might need transparent material to really show the location or you might decide on

hollowing the structure and then putting connectors so that it hangs within the hollow

structure. (...) After the segmentation, the design part might also be quite challenging de-

pending on what you want to show or what you want to design. (MB – Hospital 1, 2020)

Another manager highlighted that printing implants in-house has a huge influence in the central

workflow especially from the point of medical regulatory requirements. He elucidated that in

his hospital they generally produce at some degree implants by themselves using a hybrid ad-

ditive manufacturing methodology via molding technology. However, the production of patient

specific implants that are introduced directly to patients is outsourced to an external partner

because producing them in-house comprises much more than just printing.

…you need certification, risk analysis protocol, well-established quality management sys-

tems. …so usually, you need a partner who is certified for printing surgical implants and

takes over the responsibility for the implants as the manufacturer. For example, if we want

to print a titanium implant, we can send it to an external company, they will produce it for

us and fulfilled the regulatory issues that are needed so that we have a certified workflow

and a certified implant. (MA – Hospital 1, 2020)

Table 11 provides an overview of the perceived difficulties of the intervention reflected by the

required skills to understand it and the characteristics of its development process.


46

Table 11: The complexity of implementing patient specific implants.

Complexity

Required skills

Knowledge in anatomy, biomaterials, and biomechanics

Experience in medical image segmentation

Computer skills such i.e. CAD-design, preparing STL-files

Development

process

- Time consuming development process

- Too many different tasks to monitor and coordinate

- Complex workflow due to medical regulatory requirements

Trialability

Trialability is the degree to which an intervention can be tested on a small scale (Damschroder,

et al., 2009). The testing of PSIMs is conducted through pilot or clinical studies. In Sweden to

initiate a clinical study, for example in developing patient specific plates for tumor cases, it

requires the approval from local authorities such as the Swedish Medical Products Agency

(SMPA; in Swedish Läkemedelsverket) which is characterized as an “excessively bureaucratic

procedure”.

It is quite complicated to do the clinical studies because you need to ask for approval from

the beginning, otherwise you must start your research all over again. To get the approval

you have to deal with a long line of regulatory and ethical local requirements… sometimes

you need licensing too; all of these requirements include quality control and a lot of docu-

mentation. (MD – Hospital 3, 2020)

Cost

The parts of the workflow that are costly during the development of PSIMs are the equipment

software and hardware maintenance plus the regulatory procedure that has to be followed so

that the workflow is certified. Other expenses that were mentioned being included in the im-

plementation of PSIMs are salaries, purchase of material, installation of quality management

systems, network monitoring systems and available premises for equipment i.e. 3D printers.

In comparison to conventional methods the financial benefits of PSIMs are many but to prove

them is quite difficult because there are a lot of factors that influence the cost of the procedures.

One of the managers described a study analysis of reconstructing orbital defects with the use

of patient specific implants (PSIM). The purpose was to find the factors that was influencing

the cost of the procedure in order to set a price on the specific health care service. It was found

that compared to conventional methods, the use of PSIM was giving approximately an ad-

vantage of 30-minutes in operation time. However, it was difficult to draw conclusions based

on the time reduction.

It is said that one minute in operating theatre is about $100. Can we just multiply 30 by

100 and say that we had a cost reduction of 3000 US dollars? (MA – Hospital 1, 2020)

The reduction in operation time can be interpreted as a benefit for the patient due to the shorter

anesthesia time but also as a disadvantage for the hospital because it reduces the average oper-

ating room utilization rate which is not consistent with the goals of operating room directors or

administrators.

...it is a benefit for the patient because the time the patient will have in the narcosis will be

less (compared to conventional methods) but regarding the cost, it may not be a benefit for


47

the hospital because if you have a new operating theatre, you will not have a 90% booking

of the operating theatre rooms. There are so many factors that influence a cost analysis…

(MA – Hospital 1, 2020)

Another manager explained that shorter operating room time is probably the largest counter-

weight to have for the additional costs and therefore if it is reduced by a certain number of

minutes then a “break-even point” will be reached in which any additional costs will be savings.

…in case series with several co-founding factors (i.e. multiple fractures treated at once, frailty of

patients, different severity of injury) is difficult to make conclusive statements regarding the cost

effectiveness of the implant based only on the reduction of surgical operation time. (MB – Hos-

pital 1, 2020)

The same manager further elucidated that it is reasonable of not having yet conclusive state-

ments regarding the cost-effective of patient specific implant in comparison to standard one

since the technology is currently at an infant state. He illustrated with an example the reason

for why patient specific implants are more expensive than standard ones.

If you have a standard CNC milling machine, you can program it to make thousands or

millions of standard implants overnight; press the button and the implants will come out.

It seems simpler and much cheaper to produce the standard ones than making a specific

3D printed design for every patient where a designer and a doctor are working hourly on

the implant. However, …the more this technology is used, the more the prices will fall and

after five to ten years it will be clearer to see the (financial) benefits of patient specific

implants. (MB – Hospital 1, 2020)

An additional argument that was highlighted was the bias created from the comparison between

PSIM-cases and cases that use conventional methods. For the moment, PSMIs are used as a

last resort only in complex cases which are less in number than the average number of simple

cases in which conventional methods are being used. This means that any comparison between

PSIM-cases and simple cases with conventional methods will lead to inept conclusions. How-

ever, as one of the hospital managers stated, there is a strong belief that PSIMs are immensely

beneficial.

There are so many implications in studies that it is very difficult to find out concrete cost

benefits… but in the end I think, from my personal experience and the experience of other

surgeons who use patient specific implants and models in their daily work, it is a huge

benefit but to prove it, it is quite difficult. (MA – Hospital 1, 2020)

There were also discussions concerning the reason for choosing to outsource the production of

implants instead of producing them in-house. It was clarified that the problem with implants is

that production facilities usually are quite expensive. For instance, titanium implants are pro-

duced by metal printers which are expensive and need people to operate it. To make such an

investment the hospital will have to make sure that the investment will be profitable to justify

buying the machine which is difficult because hospitals do not have the customer base that will

cover the expenses. On the contrary, an external company that delivers implants to multiple

hospitals has a bigger customer base and therefore they can justify the investment more easily.

However, managers believe that the more familiarized 3D printing gets within the hospital and

more doctors use PSIMs then eventually a break-even point will be reached where it will be

more economical to have the production facility in-house. The argument was exemplified by


48

referring to the Hospital for special surgery in New York. It is the first hospital in the world

that bought its own metal printers to produce implants.

… they had like 200 physicians there that made use of the machine and they all asked for

its products and so the break-even point for them was reached easily but in our hospital we

only have approximately 30 physicians that want to make use of our products so we have

not reached that break-even point. That is why we need to search for an external company

that wants to produce it for us. (ME – Hospital 2, 2020)

Another example that was discussed was the difference between the break-even point of im-

plants and anatomical models. It was elucidated that it is difficult to reach the break-even point

of implants it requires to justify the expenses for buying advanced 3D printers. One the contrary

printing the anatomical model does not require to invest in expensive equipment and therefore

the break-even point can be reached easily by having low caseloads. This is the reason for why

some hospitals are investing first in 3D printing anatomical models before they enter the market

of patient specific implants.

…if you want to replicate a model then all you need is quite low cost printer that has low

maintenance and so um in this case, the break- even point is already been reached by print-

ing 30 or 50 anatomical models per year. But if you want to produce surgical guides like a

drill or a saw guide… then you need to use for instance an SLS printer that prints in bio

compatible nylon material. But such a printer costs around 100,000 euros each and so, to

reach the break-even point… uh you need to have high caseloads. (ME – Hospital 2, 2020)

An overview of the implementation cost and the factors influencing the cost-effectiveness of

PSIMs is illustrated in Table 12.

Table 12: Main implementation costs and cost-effectiveness of PSIMs.

Cost

Main

implementation

costs

Equipment such as software and hardware, maintenance

Certification and procedure to fulfill the regulatory requirements

Other expenses: salaries, material, quality management systems, network monitoring sys-

tems, room vacancy/premises for equipment i.e. 3D printers.

Cost-

effectiveness

- Lot of factors that influence the cost of the procedures.

technology is currently at an infant state and financial benefits are not visible.

- Difficult to draw conclusions based on reduction in operation time due to complexity in

the correlation between different cost factors.

- Risk for bias – PSMIs are used only in complex cases as a last resort which are less in

number than the average number of simple cases

+ Requires a high demand on PSIMs to reach the break-even.

- In-house production of implants is quite expensive.

+ The bigger the customer base the better are the chances to reach the break-even point of

in-house implant production.

5.1.2 Outer Setting

The new medical device regulations are one of the main reasons for why PSIMs are not so

widely used in healthcare. Currently, the industry is trying to adapt to the new regulations. Four

of the managers elucidated that there is an uncertainty on how to operationalize the MDR into

the workflow. One manager, after attending several conferences on the topic, confirms that few

people can assert the implications of MDR on daily routine. He identifies two main problems


49

regarding the regulatory requirements. The first one is the sparsity of notified bodies and the

second one is the high cost of acquiring a certification.

…As far as I know there are not many notified bodies that allow to certify the production

of PSIMs or allow certification in accordance to the new MDR… the other problem will

certainly be the money to get the certifications… (MB – Hospital 1, 2020)

Another manager confirms that it is difficult to get a straightforward answer on questions re-

garding the requirements of a certified workflow that produces PSIMs and the difference be-

tween being a business unit that produces implants and being a unit that sells them.

…I have heard so many different opinions, but no one wants to be clear and would like to

define a specific way. …of course, there is not always one way but still, I think we could

be much more advanced if we had some people who could take care of these questions.


In a follow up question of how an MDR legal adviser could assist a hospital become an implant

manufacturer, the response was to give the MDR expert a tour in the lab to identify the weak-

nesses of the workflow. Based on the identified weaknesses, the MDR-advisor would then

provide recommendations on how to comply with the regulatory guidelines.

The MDR-expert would probably have to be a hybrid legal-engineering advisor who would

inspect our workflow, tell where he sees the weaknesses regarding the existing legal re-

quirements and then based on that, we would improve things. It is not disputable that you

must comply with those guidelines at one point. (MB – Hospital 1, 2020)

Time and experimentation will be required to find the best and most efficient way for the hos-

pital to comply with the regulatory requirements and produce the implant.

Whether it is effective to produce the implants in house or to outsource them or to do some

public private partnership (PPP) with someone who is creating the implants or providing

the printing technology (…) is something that we will have to evaluate and show what is

the best way we can comply with. (MB – Hospital 1, 2020)

The effectiveness of MDR was also another topic. One of the respondents alluded to the PIP

(Poly Implant Prostheses) breast implant scandal where a French firm used industrial grand

silicone in the implants instead of medical grand silicone. The PIP scandal had a profound

influence on the formulation of MDR which was created with the purpose for more transpar-

ency, communication, market surveillance etc. However, it was argued that there is always

going to be a “back door” for the big companies that want to bring implants into the market

easier. Especially, with the patient specific implants the risk is higher because the regulatory

requirements for every implant varies depending on the individual case; consequently making

the process of identifying an unauthorized implant or as the respondent named it “ to spot the

black sheep” difficult.

If somebody wants to cheat (s)he will be able to do it even now with the MDR because

you can still use silicone that is not approved or low-quality titanium without anyone being

aware of it. This can happen with patient specific implants since there is no need for CE.

From my personal perspective when it comes to patient specific implants, more strict reg-

ulations would be necessary especially because they require a high level of experience.

(MC – Hospital 1, 2020)


50

The same manager elucidated that until the medical community gains more insight on the ap-

plication of patient specific implants, how the biomechanics work and what the risks are, it

would be helpful, especially for beginners, if clear guidelines could be provided.

I think it will be helpful to have clear guidance regarding how to make an implant based

on a specific material, what is possible and what is not based on the method you apply etc.

I think, at the moment, this would be something more helpful than any general regulatory

requirement or recommendations for patient specific implants. Of course, this will change

in 5-10 years, probably when we have more experience. (MC – Hospital 1, 2020)

Among the respondents there was one manager who had applied the regulatory requirements

into the workflow of a 3D printed patient specific spinal implant. In his opinion the most chal-

lenging part when it comes to integrating the MDR into the workflow is the documentation.

More specifically, the regulatory requirements that need to be fulfilled involve a technical file

that will include specific details for the whole development procedure of the implant. Every

time there is a new patient case the technical file together with the certificate should always be

delivered. The benefit with these documents is that they have a standard structure which can

be used for every new patient case. For example, there is no need to apply for a certification in

every new patient case rather than coping it until it expires. Certificates need to be updated

every five to ten years. Getting all the requirements in these files for the first time is quite

intense because one of the problems with MDR is that it has a lot of gray areas.

…the problems is that the MDR is quite gray; they do not really discuss what is abso-

lutely needed and they also do not agree on what is absolutely not needed so they leave

a little bit of a gray spot for you to interpret yourself. So, (…) we took all the documents

and safety measures we could find and integrated everything into the workflow. (…)

nobody wants to be that first failed case so everybody tries to stay on the safe side. (ME

– Hospital 2)

Lack of reimbursement codes for hospital 3D printing-based programs was an additional issue.

Two of the managers stated, political support is necessary to help insurance providers and the

national DRG systems (Diagnosis Related Groups) with the reimbursement of 3D printed pa-

tient specific solutions.

There is a need for political support regarding the reimbursement of certain procedures

such as the creation of anatomical models based on additive manufacturing, the digital

planning of surgical guides and the printing process. ...basically, besides the dental

realm, nothing is reimbursed at the moment. (MB – Hospital 1, 2020)

At the moment we have no remuneration or tariff policies for patient specific solutions.

There are some exceptions like for targeted therapy and oncology (…) but to introduce

additional costs in the healthcare system you have to fight for a long time in order to

be covered by either the hospitals or insurance companies (…). It is difficult for hospi-

tal economists and administration to understand why they should pay for something

which in their opinion may not be necessary. (…) Hence, you need a concept of remu-

neration. (MA – Hospital 1, 2020)

Another factor influencing implementation is the policies of the hospital for the allocation of

health care resources. If the hospital has budget issues, then patients may not get the right

treatment because hospitals are focused more on withholding and preserving existing


51

resources. The scarcity of resources affects in addition how the hospital decides to provide

healthcare service and who gets treated. In the end, it is just a matter of priority.

The red figures in the hospital budget has been an issue and it is getting worse and

worse. (…) And so, the questions that comes up in budget related situations are: what

is important? what are our priorities? Who should we treat? (MD – Hospital 1, 2020)

The decision regarding the allocation of resources is influenced by the politicians and therefore

the support of political leaders could be helpful for the implementation of new medical tech-

nologies because it increases the chances of sufficient resource allocation. Table 13 gives an

overview of how MDR affects the implementation of PSIMs. The “+” sign indicates a positive

perception while the “-” sign denotes the opposite.

Table 13: The impact of MDR on the implementation of PSIMs.

Outer setting

Medical device

regulations

- Uncertainty on how to operationalize the new regulations into the workflow/produc-

tion process.

- Sparsity of notified bodies.

- Lack of clear and straight forward regulatory guidelines on the requirements of a cer-

tified workflow that produces PSIMs and the difference between being a business unit

that produces implants and being a unit that sells them.

- Expensive to acquire a certification.

+ Necessary to include MDR-experts in the implementation process of PSIMs.

- More strict regulations are needed to be able to spot unauthorized implants.

+ More specific guidelines to help the beginners. The formulation of regulation should

also consider beginners too.

- Involves a lot of bureaucratic work.

- Has a lot of gray areas.

Reimbursement

+ Need for political support for better allocation of healthcare resources.

- The allocation of resources is a matter of priority.

- Lack of reimbursement codes for 3D printed patient specific solution.

5.1.3 Inner Setting

The inner setting as a domain represents the internal forces or factors that affect the implemen-

tation of PSIMs in a hospital setting. The constructs that were investigated were structural

characteristics, network and communication, tension for change, organizational incentives and

rewards, leadership engagement and access to knowledge and information. Hospital managers

were asked how these constructs influenced implementation.

Structural characteristics

In the question of what kind of structural changes the implementation of PSIMs would require,

all managers agreed that if a hospital wants to use more of this technique and make it a daily

routine then it is a must to build its own 3D printing facility which at the beginning will focus

only on providing anatomical models until it substantially evolves into a business unit produc-

ing PSIMs. However, it was highlighted that the establishment of a 3D Printing Lab in a hos-

pital environment is a quite complex procedure (Table 14).

Hospital 1 and 2 support that a centralized 3D Printing Lab is more productive and cost-effec-

tive than having 3D printers standing around the hospital. It also facilitates the communication


52

and collaboration among involved stakeholders; doctors can visit the lab, be inspired from other

doctors that use the technology and be educated on how to apply the printing technology to

their practice.

... interaction with the stakeholders is quite important. ... perhaps virtual communica-

tion becomes more normal due to corona virus; however, our experience has shown

that it is very rewarding for both sides to have a discussion over the model or over the

implant in person ... I see the lab more as a crossroad of several disciplines with the

aim of diffusing the 3D printing technology in other involved areas. (MB – Hospital 1,

2020)

Furthermore, 3D printers require people who know how to operate them. Therefore keeping

the 3D printers in one place and close to the working place makes the supervision of them

easier and ensures their sustainable use regardless “if the research project is over or the person

who operates the printer goes to another hospital” (MB – Hospital 1, 2020). Currently it might

seem easier to outsource the development and production of PSIMs because it is quite expen-

sive to have it in-house. However, Hospital 2 explains the importance of keeping at least the

development of implants in-house. It was highlighted that keeping the design and development

of implants in-house saves a lot of time than it would have if it was outsourced. If the develop-

ment of PSIMs is outsourced, then the external company would have to make five to ten itera-

tions and discussions with the surgeon before the designer or developer from the company

could develop an implant the surgeon needs. All those iterations and discussions between sur-

geon and the company will make the process time consuming.

If you have an external company like Materialize for example then you have to send

them an email and after a few days you get an email back with an adjustment only to

realize that the adjustment is not ready yet or is not what you needed and then you have

to send another message asking them to readjust it and then wait for them to respond…it

is really time consuming… On the contrary, if you have the whole process within the

hospital in the same corridor as the surgeon then you can just walk into his office, show

him the model and he will show you what to alter. And within a couple of hours or

even a day or two we can have a finished implant. (ME – Hospital 2, 2020)

Having a 3D Printing Lab in-house will help the clinics gain more experience on the technology

and use it more often. To strengthen the argument the implementation of 3DP was metaphori-

cally compared with the implementation of CT scanner. When the first CT scanner was intro-

duced in the market, it was easier for the hospitals to outsource the medical imaging procedure

to an external company. As the CT-scanners got improved, they became easier to use and every

doctor wanted to have them consequently forcing hospitals to incorporate companies with ex-

pertise in the technology into their organization.

If you want to use a technique more and more until it becomes a daily care, then you

want your own CT scanner. you do not want to refer all your patients to external com-

panies because they are more knowledgeable. You want to incorporate such a company

within your own hospital, and this is how, for instance, the radiology Department was

developed. Today you can just send the patient for CT scanner and within 15-30

minutes he is back in your clinic. I think 3D printing will have the same fate. (ME –

Hospital 2, 2020)

One of the respondents supported that in-house additive manufacturing is not only an imple-

mentation facilitator but also the future of the technology. As an example, he referred to the


53

efforts of his hospital where a 3D Printing Lab is established and is oriented in providing and

developing patient specific solutions. Healthcare providers with their own 3D Printing facili-

ties, being able of producing their own implants is the future of healthcare.

…I think this will definitely be the future; As 3D printing gets more and more improved

each hospital will have its own 3D Printing Lab in house or have a certain chain of

hospitals that share one lab together where the implants are made. This new lab or

facility can of course be a certified company located inside the Hospital making im-

plants by themselves. Big companies will not be necessary anymore for distributing

implants. (MC – Hospital 1, 2020)

In Hospital 1, the current workflow of 3D printed models and implants is very straight forward

and streamlined consisting of standard operating procedures. The process that was followed to

establish the 3D Printing Lab was not planned and structured rather “an organic development”

was followed, and several infrastructure requirements were necessary to be fulfilled.

...it is necessary to have available rooms for hardware and software, network infrastruc-

ture, policies to cope with the security issues, financing, established sterilization pro-

cesses, support from different stakeholders in the hospital such as administration, legal

advisers, nurses... This is something we established, or we learned ... after starting with

some printers. We gained experience and learned what was necessary... It was more of

an organic development. (MA – Hospital 1, 2020)

Another factor that plays important role in the workflow is the proper network that will make

the accessibility and ordering of 3D models and implants faster and easier. Hospital 1 has in-

tegrated the ordering system of the 3D Printing Lab into the network of the hospital. There is

an electronic medical health record system wherein the doctor can open patient’s file and order

a 3D printed model by a mouse click. Another tool that is used for facilitating the workflow is

a cloud-based solution for monitoring the printers 24-7 remotely.

…we have established a kind of cloud solution for the printers so that we can access

them from everywhere. …we can check remotely if the printer is working or not; for

every printer we have a camera system so if there is an error, we will get the message

and can start working from everywhere. All you need is just an Internet connection.


Proper maintenance support and plan is also something that should be considered when

implementing 3D Printing Lab. Hospital 1 describes a case where IT maintenance had

to, sometimes, interrupt the monitoring of the printers without considering alternative

solutions to maintain the continuity of the workflow.

…sometimes we had the security officer of our IT in the lab saying that we recently had a break

in through the printer platform into the University Hospital network and therefore the cloud

services had to be shut down temporarily... It was difficult for us because we needed an alter-

native to continue monitoring the printers …so we had to work on new ideas by ourselves and

develop something. (MA – Hospital 1, 2020)

In a follow-up question of where the 3D printing should be located, Hospital 1 replied that it

has its 3D Printing Lab close to the radiology department. There are also several rooms avail-

able in the Department of biomedical engineering located 15-20 minutes away from the hospi-

tal by public transportation, but this is regarded as a disadvantage:


54

…this is a drawback; I would always recommend if you would like to start, you have

to start on the medical campus, not somewhere remotely and that is very important in

my opinion. (MA – Hospital 1, 2020)

The main challenging aspect for Hospital 1 is how the current workflow can become more

“professionalized” so that it can respond to regulatory requirements and to future high demand

of models and implants (high caseloads). Deploying such a setup is expensive and among other

things, it requires a payment system for patient specific solutions, something that is character-

ized as “quite consuming and painful process to establish” (MA – Hospital 1, 2020). Hospital 2

has no affinity with the radiology department as Hospital 1. Instead, they have chosen to col-

laborate with the department of Medical Technology and Clinical Physics because they have

the certificates to produce medical devices.

Our hospital is dedicated in the technical cluster. They have the certificate, an ISO

13485, to produce medical devices. It is nice to work under their umbrella and super-

vision because we can produce medical devices and also be guided through the process.

(ME – Hospital 2, 2020)

Table 14: The required structural changes to facilitate implementation of PSIMs.

Inner setting: Structure

+ A centralized 3D printing facility fosters communication, diffusion and accelerates the learning curve of

employees. Developing implants in-house saves time.

+ PSIMs workflow should be designed to respond to high caseloads.

+ Need for standard operating procedures to accelerate development process.

+ Digital systems that facilitates and accelerates ordering process and monitoring the printers.

+ Maintenance plan and support to keep printers up to date and running.

+ The 3D printing facility should be located in the medical campus.

Networks and Communication

All managers confirmed that the development of PSIMs is a collaboration among several stake-

holders with well-defined job responsibilities. One main challenging aspect of the collaboration

is the language that each stakeholder uses. One of the managers pointed out the importance of

creating a shared language without complicated terminologies and making sure that everyone

is on the same page through regular communication. Iterative communication among stake-

holders is a facilitator to spot, in advance, errors or misunderstandings.

The engineer has a certain understanding about anatomy and certain “know-how” about

the situation, the radiologist has another understanding and the surgeon has another

understanding, so it is quite important that one uses a clear language so that you all

know what you are talking about. ...on the other hand, if the surgeon is not on the same

page with the engineer or the engineer is not on the same page with the treating sur-

geon…it will show sooner or later in, at least, one of those iterations. (MB – Hospital,

2020)

Two managers clarified that engineers with pure engineering background will find difficult to

understand the clinical requirements and the anatomical features of an implant.

They understand how to design the implant but the idea or the knowledge behind it, is

very limited. You have to explain everything regarding the medical information

needed. …sometimes it happens that they put a screw in an area where the nerve might

be. (MA – Hospital 1, 2020)


55

A second example was provided regarding the communication challenges between engineers

and surgeons. The example was about a surgeon who asked an engineer to design a saw guide.

The engineer provided a design of the saw guide which was regarded by the surgeon as very

well-developed but not adequate for the patient.

The engineer shows it to the surgeon and then surgeon says “well it is a really nice saw

guide but to place it on this certain part of the bone you need to release three muscles,

dissect the vessel and remove a nerve” and that will not be good for the patient. Of

course, the engineer cannot think of what muscles are attached to a certain body… He

just prepares the STL files or designs an atomic model and thinks he can design any-

thing. (ME – Hospital 2, 2020)

To cope with the communication challenges between surgeons and engineers it is recom-

mended to recruit biomedical engineers with modeling skills or engineers with medical back-

ground. Another solution would be to use an intermediary who will facilitate communication

between the two parties.

…what you need is a technical medicine graduate who will be capable of translating

surgeon’s needs into the language of the engineer and transfer the message to the engi-

neer. In our project we had two people who were the link between the surgeon and

engineers. One of them was me… I'm not really from a technical medicine facility but

because of my experience in medical 3D printing I know a bit what engineers do. (ME


There was only one manager who, although admitting that there are differences in language

between doctors and engineers, argued that having communication difficulties is something

that it is encountered everywhere, not only in medicine but in daily life also; even between

doctors and nurses who also have a different language and different attitude.

I think that when you are working in a multidisciplinary team you have to learn how to

communicate. Some people are good in communicating and others are not. (MC – Hos-

pital, 2020)

A summary of the main points in this section is provided in Table 15.

Table 15: Statements regarding internal communication.

Inner setting: networks and communication

+ The development process of PSIMs is a collaboration among several stakeholders.

- Engineers without medical background do not understand the clinical requirements and the anatomical fea-

tures of the implant.

Communication among stakeholders becomes easier if:

+ job responsibilities are well-defined.

+ there are regular meetings and iterative communication.

+ simple language is used, and advanced terminologies are avoided.

+ the engineer has a medical background or the biomechanical engineer with modeling skills.

+ Communication difficulties in multidisciplinary teams is a common phenomenon. It is all about having

good communication skills.

Tension to change

The healthcare system was described by managers as conservative meaning that any effort of

implementing something new will be impeded by internal inertia. The main obstacles were


56

considered to be the lack of sufficient interest to overcome the barriers to market entry and the

lack of innovative capacity.

There have been efforts at the hospital to implement 3DP into medical practice, but the

problem is the lack of innovative capacity. Also, the interest in entering such a market

is not that high. I think that when you are interested…you are making sure to collabo-

rate with the right people; people who can build the knowledge base of your business

and expand it. …this is definitely an area that needs to be improved. (MD – Hospital

3, 2020)

Resistance to change can come from co-workers and superiors in the form of rationalized state-

ments to discourage any efforts of implementing the innovation. Therefore, it is requisite to

form alliances, even outside of the hospital, that will financially support the implementation

and hire people who will have the competencies to conduct the implementation tasks.

if you ask me…the main obstacle is when people say “you're not allowed to do this”,

“we cannot afford to do it”, “you do not have time to do it”. So, you must fight these

people; sometimes you even have to argue with your boss to get financial support. If

you do not get funding, then you need to get it from somewhere else. That is why it is

important to form alliances and build a strong team. (MD – Hospital 3, 2020)

One manager supported that resistance to change has always been an issue because there are

always people who prefer to maintain the old conventional methods since it has been proved

that existing methods are working. In the end, it is all about practitioners’ beliefs and attitudes

towards PSIMs and new technologies in general.

If practitioners want to keep treating patients as they learned 30 years ago then the

implementation does not stand a chance. So, all these people who are attached to the

traditional implants have reasonable arguments; we have seen the advantages of PSIMs

but still, there are disadvantages because the technology is not at a level we want it to

be. For example, standard implants have much higher quality, but this will change over-

time and in 20-30 years, patient specific implants may become the new standard. (MC


Staying to conventional methods is currently the biggest obstacle for 3D printed patient specific

implants and is regarded as a psychological drive which is associated with tendencies of risk

aversion and the need for staying on the safe side. To better understand this, the old Columbus

problem was mentioned.

…either you jump on your ship and go out or you stay on the harbor and be safe. This

also has to do with entrepreneurship in which you are aware of the risks and drawbacks,

but you keep going on because you believe in this. If you do not have this strength,

then it will be difficult to bring something new into the field. (MC – Hospital 1, 2020)

One way to cope with resistance from co-workers is to include them in the development process

of PSIMs. In this way the doctors will have the opportunity to witness that the engineer can

develop what the surgeon wants and together, through regular communication, they can make

a difference.

Making doctors part of the design process gives them the feeling of product ownership

and the power to influence the product… and so they might become less hesitant to use

the technique. (ME – Hospital 2, 2020)


57

Table 16 gives an overview of the main statements associated to the construct “tension

for change”.

Table 16: Statements related to the construct “tension for change”.

Inner setting: Tension for change

- Lack of sufficient interest.

- Lack of innovative capacity.

- Maintain the old conventional methods.

+ Make clinicians part of the development process.

+ Form alliances and build a reliable implementation team.

+ Requires entrepreneurial mindset and strength to cope with resistance to change.

Organizational incentives and rewards

In the question of whether the hospital gives any rewards to encourage practitioners to engage

using PSIMs, all respondents replied negatively. One of the interviewees explained that the

hospital is always cost driven and if the innovation does not provide obvious profitable ad-

vantages then there will be no support.

For them it is too expensive. They can see that PSIMs is an innovation and that we need

it. They are open to suggestions but there is no special reward at the moment because

the hospital is always looking on the numbers at the end of the year; in other words, we

cannot put any money there so you have to do it by yourself. (MC – Hospital 1, 2020)

Another manager elucidated that hospitals are not eager to encourage other doctors because

most of their funding now comes from the government budget components which is a fixed

amount of funding. This means that if the hospital wants to invest more into 3DP then they will

have to cut budget away from another project or department. Instead of doing that Hospitals

are working with insurance companies to get financial support.

…when insurance companies decide to pay their share I think then the hospital will

encourage the surgeons to use PSIMs because PSIMs are quiet a novelty which the

hospital can use to promote the fact that they have 3D guided surgeries instead of just

conventional surgeries. (ME – Hospital 2, 2020)

There was one manager who although admitted that there were no monetary rewards, viewed

flexibility and high degree of autonomy as a counterweight to other types of rewards. However,

he pointed that flexible working conditions usually tends to lead to overtime.

…the good thing is that I'm in a position where I can decide by myself, more or less,

what I would like to do. And I have the support by my head of the Department (…) but

in the end, you end up working much more than you usually had to depending on your

contract with the hospital. (MA – Hospital 1, 2020)

A synopsis of the main points presented in this section is given in Table 17.


58

Table 17: Statements related to the construct “organizational incentives and rewards”.

Inner setting: Organizational incentives and rewards

- No rewards. Hospital are cost driven.

- Limited financial resources to provide rewards for something that is regarded expensive.

- Need for financial support to start encouraging surgeons to use PSIMs.

+ Work flexibility and high degree of autonomy over monetary rewards.

- Work flexibility tends to lead to overtime.

Leadership engagement

All hospital managers concurred that the role of management is to drive the delivery of

healthcare service, therefore their engagement in the implementation of a new technology is

important. For hospital 3 management is focusing more on the profit and how to keep costs

down rather than on how to invest on new technologies.

Today management is a problem. They do not understand what is going on because

they are not medical people. I mean they are there to deliver service to the population

and they have to look after the budget. It is always a question of budget. So, if you

introduce something new, you have to convince Hospital administration which is

driven by politicians…you have to know how to negotiate with them and be clever.

(MD – Hospital 3, 2020)

It is also important to find a sponsor who will support the research and development related to

the medical technology and will see the commercial potential of it; Invest in cost-efficient

medical technologies that will improve the delivery of healthcare treatment and optimize the

utilization of resources so that everyone can get the right treatment. Respondents from Hospital

1 acknowledged that without management support it would not be possible to startup the 3D

Printing Lab. In their case, one of the major contributors was the head of radiology who pro-

vided funding and rooms to be used free of charge. They gained also access to premises in the

Department of Biomechanical Engineering. Then the hospital administration provided grand

innovation funding to purchase certified medical software and printers. Management support

had also a huge impact on the reputation of the 3D Printing Lab. This is what one of the re-

spondents called “marketing effect”; namely that the 3D Printing Lab gained a lot of attention

once “the highest board of the University Hospital declared it as an innovation project”.

…we got, let us say, a kind of marketing effect giving the perception that what we do,

is our daily work and is perceived as important and that the 3D Printing Lab is officially

more or less a part of the University Hospital organization. (MA – Hospital 1, 2020)

One area of improvement that Hospital 1 is currently working on is to get financial support for

future employee compensation and time to dedicate in the development of 3D Printing Lab.

People from different departments work here but we still have to fund the people which

we employ by ourselves. …we only have 20% full time equivalent… that means that

some may have one day per week to work officially in the Printing Lab but for me, I

need to find the time where I can invest my efforts on my work in the print lab. Usually

I have to work at night or in the evening or on the weekends. I need to find some time

to invest during my daily clinical business. (MA – Hospital 1, 2020)

Another manager elucidated that it everything depends on whether the management believes

in the technology or not. If the administration are people who prefer to continue “doing things


59

in the old-fashioned way” then support will not be given, and the implementation will be “a

real struggle”. As an example of ideal management support, the respondent referred to the for-

mer chief of his department who is regarded a pioneer in 3DP technology.

He provided the biggest support a doctor can ever wished for. He was a fan of 3DP

technology and brought it into the hospital with the thinking that we will get experience

He drove every effort of the implementation by pushing for more research, more fund-

ing, more grants to make the state-of-the-art standard technology and overcome the old

traditions. The new networks he opened in the AM industry brought people with dif-

ferent competencies together. He also had close communication with us giving a lot of

support. (MC – Hospital 1, 2020)

The respondent clarified that his chief supported employees and co-workers in their thinking

that 3DP will be the future and that they must head in this direction. He encouraged them to

bring the technology to a top standard and offered reassurances regarding financial support and

assistance when needed.

For hospital 2, there was no management support to open the 3D Printing Lab. Once they

proved that the lab would be viable, the first few designers were recruited. After that, more

departments got enthusiastic because of the quality of 3D printed products.

We needed first to prove to management that we had the right to exist. Eventually they

saw the quality of the products and thought that it would be nice to do this more often.

(…) It was not an easy implementation. (ME – Hospital 2, 2020)

Table 18 provides a synopsis of the main points in this section.

Table 18: A synopsis of how leadership engagement affects implementation of PSIMs.

Inner setting: Leadership engagement

- Management focus on profit and not on investing in new medical technologies.

+ Purpose of management is to invest in cost-efficient MedTech, optimize utilization of resources, ensure that

everyone get the right treatment.

+ Management support for accessing premises; gaining funding and formal authority; fostering implementa-

tion; arranging workshops, opening new networks, facilitating collaboration with the industry.

- Implementation without management support is a real struggle. Need for evidence that the new technology

is viable.

Access to knowledge and information

All managers supported the necessity of annually organizing workshops and seminars in 3DP

and medical applications since there is not any formal education in academic institutions that

combines all the necessary knowledge to cope with the challenges of 3DP implementation in

healthcare (Table 19). One of the managers clarified that organizing training events is not the

initiative of the hospital. The initiative has to come from the 3D Printing Lab itself whereas the

responsibility of the hospital is to support these initiatives.

The initiative has to come from the print lab itself. We (the practitioners) are responsi-

ble for distributing the technology and knowledge into the world. The hospital is not

the real driver of this. (MC – Hospital 1, 2020)


60

Table 19: Statements related to knowledge and information accessibility.

Inner setting: Access to knowledge and information

- No formal education in academic institutions that provide courses in 3DP and its medical applications.

+ Necessity to arrange annual workshops and seminars.

+ Arrange training opportunities should be initiated by practitioners and supported by the hospital.

5.1.4 Implementation Process

The four main steps in an implementation approach consist of planning, engaging, executing,

reflecting and evaluating (Alexander, Kirsh et al. 2009). Since research participants have not

implemented PSIMs into their daily practice the focus of the conversation was mainly on the

implementation of the 3D Printing Lab. The constructs that were discussed were implementa-

tion plan, key stakeholders engaged in the implementation and few comments regarding the

evaluation of the implementation process. Implementing a new medical technology (MedTech)

into a hospital was likened by one of the participants to a “svänghjul” which means a big wheel

that you have to push very hard in order to get it start rolling.

At the beginning it rolls very slowly, and then after years of effort it starts accelerating.

You have to “push” for more innovation in order to finally see some significant impact

and influence. It is generally a common picture in the industry. (MD – Hospital 3, 2020)

Implementation plan

All managers agree that it is necessary to have proper implementation plan when it comes to

3D printed custom-made implants. Introducing an innovation in a hospital setting involves the

corporation of different departments. What makes the implementation of an innovation difficult

is the collaboration between different departments. The hospital may have the resources to

successfully implement an innovation but without proper guidelines to communicate the con-

cept to employees, and to coordinate implementation, delegate responsibility and allocate re-

sources, people will not engage.

People usually want to do their daily jobs…if you start with something new, they will

say “Oh, okay this sounds very interesting. Could you write a business plan or a con-

cept” …you have to explain everywhere what you are planning to do, why it is im-

portant, how you would like to do it… I would say that in 75% of the cases you have

to do the work of others. (…) The Departments function very well on their own but to

come up with something new, it is very difficult. (MA – Hospital 1, 2020)

Hospital 1 acknowledges that planning the implementation is an area of improvement. It was

explained that the implementation should be the responsibility of someone with knowledge in

implementation management and Medical Technologies (MedTech), not the responsibility of

a medical doctor.

The problem is also here that you have to fight on so many different areas that even if

I stop immediately working with patients, I will still not have the time to cover all the

topics. But someone who is expert in implementation, well trained in medical technol-

ogies and knows the different stakeholders in the hospital could be an asset. (MA –

Hospital 1, 2020)

Hospital 1 asserts that in order to achieve a successful implementation with this innovation it

is necessary to develop a new business model, establish completely new structures and


61

operational procedures. Implementing 3D printing in a hospital setting requires “more than just

buying a 3D printer”.

...there have been cases at other hospitals where the administration bought in printers

which in the end proved to be not the right ones for the tasks. …it is much more than

just buying a printer because… for the translation of medical 3D printing, there are so

many different aspects that you need to respect that I can more or less already predict

that the hospital that would just buy a printer will not be happy after some weeks. Even

if they manage to start… without proper implementation processes, it will not work.


Hospital 2 shares similar opinion and adds that successful implementation requires time and

proper guidelines to facilitate adoption efforts.

Not a lot of people know how to engage with patient specific implants, so we definitely

need guidelines on how to go about it. In addition, we need to optimize the workflow

and the legislations, but this is not going to happen within a week nor within a year. I

think in the upcoming years we will still need to work on how to implement new tech-

niques within hospitals. (ME – Hospital 2, 2020)

Hospital 2 also named the kind of strategic tools they used for the establishment of their 3D

Printing Lab. They used business model canvas to convince upper management that their idea

was viable and waterfall methodology to plan implementation. According to them using a busi-

ness model is a good way of showing to other departments the benefits of centralizing the 3D

Printing Lab within one legal entity.

Engaging

Engaging appropriate individuals early in the implementation is important (CFIR Research

Team-Center for Clinical Management Research, 2020). All respondents referred to the exist-

ence of a multidisciplinary team that drives the development of patient specific implants. The

team may be composed of:

➢ The surgeon who conducts the surgical procedure and supervises that the implant meets the

clinical needs.

➢ An external partner, biomechanical engineers, or a 3D Printing Lab who produces the im-

plant.

➢ Engineers who design preoperative 3D models if the hospital has a 3D Printing Lab in-

house. If not, then it is the external partner who takes care of this task.

➢ Extra personnel responsible for post processing the implant. For hospital 1, this task is taken

care of by engineers and nurses.

➢ A radiologist who is involved only in complex cases. According to Hospital 1, the compe-

tence in radiology, in most of the cases, can be covered by (maxillofacial) surgeons them-

selves.

➢ Medical technicians who will facilitate communication between engineers and doctors.

When it comes to the main stakeholders engaged in implementation efforts for the establish-

ment of in-house 3D Printing Lab, only Hospital 1 replied to this question. Initially, there were

four main stakeholders involved: two well-connected physicians responsible for the coordina-

tion of the development process and implementation; and two managers (heads of departments)


62

who supported the implementation by providing premises and financial support. During the

interview it was noticed that the two well-connected physicians were well-known by the other

interview respondents who characterized them as “well-connected”, “expert in his field”, “the

person you turn to when seeking advice on 3DP”, “a nice guy”, “determined” and “challenges

the status quo”.

Reflecting and Evaluating

Only Hospital 1 gave answer to this construct. It was mention that there were not specific

measurable objectives to assess the implementation of establishing the 3D Printing Lab. One

of the managers commented that this is not a job for a doctor.

…we do not have the time. Perhaps we need an implementation manager; someone who will

be the link to all of this. (MA – Hospital 1, 2020)

Table 20 gives an overview of participants statements regarding constructs implementation

plan, engaging and reflecting and evaluating. The “+” sign indicates a positive perception

while the “-” sign denotes a negative perception.

Table 20: Statements regarding the implementation process of PSIMs.

Implementation process

Implementation

plan

➢ + Need for guidelines on how to navigate implementation of innovations in a hos-

pital setting.

➢ + Need for implementation managers.

➢ Implementation of 3DP is more than just printing objects. It is about the transla-

tion of medical 3D printing.

➢ - Few people know how to engage with PSIMs.

➢ + Use of business model canvas to communicate the idea of 3D Printing Lab to

management.

➢ + Use of waterfall methodology to implement the idea.

Engaging

➢ + Multidisciplinary team consisting of nurses, surgeons, radiologists, internal or

external engineers, intermediaries to facilitate communication between surgeons

and engineers.

➢ + Main implementation stakeholders: two well-connected physicians and two hos-

pital managers. Words describing the two physicians “experts in their field”, “per-

son you turn to when seeking advice on 3DP”, “a nice guy”, “determined”.

Reflecting

and

evaluating

➢ - Lack of specific, measurable goals to assess the implementation of 3D Printing

Lab.

➢ - Evaluating implementation process is not a job for a doctor.

➢ + Need for implementation managers.

5.2 Medical doctors’ characteristics and perspectives This chapter presents the answers and views of medical doctors on the factors influenc-

ing the implementation of 3D printed custom-made implants. MDA has six years of

3DP experience and is working at the department of traumatology in Hospital 1, treating

pelvic and lower extremity injuries. 3DP in his department is mainly used to treat pelvic

fractures in trauma cases where people have been injured and have their fractious and

bones stabilized with plates or screws and implants. He got involved with 3DP upon

request from the maxillofacial surgical unit.


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We have a maxillofacial surgical unit here that is conducting surgery on the face after

trauma and they use 3D printing on a regular basis. They asked us if we could see any

potential for 3D printing use in trauma surgery and so we started using it in a simple

pelvic surgery. (MDA – Hospital 1, 2020)

MDA does not use patient specific implants because the cases he is handling are simple. Alt-

hough he can see the benefits with PSIMs, for the time being he does not see the necessity for

making the daily process more complicated.

At the moment, I do not see the need for patient specific implants in trauma surgery. I

think we have implants that are relatively good and if they do not fit 100 percent then

we can bend them until they fit. I do not see any advantages by making the process

more complicated and more expensive using PSIMs…. I can see the benefits on other

fields such as tumor or hip cases but not for the simple cases I deal with. (MDA –

Hospital 1, 2020)

MDB consultant at the department of neuroscience and neurosurgery in Hospital 3 and works

on trauma cases where patients have been in an accident and suffer from vascular diseases,

cerebral hemorrhages and varicose veins. He has five years of experience in 3D printed models.

He got involved with 3DP after reading about the benefits of the technology on the media.

Currently, 3D printing is used to produce anatomical models. They do not have so many cases,

but their future ambition is to go into implants and start producing in-house. His role in the

development of 3D printing models is to plan the operation, identify suitable cases for 3D

printing, bring stakeholders who would be interested in 3DP together and initiate discussions

regarding 3DP.

I thought it could be good for us, not only regarding patient-specific implants but also

for educational and information purposes; 3DP facilitates the training of future doctors

and acquisition of patient consent. There is a big need for 3D models. There are differ-

ent applications that may be relevant for us. I have been a little more interested in vis-

ualizing different conditions and developing models, but the idea is to go into the pro-

duction of implants. (MDB – Hospital 3, 2020)

MDC is an oral and maxillofacial surgeon in Hospital 3 with long experience in 3D printing,

biomaterials, and virtual planning av reconstructive surgery. He is working according to three

principles: to make surgery faster, more affordable and comfortable for patients. These are the

three reasons that made him start using 3DP.

I think these are three good things to work on when developing things; I believe in

minimizing surgery times, doing it better because it is all about doing as much as pos-

sible for the patient, and simplifying things in your work where you have to collaborate

very closely with engineers. You also get better outcomes which makes you have the

strength to deal with patients who have extremely difficult problems. (MDC – Hospital

3, 2020)

Table 21 provides a synopsis of medical doctors’ characteristics such as motives, expe-

rience, skills and personal beliefs regarding 3DP and PSIMs.


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Table 21: Medical doctors’ individual characteristics.

Individual Characteristics of Medical Doctors

Skills

Orthopedic surgery traumatology; Neurosurgery – 3D printed models, surgical

planning; Oral and maxillofacial surgery -Biomaterials, reconstructive surgical

planning, 3D printing.


experience

5 to over than 15 years.

Incentives

➢ Motivated by co-workers – job requirements.

➢ Inspired by media after reading the benefits of the technology in clinical ap-

plications.

➢ To improve surgical treatment for the patient.

➢ To make the working routine easier.

Personal beliefs on the

technology

➢ Minimizing surgical time.

➢ Make it easier to deal with very difficult patient cases.

➢ Good aid to train future doctors.

➢ Facilitates communication with the patient – patient consent.

➢ Stimulates doctors to handle difficult cases.


In this section we will go through medical doctors’ perception on the attributes of patient spe-

cific implants. The main topics that were raised by medical doctors were the advantages and

disadvantages of AM, complexity and cost of patient specific implants (PSIM).

Relative advantage

According to medical doctors, one of the main advantages of PSIMs is their anatomic fit which

provides better surgical outcomes and saves surgical time since the right implant fit can be

achieved without several surgical iterations.

We save time because we do not have to put the plate into the patient, take it out if it

does not fit, bend it and put it back into the patient again to see if it fits. We also get

better results because we can bend the plate atomic and place it in the right position.

(MDA – Hospital 1, 2020)

Another perceived advantage of PSIMs was the development process itself and more specifi-

cally the surgical planning stage which enables the use of patient specific anatomical models

to shape and evaluate the implant. Anatomical models are of significant aid when it comes to

illustrating complex structures and pathologies. With better visualization surgeons can clarify

the problem and understand patient needs.

3D printing in general is very user-friendly. In simple cases the doctor does not need

special skills. I think it makes surgery easier for us; we get a good understanding of the

pathologies because we can see the fractures. (MDA & MDB – Hospital 1 & 3, 2020)

Consequently, the surgical planning of PSIMs helps the surgeon to properly prepare before

surgery. Already at the planning stage the surgeon is aware of how much to do, what needs to

be done, and how to install the implant thanks to patient specific instruments (PSI).

…If we are talking about bone surgery or bone replacement which is where the im-

plants are mostly used in our department, then you know exactly how much bone to

remove and from where you have to remove it. This is done with the patient specific

guides that are developed during surgical planning. Now, if you also have the implant

ready in the operating theatre then it can be directly placed and screwed into the patient.

(MDC – Hospital 1, 2020)


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Despite the perceived benefits, medical doctors acknowledged that PSIMs cannot be developed

and produced fast enough to be suitable for urgent cases.

In trauma surgery we do not use patient specific implants because we need implants

within one or two days most. The patients that we get need to be treated within 24 or

48 hours. We cannot wait any longer. (…) I think a faster (development) process would

be an improvement. (MDA – Hospital 1, 2020)

One medical doctor specified that the parts of the development process which required a lot of

time involved data and image processing while another doctor referred to the time-consuming

surgical planning.

The time spent on processing the data and the models before you start printing is long

and therefore may not be suitable for us. (MDB – Hospital 3, 2020)

The surgical planning takes time. We need a week or two because we are currently

working with engineers from a company abroad. (MDC – Hospital 3, 2020)

Table 22 provides an overview of the perceived advantages of PSIMs from medical doctors’

point of view.

Table 22: Advantages and disadvantages of PSIMs.

Relative advantage of 3D patient specific implants

+ Saves surgical time due to anatomic fit.

+ Achieves better results in terms of implant alignment and placement.

+ Better understanding of pathologies.

+ Requires surgical planning which helps the doctor prepare sufficiently for surgery.

- Not suitable for urgent case due to the time it requires for implant development and surgical planning.

Complexity

Complexity is the ‘degree to which an innovation is perceived as relatively difficult to under-

stand and use’ (Rogers, 1995, p. 242). All medical doctors acknowledged that PSIMs require

high degree of technical expertise. Involved physicians must be a little bit of engineers and

have an interest in the technology to be able to understand it. Especially, when it comes to

image processing i.e. segmentation, clinicians have to know which parts are important to be

highlighted. One medical doctor supported that the development of patient specific models is

labor-intensive and time-consuming process. Therefore, it would be much easier if this task

was assigned to someone with computer skills and good knowledge in anatomy.

I do not think that we (medical doctors) are meant to work overtime just to produce

models. This task should be given to perhaps a technical-medical engineer who would

be suitable for this task and with whom the doctor can discuss. (MDB – Hospital 3,

2020)

Another doctor highlighted that the development of PSIMs is a collaboration which requires

effort, time and commitment to plan the procedure and get acquainted with the technology and

the way implants are being created. It also requires experience and knowledge in biomaterials

and biomechanics.

You have to understand the biological requirements; to be aware of how bones and soft

tissue react in the normal case and in compromising situations such as after radiation


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treatment. You have to keep track of biomaterials and biomechanics when performing

strength calculations to create durable implants. (MDC – Hospital 3, 2020)



Table 23: Complexity of developing 3D printed patient specific implants.

Complexity

Required skills

Technical skills (be a little bit of engineer).

Interest in the technology.

Experience and knowledge in biomaterials, biomechanics and image processing (i.e.

segmentation, they have to know what part is important to be highlighted/isolated).

Development

process

- Time consuming.

- Involves labor-intensive tasks such as segmentation.

- It is a collaboration. Requires commitment and effort to coordinate and plan.

Cost

The general opinion regarding the profitability of 3D printed implants produced in-house is a

profitable investment but to prove it is, for the moment, difficult. One of the doctors explains

that the main problem is to find suitable metrics – measurable values – that will assess the cost-

efficiency of the technology.

I think in our hospital we use patient specific implant mostly because we think it is

interesting and that there is an advantage but to prove it is difficult. Now we are putting

serious efforts to create some measurables objectives such as operating time, blood

loss, complication and quality of production but until now it is just on an experimental

level. (MDA – Hospital 1, 2020)

Two doctors mentioned that 3D printed implants are expensive because the production of them

is outsourced to external partners. There is the perception that in-house manufacturing of 3D

printed implants will be easier and financially more beneficial for the hospital than outsourcing.

We do not deal with 3D printed patient specific implants. Instead we leave that part to

be taken care of by external companies. However, it feels like as if we could easily do

this on ourselves using the 3D printing technology. Ordering implants is a big expense.

So, being able to do it yourself would be an advantage in terms of price. (MDB – Hos-

pital 3, 2020)

An overview of the factors influencing the cost-effectiveness of PSIMs is depicted in Table 24.

The “+” sign indicates a positive perception while the “-” sign denotes a negative perception.

Table 24: Cost-efficiency of patient specific implants.

Cost

+ Need for measurable values to assess the cost-efficiency of 3D custom-made implants.

- Difficult to verify the cost-effectiveness of implants produced in-house.

- Outsourcing of implants is expensive.

+ In-house development and production of implants is possible and more beneficial than outsourcing it.


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5.2.2 Outer Setting

The Medical Device Regulation (MDR) was regarded as a major external factor influencing

implementation. MDR was perceived as complicated and unclear especially the part regarding

the acquisition of CE-certification.

Getting CE-certification…that part can be a bit tricky because there are so many regu-

lations and authorities involved. It is difficult to keep up. The problem is that the re-

quirements are so many that makes the whole development process complex. Eventu-

ally you have to look at the regulations and see where there are opportunities. (MDB –

Hospital 3, 2020)

Another doctor characterized the MDR as a jungle where anyone who has looked at the regu-

lations can present the difficulties in a conference, but no one comes with solutions. Further-

more, the regulatory requirements make the whole process more complicated and time-con-

suming. It was mentioned that the translation and application of the regulatory requirements is

a “dynamic issue” that must be handled by the healthcare organizations, the industry – compa-

nies that print implants commercially – and MDR-experts.

…it is a very complex question, and we need to work together so that everyone benefits

from it. We need to think about how and where we want to use 3D printed implants in

live science-healthcare and then think a little about what it is required or how it can be

simplified for us to get the implant, done quickly. I just ordered a jaw joint prosthesis

for a young girl and it takes 8 weeks to fabricate; it is quite a long time. (MDC – Hos-

pital 3, 2020)

Table 25 gives an overview of how MDR affects the development process of PSIMs.

Table 25: The impact of MDR in the development process of implants.

Outer setting

- Unclear medical device regulatory requirements.

- Many regulations to keep track.

- Application of MDR makes the development process time-consuming and complex.

+ Need for regulatory simplification to accelerate the development process.

+ Requires the collaboration of Healthcare organizations, Industry and MDR-experts to cope with the regula-

tory challenges.

5.2.3 Inner Setting

The internal forces influencing implementation were associated to the constructs: structural

characteristics, network and communication, tension for change, organizational incentives and

rewards, leadership engagement and access to knowledge and information.


All medical doctors mentioned the establishment of a unit within the hospital, located prefera-

bly near the radiology department, that would provide 3D printing services to other disciplines

and show the benefits of the technology. This unit should be driven by a multidisciplinary team

that will have the authority to implement and diffuse the technology in the hospital. To establish

such a unit, it is necessary to have support from the hospital administration in terms of finance

and premises. Especially when it comes to implants the lab must be equipped with 3D printers

that can respond to the various clinical needs of every medical discipline such as supply them


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with the material they are interested in. Equipment for acquiring proper imaging data of the

patient, software to design good models as well as well-developed procedures to accelerate the

surgical planning are additional factors that must be considered. Table 26 provides an overview

of required structural changes to implement PSIMs.

Table 26: The required structure to facilitate implementation of PSIMs.

Inner setting: Structure

+ A new business unit within near the radiology department.

+ Committed multidisciplinary team responsible for the implementation of the innovation in the hospital.

+ Available premises.

+ Well-established procedures to accelerate development process.

+ Adequate equipment such 3D printers, material, high quality CT-scanner, design software.

Networks and communication

The main topics of discussion in this construct were the collaboration of multidisciplinary

teams and the communication among doctors and engineers. For the orthopedic department in

Hospital 1, 3D printing services is being provided in-house by the cranio-maxillofacial sur-

geons and the radiology department.

We in orthopedic department have a good collaboration with the maxillofacial sur-

geons. Together with our Radiology department, they are the ones who make 3D prints

for us. (MDA – Hospital 1, 2020)

For hospital 3, 3D printing services is being offered by external partners (Synthesis, OssDesign

and Materialized). One of the external partners is a 3D Printing Lab outside the hospital that

provides 3D printed models for visualization and for shaping implants.

There is not any official group. It is just me, a plastic surgeon and a craniomaxillofacial

surgeon who are interested in 3D printed implants. We meet from time to time and

discuss a couple of different things. We had planned to buy a 3D printer to have it in

the hospital, but it is quite complicated. Instead we are collaborating with an external

3D Printing Lab. They are very good. I see that in the future we will work more with

them. (MDB – Hospital 3, 2020)

When it comes to the communication with the engineers, doctors are not experiencing any

particular problems. What facilitates communication according is that the engineers are famil-

iar with the medical field and are avoiding the use of advanced technical terminologies.

I have only met smart engineers who have easily been able to resort to a medical ter-

minology and who avoid talking too much advanced technology with us. Especially, if

they are familiar with their field, it is easy to make them understand. So, there are no

problems at all. (MDC – Hospital 3, 2020)

There were also statements regarding the importance of involving radiologists in the develop-

ment of 3D printed implants. The development of an implant or using 3DP for visualization,

involves a lot of imaging process and therefore, it is beneficial to include radiologists in the

process due to their expertise in imaging acquisition and analysis.

There is quite a lot of data and image processing before printing models. Because you

might need to highlight different structures such as vessels, tumors, defects. You really

need to get good quality images before you print your models. A radiologist would be


69

helpful in this case because they know where to look, what to include or exclude during

the process. Collaborating with them is something that we have not done yet. (MDB –

Hospital 3, 2020)

One of the doctors highlighted that the most challenging aspect when dealing with a multidis-

ciplinary team is to coordinate the communication and collaboration of the involved stakehold-

ers in the development process and operational planning. It requires good communication and

leadership skills as well as willingness to invest time.

That is the hard part; To cope with it, you have to be a little eager and able to run things.

You also need to make sure that every member is a part of the surgical plan, can influ-

ence the decision-making process and contribute with feedback on the surgical plan.

(…) To do everything right you must have regular meeting which means working over-

time. Sometimes I had to sit on Christmas Eve writing the plan and work on it on New

Year's Eve. (MDC – Hospital 3, 2020)

A summary of the main points in this section is provided in Table 27.

Table 27: Factors affecting internal communication.

Inner setting: Networks and communication

+ Regular meetings and open communication with well-defined goals.

+ Avoid advanced technical and medical terminology.

+ Engineers with experience in the medical field.

+ Include radiologist to the development team.

- Challenging to coordinate multidisciplinary teams. It requires good communication and leadership skills

and time.

Tension for change

Two medical doctors mentioned that lack of innovative capacity is a factor hindering imple-

mentation. What they mean with lack of innovative capacity is that people are excited with the

technology and PSIMs but they are reluctant of using it. There have been efforts to influence

other doctors through short seminars but still the doctors are not engaging.

We had a mini seminar a few years ago but not all doctors understand or are interested

in such things. Many say “yes it sounds exciting” but they do not want to do anything.

(MDB – Hospital 3, 2020)

One of the doctors characterizes the absence of action and initiation as resistance due to lack

of time and the uncertainty on how to cope with the challenges of 3D printed implants such as

the regulatory requirements.

There is always a certain resistance before you start trusting a new technology. I think

the biggest challenge is to get an organization that has the strength to run this, handle

the uncertainty with the regulatory requirements and when it comes to the doctors – us

– we need to find time because most of our working hours go to something else. (MDB


Another doctor perceived innovative capacity as reluctance of exploiting 3DP to resolve more

advanced unsolved problems. As an example, it was mentioned that a 3D Printing Lab was

build outside Hospital 3 to help clinicians, but the business direction of the Lab is not consistent

with clinicians’ needs.


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The university took the initiative to build a 3D Printing Lab with the intention to help

here at the hospital, but printing 3D models is something we have already done, is not

impressive anymore. We need to move on. (…) The Lab is oriented in a direction that

is far away from what we are clinically interested in. This is the small gap that we must

try to bridge. (MDC – Hospital 3, 2020)

Another factor that hinders implementation is the conventional thinking that since there is al-

ready a known method that works well for years, then there is no reason of implementing a

new one. It was stated that some doctors have learned and worked in a specific way for years.

Hence, when a new technology is introduced and they realize that they have to learn to work

in a different way, even if the new way works well they do not see the reason of putting the

effort to change.

We have implemented this method for years. It is something we have always done right

and we know it has worked well for years, so we should continue with it. Why put an

effort to change it? There is no reason. This is often the traditional thinking in

healthcare. (MDC – Hospital 3, 2020)

Another doctor complemented that there should be a need to implement 3D printed implants.

He explained that 3D printed implants are not meant to be applied in every case. In simple

cases such as bending plates good results can be achieved without the use of 3D printed im-

plants. There is no need of making the process more complicated and costly.

In my opinion, we are adding an extra cost for something that is not necessary. Our

department is doing it too because we think it is a good idea to follow the example of

craniomaxillofacial doctors while in fact we can achieve good results without it. (MDA


Overall, change is something that must be initiated by the doctors and supported by the man-

agement. One of the research participants explained that the doctors have to contact admin-

istration and convince them that 3D printed implants is a profitable area to invest and that is

something the hospital needs.

We need to build a group that will have the authority and support from the hospital

administration to make changes; to connect a small unit in the hospital without thinking

in the beginning of how much money is required. (…) Perhaps we might need to go up

to the hospital management and say that we want this. (MDB – Hospital 3, 2020)

Table 28 provides an overview of the main barriers and facilitators associated to the

construct “tension for change”.

Table 28: Factors that hinder or facilitate change.

Inner setting: Tension for change

- Lack of innovative capacity: Reluctance of exploring further the potential of applying the technology in

other areas.

- Resistance to change due to lack of time to learn the new technology and uncertainty on how to cope with

the regulatory challenges.

- Conventional thinking: since existing treatment methods have worked for years there is no reason to change

them.

+ There should be a need to implement the change.

+ Changes should be initiated by doctors and supported by hospital administration.


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Currently there are no rewards to encourage doctors get involved with the implementation of

3DP. The reason for that is because the implementation of 3D printed patient specific implants

is not a priority for the hospital. There are already other methods that work without adding

additional costs. In a question of what would encourage doctors start using 3D printed implants,

three factors were named. The first factor was about the necessity of showing what it can be

achieved with the utilization of 3D printing. For example, if 3DP is known for visualizing

complex structures then a demonstration of a few 3D printed models with complex structures

or more advanced models would be a sufficient proof.

They say that you can print very fine details with 3D printing. So, if it is to impress and

convince colleagues then you must be able to show the degree of details that you can

print, otherwise doctors will not be able to see the great advantages it offers. (MDB –

Hospital 3, 2020)

The second factor is related to the fact that doctors do not have time to invest in the learning of

the technology.

…from the medical side, our working hours go to something else. Finding avail-

able tine is exactly the problem”. (MDC – Hospital 3, 2020)

And lastly, there has to be a need for implementing 3D printed implants.

There should be a need. Without it, even if I can see the benefits of the innovation, I

would still not use it. Why use something that would add extra costs while you already

have other techniques that work? (MDA – Hospital 1, 2020)

A brief description of the main points presented in this section is given in Table 29.

Table 29: Incentives that facilitate or hinder implementation of 3D printed implants.

Inner setting: organizational incentives and rewards

- No rewards are provided for encouraging engagement.

- 3D printed implants are not a priority.

+ Show the benefits of the technology.

+ Make time for the doctors to learn the technology.

+ There should be a need for the technology.


According to medical doctors, management support is one of the main driving forces for sup-

porting the implementation of 3D printing. In Hospital 1, the management is covering the ex-

penses of using services from the 3D Printing Lab. As MDA states,

Our hospital has its own lab. We do not have to deal with the economy so our depart-

ment can use 3D printing services without being charged. (MDA – Hospital 1, 2020)

For hospital 3, management support would be helpful by providing finance to build a 3D Print-

ing Lab located inside the hospital and not somewhere outside the campus.

There is a 3D Printing Lab facility, but it is not located near the hospital. I think that if

they want doctors start using this technology then it is necessary to have a 3D Printing

Lab facility inside our hospital too. We may need to see a little bit more commitment

from the management regarding that. (MDB – Hospital 3, 2020)


72

One of the doctors explained that usually people who are in management do not have specialty

in medicine. Most of them are aware that there are different disciplines and departments in the

hospital, but they do not have insight on what the departments are doing or what the latest

advanced treatment in each medical specialty are in progress.

I do not think that the management can go around and make a list with the latest treat-

ment each department uses or experiments with. Therefore, it is not easy to get encour-

agement from management. Maybe we, the doctors, have to communicate here too;

make sure that there are forums for promoting innovative treatments such as what is

the latest advancement or trend in orthopedics 2020? (MDB – Hospital 3, 2020)

Table 30 provides a synopsis of the main points in this section.

Table 30: Statements related to management support and implementation.

Inner setting: Management support

+ Management support facilitates the establishment of 3D Printing Lab.

- More commitment is required in terms of financial support.

- Most of the managers do not have a medical background.

- It is difficult for managers to be aware of the latest medical advancements in each department.


All research participants talked about the necessity of organizing regular training courses in

3D printing and medical applications (Table 31). One medical doctor was not aware that there

were training activities at the hospital organized by the 3D Printing Lab. Another doctor

pointed out that the initiative of organizing courses will not come from the hospital administra-

tion but from the doctors or the people working at the 3D Printing Lab.

We want to invest in the training of doctors. But then again, this initiative has to come

from the doctors. It is our responsibility to go to the hospital management and say that

we want this. (MDC & MDB – Hospital 3, 2020)

Table 31: Statements related to the construct “access to knowledge and information”.

Inner setting: Access to knowledge and information

- Lack of education within 3D printing and medical applications.

- Doctors might not be aware of existing training workshops and courses.

- Organizing courses or workshops is the responsibility of doctors.

- Need for doctors to ask for support from hospital management regarding training initiations.

5.3 Research engineers’ characteristics and perspectives This chapter presents the answers and views of research engineers regarding the factors influ-

encing the implementation of 3D printed custom-made implants. Table 32 provides a synopsis

of research engineers’ characteristics. The research participants in this group consisted of a

biomechanical engineering researcher (ENGA) and a mechanical engineering researcher

(ENGB). ENGA has five years of experience in 3D printing and is working in a 3D Printing

Lab that helps researchers and clinicians in the design and fabrication of custom-made objects.

The two main areas of our business are to provide support with the development of 3D

printing, to support clinicians with the production of models for preoperative planning


73

and for shaping implants and bioprinting – which is more of a research area at the

moment since the technology is quite young. (ENGA – 3D Printing Lab 1, 2020)

ENGA got involved with 3DP in his efforts to find a manufacturing method that enabled the

production of equipment tools easily, quickly and at a low price. Using additive manufacturing

has increased his self-confidence due to the empowerment and the flexibility to manifest ideas

in a very short amount of time.

It is a great feeling to manufacture something that it was just an idea couple of days

ago…and that makes you confident. You realize that you can actually solve problems

in your daily work thanks to this technology. I feel quite confident every time I man-

aged to produce something that is usable. (ENGA – 3D Printing Lab 1, 2020)

ENGB has almost 20 years of experience in additive manufacturing using electron beam melt-

ing. He got involved in 3DP through his doctoral thesis with the purpose of improving the

manufacturing technique. At the same time, he was participating in pilot studies investigating

the potential of 3DP in medical applications such as orthopedic and maxillofacial.

My first contact with 3D printing was when I conducted my doctoral dissertation. Par-

allel we started a collaboration with the hospital in Östersund where we tested if we

could print plastic models of complicated bone fractures. When we bought our own

plastic printer, I started learning on my own how to prepare the files, designing them,

and printing them etc. (ENGB – 3D Printing Lab 2, 2020)

Table 32: Engineering researchers’ individual characteristics.

Individual characteristics of Engineering researchers

Skills Biomechanical engineering researcher; Mechanical engineering researcher. 3D

printing, materials, manufacturing techniques, CAD-modelling, data processing.


experience

5-20

Incentives ➢ To find affordable, easier and faster manufacturing methods.

➢ To improve material properties and manufacturing techniques.

Personal beliefs on the

technology

➢ Enhances self-confidence, empowers employees.

➢ Increases creativity.

➢ Enables more experimentation.

➢ Solves manufacturing problems in daily work.


In this section we will go through engineers’ perception on the attributes of patient specific

implants. Main topics that were raised by research engineers were the advantages and disad-

vantages of AM in comparison to traditional methods, complexity and cost of patient specific

implants.

Relative advantage

Both engineers had limited experience on the development of PSIMs therefore the discussion

was focus more on the advantages of AM in comparison to conventional methods. Although

that was not the aim of the study the collected information proved to be very useful since any

limitations related to AM will affect the sustainability of the implants. In contrast to traditional

manufacturing methods, AM enables the possibility to create parts of higher geometrical


74

complexity such as objects that are hollow with small crevices on the inside. Complex parts

can be manufactured easier and faster without the need of skilled or experienced operators.

Manufactured with milling and machining requires a lot of operations and very skilled

workers with a lot of experience in setting up this multi operation manufacturing pro-

cedures while with 3D printing it is often quite easy to create a very complex part in 24

hours which is difficult with the traditional manufacturing methods especially if you

have a high workload so AM speeds things up. (ENGA – 3D Printing Lab 1, 2020)

In medicine, the geometrical freedom in design enables the production of patient specific ana-

tomical models which are used for visualization of complex pathological case, surgical prepa-

ration and shaping the implants. In contrast to 3D virtual models, patient specific anatomical

models improve communication with the patient and enhance surgeons’ understanding of a

patient’s unique needs.

It is easier to visualize complicated fractures or defects. The anatomical models used

for the shaping of implants give greater understanding in very complex cases. Doctors

can use a physical model to discuss with other doctors, educate the patient or the pa-

tients’ relatives and clarify where the problem is and how it is going to be solved…so

there is a completely different support in terms of surgical planning. (ENGB – 3D

Printing Lab 2, 2020)

However, the variety of materials used in AM is considered to be limited compared to the

materials used in traditional manufacturing. There is also an uncertainty regarding the strength

of materials which does not affect the patient specific models, but it may be a limitation for the

sustainability of 3D printed implants.

I think the materials are a bit limited compared to traditional manufacturing. There are

metal 3D printers as well but they suffer from their own problems of course. …It defi-

nitely has to do with the strength of the materials. (ENGA – 3D Printing Lab 1, 2020)

From the perspective of ENGB, 3DP technology is in general sufficient and there are no prob-

lems with the material properties. Nevertheless, it is possible during the manufacturing process

to occur errors because, for example, some powder pores or particles are not being fused

properly. This in turn may create small defects in the material which can soon or later cause

the material to break. Ergo, the uncertainty on the materials is since there is limited experience

on how 3D printing implants behave when they break and how the consequences of a failed

implant will affect the patient.

So, in general we have great material properties, but things can happen that can make

the printed products not perfect. We have not yet really understood when, where and

how these small defects occur or what the consequences will be. Therefore, you need

to have a system that provides quality assurance on the printed products. It is a problem

that you encounter in all sorts of different industries, not only in implants but also in,

construction, energy industry... (ENGB – 3D Printing Lab 2, 2020)

Table 33 provides an overview of the perceived advantages of PSIMs from research engineers’

point of view.


75

Table 33: PSIMs relative advantages in terms of manufacturing technique and aiding tools.

Relative advantages of 3D printed patient specific implants

AM

vs

traditional manufacturing

methods

+ Higher geometrical freedom in design.

+ Easier and faster production; even for complex structures.

+ User-friendly; does not require special skills or long experience.

+ Enables the production of patient specific models and implants.

- Limited materials. Low predictability of manufacturing errors.

- Limited experience on how 3D printed implants behave in case of material

failure and their impact on the patient.

3D anatomical vs

3D virtual models

+ Facilitates visualization, surgical preparation and shaping of implants. In-

creases understanding of complex cases. Facilitates communication with the

patient.

Complexity

The development of patient specific implants was regarded as a complicated process because

it involves both engineering and medical skills. More specifically, it requires knowledge in

additive manufacturing technologies and materials as well as experience in image analysis.

Segmentation is regarded as a challenging part in the development process of PSIMs because

it requires proper education and experience. The more complicated the geometry of the model

is the more time will be spent on segmentation and preparation of the STL files. It was men-

tioned that the segmentation stage may take up to 8 hours depending on the size of the object

and the complexity of the geometry.

Segmentation is the most challenging and time-consuming part especially when you

have to differentiate a soft tissue from another soft tissue… it involves a lot of manual

work. (ENGA – 3D Printing Lab 1, 2020)

Another challenging part in the development process is the different design and manufacturing

parameters that must be considered depending on the available AM technology and materials

as well as the correlation among these parameters. It is also a question of how these parameters

will affect the implant.

There are so many things that you have to be aware of and look after, especially from

the point of manufacturing technique; what happens if we print the implant in a ma-

chine that melts powder in the electron beam alternative in a laser beam? What kind of

powder do we have in our machines? What is the safety factor – since it changes de-

pending on the design and the choice of materials. (ENGB – 3D Printing Lab 2, 2020)

To be able to supervise the development process and minimize potential of errors, well-estab-

lished quality control procedures are required. They are also necessary to confirm and show

that the anatomical models are actually accurate enough to be used for surgical planning and

for shaping the implants. It was elucidated that the errors may occur during segmentation and

printing process. One of the engineers explained that one step of quality control is usually

taking place after the segmentation where the surgeon is contacted to see the progress of the

work and check if the regions he is interested in are included in the model or if there is some-

thing vital missing. Regarding the errors in the printing process, it depends on the resolution of

the printer.

I think from my perspective this discussion has circled around the resolution of the

printers compared to the resolution of the medical image data that we acquire and as


76

long as the resolution of the printers are higher than the medical image data, we do not

expect any problems. (ENGA – 3D Printing Lab 1, 2020)



Table 34: Perceived complexity of developing patient specific implants.

Complexity

Required

skills

- Engineering and medical skills; Knowledge in additive manufacturing technologies

and materials, experience in image analysis.

Development

process

- Time consuming.

- Involves manual work.

- Too many design and manufacturing parameters included.

- Requires well-established quality control procedures.

Quality control

procedures

+ Enhance quality and accuracy of the development process.

+ Minimize design and manufacturing errors.

Cost

The main cost included in the implementation of PSIMs are the initial investment to buy the

3D printers; the development of patient specific implants requires highly sophisticated FDA

approved 3D printers, maintenance of the machines and regular software updates to keep the

3D printers in operation. Other expenses are associated with the time spent to design the im-

plant and prepare the STL-files.

I think most of the cost comes from the time spent on preparing the files… and that

differs widely depending on how complex a model is… I expect this cost to fall quite

drastically if there is someone who has a formal education and experience in doing

segmentation. (ENGA – 3D Printing Lab 1, 2020)

One of the big conclusions we drew in several of our studies was precisely that what

costs the most was a lot of engineers' time perhaps because it takes so much time being

in front of the computer designing the implants and doing all the other tasks you have

to do before you push the “print” button. (ENGB – 3D Printing Lab 2, 2020)

High implementation costs mean that the hospital has to produce high quantities of implants to

reduce the cost per printed implant, something that is regarded difficult even if it is the largest

hospital. Due to their complexity and high cost, PSIMs are being used only as the last resort

treatment in cases where patients had no other alternative than to be treated with PSIMs. One

of the engineers concluded that today’s hospitals (referring to hospitals in Sweden) do not have

the capacity to become their own manufacturers. And hence, the production of PSIMs will be

taken care of by external partners who will provide PSIMs to several hospitals.

I do not think that in the foreseeable future Swedish hospitals will become their own

manufacturers. Probably there will be specialized service agencies to receive orders

from several different hospitals and perhaps provide PSIMs in a region at best. PSIMs

require to have a complex and expensive equipment…you need available premises,

storage for raw materials and funding and simply put… you do not get that in a hospital

today. (ENGB – 3D Printing Lab 2, 2020)

Due to high initial and development costs, PSIMs require a very large market in order to be

profitable. As an example, the market in Sweden was mentioned. Currently, the market in


77

Sweden is very small while the development cost of PSIMs is very high. This means that com-

panies who decides to operate in Sweden will have difficulties to deal with the expenses. On

the contrary international companies which operate in larger markets have bigger chances to

succeed.

Implementation is difficult because the market in Sweden has been too small while the

cost in terms of engineering hours before printing implants is very high. At the moment,

the necessary support to get PSIMs can be provided by large suppliers who operate in

Europe. These companies can survive because they take orders from a very, very large

market and thus get a more efficient process. (ENGB – 3D Printing Lab 2, 2020)

An overview of the implementation costs and the factors influencing the cost-effectiveness of

PSIMs is depicted in Table 35.

Table 35: Main implementation costs and cost-efficiency of PSIMs.

Cost

Main

implementation

costs

- High initial capital for the equipment.

- Regular maintenance of hardware.

- Support and update of software.

- Segmentation and preparation of STL-files.

Cost-

effectiveness

- Requires producing high quantities of implants to reduce the cost per printed im-

plant.

- Due to complexity and high cost, PSIMs are being used only as the last resort

treatment.

- PSIMs require a large market to be profitable due to their high development

costs.

- Hospital do not have the resources to support in-house development.

5.3.2 Outer Setting

Medical device regulations (MDR) were another topic raised. Both participants shortly com-

mented on the influence of regulations in the workflow. ENGB clarified that the requirements

of MDR enables additional bureaucratic work.

We were responsible for imparting all knowledge and everything we did regarding ma-

terials, data management, machine management and so on. There was a lot of docu-

mentation and it took time because most of the time we had to ask doctors if what we

wrote in the report was correctly described. (ENGB – 3D Printing Lab 2, 2020)

ENGA elucidated that one of the reasons of not entering yet the market of patient specific

implants is MDR.

I think there is still a lot of work to be done on the technology, the materials and also

the regulatory aspects of making implants that are introduced into actual humans.

Therefore, what we are doing now is visual models for preoperative planning, that is

our focus towards the clinicians. (ENGA – 3D Printing Lab 1, 2020)

Table 36 gives an overview of participants opinion regarding the MDR.


78

Table 36: External factors affecting the implementation of 3D printed implants.

Outer Setting

Medical Device

Regulations

- Complex.

- Involves time consuming documentation.

- Needs to be improved.

5.3.3 Inner Setting

The internal forces influencing implementation were associated to the constructs: structural

characteristics, network and communication and access to knowledge and information.


In the question of what kind of structural changes would be necessary to facilitate the imple-

mentation of patient specific implants both engineers mentioned the establishment of a central-

ized 3D printing facility that will be operated by people who can conduct regular maintenance

on the printers and offer technical support.

I think it makes sense to have a centralized 3D printing facility instead of having print-

ers scattered everywhere because you need someone who can handle the printers. It

also enables people to improve their workflow without having to become an expert in

3D printing set up. (ENGA – 3D Printing Lab 1, 2020)

It is much more than buying a 3D printer; you need personnel on the side, people who

will make sure that the equipment is working as it should, who will offer technical

support, make sure to order materials etc. (ENGB – 3D Printing Lab 2, 2020)

The 3D printing facility needs also to be equipped with different 3D printing technologies and

materials in order to be able to respond to the needs of doctors from different disciplines.

Depending on the quality of the image data and the type of surgery we use different

technologies and that also results in using different materials to respond to the demands

of orthopedic and maxillofacial surgeries. (ENGB – 3D Printing Lab 2, 2020)

Table 37 provides an overview of required structural changes to implement PSIMs.

Table 37: Required organizational structural changes to facilitate implementation.

Inner Setting: organizational structure

+ A centralized business unit.

+ Need for people operating and taking care of the 3D printers.

+ Use of different 3D printing technologies and materials.

Networks and Communication

The main subject of discussion was the communication between the doctors and engineers.

Employees with pure engineering background experience difficulties in the communication

with the doctors because although they can design, they cannot understand what they are doing

wrong or where the different components should be placed. Furthermore, there are medical

terminologies and concepts that are being used by the doctors and are unknown to engineers.

This difficulty in communication is something that subsides over time.


79

The biggest challenge is that we as engineers need to understand what a maxillofacial

surgeon is doing. It is about understanding each other’s perspectives in a working sit-

uation. In my first collaboration with the doctors there were a lot of concepts and words

that was difficult to understand…, communication in general was a huge challenge but

at the same time it was fun, very fun… (ENGB – 3D Printing Lab 2, 2020)

In a jaw surgery case, ENGB recalled that the factor which facilitated communication with the

doctors was the fact that they had in their team two surgeons who were “driven” and “incredibly

interested to lead and complete the project successfully”.

We had two very inspiring surgeons who led the project. One of them made it extra

easier for us to communicate with each other because he had an incredibly great under-

standing of engineers; the work with 3D modeling and 3DP. Without such a person, it

becomes immediately much more difficult to try explaining what limitations there are

regarding modeling, how long it takes etc. (ENGB – 3D Printing Lab 2, 2020)

From the ENGA’s perspective, if the engineer has a medical or biomechanical background

(s)he will not experience any problems in the communication with the clinicians.

Working with clinicians has not really been a problem. What helps I think is having a

cell biology or a research background and not an actual purebred engineering back-

ground. (ENGA – 3D Printing Lab 1, 2020)

Other key factors are the open and regular communication among group members involved in

the development process as well as the feedback from the clinicians who receive 3D printing

services; A working environment where exploitation and exploration are of priority.

We are brainstorming almost every day. We have a very good system of making deci-

sions and have internal meetings where we discuss the different strategies we want to

focus on. The most valuable information however comes from our users; the clinicians

who give feedback regarding the functionality of the workflow and the quality of the

3D printing objects. (ENGA – 3D Printing Lab 1, 2020)

ENGB complemented that communication problems may occur due to doctors’ unrealistic ex-

pectations regarding the possibilities of AM.

I think one of the biggest challenges with doctors is that they do not realize what the

technology entails and what are the limitations behind it. They think they can sit in

front of a computer, design the model and then just push a button and print whatever

they want but this is just an illusion… it requires a lot of prep-work (i.e. prepare the

files, check for error, prepare the 3D printers) and iterations until you achieve that

perfect fit for the patient. (ENGB – 3D Printing Lab 2, 2020)

A summary of the main points in this section is provided in Table 38. The “+” sign

indicates a positive perception while the “-” sign denotes a negative perception.


80

Table 38: Statements regarding communication between physicians and engineers.

Inner Setting: Network and communication

- Communication is challenging for engineers with no medical background or previous experience working

with doctors.

- Unknown concepts and terminologies.

- Unrealistic expectations; doctors think they can print anything.

- Lack of understanding in each other’s perspective on a working situation.

+ Helps if the engineer has a medical or biomechanical background.

+ Helps if there is an intermediary to facilitate communication between doctors and engineers.

+ Regular meetings.

+ Feedback from the doctors regarding the workflow and quality of printed object.


Training courses and workshops on 3D printing for life science applications or additive man-

agement applications where participants are learning on how to handle the different 3D printing

technologies are considered a good way to both disseminate the technology and improve im-

plementation.

It is a great way of partly exposing the technology to students and PhD doctors who

have not come in contact with 3D printing…it also sparks their imagination a bit…a

lot of people realize what they can do when they get some hands-on experience.(…)

people are coming back to us with ideas on how things can be made easier in the lab.

(ENGA – 3D Printing Lab 1, 2020)

In the question of where they seek help in case of a problem with the intervention or with the

workflow, the engineers have a variety of resources to choose from. They either seek help in

online resources or by asking more experienced colleagues, researchers and even operators

from other 3D Printing Labs. One 3D printing facility that was mention was the 3D laboratory

in Lund for its expertise in making patient specific models and handling medical imaging data.

We mostly ask for help online or with colleagues that have more experience. We also

have close contact with the 3D printing facility in Lund. They have developed their

own software for processing image data. They are very experienced and therefore we

are trying to learn from them. (ENGA – 3D Printing Lab 1, 2020)

Another communication-related factor was the importance of establishing an affiliation with

the hospital to make the ordering process easier and the 3D printing services more accessible

to the clinicians. ENGA elucidated that communication with the doctors as well as the ex-

change of documents and images is usually via e-mail. This part of the process could be im-

proved if the 3D Printing Lab had an affiliation with the hospital. In that way the doctors would

be able to supply the necessary files to the 3D Printing Lab using one system without having

to send everything through a separate e-mail. It was argued that this kind of affiliation with the

hospital would also be an effective way to disseminate 3D printing services into the hospital

since physicians would order through a system that is already known to them and used in their

daily work.

Communicating via e-mail is a bit of a hassle. I think that the process or the workflow

could be made easier by being an integral part with the hospital. If our ordering process

was handled by a system that the surgeons and doctors are already using would make


81

our lab more accessible to the surgeons because it would be easier for them to ask us

to manufacture models. (ENGA – 3D Printing Lab 1, 2020)

Table 39 provides a synopsis of the main points in this section. The “+” sign indicates

a positive perception while the “-” sign denotes a negative perception.

Table 39: Type of education-training and support that facilitates implementation.

Inner Setting: Access to knowledge and information

+ Courses and workshops within 3D printing and medical applications.

+ Support from online sources, experienced colleagues, and experts from other 3D Printing Labs.

+ Need for affiliation between 3D Printing Lab and hospital:

+ Facilitates diffusion of the 3D printing services.

+ Accelerates the ordering process.

+ Facilitates communication and the exchange of medical documents.

5.4 Summary of results Participants expressed in general a positive attitude towards AM and PSIMs. There are simi-

larities and differences in what motivates each stakeholder group to get involved with 3DP.

Medical doctors are looking for MedTech that will improve the surgical procedure, increase

patient satisfaction and enhance autonomy and self-confidence in complex cases. Engineers,

on the other hand, are focused on the development process of PSIMs in terms of improved

material properties, manufacturing and design techniques such as creating biocompatible ma-

terials or accelerate the development and manufacturing process. Since engineers do not have

any contact with the patient, their main role is to support clinicians in the development process

of 3D anatomical models and implants. Lastly, the main incentives of hospital managers are to

improve the surgical process, enhance employee experience, increase patient satisfaction, and

grow the business. Research participants expressed medium to high levels of self-efficacy re-

garding the application of 3DP in the development of PSIMs. The area where all respondents

felt uncertainty was the compliance with the regulatory requirements. For research engineers,

the feeling of uncertainty was also related to the limitations of materials properties and additive

manufacturing technologies.

All participants acknowledged that the main relative advantage of PSIMs is adaptability. The

implant can be tailored to fit patient’s bone structure in comparison with standard implants.

Perceived disadvantages were the high degree of complexity, low degree of trialability and

high implementation costs. Complexity of PSIMs was associated with their development pro-

cess which was perceived as difficult to navigate due to complex regulatory requirements; high

level of experience in implantology and imaging analysis as well as expertise in design, mate-

rials and AM technologies. Conducting clinical trials on a small scale was also perceived as

difficult due to long regulatory procedures and time-consuming preparation. The high imple-

mentation costs were associated with the financial, human and physical resources required to

implement a development workflow in the hospital. In relation to implementation cost, hospital

managers were also acknowledged the difficulty to provide evidence regarding the cost-effec-

tiveness of PSIMs compared to standard implants.


82

The external factors mentioned to impede the implementation of PSIMs in hospitals are the

lack of comprehensive regulatory implementation framework and the lack of reimbursement

for 3D printed patient specific solutions produced in-house. Internally, Hospital managers sup-

ported that the implementation of PSIMs requires new structures. Research participants re-

ferred to structural changes such as the acquisition of premises for 3D printers and storage

material; high IT infrastructure capacity; performing regular maintenance; installation of mon-

itor, security and quality management systems. Facilitating these changes will require building

a separate business unit inside the hospital with streamlined standard operational procedures.

Other internally challenging aspects related to implementation of PSIMs are the communica-

tion difficulties between doctors and engineers, lack of management commitment, lack of train-

ing programs in the medical applications of 3DP and resistance to change due to lack of inno-

vative capacity, desire for maintaining conventional methods, not enough time to learn the new

technology and uncertainty on how to cope with the regulatory challenges.

All respondents reported several mechanisms to cope with these challenges. Factors facilitating

communication involved the use of simple language without advance terminologies, regular

meetings, tasks with well-defined goals and job responsibilities among team members and col-

laboration with engineers who have a medical background. To cope with behavioral resistance

hospital managers recommended making clinicians part of the development process, building

an implementation team and acquiring an entrepreneurial mindset. Medical doctors recom-

mended creating a sense of urgency and allowing a bottom-up approach. Increasing accessibil-

ity to knowledge and information regarding PSIMs requires the annual arrangement of training

programs initiated by the doctors or 3D Printing Lab. Research engineers added the support

from online courses, AM experts and established affiliation with the hospital as factors facili-

tating the dissemination of information and knowledge regarding PSIMs and 3DP.

Lastly, when it comes to the domain implementation process, it was pointed out that imple-

mentation guidelines, measurable objectives to assess the implementation, the engagement of

a multidisciplinary team and implementation managers to monitor implementation processes

were regarded significant facilitators for the implementation of 3DP. Table 40 provides a sum-

mary of the implementation barriers and facilitators related to PSIMs identified in the empirical

study. For a detailed overview of the results refer to appendix E.


83

Table 40: A synopsis of the results from empirical investigation.

Domains Barriers Facilitators

Individual

characteristics

Not applicable High self-efficacy to use 3D printed

patient specific implants

Intervention

characteristics

Cannot be tested as thoroughly as a standard

one; Not easy to undo implementation; High im-

plementation costs including initial capital; Ex-

pensive to outsource production; requires expe-

rience and a specific skill set; time consuming

tasks in the development process; Limited expe-

rience on manufacturing errors and implant fail-

ure; financial benefits are not visible.

Easy to be modified; Increased sur-

gical quality; Complex cases are

simplified; Shorter hospitalization

time; the benefits of the technology

are easily to be seen; enhances the

self-confidence of physicians; hospi-

tal affiliation; entrepreneurial cul-

ture.

Outer

setting

Lack of structured guidelines on how to imple-

ment MDR into the development process of pa-

tient specific implants; gray areas in the MDR;

lack of reimbursement.

MDR and political support.

Inner

setting

Not enough financial, physical and human re-

sources; communication difficulties between in-

volved stakeholders; lack of innovative capac-

ity; resistance to change; insufficient manage-

ment commitment; lack of reward systems; lack

or scarcity of training opportunities.

An implementation team that meets

regularly; Annual workshops and

regular seminars; management sup-

port in the form of encouragement,

funding, access to premises, empow-

erment; create a sense of urgency;

build alliances; bottom-up imple-

mentation.

Implementation

process

Lack of implementation plan and measurable

objectives for evaluating implementation.

Recruit implementation advisors; en-

gage well-networked clinicians to

lead implementation.

ANALYSIS

84

Chapter 6. Analysis In this chapter the empirical findings are analyzed and synthesized in order to identify further

implementation factors and their correlation among them. Analyzing the empirical findings

inductively led to 18 themes: regulatory impediments, lack of reimbursement, trialability, rel-

ative advantage, complexity, observability insufficient evidence of cost-effectiveness, lack of

business model innovation, management support, resistance to change, lack of time, skill short-

age, communication difficulties, location of 3D printing facility, scarcity of resources, lack of

innovative capacity, lack of implementation plan and evaluation procedures and key imple-

mentation actors. The 18 themes were grouped into the five domains of CFIR and this is how

the content of this chapter is structured starting first by analyzing the characteristics of involved

stakeholders followed by the analysis of themes included in the outer and inner setting of the

hospital and closing with the perceived attributes of PSIMs and their implementation process.

Each theme inside a domain generated its own implementation barriers and facilitators which

are presented in a tabular form when necessary at the end of each section.

6.1 Characteristics of involved stakeholders Analyzing the characteristics of involved stakeholders led to the generation of four main

themes indicating the requirements a technology must fulfil in order to be adopted. The new

technology must facilitate the surgical process, enhance employee experience, increase patient

satisfaction, and grow the business. Facilitating the workflow comprises making the surgical

process easier and simpler by improving its quality in terms of accuracy, time, predictability,

and outcome. The technology must also facilitate the diagnostic process by providing clinicians

insight regarding patient’s needs. The more insight into patient’s needs the better understanding

doctors will have regarding patient’s pathology. Better understanding of the situation gives to

the doctor more control and empowerment. With more control and empowerment, the doctor

feels more confident and will approach the patient with motivation and conviction. The doctor

becomes “a better doctor” who can understand the pathology of his patient and provide a treat-

ment that best fit to the patient. Hence, patient satisfaction increases while doctor’s working

experience is enhanced.

Medical doctors are looking for new technologies that will facilitate the surgical process - their

“daily routine” – enhance their own working experience and increase patient satisfaction by

making the treatment “faster, easier and more comfortable for the patient”. Engineers are also

focused on the workflow but more on the technical aspect of it in terms of materials, manufac-

turing and design techniques with the purpose of supporting clinicians in the development pro-

cess of 3D anatomical models and implants.

Managers on the other hand have a broader perspective of things and therefore higher demands

when it comes to innovations. Their focus is not only on how to facilitate the workflow and

increase patient satisfaction or enhance employee experience but also on how to grow the busi-

ness. Growing the business means for them gaining a competitive advantage and acquiring a

better position in the market, thus the statement “become at least one of the best hospitals in

Europe”. Managers seem to consider not only the individual benefits but also the benefits of

the technology at organizational level. They also have more insight and experience when it

ANALYSIS

85

comes to implementation matters than the other group categories. However, what all stake-

holders have in common is their interest for more innovation and knowledge seeking a balance

between exploration and exploitation.

6.2 Outer setting The external factors affecting hospital implementation of PSIMs are the medical device regu-

lations and reimbursement policies. Analyzing these factors revealed their dynamic correlation

and impact at macro, meso and micro level.

6.2.1 Regulatory impediments

Hospital managers focused on the sparsity of notified bodies, the high cost of acquiring a cer-

tification, extensive documentation, and the lack of comprehensive regulatory framework on

how to operationalize the new regulations into the development process of PSIMs. They also

raised concerns regarding the gray areas in the MDR and concerns over whether or not the

requirements of MDR were sufficient enough to identify unauthorized implants since PSIMs

do not require CE-certification. For Medical doctors, the difficulty of MDR lies on the plethora

of unclear requirements which increases the lead time in the manufacturing of PSIMs. Engi-

neers clarified that the development process becomes more complex and time-consuming due

the additional documentation from the MDR. In general, primary data showed that there is an

uncertainty on how the MDR will be implemented into the workflow.

The uncertainty that respondents experiencing is natural since the provision in MDR does not

preserve the status-quo; the new regulations apply also to old manufactured products requiring

the highest level of transparency (Müller, 2019). Transparency means documenting everything

that is included in the process, from its beginning to its end. End to end documentation was

mentioned by hospital managers and engineers as “bureaucratic work” and “time-consuming

documentation” which indicates how intensive the data documentation is. Uncertainty is also

related to the so called “gray areas” of MDR namely incomplete or non-existent requirements

for PSIMs that leave room for the hospitals to decide for themselves how to organise the de-

velopment process for PSIMs and which regulatory requirements is necessary to be included.

Gray areas, in the regulation as well as the variety of them for each specific implant raises

concerns over the effectiveness of MDR to directly spot an unauthorized implant. The plethora

of regulatory requirements with no comprehensive frameworks to guide the application of these

requirements into the development process of PSIMs makes research participants to think that

implementation of MDR is complex. The complexity of MDR causes uncertainty which leads

to reluctance in using PSIMs. Uncertainty and complexity of MDR lead healthcare providers

to outsource the production of PSIMs increasing the costs as well as the turnaround time from

hours to weeks.

Secondary data verified the empirical findings and indicated that the reason for the lack of

structured and complete regulatory framework for PSIMs is because product performance and

patient safety standards for PSIMs are not yet established. Perhaps, this could be explained by

the answers from one of the engineers who stated that “We have not yet really understood

when, where and how small defects (in the implant) occur or what the consequences will be.

Therefore, you need to have a system that provides quality assurance on the printed products”.

ANALYSIS

86

It seems that the required tacit knowledge or experience on how 3D printed implants behave

when they break and how the consequences of a failed implant will affect the patient, is not yet

acquired. Perhaps without this knowledge it is difficult to set product performance standards.

This raises the question of what kind of quality control technologies will be sufficient to accu-

rately monitor and control several aspects of the development and production process. And will

this quality control vary for different 3D printing technologies?

Another concern regarding the impact of MDR is the lack of established assessment implant

procedures; consequently leading to a market where defective products are not prohibited from

being introduced into the market while the introduction of high quality and safe implants in the

mainstream market are being delayed. Furthermore, there is the scarcity of notified bodies

which may be an indication of lack of qualified staff to implement the new regulations. As one

manager stated “PSIMs requires experience…” and therefore to set the regulatory requirement

on the medical application of PSIMs would probably require experience which currently in-

dustry seem to not have.

Meeting the regulatory requirements can be a long and rigorous process (Morrison, et al.,

2015). The lengthy and bureaucratically complex regulatory procedures indirectly impede the

diffusion of disruptive innovation and might unintentionally lead to the creation of high-cost

models of care (Christensen, et al., 2017). This could be one of the reasons for why PSIMs are

being expensive. The precariousness experienced by research participants is interpreted by

Clayton as the effects of the changes a disruptive innovation brings. To ensure the safety of

PSIMs new regulations are required; this is happening because the disruptive innovation, in

order for it to be established, will expose the industry and healthcare to changes that have never

experienced in the past, disrupting the status quo which is one of the effects of disruptive in-

novation (Christensen, et al., 2017).

Research participants referred to factors that will facilitate the compliance to MDR and conse-

quently the implementation of PSIMs. There is a need for a regulatory framework that will

include guidelines for material selection and 3D printing technologies assessment. Guidelines

should be structured and clear so that even a young physician will be able to follow them.

Furthermore, healthcare organizations, the industry and MDR-experts must collaborate to de-

velop a regulatory framework that will simplify the regulatory process and focus more on low-

ering the cost and maximizing population health. MDR-experts can also be included in the

implementation process of PSIMs to guide clinicians on how to comply with the MDR based

on the workflow each hospital uses. Another alternative would be for physicians to visit a pro-

vider who has successfully integrated PSIMs and study how they manage to comply with the

requirements in the MDR. Table 41 is a synopsis of the regulatory barriers and facilitators

related to the implementation of PSIMs.

ANALYSIS

87

Table 41: Regulatory barriers and facilitators acting at macro, meso and micro level.

Level Barriers Facilitators

Macro

Lack of comprehensive regulatory frame-

work for MDs.

Collaboration of regulatory bodies, providers and

AM industry to address improve and simplify

MDR.

Lack of long-term product and safety stand-

ards.

Quality control technologies to accurately monitor

and control several aspects of the development pro-

cess. Scarcity of notified bodies.

Transfer restrictions for hospitals to produce

on industrial scale.

Meso

Lack of structured guidelines on how to im-

plement MDR into the development process

of PSIMs.

Engagement of MDR-experts in the implementa-

tion to establish a valid development workflow for

PSIMs in the hospital.

Limited availability to produce large vol-

umes of PSIMs affects the cost-effectiveness

of the PSIMs.

Policies for material selection and 3D printing

technologies assessment.

Visit other providers who have successfully com-

plied with the MDR.

Micro

Regulatory uncertainty and reluctance to use

PSIMs; Fear of failure.

Clear and structured implementation guidelines on

how to comply to integrate MDR into development

process.

6.2.2 Lack of reimbursement

The purpose of a payment system is to provide attractive rewards and financial incentives to

overcome the reluctance of healthcare provider to adopt innovative technologies (Barlow,

2017, p. 208; Grol, et al., 2007). Lack of reimbursement models for 3D printing-based pro-

grams is regarded as a barrier for the implementation of PSIMs. Empirical data showed that

there are no medical codes for 3D printing services produced in-house or in-office. This is

indicated by the statements from hospital managers such as “basically, nothing is reimbursed

at the moment”, “we have no tariff or payment for patient specific solutions”, implying that

payers do not remunerate expenses for patient specific solutions such as implants produced in-

house. Due to lack of reimbursement, PSIMs appear to add cost to the overhead of health care

institutions (Chen & Gariel, 2016). Not having remuneration systems may be attributed to the

absence of scientifically proven conclusions that PSIMs are more cost-effective than conven-

tional methods and that they will not cause financial problems in the future.

Lack of reimbursement systems makes difficult the establishment of payment models for 3D

printing patient specific services. It also “limits the accessibility of 3D printed medical devices

(MDs) to patients with low income and to hospitals that do not have the funding to invest in

MDs (Vinck, et al., 2018). Hospitals do not have the financial incentives to use PSIMs and

perhaps that could be one of the reasons for why PSIMs are currently being used as a last resort.

Furthermore, there is no constrains on the price and the cost of PSIMs; consequently letting

manufactures determine for themselves how much they will charge the patient (Vinck, et al.,

2018). Without proper remuneration systems, hospitals and physicians will struggle to fulfil

their value propositions of providing high quality patient specific treatment at an affordable

price for the patient (Hwang & Christensen, 2008). Therefore, lack of reimbursement models

for PSIMs are considered an implementation barrier. Primary data indicated that the process of

ANALYSIS

88

receiving reimbursement is not streamlined to facilitate the adoption of innovation. As one

hospital manager stated: “To introduce additional costs in the healthcare system you have to

fight for a long time in order to be covered by either the hospitals or insurance companies”

while another hospital manager highlighted the need for a remuneration concept that will in-

troduce reimbursement codes for medical 3D printing which is “a key milestone on the way

towards widespread adoption of 3D printing in healthcare” (AMFG Autonomous

Manufacturing, 2019). Empirical data also showed that the focus of hospitals that cannot afford

investing in new technologies due to budget issues is to withhold and preserve existing re-

sources with the risk of not providing patients the right treatment. Therefore, reimbursement

systems or models that foster the adoption of new technologies and focus on compensating

doctors to keep patients healthy are requisite to ensure that the hospital will have sufficient

resources to provide the right treatment to patients (Barkman & Forsberg, 2018). Political sup-

port is necessary for the development of reimbursement systems for 3D printed patient specific

solutions and making PSIMs accessible to low end market. Keeping patients healthy should

always be a priority. Table 42 is an overview of the main points raised in this section.

Table 42: Barriers and facilitators related to reimbursement of PSIMs.


Macro

Lack of reimbursement models for patient specific

solutions produced in the hospital.

Political support for developing a con-

cept of remuneration.

Limited price transparency – prices of PSIMs is

controlled by manufacturers who have higher bar-

gaining power than healthcare providers.

Streamlining processes related to

healthcare reimbursement; administra-

tive simplification.

Lack of evidence that PSIMs are more cost-effec-

tive than alternative solutions.

Time and resource consuming reimbursement pro-

cedures.

Meso

Lack of financial incentives for hospitals to use

PSIMs.

Reimbursement systems and models that

foster the adoption of new technologies.

Insufficient resources to produce PSIMs; use of

PSIMs as a last resort.

Micro

Not having the right tools to provide value-based

treatment. Physicians do not get compensation or

the financial support to provide high quality care at

a low cost.

Sufficient resources to provide the right

treatment to patients.

6.3 Perceived attributes of innovation The attributes of patient specific implants (PSIMs) that were regarded as implementation facil-

itators were relative advantage and observability while the attributes that were perceived as

hindrances were trialability, complexity and cost of innovation.

6.3.1 Trialability

The trialability of PSIMs seems to be a disadvantage. Occasional studies such as clinical pilot

studies on PSIMs are not easy to be conducted because they require a lot of investment in terms

of time, preparation work, documentation of procedures, human and financial resources and

advanced equipment especially if the hospital does not have an in-house 3D Printing Lab. As

ANALYSIS

89

one manager stated, “approval from local authorities and licensing, to deal with a long line of

regulatory and ethical local requirements; all of these requirements include quality control and

a lot of documentation”.

Furthermore, once the surgeon decides to implement a PSIM, the surgical system i.e. implant

and surgical tools, becomes individualized. This means that if a tool breaks or the implant does

not fit then the whole surgical operation will be affected. On the contrary in conventional sur-

gical methods where a standard implant is used, if the implant or the tool for some reason

breaks then the doctor can replace it with a new one of the shelve. But in case of a patient

specific implant, the doctor does not have a reserved implant or extra tools to be used as a back-

up in case of operational failure. Consequently, once implementation of PSIMs has been de-

cided it is not easy to undo the process. Overall, it requires a lot of prep-work and there is only

one chance to achieve proper fit. In case of a failure the consequences are high in terms of cost,

time and additional work. As one manager clarified: “if the implant does not fit or the cutting

guide breaks then the whole system will be affected. The operation will take longer, or a stand-

ard implant might even need to be used leading to higher costs”. It seems that once the imple-

mentation of a PSIM is initiated then it is not easy to undo it. Therefore, the degree of triala-

bility, namely how easy it is to conduct experiments using PSIMs on a limited basis and how

easy it is to return to old methods after implementation is considered to be low. Low trialability

means limited possibility to assess the attributes of the technology, its effectiveness and poten-

tial risks (Rudenstam & Tennby, 2018).

Respondents pointed out that PSIMs require high caseloads to be able to cover the cost of their

development therefore it is recommended to conduct clinical trials on medical disciplines with

high number of cases handled. It is also recommendable to implement changes substantial on

a very small scale at first. For example, Hospital 1 started with small desktop printers before

they acquire advanced ones. They started by providing anatomical models to craniomaxillofa-

cial surgeons and substantially went into patient specific surgical guides. Today, Hospital 1

provides 3D printing services to several disciplines and can produce implants using a hybrid

approach. Their anticipation is to become an independent manufacturing business (or depart-

ment) producing implants that will be introduced directly into the patient. Until then hospital 1

is outsourcing the production of PSIMs while at the same time building alliances and conduct-

ing research on materials and AM-technologies to prepare themselves for the implementation

of PSIMs-workflow. Table 43 depicts a synopsis of the main points raised in this section.

Table 43: Implementation barriers and facilitators related to low degree of trialability.

Barriers Facilitators

Difficult to undo implementation of PSIM due to

limited contingency – one chance to get it right. No

extra implant for back-up.

Simulate the implementation before initiation.

Capture local knowledge on how other clinicians have

managed to handle similar difficulties.

Difficult to test on a small scale due to complex

regulatory procedures. High investment on human,

financial and physical resources.

Start with cyclical small tests of change in medical

discipline with high caseloads and then scale-up the

implementation substantially.

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90

6.3.2 Relative advantage

One of the main benefits of PSIMs is adaptability; the implants can be easily tailored to pa-

tient’s anatomical morphology and adapted to the requirements of the doctor in terms of size,

design, and materials increasing patient-fit and biocompatibility. Consequently, adaptability

facilitates the surgical process because the surgeon does not have to “make repeated adjust-

ments until a best fit is found” which saves time in the operating theatre. Reduced surgical time

means that the patient will spend less time opened at the operating table which in turn means

less exposure to contamination, reduced blood loss, reduced usage of anesthesia and faster

rehabilitation.

On the contrary, conventional or traditional methods require from the surgeon to visually place

the implant in the patient. In return, the surgeon has to make repeated adjustments until a ‘best

fit’ is achieved which leads to longer operative times, increases the risk for infections, and

unreliable results in which the patient has to be subjected to additional surgeries. 3D printed

implants help to resolve these problems and enhance accuracy and predictability in surgery.

Adaptability is important for research participants because it creates value for both the surgeon

and the patient.

6.3.3 Complexity

Complexity is defined as “the degree to which an innovation is perceived as relatively difficult

to understand and use” (Rogers, 1995, p. 16). The complexity of implementing PSIMs is per-

ceived as high by the research participants partly because developing PSIMs requires a specific

set of skills; and partly because the development of PSIMs is time consuming comprising many

tasks to be supervised. Some of these tasks require manual work in which the stakeholders

must spend hours in front of the computer. One of the most commonly mentioned tasks in the

development process that was regarded as challenging was the segmentation of medical images

because it requires knowledge in the different segmentation techniques and experience on

which area of interest to highlight in each patient-specific case. Another challenging aspect in

the workflow is the plethora of unstructured regulatory requirements which produces a lot of

paperwork as well as the different design and manufacturing parameters that must be included

when designing an implant. It was pointed out that the parameters during the modelling process

were too many to handle. Difficulties in organizing the design and manufacturing parameters

indicates the lack of proper design frameworks (Martinez‐Marquez, et al., 2020). Perceived

complexity is also due to the shortage of skill set to put the technology into practice which

could also denote the need for training. Since the doctors do not have the required skill set to

understand PSIMs it will be difficult for them to use them in their daily routine. As one doctor

explained: “why should I use something that makes the process more complex and expensive

while I have already the tools that can help me achieve the same outcome”. In this case the

doctor who made the above statement was talking about how unsuitable PSIMs were for simple

cases which explains why PSIMs are used only in very complex cases. It also indicates that the

innovation has to be easy to use, simplify the process, reduce the costs and lead to better out-

come in comparison to existing alternatives in order to be widely implemented.

Three of the most commonly used by hospitals strategies to cope with the perceived complexity

of the technology are the development of a formal implementation plan with well-defined goals

ANALYSIS

91

and strategies, and promotion of adaptation through the arrangement of training programs

(Waltz, et al., 2015). Greenhalgh et al. (2004) support that “perceived complexity can be re-

duced by practical experience and demonstration” and advise to break down the implementa-

tion changes into more manageable parts then the innovation will be easier adopted. Table 44

provides a summary of the generated implementation barriers and facilitator from participants’

perceived complexity of the technology.

Table 44: Perceived barriers and facilitators due to high degree of complexity.


Easy to use during surgery but the development

process is complex; brings the need for new or ad-

ditional skills; requires high level of experience.

Promotion of adaptability by planning and conducting

regular training opportunities in the hospital to in-

crease specialization.

Time-consuming product development due to pa-

perwork and bureaucracy.

Development of a formal implementation plan with

well-defined goals and incremental changes.

Parameters during the modelling process are too

many to handle.

Proper design frameworks.

6.3.4 Observability

There were several statements denoting the high degree of PSIMs observability. One hospital

manager stated that it got involved with 3DP after his boss demonstrated for him the benefits

of the tech in his work. Another participant disclosed that when administration saw the benefits

and the quality of the products “thought that it would be nice to do this more often”. The fact

that 3DP allows people to create something ostensibly out of nothing and be able to see the

results of their work immediately and share it with colleagues encourages doctors to create and

exploit the technology more (“just the act of creating something tangible”, “I feel great every

time I create something useful.”) This is an apparent indication that the observability of the

technology is high and important condition to convince clinicians adopt the technology.

However, observability may not be enough to start using PSIMs. The following statements: “if

I do not see the need, even if I can see the benefits, I will not use it” and “Many say “yes it

sounds exciting” but they do not want to do anything.” denote that just hearing or seeing the

benefits is not enough for the majority to start using 3D printed PSIMs in surgery. This phe-

nomenon can also be interpreted using Rogers’ theory. Rogers supported that the majority of

adopters are risk averse; more specifically the early majority needs evidence that the innovation

works while the late majority are more sceptical and prefer to wait for the technology to become

well established within the market before adopting it. Considering that PSIMs are still in their

infant stage it is theoretically reasonable if most doctors are reluctant to use PSIMs. Therefore,

increasing the observability of the technology will not persuade the majority to use PSIMs but

it seems to be necessary to create awareness and achieve adoption. To summarize the tech has

high degree of observability because its benefits can be easily seen. Nevertheless, observability

may not be enough for the majority to start using PSIMs. For that there has to be a feeling of

necessity, the technology has to be easy to use, simplify the daily process and be cost-effective

(be well-established).

Participants are using different strategies to increase technology’s degree of observability. One

strategy is by arranging courses and workshop in 3D printing and its surgical applications.

Another strategy is by increasing the availability of 3D printing services inside the hospital.

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92

This seems to be done in two ways. This first one is by building a 3D Printing Lab in-house so

that surgeons can easily visit the Lab between operations, ask for a model and then continue

with their daily working routine. The second one is by linking the 3D printing services into an

order within the electronic medical record. This way the surgeon can see that there are available

3D printing services every time (s)he opens a patient’s medical record. It also accelerates the

ordering process and ensures fast and safe exchange of data such as medical images, DICOM-

files etc. Participants considered this to be an effective approach to disseminate 3D printing

services into the hospital since physicians will order through a system that is already known to

them and is used in their daily work. Having a 3D Printing Lab also creates the impression that

3D printing patient specific solutions are already an established method within the hospital.

Lastly, there is the use of various channels; both mass media and interpersonal channels are

being utilized in this case to increase observability and create awareness of the benefits of

PSIMs. As Rogers (1995, p. 194) elucidated the use of mass media aims to inform while the

use of interpersonal channels aims to persuade.

6.3.5 Insufficient evidence of cost-effectiveness

Managers and medical doctors believed to the potential of PSIMs for cost savings but proving

the benefits remains anecdotal; It is still on an experimental level. One reason for the limited

evidence is due to the lack of suitable metrics (i.e. operating time, blood loss, complication,

and quality of production) to assess the cost-efficiency of the technology and process. The lack

of metrics may also explain the insufficient transparency of cost analysis reported in scientific

articles. Another reason is the plethora of factors that influence the cost of the surgical and

development procedures. Managers referred to the cost reduction due to shorten operational

time. However, reducing operational time is not enough to prove that PSIMs will create savings

in the overall budget. Furthermore, the verification of the technology’s cost-effectiveness is

conducted via pilot studies. Each pilot study is an individualized case study tailored to the

patient and the research methods used in it. Therefore, it seems that the cost-effectiveness de-

pends also on the complexity of the case, the medical discipline – whether it is an orthopedic

or cranial case – and the number of the cases that have been conducted in each discipline. Since

PSMIs are used only in complex cases as a last resort, it becomes difficult to draw conclusive

statements on the cost savings in comparison to the standard implants. Henceforth, this indi-

cates the need for more experimentation to be able to generalize potential savings. According

to managers’ statements there is a break-even point in which expenses become savings. To

reach the break-even point a sufficient number of surgical cases must be handled annually. This

means that the hospital must produce large volumes of PSIMs. Nevertheless, producing in-

house PSIMs is not allowed by the MDR. Therefore, the question that is left to be answered is

whether or not it will ever be cost efficient for a hospital to invest in 3D printing equipment for

the development of PSIMs. If there are no conclusive statements regarding the potential savings

of the innovation then hospitals will be reluctant to “drop conventional outdated practices and

adopt new ones” (Barlow, 2017, p. 209). If this is the case then new funding formulas provided

by government and payers to motivate healthcare providers are essential for the adoption and

implementation of the innovation (Waltz, et al., 2015). Insufficient evidence of PSIMs cost-

ANALYSIS

93

effectiveness is regarded as an implementation barrier. A summary of implementation barriers

and facilitators related to cost-effectiveness of PSIMs is depicted in Table 45.

Table 45: Implementation barriers and facilitators related to PSIMs’ cost-effectiveness.


Lack of measurable variables to assess the ef-

fectiveness of the technology in each surgical

procedure.

Associate cost-effectiveness with short- and long-term

savings.

Plethora of factors that influence the cost of the

procedures.

Need for an economic framework for recording the differ-

ent factors and assessing the cost of the procedures.

Reluctance to adopt new practices. Access to new funding.

Low number of pilot studies on PSMIs. Need for more pilot studies.

Regulatory restrictions on the volume of PSIMs. Consult with an MDR-expert to specify the maximum an-

nual volume of PSIMs.

6.4 Inner setting Nine themes were identified under the domain inner setting. These themes include lack of busi-

ness model innovation, management support, resistance to change, lack of time, skill shortage,

communication difficulties, location of 3D printing facility, scarcity of resources and lack of

innovative capacity.

6.4.1 Lack of business model innovation

The benefits of having a 3D Printing Lab in-house is the independency of the hospital from

external service providers; the immediate availability of printed products to physicians; im-

proved communication and collaboration among departments and the easier implementation of

3D printed solutions in the hospital. Most of the research participants underlined the necessity

for an in-house business unit that will operate independently from the hospital providing 3D

printing services. This unit can be initiated at first as a 3D Printing Lab providing only 3D

printed anatomical models and guides to eventually become an independent unit providing 3D

PSIMs. One of the managers mentioned the need for a “concept” to convince other co-workers

while another manager referred to the use of business model to justify the existence of the 3D

Printing Lab. More specifically, Hospital 2 disclosed that the strategic tools they used to estab-

lish the 3D Printing Lab was the business model canvas and waterfall tool. Hospital 1 asserted

the need for developing a new business model to facilitate implementation of 3DP. Since 3DP

has been characterized as a disruptive innovation (DI) it is reasonable, according to Christensen

et al. (2017), not knowing how to implement it in a hospital setting.

Christensen et al. (2017) support that most innovations that have been implemented in

healthcare are sustaining innovations rather than disruptive. The authors explain that healthcare

is not designed to help practitioners implement new ideas. Due to that, very little is known on

how to develop DIs and how to establish them into existing business models. The lack of busi-

ness model innovation is one of the reasons for failing implementing technologies that enable

the delivery of high-quality treatment at a low cost. The question now that remains to be an-

swered is what kind of business model would be adequate to implement a 3D printing manu-

facturing facility for patient specific implants transforming the hospital a profitable manufac-

turer.

ANALYSIS

94

Having a 3D printing facility is regarded as a facilitator to the implementation of the technology

while the lack of business model innovation is regarded as a barrier. As one manager under-

lined: “to achieve a successful implementation with this innovation it is necessary to develop

a new business model, establish completely new organizational structures and operational pro-

cedures.” Table 46 provides an overview of the main points in this section.

Table 46: Implementation barriers and facilitators related to lack of business model innovation.


Lack of business model for the establishment of

PSIMs in a hospital setting.

Establishment of an in-house 3D Printing Lab that will

evolve in time into a 3D Printing Facility for PSIMs.

Healthcare is not designed to help practitioners

implement new ideas; little knowledge on how

to develop and establish DIs into existing busi-

ness models.

New organizational structures and operational procedures.

Application of new business model suitable for disruptive

innovations.

6.4.2 Management support

The degree of management support is an indicator of the hospital’s commitment to implement

the innovation (Damschroder, et al., 2009). During the interview, managers and medical doc-

tors were focused on the behaviour of top managers and hospital administration while engineers

focus more on the characteristics of individuals who coordinate the development team. Perhaps

the reason for this outcome is because none of the engineers who were interviewed were work-

ing in a health care organization. Instead they are external partners collaborating with hospitals

and the only contact they have is with physicians.

Research participants in hospital 1 are experiencing high degree of management support and

commitment. Implementing 3DP in Hospital 1 was an initiation from management namely a

top down initiation which gave to the physicians a sense of priority. Management also ex-

plained to physicians the reason and the need for implementing 3DP; that the technology “will

be the future in medicine and that they have to go in this direction”. They also showed their

commitment by investing time on the implementation and providing financial support and

premises so that the 3D Printing Lab can be easily accessible by the physicians. Although the

implementation of 3D Printing Lab was top-down initiation it became a down-top approach

when management acknowledged the development team and 3D Printing Lab as an important

part of the hospital. In other words, top management gave official authority to the development

team to lead the implementation. As one management stated: “…we got, let us say, a kind of

marketing effect giving the perception that what we do, is our daily work and is perceived as

important and that the 3D Printing Lab is officially a part of the University Hospital organiza-

tion”. With this action Hospital 1 acknowledged the formal authority of the 3D Printing Lab

and gave them empowerment and responsibility to determine their own goals during daily

work. One manager stated that although there were no rewards to encourage implementation,

he got a position where he had the freedom to decide for himself in which implementation tasks

to focus on. This mix of top-down and bottom-up management approach seems to create a

shared commitment for sustaining implementation. Perhaps another reason for the effective-

ness of the top-down initiation is because the management and physicians in Hospital 1 have

‘similar socioeconomic, educational, professional, and cultural backgrounds as their clinicians’

(Greenhalgh, et al., 2004). This means that management understands the motivation and

ANALYSIS

95

incentives of other clinicians. Another interpretation could be that since people in management

have already ‘walked the walk’, management earns ‘credibility and insights into the needs of

the physicians’ (Stoller, et al., 2016).

Another important observation is the channels management used to communicate with clini-

cians. Interpersonal channels were utilized to persuade physicians’ attitudes by reinforcing

their expectations that 3DP will lead to positive surgical outcomes. This is indicated by the

statements “demonstrated for him the benefits of the technology in surgical planning and the

production of patient specific implants” and “had close communication with the physicians”.

This is consistent with Rogers’ (1995, p. 207) observations that interpersonal channels are

proper to use when the complexity of innovation is regarded high. Management also arranged

learning events to increase awareness of the 3DP technology and involved in the implementa-

tion process external change agents such as academic researchers, government agencies, actors

from industry to bring the necessary competencies in the hospital. Johnsson, (2017) supports

that high degree of management support speeds up product development and commercializa-

tion, accelerates the learning curve of the team and reduces their anxiety. However, low levels

of management support do not have the opposite effect.

For Hospital 3, implementing 3DP was an initiation by the surgeons namely a bottom-up initi-

ation. The implementation was experienced difficult because the involved physicians had to

struggle to convince management that their idea was viable. As one participant explained: “We

needed first to prove to management that we had right to exist”. Once the implementation team

proved that 3DP was useful for the hospital, they earned the support of hospital management,

but their support came with conditions. This could be an indication that an implementation

initiated by clinicians is, without management support difficult, but not impossible.

For Hospital 2, respondents experienced that management is “a problem” because it focuses on

the budget and preservation of existing resources. Another factor that seems to play significant

role in the implementation is whether or not management have a medical background. The

statement “They do not understand what is going on because they are not medical people.” is

an indication that the manager has to understand first the needs of clinicians in order to be able

to know what changes to implement and create a sympathetic environment for them. Finally,

the statements “they are not aware of what the departments are doing or the latest advanced

treatment in each medical specialty”, “Maybe we, the doctors, have to communicate here too”

or “Perhaps we might need to go up to the hospital management and say that we want this”

show that there is limited to no communication between management and clinicians which may

explain the absence of discussion or negotiation from either sides to initiate implementation of

PSIMs in Hospital 3. Kotter (2001) underlines that management who have learned to deal only

with plans and budgets do not understand, do not look favourably or find difficult to actively

participate in the processes of restructuring and transformation of their organization. Since

there is no communication clinicians experience that the management invest efforts in a direc-

tion that is not consistent with what clinicians need. Ineffective communication between man-

agement and employees and lack of knowledge on how to implement change programme in an

organization are critical obstacles in management implementation and is one of the reasons for

physicians in Hospital 3 experiencing insufficient management commitment (Mosadeghrad &

ANALYSIS

96

Ansarian, 2014). As one doctor stated: We may need to see a little bit more commitment from

the management. Table 47 summarizes the mentioned implementation barriers and facilitator

related to management support at organizational and individual level.

Table 47: Implementation barriers and facilitators related to management support.


Meso

Budget and plan oriented; lack of management

engagement.

Management commitment in the form of prem-

ises, financial support, reinforcement; acknowl-

edgement of implementation team, having a vi-

sion.

Lack of medical background; limited commu-

nication, lack of understanding clinicians’ mo-

tives and needs.

Expand network to bring new competencies

and skills; collaborating with external stake-

holders; Mix of top-down and bottom-up im-

plementation.

Micro

Increased level of uncertainty and anxiety.

Experiencing insufficient management com-

mitment.

Not engaging in implementation initiatives or

engages without understanding the need and

therefore the effort will not be sustainable.

Employee encouragement and empowerment;

creating a sense of urgency; Use of interper-

sonal channels to persuade and recruit new

member for the implementation.

6.4.3 Resistance to change

Resistance to change occurs in the form of passivity for two reasons. Some physicians prefer

maintaining the old traditional methods since it has been proved that existing methods are

working. This tendency was regarded by one of the hospital managers as a psychological prob-

lem which relates to fear of failure, namely physicians want reassurances that the new treatment

works (“we have seen the advantages of PSIMs but still there are disadvantages because the

technology is not at a level we want it to be.”, “nobody wants to be the first failed case.”). Fear

of failure is also related to the uncertainty on how to cope with the logistical and regulatory

challenges that PSIMs bring. The feeling of uncertainty is indicated in the following state-

ments: “the regulatory requirements are so many that makes the whole development process

complex”, “There are so many things that you have to be aware of and look after, especially

from the point of manufacturing technique.”

Another reason for remaining loyal to the old methods is because of the conventional wisdom

that there is no need to replace existing treatment methods with new ones since similar and

satisfying outcome can be achieved with existing methods. This attitude is regarded by man-

agers as the main obstacle to implementation; “if practitioners want to keep treating patients as

they learned 30 years ago then the implementation does not stand a chance”. Perhaps this be-

havior can be explained by the reply of one medical doctor who pointed out that “There should

be a need. Without it, even if I can see the benefits of the innovation, I would still not use it.

We are adding an extra cost for something that is not necessary… we can achieve good results

without it.” According to Kotter (2012), phrases such as “why make a change, the old way still

works” or “ we have always done it this way” indicate high degree of complacency in which

the employee is satisfied with the status quo. This is happening because the employee does not

see the reason for the change to take place. Therefore, lack of urgency could be a key factor to

consider before implementation. Furthermore, the above statement from the medical doctor

also confirms the assertion of Rogers’ regarding complexity and compatibility; if the new

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97

technology is difficult to use and is not aligned with individual’s needs then the chances of

adopting the innovation will be limited (Rogers, 1995, pp. 228, 242). In this case the surgical

planning of PSIMs is perceived as complex process which requires from clinicians to conduct

their duties in a different way making the daily routine more complicated and costly.

Resistance to change is also related to the nature of innovation. According to Christensen,

(2017) disruptive innovation (DI) is unpredictable in nature and in order for it to blossom it

requires change in the business model of a hospital which means cannibalization of existing

organizational structures and interventions threatening the status quo of established stakehold-

ers and powerful institutional forces. Hence the introduction of it will be encountered with

resistance (Christensen, et al., 2000).

The coping strategies mentioned from hospital managers were to include medical doctors into

the development of PSIMs and demonstrate the benefits of the technology by reporting the

positive outcome from patient cases to increase awareness. A sense of urgency is also needed

in the change process to fight against complacency which is noticed in employees who are

satisfied with the status quo (Kotter, 2012, p. 38). Rogers (1995, p. 396) supports that a per-

ceived need may originated from a general problem an organization has. The innovation is

‘more likely to be successfully implemented, as the innovation more closely fits the organiza-

tion’s situation, and the organization’s participants identify the innovation as theirs’ (Rogers,

1995, p. 396). Perhaps to create a sense of urgency, it requires first to understand the needs of

a hospital and the needs of its stakeholders and then adapt the innovation to meet those needs.

An additional way to overcome resistance to change is the use of champions. Howell and Hig-

gins (cited in Rogers 1992, p. 398) define the concept champion as ‘a charismatic individual

who … overcomes the indifference or resistance that a new idea often provokes in an organi-

zation’. During the empirical investigation there were participants that carried these character-

istics as well as statements regarding an authority figure who acted as a champion i.e. “He

pushed for more research, more funding, more grants to make the state-of-the-art standard tech-

nology and overcome the old traditions”. A synopsis of the main points discussed in this section

can be studied in Table 48.

Table 48: Staff resistance to change and implementation.


Resistance in the form of passivity due to fear of

failure and lack of sense of urgency.

Make doctors part of the development process to see the

benefits of the technology and the advantages of collab-

orating with technicians.

Disruptive innovation requires a lot of changes

which threatens the status quo and may lead to

cannibalization.

Awareness, a sense of urgency, understanding organiza-

tional and stakeholder needs, match innovation with or-

ganizational problem, use of champions.

6.4.4 Lack of time

The development process of PSIMs comprises various time-consuming tasks. According to

research participants, the development and printing process is not fast enough to be suitable for

urgent cases. Furthermore, due to regulatory requirements the development process of implant

may take weeks. Other time-consuming tasks are the documentation procedures to fulfil the

regulatory requirements, the surgical planning, the regular meetings with physicians and

ANALYSIS

98

engineers and the data analysis. Some respondents stated that they had to work overtime: “in

the end, you end up working much more than you usually had to”, “I need to find the time

where I can invest my efforts on my work in the print lab. Usually I have to work at night or in

the evening or on the weekends”, “I do not think that we (medical doctors) are meant to work

overtime just to produce models.” “Sometimes I had to sit on Christmas Eve writing the plan

and work on it on New Year's Eve”. This is an indication that lack of time and high workload

may act as barriers to implementation. According to Mosadeghrad & Ansarian, (2014) extra

workload and lack of time is a sign of employee shortage as well as an indication that managers

have not calculated the workload changes that the implementation of 3DP may create. Table

49 is a summary of the main implementation barriers and facilitators generated from the theme

“lack of time”.

Table 49: Factors affecting implementation of PSIMs due to lack of time.


Lack of time; shortage of employees; un-balanced

work schedule; increased stress due to workload.

Better allocation of time; well-balanced work schedule

for employees; recruit extra personnel; pre-calculation

consequences of implementation such as workload

changes.

6.4.5 Skill shortage

3DP technology has created positions in healthcare that are not covered yet. As one manager

stated: “at the moment there still not a profession which covers all the topics in medical 3D

printing”. One reason for this is because PSIMs require experience – that undocumented

knowledge (tacit) which is gained after exploiting and exploring the technology (Bennet &

Bennet, 2008). The other reason is that it requires a combination of technical and medical skills

which at the moment are scattered in different scientific fields. Poor or lack of education and

training in the medical applications of 3DP are considered obstacles to the development and

implementation of PSIMs. All respondents emphasized the need for practical training in the

workplace to cope with the knowledge PSIMs create and the challenges they bring. Insufficient

information on the utilization of the technology and its impact on patients – as one engineer

stated “We have not yet really understood when, where and how these small defects occur or

what the consequences will be” – as well as the lack of support regarding the regulatory process

(“no one wants to be specific, I have heard so many different answers”) denotes that there is a

knowledge gap and shortage in qualified manpower withing 3DP medical applications and

more specifically 3D printed patient specific medical device. Furthermore, the perceived com-

plexity of the technology indicates the need for qualified personnel. “I expect this cost to fall

quite drastically if there is someone who has a formal education and experience in doing seg-

mentation”. A synopsis of the main points highlight in this section can be studied in Table 50.

Table 50: Implementation barriers and facilitators related to the theme “skill shortage”.


Lack of experience; fragmented competencies; lack of ed-

ucation and training in PSIMs; insufficient information on

the use of PSIMs and its consequences on patients in case

of implant failure; shortage in qualified manpower.

Engaging tacit knowledge; training programs to

gain experience; recruit qualified personnel

with expertise in materials and image acquisi-

tion and analysis.

ANALYSIS

99

6.4.6 Communication difficulties

The development of PSIMs is required to be driven by a multidisciplinary team. Although

multidisciplinary teams “have a high potential of creativity they are confronted with difficulties

arising from different working- and communication styles” (Bouncken, et al., 2016). Commu-

nication challenges are associated with the diversity in professional culture of engineers and

medical doctors. Different professional disciplines have different methods and ways of inter-

preting and doing things (Yasseri, 2017). As one research participant stated: “It is about under-

standing each other’s perspectives oi a working situation”. Another reason for having commu-

nication difficulties among medical doctors and engineers is the unrealistic expectations from

both partners. From the perspective of engineers, medical doctors “do not realize what the

technology entails and what are the limitations behind it. They think they can sit in front of a

computer…push a button and print whatever they want but this is just an illusion…”. On the

other hand, from the perspective of the medical doctors, engineers think that they “can design

anything”.

To cope with the communication challenges, research participants recommended to recruit bi-

omedical engineers with modeling skills or engineers with medical background. Another alter-

native would be to use an intermediary who will facilitate communication between the two

parties.

6.4.7 Location of 3D printing facility

Another theme that was generated from the empirical research was the location of the 3D Print-

ing facility within the hospital. The factors which seem to be important to research participants

for determine the location of 3D Printing facility are availability of skill labor, availability of

premises in the hospital, degree of accessibility to physicians and implementation stakeholders

and fast delivery of 3D Printing services. Hospital 3 decided to build their 3D Printing Lab in

the department of Biomechanical engineering to have sufficient access to skill labor since they

are the ones who have the technical expertise to guide physicians through the process and have

the license to produce medical devices. Hospital 1, on the other hand, has its central facility

close to radiology department due to their expertise in image acquisition and analysis but also

close to craniomaxillofacial (CMF) surgical department to facilitate accessibility to the sur-

geons. Hospital 1 has also extra available room in the Department of Biomedical Engineering,

but the location is regarded to be a disadvantage because it is located outside the medical cam-

pus; “15-20 minutes away from the hospital by public transportation”. Skill labor, easy acces-

sibility and fast delivery of 3D Printing services seem to be the determining factors of the

location. Another factor that might played significant role for determining the location of 3D

Printing Lab in Hospital 1 is the fact that the implementation funding and provision of premises

were given by the radiology and CMF department. It seems that the location of the business

unit facilitates routinization not only because it makes accessibility easier but also because it

accelerates the workflow.

In industry, determining the location of the manufacturing unit is of strategic importance. This

is where knowledge from operational management can shred light if there are additional factors

to be considered when deciding the location of a manufacturing unit. Some of the reported

factors affecting the location of a manufacturing unit which may be relevant for the health care

ANALYSIS

100

industry are availability of raw materials, cost, availability of infrastructure, nearness to power

source, availability of housing, supply of labor, communication and collaboration with other

departments and facilities, environmental policies, regulations and safety requirements

(UKEssays, 2018). Similar factors were mentioned by research participants but in terms of

“more professionalized workflow”, “new infrastructure”, “storage for raw material”, “affilia-

tion with the hospital”, “people to operate the machines”, “available premises” etc. Having a

3D Printing Lab that produces anatomical models is not the same as if having a 3D Printing

facility that manufactures PSIMs. The requirements for building and sustaining a manufactur-

ing unit are more demanding. Therefore, the questions that remains is whether the hospital has

the required resources (premises, infrastructure etc.) to fulfil the demanding requirements of

the 3D Printing facility.

6.4.8 Scarcity of resources

To build and sustain an additive manufacturing unit that will produce enough implants to cover

the local demand it requires having enough human and financial resources. As one engineer

stated during the interview: “PSIMs require to have expensive equipment… available premises,

storage for raw materials…simply put… you do not get that in a hospital today”. Therefore,

insufficient human, physical and financial resources is a barrier in the implementation of in-

house 3D printed patient specific implants.

According to Managers and engineers’ statements, the cost of creating and sustaining an in-

house 3D Printing facility consists of capital and operational costs. Capital costs include hard-

ware, software and available or new premises in the hospital. Operational expenses are related

to costs generated from daily functions and activities. Table 51 illustrates examples of costs

included in the capital and operational cost. Data are gathered from empirical research and

literature review.

Table 51: Main implementation costs.

The main cost for in-house 3D Printing facility

Capital Costs Operational Costs

➢ FDA approved 3D printers

➢ Computers for administrative tasks

➢ Imaging, segmentation and CAD/CAM software

➢ High resolution monitors for sharper image quality

➢ Control and monitor systems for 3D printers

➢ Quality management systems for AM

➢ Facility costs

➢ Personnel salaries

➢ Maintenance

➢ Training costs

➢ Annual licensing for software

➢ Material costs

To be able to cover all these expenses the hospital has to produce high quantities of implants,

operate in a big market and use PSIMs in daily basis. According to empirical research PSIMs

are used only as a last resort when conventional methods are insufficient. Furthermore, the

regulatory requirements set constrains on the market share of hospitals – hospitals are allowed

to provide in-house PSIMs only to their patients but not to sell them to other hospitals or clinics.

Ergo, lack of financial resources and low caseloads to overcome capital and operational costs

are barriers for PSIMs implementation.

ANALYSIS

101

6.4.9 Lack of innovative capacity

According to research participants innovative capacity is associated with collaborative net-

work, entrepreneurial mindset and individual absorptive capacity. When a firm is interested in

implementing a change in its organization it makes sure to form partnerships or alliances that

will support and facilitate implementation - “making sure to collaborate with the right people;

people who can build the knowledge base of your business and expand it.” Collaborative net-

work is useful for the hospital to acquire capabilities and skills expanding and accumulating

the knowledge base of the hospital (Cinelli , et al., 2019).

Entrepreneurial mindset was defined by research participants as the ability to seek out for op-

portunities, understand the value of innovation and insist moving forward with its implemen-

tation despite the obstacles and accepted risks – “it is all about entrepreneurship in which you

are aware of the risks and drawbacks, but you keep going on because you believe in this”.

Without the strength of entrepreneurial spirit, it “will be difficult to bring something new into

the field”. Lack of entrepreneurial mindset may be an indication that the underlying culture of

a hospital is strongly a risk averse or has low tolerance to risk taking which is an anathema to

innovation (Ashkenas & Bodell, 2014).

The subtheme absorptive capacity was generated from the reluctance of physicians to “exploit

3DP to resolve more advanced unsolved problems”. The statement “printing 3D models is

something we have already done... We need to move on. The Lab is oriented in a direction that

is far away from what we are clinically interested in” indicates that the knowledge withing 3DP

is not being harvested or exploited to create new treatment methods or improve existing ones.

According to Zahra and George (2002) one reason for having insufficient absorptive capacity

may be due to “familiarity of a certain type of knowledge while overlooking or underutilize

other skills” leading consequently to overusing certain type of skill. Absorptive capacity is

enhanced via entrepreneurial activities which is elevated by organizational innovative capacity.

Organizational innovation capacity facilitates in turn product development and increases en-

trepreneurial performance (Tajvidi & Karami, 2015). The question is how absorptive capacity

correlates to implementation. Absorptive capacity means acquiring and exploiting knowledge.

If new knowledge is not acquired and used, then implementation would be difficult because

the hospital will not have the required skill set and qualified people to put the technology into

practice. Therefore, organizational innovativeness depends on the individual absorptive capac-

ity which affects implementation.

On the other hand, organizational innovativeness is associated, according to Rogers (1995),

with organizational structure. This means that perhaps the individual’s ability of exploiting

new knowledge is hindered by the structure of the organization. Research participants refer to

lack of time to invest in implementing PSIMs, shortage of skill set and bureaucratic procedures

which may be a sign of high degree of formalization; something that is consistent with the

conservative environment of a hospital. As Rogers (1995, p. 380) stated, high degree of for-

malization ‘inhibits the consideration of innovation but encourages implementation of innova-

tion’. Table 52 is an overview of the main implementation barriers and facilitators acting at

meso and micro level related to the theme lack of innovative capacity.

ANALYSIS

102

Table 52: Lack of innovative capacity and implementation.


Meso

Low degree of organizational innovativeness

due to: high degree of formalization; lack of

entrepreneurial activities, risk averse culture.

Develop an innovative culture; collaborative net-

work; balance between mechanistic and organic

organizational structure.

Micro

Insufficient absorptive capacity; risk-averse

oriented.

Engage entrepreneurial activities; encourage em-

ployees to exchange, share and exploit

knowledge.

6.5 Implementation process Main themes generated under the domain implementation process were “lack of implementa-

tion plans and evaluation procedures” and “key implementation actors”.

6.5.1 Lack of implementation plans and evaluation procedures

Hospital 1 and 3 highlighted the significance of having proper implementation processes for

the establishment of 3D Printing Lab in the hospital. Hospital 3 used the waterfall methodology

while hospital 1 followed a more agile approach without using a step by step guide with clear

start and end lines. As one manager expressed it: “it was more of an organic development”,

namely that there was not an implementation plan rather than the team learned what was nec-

essary after starting with some printers. Members in Hospital 1 had regular meetings and

worked overtime to get the system up and running as quickly as possible. Their experience

taught them that without proper implementation processes it will not be able to build the 3D

Printing facility for patient specific implants. Although, none of the hospitals are producing

PSIMs in-house, all of them are making efforts into that direction. Only question that remains

is what kind of implementation framework and plan will be adequate to facilitate integration

efforts. What will be the set of internal activities to cope with the logistical challenges; to create

a sustainable supply chain that enables the production of implants on site making the hospital

a manufacturer? No matter what the implementation plan will be, the content of steps included

in the implementation plan will vary depending on the chosen theory to guide implementation

and promote change as well as the context in which the implementation plan is applied to

(Damschroder, et al., 2009; Grol, et al., 2007). Lack of implementation plan was regarded as a

barrier to the adoption of PSIMs. Due to the complexity of the innovation and the regulatory

requirements proper implementation plans are necessary to facilitate integration. As two hos-

pital managers explained: “without proper implementation process it will not work” and “need

guidelines on how to go about”. Lack of evaluation procedures was another issue hindering

implementation. It was highlighted that there was not any time to reflect on the implementation

process followed to build the 3D Printing Lab nor there were any specific measurable goals to

assess implementation. This may indicate the lack of expertise on how to implement a change

or the lack of tools to monitor and evaluate implementation process (Damschroder, et al.,

2009).

6.5.2 Key implementation actors

The implementation of PSIMs is a collaboration of multiple stakeholders. According to the

statements gathered from empirical data the main actors involved in the implementation

ANALYSIS

103

process are a development team, clinicians, hospital management, engineers, community, re-

search institutes, system providers, material suppliers, IT-support, MDR experts and imple-

mentation advisers. All respondents mentioned the existence of a multidisciplinary develop-

ment team responsible for driving the 3D Printing Lab including the development process of

implants. It seems that the development team is built by members who work at different de-

partments. Statements such as “…we only have 20% full time equivalent… that means that

some may have one day per week to work officially in the Printing Lab” or “we meet from

time to time” indicate that the members of the development team are not dedicated full time in

the project which is a characteristic of a lightweight team (Schilling, 2017, p. 272). However,

the ideal development team has to be autonomous since the development process, according to

research participants, requires “dedication, time and experience”. The composition of the de-

velopment team may consist of:

1. A project manager who coordinates the development. Empirical data indicated that the

head of AM group is preferable to be taken by one or two physicians with expertise in

surgical procedures, advanced medical imaging and experience in 3D printing. This

task can also be assigned to “a biomedical engineer who is trained to understand anat-

omy and surgical procedures” (Willemsen, et al., 2019).

2. Partners responsible for producing the implants. If the hospital does not possess the

necessary skill set, license and equipment for an in-house production, then the implant

manufacturer will be an external company with CE-certification and specialization in

AM and medical patient specific solutions. If the contrary, then this task is preferable

to be assigned to a department near the hospital that is ISO 13485 certified for the de-

velopment and manufacturing of medical devices (Willemsen, et al., 2019). For hospital

3, the manufacturing task was handled by the department of Medical Technology and

Clinical Physics.

3. Engineering designers who will design preoperative 3D models.

4. Medical technicians with experience in 3D printing to facilitate the communication be-

tween engineers and surgeons.

5. Extra workforce to take care the post-processing of the implant which may include heat

treatment to improve material property, polishing, hole finishing and finally steriliza-

tion (Willemsen, et al., 2019).

6. Staff with expertise and experience in medical imaging i.e. a radiologist. Although there

were participants who stated that the role of radiologist could be covered by a surgeon

or the imaging process could be conducted by biomechanical engineers, most of re-

search participants are of the opinion that the contribution of a radiologist is significant.

It contributes in the translation of medical images into manufacturing measurable vari-

ables which is necessary since the printers interface are engineering-oriented (George,

et al., 2017).

Empirical research also denoted the need to include MDR advisors in the implementation pro-

cess of PSIMs, who will provide legal advice on how to build a certified workflow for the

development of implants. As one manager stated: “The MDR-expert…would inspect our work-

flow, tell where he sees the weaknesses regarding the existing legal requirements and then

ANALYSIS

104

based on that, we would improve things”. MDR experts can be a business unit within the hos-

pital that takes care the legal affair or a “department of medical technology, which has exten-

sive knowledge of implant legislation and legal matters” (Willemsen, et al., 2019).

Research participants also mentioned the importance of having IT support services and sys-

tems. The IT department is responsible for the maintenance and monitoring of the printers

which regularly require service, routine checks, scheduled and emergency repairs. Another re-

sponsibility involves the management of big data such as patient and product information. The

development of PSIMs will produce a lot of documented data which will be necessary to store,

process, evaluated and transferred safely. The digital platforms meant for this administrative

task “need to stay up to date and regularly be tested for their efficiency and suitability” (Müller,

2019).

The research participants mentioned the need for materials, advanced 3D printers, systems to

monitor the printers, cloud software for data storage as well as quality control systems to min-

imize potential design and manufacturing errors providing quality assurance of the entire prod-

uct development process and MDR compliance. All these statements denote the necessity for

suitable system providers and material suppliers who will be able to supply these kinds of ser-

vices to ensure the functionality of the 3D printing facility.

Management support is requisite for developing implementation strategies, expanding the net-

work, bringing new knowledge and skill set into the hospital, providing funding, premises and

promoting the 3D printing development team. The role of management was described in detail

in previous section 6.4.2.

Other important stakeholders are research institutions, policy makers and insurance companies.

The lack of reimbursement for 3D printed patient specific implants (PSIMs) denotes the need

for political support. Policy makers and payers should be involved in the implementation pro-

cess to develop suitable reimbursement models.

Figure 12 shows the main stakeholders who are necessary to facilitate implementation of 3D

printed patient specific implants (PSIMs). At the centre of the figure there is the 3D Printing

Lab which is surrounded by the key stakeholders. Each stakeholder has been marked with dif-

ferent colour. The areas enclosed in dashed ellipses are examples of the support each stake-

holder provides based on the information gathered from empirical research.

ANALYSIS

105

Figure 12: Main stakeholders involved in the implementation of 3D Printing Lab.

6.6 Summary of analysis There are several barriers and facilitators regarding the implementation of 3DP for the devel-

opment of PSIMs in a hospital setting. Analyzing the empirical findings inductively led initially

to the identification of 18 themes: 14 barriers, five facilitators which are illustrated in Figure

13. The red outlined boxes denote implementation barriers whereas the green outlined boxes

depict implementation facilitators. The 18 themes were structured under the four domains of

CFIR framework (perceived attribute of innovation, outer setting, inner setting and implemen-

tation process). There are also six additional factors (high self-efficacy, simplify surgical pro-

cess, improve manufacturing techniques, enhance working experience, increase patient satis-

faction, expand market share) which were placed under the domain Stakeholder Characteristics

and are considered to be implementation drivers since they indicate clinicians’ motives and

incentives (Figure 13).

ANALYSIS

106

Figure 13: 18 themes and six driving forces organized under the five domains of CFIR.

Analyzing the 18 themes in the pursue of identifying potential correlations or additional barri-

ers and facilitators, generated in total 48 barriers and 35 facilitators that seem to affect the

implementation of a change program related to the integration of 3D printed custom-made im-

plants into a hospital setting. To provide a compact presentation of the final analytical results,

the barriers were classified into seven themes: regulatory, financial, strategic, structural, pro-

cedural, contextual and competence barriers (Table 53). Competence barriers are problems as-

sociated with the factor “skill set” and include inhibitors such as lack of training opportunities

and poor availability of information. Contextual barriers are obstacles that are related to the

human factor such as employee shortage, employee resistance to change and factors related to

implementation climate such as lack of rewards, diversity of professional culture and poor

communication. Procedural problems are associated with obstacles related to the implementa-

tion of development process for example lack of implementation plan and evaluation proce-

dures, bureaucracy and paperwork. Structural barrier are associated with the “systems and re-

sources required to implement” the development process of PSIMs into the hospital and make

it a daily routine (Mosadeghrad & Ansarian, 2014). Strategic barriers involve inhibitors related

to management like budget and plan oriented management, insufficient management support

and lack of business model innovation. Lastly financial obstacles include reimbursement poli-

cies and cost-effectiveness related issues while regulatory barriers contain impediments asso-

ciated to the MDR, for example unstructured content, gray areas, scale up and transfer re-

strictions. The same reasoning was followed for the classification of the 35 facilitators (Table

54).

ANALYSIS

107

Table 53: Implementation impediments classified into regulatory, financial, contextual, structural, procedural, strategic and

competence barriers.

Regulatory barriers Contextual barriers Procedural barriers

➢ Regulatory uncertainty

➢ Lack of long-term product

and safety standards

➢ Lack of comprehensive

regulatory framework for

MDs

➢ Lack of MDR implementa-

tion framework for PSIMs

➢ Transfer and scale up re-

strictions

➢ Bureaucratic and unstruc-

tured content

➢ Insufficient experience in

PSIMs

➢ Gray areas

➢ Limited awareness regard-

ing the content of MDR

➢ Scarcity of notified bodies

➢ Lack of time

➢ Shortage of employees

➢ Un-balanced work sched-

ule

➢ Lack of innovative capac-

ity

➢ Limited entrepreneurial ac-

tivities

➢ Insufficient absorptive ca-

pacity

➢ Risk averse culture

➢ Lack of rewards

➢ Resistance to change (pas-

sivity)

➢ Lack of sense of urgency

➢ Fear of failure

➢ Maintain status quo

➢ Lack of implementation

plan and evaluation proce-

dures

➢ Time-consuming develop-

ment process

➢ Bureaucracy and paper-

work

➢ Lack of proper design

frameworks

➢ Lack of expertise to imple-

ment changes

➢ Limited possibility to undo

implementation

➢ Lack of standard operating

procedures

➢ Lack of tools and systems

to monitor implementation

➢ Communication difficulties

➢ Diversity of professional

culture

➢ Unrealistic expectations

Financial barriers Structural barriers Strategic barriers

➢ Lack of reimbursement

models for in-house PSIMs

➢ Time and resource con-

suming reimbursement

procedures

➢ Inconclusive statements of

PSIMs cost-effectiveness

➢ High implementation costs

including capital invest-

ment

➢ Scarcity of financial re-

sources

➢ Lack of physical (i.e.

premises) and human re-

sources support

➢ Advanced software (qual-

ity management and moni-

tor systems) and hardware

systems

➢ High infrastructure capac-

ity

➢ Lack of business model in-

novation

➢ Insufficient management

engagement and support

➢ Budget and plan oriented

management

➢ Management direction not

aligned with clinicians'

goals

Competence barriers

➢ Shortage of high skilled manpower

➢ Limited training opportunities

➢ Poor availability of information

ANALYSIS

108

Table 54: Implementation catalysts classified into regulatory, financial, strategic, structural, contextual, procedural and com-

petence facilitators.

Regulatory facilitators Strategic facilitators Procedural facilitators

➢ Engagement of MDR-

experts in the implementa-

tion

➢ A guideline on how to

comply to MDR

➢ Observing how other hos-

pitals have successfully

implemented MDR

➢ Collaboration with AM in-

dustry and regulatory bod-

ies aiming for administra-

tive simplification and

MDR improvement

➢ Having a vision related to

the innovation

➢ Support in terms of prem-

ises, funding and training

➢ Employee empowerment

➢ Preparing champions

➢ Use of mass media and in-

terpersonal channels

➢ New business model inno-

vation

➢ Collaborative networks

➢ Homophily

➢ Formal implementation

plan

➢ Quality monitoring sys-

tems for the development

process

➢ Tools for evaluating im-

plementation process

➢ Implementation consult-

ants

➢ Small clinical tests of

change

➢ Implementation team that

will meet regularly

➢ Design frameworks

Financial facilitators Contextual facilitators Structural facilitators

➢ New funding

➢ Resource sharing agree-

ments

➢ Political support

➢ Economic framework for

assessing cost related

PSIMs services

➢ Champions

➢ Sense of urgency

➢ Medical doctors’ engage-

ment into parts of the de-

velopment process

➢ Insight of stakeholders’ and

organizational needs

➢ Innovative culture

➢ Perceived relative ad-

vantages of PSIMs

➢ Adaptation to the hospital

structure

➢ Establishment a 3D Print-

ing Lab

➢ Location that allows in-

creased access to 3DP

clinical services

Competence facilitators

➢ Ongoing training and consultation

➢ Educational meetings and materials

➢ Collaboration with educational institutions

DISCUSSION AND CONCLUSION

109

Chapter 7. Discussion and conclusion In the discussion section we synthesize findings from literature review and analysis. As it was

mentioned in chapter 1, the overall aim of this research was to gain an advanced understanding

of the implementation issues of AM in a hospital setting particularly in relation to the develop-

ment of high-risk custom-made implants. Gaining insight into the implementation determinants

of medical technologies is requisite to ensure a sustainable development of health care industry

where resources are allocated in a way to meet the care needs. The specific objectives of this

research were:

1. What are the main driving forces and barriers for the delivery of custom-made implants?

2. What are staff stakeholder views and practices regarding the implementation of 3DP for

the development of custom-made implants?

3. How may this knowledge be utilized to prepare healthcare practitioners for future introduc-

tion of the intervention in surgery?

In this section, the above-mentioned research objectives are being revisit summarizing primary

and secondary findings and offering conclusions. Furthermore, a section reflecting on the re-

search methods, theory and process that have been undertaken is included. Finally, recommen-

dations for future research are discussed.

7.1 Implementation drivers Implementation drivers are forces that promote a change towards adoption of patient specific

implants (PSIM). According to literature review findings, the main drivers of adopting patient

specific implants in surgery are the technological advancements in digitalization such as med-

ical software, imaging and 3D printing techniques; the rise of elderly population, the increased

number of brain cancer and trauma cases and the increasing economic pressure to optimize

health care treatment while reducing the costs. Empirical data complemented that physicians

either at the position of a medical doctor or middle manager can act as driving forces in

healthcare for promoting the use of PSIMs. The reasons for research participants getting in-

volved with 3DP were to facilitate the working process, enhance employee experience, increase

patient satisfaction, and grow the business. Understanding the needs and expectations of stake-

holders will help justify to administration the initiation of a PSIM program and will also ac-

commodate in developing implementation strategies (action plans) that will be consistent with

the clinical needs. Ergo, what motivates involved stakeholder can be perceived as additional

drivers for hospitals engaging with 3D printed custom-made implants.

7.2 Implementation barriers When it comes to implementation barriers, the literature review denoted impediments acting at

three different socio-ecological levels: macro, meso and micro. At macro level the major bar-

riers are the lack of reimbursement and regulatory framework for 3D printed patient specific

solutions produced in-house. These factors hinder the delivery of PSIMs to customers with low

income and even health care providers with budget limitations. At meso or organizational level,

the challenges are associated with communication difficulties, insufficient management sup-

port, internal inertia, time-consuming and complex product development process, product qual-

ity related challenges and limited availability of resources. However, most of these


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organizational barriers are not associated directly with the PSIMs rather with innovation related

impediments in general. Lastly at micro or individual level, the major barrier is the reluctance

of physicians to use PSIMs which is associated with low self-efficacy and the attributes of the

technology including its cost-effectiveness. The literature review also indicated limited studies

on the required organizational changes to implement a PSIM-workflow in a hospital setting,

and on theory-based analysis and interpretation of implementation issues from a multi-perspec-

tive stakeholder view.

The empirical investigation filled the gap of the literature review by shedding light on the im-

plementation barriers and facilitators related to PSIMs that occur at meso level, namely at a

hospital setting. The use of CFIR framework identified several barriers and facilitators related

to PSIMs. The main perceived barriers involved (1) not having enough resources for the im-

plementation, (2) resistance to change from clinicians and management, (3) communication

difficulties between doctors and engineers, (4) insufficient management support, (5) absence

of monetary reward systems, (6) scarcity of training opportunities, (7) lack of guidelines on

how to successfully establish an effective workflow for the development of custom-made im-

plants, (8) deficient process to evaluate implementation as well as (9) other external factors

such as the lack of compensation for implants produced inside the hospital and the lack of a

comprehensive guideline on how to apply the medical device regulations into the development

process of the implants. The analysis of empirical data identified 48 barrier which were classi-

fied into 7 themes: regulatory, financial, strategic, structural, procedural, contextual and com-

petence complications (Table 53).

7.2.1 Regulatory complications

Figure 14 provides an overview of how the regulatory difficulties at a macro level create im-

plementation barriers at a meso level. The yellow marked boxes depict primary data, the blue

marked boxes contain secondary data while the boxes with yellow-blue colors indicate data

verified from both literature review and empirical research. The new medical device regula-

tions are building a single EU-market in which the trade barriers of medical devices among

EU-countries are lifted. Theoretically, reduced regulatory heterogeneity should increase com-

petition among suppliers leading to better selling price and giving higher bargaining power to

healthcare providers since they will have the flexibility to choose different medical device sup-

pliers not only domestically but also internationally. In the case of high risk 3D printed patient

specific medical devices or implants the MDR offers health care providers the possibility to

produce them in-house becoming their own manufacturers without fulfilling all the regulatory

requirements that a mass medical device producer will have to fulfill. More specifically, 3D

printed patient specific implants (PSIMs) produced by a health care provider “do not require

CE-marking nor a prior conformity assessment by a notified body nor a Unique Device Iden-

tification system (UDI) to be implemented” (Aima, et al., 2019). It is however requisite to

provide a technical file showing how the PSIM meet the requirements in terms of safety and

performance in the essential Annex I. In practice, the literature review showed that at macro

level there is a regulatory uncertainty on how to implement the MDR into the supply chain of

PSIMs; consequently increasing the lead time and the price of PSIMs making them inaccessible

to low-end customers and delaying the delivery of a surgical treatment. Theoretically, regula-

tory uncertainty is associated with “technological uncertainty” and “content and format


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uncertainty” whereas the former is related to the lack of technological understanding on how

the new product works as well as knowledge regarding the data required to confirm its effec-

tiveness and safety while the latter is correlated with the absence of standard procedures and

guidelines to evaluate the product (Stern, 2017). In the case of PSIMs the “content and format

uncertainty” derives from the lack of guidelines on how to implement the MDR into the devel-

opment process of PSIMs; the unstructured regulatory content and the bureaucratic regulatory

procedures. The “technological uncertainty” is due to the lack of long-term product perfor-

mance and safety standards.

Empirical data verified the findings from the literature review and showed that, at meso level,

the unclear and unstructured content of MDR is not only due to the absence of guidelines on

how to operationalize the MDR into the development process but also due to the existence of

gray areas namely gaps in the regulatory requirements that do not specify exactly what is nec-

essary to be fulfilled. There was also an indication that stakeholders have limited insight on the

content of MDR. Furthermore, the lack of long-term product performance and safety standards

is attributable to limited knowledge of the life cycle of PSIMs and the consequences of various

additive manufacturing technologies on the material properties during the production of

PSIMs. The regulatory uncertainty relates also to the constraints that prohibits hospitals from

selling PSIMs to other providers and limit their ability to produce PSIMs in large volumes.

These restrictions affect the cost-effectiveness of PSIMS creating financial complications.

Figure 14: A diagram showing the hierarchical correlation between barriers caused by regulatory uncertainty at macro (in-

dustrial) level and at meso (hospital) level.

To conclude, it seems that the regulatory uncertainty at hospital level is caused by (1) the lim-

ited experience in the life cycle of patient specific implants and their long-term consequences

on the patient. Regulatory uncertainty is also related to (2) the gray areas of MDR; (3) limited

knowledge on MDR content and (4) the absence of comprehensive guidelines on how to


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operationalize the MDR into the development process of PSIMs (Figure 14). This is a signifi-

cant challenge for health care industry since tackling this knowledge gap will require constant

experimentation and use of patient specific implants as well as the detailed documentation of

their applications. Bureaucracy may be after all what we need to take safely the next step in the

development of this technology.

7.2.2 Financial complications

Figure 15 illustrates the factors that are causing financial complications in the implementation

of PSIMs. The financial complications are mainly associated with the lack of reimbursement

and the scarcity of financial resources. The literature review showed that PSIMs produced in-

house are not currently reimbursed but that does not hinder hospitals from using PSIMs rather

limits the availability or delivery of PSIMs to patients with low income. Reimbursement deci-

sions are determined by whether the innovation is more cost-effective than existing alterna-

tives. At the moment, the evidence that PSIMs are more profitable or cost-effective than alter-

native solutions such as standard implants are inconclusive. One reason for this seems to be

due to the unclear financial impact of the innovation costs for providing patient specific im-

plants. Empirical research clarified that the difficulty of providing accurate costing information

is due to the plethora of factors that influence the cost of surgical procedures and the lack of

metrics to assess these factors.

Figure 15: Hierarchical correlation between the factors causing financial uncertainty.

Other reasons for the inconclusive profitability of PSIMs are the high implementation costs

and the regulatory scale-up and transfer restrictions. There are concerns that the regulatory

scale-up and transfer restrictions will make impossible to prove the long-term financial benefits

of PSIMs. Empirical data confirmed that PSIMs require a high case load to be profitable which

means that the hospital will have to produce large volumes to reach the break-even point where


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costs become savings. However, producing in large volumes is not consistent with the require-

ments of MDR and therefore, hospitals are left with the alternatives of either outsourcing the

production of PSIMs which is regarded as time-consuming and expensive; providing standard

implants without innovating or becoming an industrial manufacturer fulfilling all the require-

ment in MDR which is even more expensive than previous alternatives. High implementation

costs raise the question of whether hospitals have the financial resources to afford a sustainable

implementation without proper remuneration support and without the ability to produce PSIMs

in large volumes.

In conclusion, the elements that cause financial impediments are (1) the plethora of factors

that influence the cost of surgical procedures; (2) the lack of metrics to assess these factors; (3)

the high implementation costs and (4) the scale-up and transfer restrictions (Figure 15). With

these barriers it becomes difficult to identify potential savings giving to the hospitals less rea-

son to drop existing methods to adopt PSIMs.

7.2.3 Contextual and competence complications

Contextual barriers are obstacles that are related to the human factor such as employee short-

age, employee resistance to change and factors related to implementation climate, namely

availability of rewards, absorptive capacity, and educational support. It seems that the imple-

mentation climate affects the receptivity of clinicians. According to literature review and em-

pirical findings, clinicians’ resistance was regarded as one of the major obstacles in the imple-

mentation of PSIMs. Analyzing the empirical data showed signs of passive change resistance

that had several possible causes. Some of them that could identified in this research are asso-

ciated with the lack of time, lack of innovative capacity and high degree of perceived complex-

ity of the PSIMs (Figure 16). Lack of time to adapt to change can cause clinicians stress and a

sense of fear that they might seem incompetent if they cannot manage the new tasks (Self,

2007). Lack of time is also a sign of employee shortage and that managers have not calculated

the consequences of implementation i.e. the workload changes (Mosadeghrad & Ansarian,

2014).

Lack of innovative capacity was shown to be related to low degree of absorptive capacity in

which staff employees do not exploit the intervention rather choose to maintain already existing

treatment method. Choosing to maintain old methods seems to be correlated to the fear of fail-

ure but also to the lack of sense of urgency and lack of rewards which indicates that the inno-

vation is not a priority. Lack of innovative capacity seemed also to be correlated to the limited

entrepreneurial mindset which denoted a risk averse cultural environment with high degree of

formalization.

Complexity was linked to the nature of the innovation, competence and procedural complica-

tions. PSIMs are regarded as an innovation with a disruptive impact that might be able to can-

nibalize existing organizational structures and interventions threatening the status quo of es-

tablished stakeholders and powerful institutional forces. A change that threatens the employ-

ees’ self-interest is one of the most obvious reasons to withstand change initiatives (Kebapci

& Erkal, 2009). Competence complications are associated mainly with the shortage of qualified

manpower which seems to be due to the lack of support in terms of training, information about


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the innovation and its upcoming changes as well as the limited experience on how AM tech-

nologies may affect the mechanical strength of PSIMs.

Figure 16: The correlation between staff resistance to change and factors related to implementation climate.

7.2.4 Procedural complications

Figure 17 illustrates how the factors related to procedural complications are correlated with

each other. Procedural complications are related to the difficulties occurring during the process

of developing a patient specific implant (PSIM) which was reviewed in section 2.2.1 and the

concerns over the implementation of PSIMs in a hospital setting which requires the establish-

ment of a 3D Printing Lab. Reviewing the development process of PSIMs in section 2.2.1

showed that the process consists of six stages: image acquisition; image processing; implant

design and evaluation; STL model generation and control; additive manufacturing and post-

processing. Each stage comprises several data file conversions, iterative quality control, and

various techniques on how to acquire images, segment data, print the model and post-process

the implant. Reviewing the literature, it was found that inaccuracy errors may occur during

image acquisition or segmentation, printing and post-processing which indicated the need for

standardization of quality management systems and comprehensive design specification frame-

works (Martinez‐Marquez, et al., 2020). Other issues are associated with the bureaucratic tasks

due to regulatory requirements and communication difficulties during pre-surgical planning

which makes the development process time-consuming (Figure 17). Empirical data confirmed

literature findings and elucidated that the communication challenges were associated with the

diversity in professional culture between engineers and medical doctors; with the use of ad-

vanced medical or technical language; and the unrealistic expectations of both parties – accord-

ing to medical doctors, engineers with no basic knowledge in medicine think they can design

anything whereas according to engineers, medical doctors foster the illusion that they can print

anything.


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Figure 17: Procedural complications in the development and implementation of PSIMs.

The implementation process was another concern to procedural complications. Making the de-

velopment process of PSIMs a routine requires the establishment of a 3D Printing Lab inside

the hospital. In general the domain implementation process, namely the approach that needs to

be followed to succeed with the implementation of a new innovation in a health care environ-

ment was regarded as difficult to define and measure due to the low degree of PSIMs trialability

and the lack of implementation plan and evaluation procedures. Theoretically, low degree of

trialability means limited possibility to assess, via pilot studies, the attributes of the technol-

ogy, its effectiveness and its potential risks (Rudenstam & Tennby, 2018). In case of PSIMs,

once they are implemented it is difficult to undo the implementation due to the high investment

in terms of time, preparation work, human, financial and physical resources but also due to the

economic costs to undo implementation. The lack of implementation plan and evaluation pro-

cedures seem to be due to lack of expertise on how to implement change but also due to absence

of appropriate tools and policies to monitor and measure implementation (Figure 17).

7.2.5 Strategic complications

Strategic barriers are associated with management issues (Figure 18). Empirical investigation

showed that managers are more budget and plan oriented than questioning the assumptions

dominating the industry. A possible explanation to this is that hospital administration is focus-

ing on preserving existing operations working on already ‘established business models that

determine the type of value proposition the hospital can or cannot deliver’ (Hwang &

Christensen, 2008). The existing business models allow incremental changes, namely ‘only

value propositions that fit the existing resources, processes, and profit formula of the organi-

zation can be successfully taken to market’ (Hwang & Christensen, 2008). Maintaining existing

business models does not allow managers to challenge the dominant logic in the industry. Cur-

rently, PSIMs are not consistence with established profit formulas and therefore management


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does not have the incentives to invest in the innovation. Management that deals only with plans

and budget are taking directions that are not aligned with clinical needs. The reason behind this

showed to be the lack of understanding clinicians’ needs since management are “not medical

people” and ineffective communication between management and medical doctors (Figure 18).

Figure 18: Correlation among factors that cause strategic complications.

7.2.6 Structural complications

Structural barriers were related to the structural changes such as “systems and resources re-

quired to implement a development workflow for PSIMs inside the hospital. Main source of

data in this case were the empirical investigation which showed that developing in house

PSIMs requires the establishment of a 3D Printing unit with people to run it, advanced software

systems, high IT infrastructure capacity and premises for material storage and advanced hard-

ware systems. There were considerations of whether the hospital would be able to provide

available premises and concerns over the set of standard requirements these premises would

have to fulfil in order to be used as material storage or as a facility for developing PSIMs. It

seems that resources and responsibility for supporting 3D printing services and products are

fragmented.

7.3 Recommendations for overcoming implementation barriers Empirical data denoted that the key implementation facilitators were (1) having a strong coali-

tion team that met regularly, (2) engaging clinicians into the development process to see the

benefits of the technology, (3) involving implementation consultants and MDR experts, (4)

providing management support in terms of premises, empowerment and funding (5) establish-

ing an independent 3D Printing unit and (6) promoting an entrepreneurial culture. The analysis


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of the empirical data led to the identification of 35 facilitators which were used to formulate

recommendations for each set of complications presented in Table 54.

7.3.1 Regulatory support and administrative simplification

To deal with the administrative burdens of the MDR, a suggestion would be to involve MDR

advisors, in the implementation process to develop a guideline and policies on how to integrate

the regulatory requirements into the development process. The role of the MDR expert would

be to map a development workflow for PSIMs based on the context and the local policies of

the hospital so that a valid workflow can be developed. It is also advisable for the hospitals and

more specifically representatives from orthopedics and craniomaxillofacial discipline as well

as representatives from the AM industry to collaborate with notified bodies with the purpose

to fill the gray areas in the MDR. Another recommendation is to visit other hospitals that have

managed to implement MDR and study their strategies (Powell, et al., 2015). Overall, there is

a need for a comprehensive MDR with a three-fold purpose: ‘to be used as a source of infor-

mation, as a guide for implementing policies’ and to simplify the administrative process so that

hospitals will not have to overuse their resources to comply with the regulatory requirements

(Organization for economic co-operation and development, 2009). Willemsen and peers’ study

(2019) offers a detailed demonstration of how the MDR can be applied into the workflow of

spinal patient specific implants.

7.3.2 Funding

Since PSIMs produced in-house lack of reimbursement it is necessary for the hospital to access

new funding sources to accommodate implementation such as raising private funds, applying

for federal funds or sharing the cost with another department within the hospital (Waltz, et al.,

2015). Developing alliances with industrial organizations that have the resources to help the

hospital implement the innovation could be another way to cope with the financial complica-

tions. Another recommendation would be to seek for political support for better resource allo-

cation and negotiate with governments and other payers to develop new funding formulas.

There is also the need for simplifying remuneration procedures as well as providing clear cri-

teria for reimbursement of 3D printed applications in a clinical setting. Finally, to acquire a

holistic view of the technology’s financial impact and deliver conclusive statement regarding

its potential savings, it is advisable to utilize an economic framework for recording the different

factors and assessing the cost of the procedures related to the development of PSIMs (Boyajian,

et al., 2019).

7.3.3 Overcoming resistance to change

The first step to cope with the contextual barriers is to conduct a local needs assessment to

identify and prioritize organizational problems and stakeholder needs and then conceptually

figure out how the innovation can resolve problems and meet clinicians’ needs. This is what

Rogers (1995, p. 391) called agenda setting. If the organizational problem and stakeholder

needs are conceptually matched with the innovation, then it will be easier for management to

create a sense of urgency and justify to administration and physicians the need for a PSIM

implementation program (Kotter, 2012, p. 38).


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It is also necessary to promote an innovative culture that fosters information sharing and en-

courages collaborative problem-solving, exploitation of innovations and engagement in the de-

velopment process.

Assessing the readiness of the hospital is another recommendation since empirical and litera-

ture review indicated resistance due to low management commitment and insufficient compe-

tence support. Barriers and facilitators related to management engagement, available resources

and access to knowledge and information are determinants for the readiness of the hospital to

implementation (Damschroder, et al., 2009). Implementation climate should also be assessed

especially the construct that relates to tension for change. This will show whether the innova-

tion is a priority and whether clinicians and hospital managers are aware of the need for its

implementation and whether they are ready for the forthcoming changes.

Powell et al. (2015) recommend identifying early adopters who can help fulfil the adoption

chasm based on their experience from previous innovations and gain access to early majority.

Early adopters are also ‘a good pool for identifying implementation champions’ (Powell, et al.,

2015). Empirical evidence indicated two participants who had the role of a champion and were

regarded by the other interviewees as responsible, supportive, and capable of overcoming re-

sistance. Therefore, identifying or preparing implementation champions could also be another

suggestion for overcoming resistance.

Additional recommendations to cope with resistance due to heavy workload is to test the inno-

vation on a small scale in order to pre-calculate the consequences of innovation such as the

workload changes after implementing the development workflow so that the responsible team

for driving the 3D Printing facility or the clinicians responsible for the surgical planning will

not have to work overtime.

Finally, feedback system so that the clinicians can express anonymously their thoughts, doubts

and concerns and ideas regarding the implementation strategies is also advisable to be imple-

mented as well as conducting regular meetings at different levels in the organization to inform

the entire organization about the forthcoming change work. The assessment and feedback pro-

cess should be monitor by managers so that they are aware of what is happening within the

hospital.

7.3.4 Skills and medical education

The development of patient specific implants requires a specific set of skills such as experience

in post-acquisition imaging processing i.e. segmentation; understanding of the imaging proto-

col so that the quality of the images is adequate to be used for 3D printing; basic medical

knowledge such as understanding anatomy so that the designed models are relevant to the clin-

ical case; good knowledge of CAD/3D software and design techniques; basic knowledge on

how to operate 3D printing hardware and good knowledge of additive manufacturing technol-

ogies and their limitations so that there is an understanding on how the limitations of 3D print-

ing techniques can affect the mechanical or material properties of the implant. This indicate the

need for highly trained and experienced technicians in order for the in-house 3D Printing Lab

or the operating facility to be viable. However, empirical data indicated shortage in qualified

manpower withing 3D printed custom-made medical device. Shortage in qualified manpower


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means that the technical and medical skills required for the development of PSIMs are scattered

in different scientific fields and the people who have the skills are not sufficient enough in

number to respond to a potential upcoming high demand for PSIMs. Empirical data also indi-

cated limited educational materials and training opportunities which may explain why there is

shortage in qualified manpower.

To cope with these challenges, it is advisable to develop strategies that will improve skill set

and increase access to knowledge and information. Elements that may be included in an imple-

mentation plan to improve skill set would be ongoing training and consultation. Although em-

pirical data showed that participants provide training in the form of courses and seminars it is

advisable to arrange on-the-job training opportunities as well as individual consultation when

necessary. On the job training involves letting the clinician first observe co-workers who use

PSIMs and then practice what (s)he learned by conducting similar tasks under the supervision

of the co-worker or a training manager (Heathfield, 2019). On the job training is suitable in

working environment where time and scarcity of resources are an issue. This training strategy

is flexible and cost-effective because it does not require to book premises or develop educa-

tional materials to disseminate knowledge. Furthermore, it saves time since the clinician does

not have to make room in his schedule to travel to a specific location outside of the hospital

rather the training is taking place in the hospital, in an operating theatre where the clinician is

actively participating in the procedure. This training strategy is also suitable to be used with

3D Printing. 3DP can provide technology-assisted training based on the level of clinicians’

knowledge which accommodates the simulation of a surgical planning giving clinicians room

to make mistakes and learn from them without affecting the patient. Ongoing consultation in-

volves giving feedback on performance and provided service as well as offering advice on

administrative and procedural concerns, for example advice on how to cope with regulatory

requirements respective on segmentation. Ongoing consultation was a strategy that was used

by 3D Printing Lab 1 where engineers got feedback from external actors i.e. customers, spe-

cialists in segmentation and co-workers from other labs. Ongoing consultation should be avail-

able for both clinicians and non-clinical staff such as managers, ‘administrators or staff with

duties that impact the implementation process’ (Waltz, et al., 2015)

To increase access to knowledge and information, it is suggested to develop and distribute

educational material; conduct educational meetings and work with educational institutions

(Powell, et al., 2015). Developing educational materials is a challenging task because they have

to reflect how en adult learns or more specifically how intellectually independent and highly

specialized surgeons learn. There is a need for developing manuals and other supporting tools

on how to safely deliver sustainable patient specific implants. These educational materials and

techniques should provide flexibility in learning, promote learner empowerment and

responsibility, facilitate knowledge updates and improve specialized skills (Roshan, 2020). The

distribution of educational materials could be electronically or in person via educational

meetings. The purpose with educational meetings is not only to provide information on how to

implement the innovation but also to monitor and assess the progress of implementation. In

order for this strategy to work the content of educational meetings have to target a specific


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stakeholder’s needs. Working with educational institutions will help to distribute materials and

also prepare future clinicians.

7.3.5 Management support and business models innovation

Johnsson, (2017) supports that high degree of management support speeds up product devel-

opment and commercialization, accelerates the learning curve of the team and reduces their

anxiety. Empirical investigation identified five main strategies that can be utilized from

managers to accommodate implementation. These strategies involved: having a vision,

buildning collaborative networks, use of mass media and interpersonal channels, empowering

employees and giving support in terms of funding, training and premises. Collaborative

networks is creating aliances within and outside of the hospital to bring new skills into the

hospital and engage key stakholders but also to “disempower supervisors that may undercute

needed change” (Kotter, 2012, p. 119)

Having a vision or a clear concept of the innovation to be implemented means appealing to a

possible picture of the future. Vision helps align individuals to work on common goals, thus

leading to a better coordingarion (Kotter, 2012, p. 72). Using different channels of

communication to effectively communicate this vision is a way to facilitate change.

Interpersonal channels are recommended for demonstrating the advantages of the innovation

and therefore persuade clinicians to work through a shared purpose related to the innovation.

Mass media on the other hand, have theoretically the purpose of informing to create awareness

and knowledge (Rogers, 1995, p. 207). In practice, as the empirical investigation indicated, the

utlimate purpose of mass media is to influence the market and increase the demand for PSIMs.

By informing the public that the hospital provides patient specific treatment that are more

benefial than traditional treatement methods is an intended way to educate the patient about the

innovation so that the next time they visit the hospital, patients will demand from their

providers to receive a patient specific treatment. This approach is also a declaration that the

innovation is a priority for the hospital and that the implementation team that mandate the

change has the authority to do so (Powell, et al., 2015).

Management support in terms of funding, training and premises is also necessary to lift

financial, competence and structural barriers that might undermine the authority of

implementation team. In general, a mix of top-down and bottom-up management approach is

preferable to create a shared commitment from both management and medical doctors achiev-

ing a sustaining implementation. It is also recommended to involve in the implementation man-

agers who can understand the clinical needs and more importantly the needs of clinicians. As-

sign the implementation to managers with medical background could be one alternative to this

since managers with ‘similar socioeconomic, educational, professional, and cultural back-

grounds as their clinicians’ (Greenhalgh, et al., 2004) will have a better insight and understand-

ing of what motivates other clinicians (Stoller, et al., 2016).

Finally, since the empirical data showed evidence that the lack of business model innovation

is one of the reasons for managers failing implementing disruptive technologies then the sug-

gestion in this case will be ‘to link the technology with disruptive business models’ (Hwang &

Christensen, 2008). To achieve this, Hwang & Christensen, (2008) suggest establishing a


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business unit and allow it to grow autonomously based on its own profit formula and disruptive

value proposition. The authors recommend the use of disruptive business models such as the

value-added process businesses and facilitated user networks coupled with technological ena-

blers. Which of these models or similar ones would be suitable to implement a 3D printing

facility for patient specific implants, is a question that is left for future research.

7.3.6 3D Printing facility

To facilitate implementation of PSIMs, empirical data indicated the need of an autonomously

independent additive manufacturing unit inside the hospital that will work as a production fa-

cility and as an innovation centre for all clinical disciplines. The facility is preferable to be

centralized in a single department to ‘avoid underutilized the printers, maximize economies of

scale, enable greater division of labor and maximize the potential for learning-curve effects

through the development of multiple projects’ (Schilling, 2017, p. 217).

The best approach to build the 3D Printing Lab is, according to Brantner, (2017) to start small

at first with entry-level 3D printers providing anatomical models. Once the demand is high

enough to make significant profit then the next step is to invest in acquiring advanced FDA

approved printers and expand the portfolio to surgical guides. During this transformation, alli-

ances or partnerships should be built with key stakeholders such as system providers, payers

and MDR experts to start planning for the creation of a valid PSIMs workflow. The idea is to

start small and gradually build the final unit by first testing in a small scale and then scale up

steadily. The benefits of having a 3D Printing Lab in-house is not only that it accommodates

implementation, but it also provides immediate availability of printed products to clinicians.

The hospital will be independent on industrial implant manufacturers reducing the lead time.

Having a 3D Printing Lab in-house creates also the impression that patient specific solutions

are already an established method in the hospital and that the innovation derives from inside

the organization. ‘If an innovation derives from inside the organization, individuals regarded

as familiar and compatible and hence they will find it easier to give meaning to the new idea’

(Rogers, 1995, p. 396).

Another factor to be consider is the location of the 3D Printing unit. The decision for determin-

ing the location was shown empirically to be based on three main criteria: fast delivery of

PSIMs, easily accessible by the physicians, availability of skill labor. Fast delivery implies that

the implant after the printing and sterilization process should be able to be delivered to the

operating theatre directly. A lab that is easily accessible suggests that is close to the surgical

discipline so that surgeons have the flexibility to make a drop-in between surgeries if needed.

If possible, the lab should also be close to the department or departments that offer qualified

personnel to drive the lab. Other factors that may be significant and are dependent on the con-

text and local needs of the hospital are cost, availability of infrastructure and premises, nearness

to power source, communication and collaboration with other departments, environmental pol-

icies, regulations and safety requirements (UKEssays, 2018).

Adaptation of the 3D Printing Lab to the hospital structure will also be necessary so that the

clinical innovation meets the local needs. One kind of adaptation is to acquire different 3D

printing technologies to be able to respond to the diverse needs of each medical discipline.


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Another adaption is to link the 3D printing services into an order within the electronic medical

record so that clinicians can easily request support and exchange data fast. This approach was

considered effective since physicians will order through a system that is already known to them

and is used in their daily work. Therefore, assessing the local needs is necessary to understand

the variations of 3D Printing application practices across the different disciplines and resolving

issues that are related to the delivery of the innovation and the anticipated outcome of the 3D

printing support.

7.3.7 Implementation and process standardization

A it was mentioned in section 7.2.4, the procedural complications are associated with the chal-

lenges that occur during development and implementation process. Inaccuracy errors, burden

of bureaucracy and communication difficulties were the main issues that occurred during de-

velopment while lack of expertise on how to implement change and absence of appropriate

tools and policies to monitor and measure implementation were factors associated with the

implementation process.

Therefore, for the development process it is necessary to have proper quality monitoring sys-

tems for ensuring the quality of the implant and design frameworks for reducing design errors.

A suggested design framework that is used in manufacturing industry for mapping the technical

requirements of the product and coordinating effectively multidisciplinary development teams

is the “house of quality” (Schilling, 2017, p. 252). The advantage of this framework is that it

can map the requirements of many stakeholders and consolidate them into one matrix so that a

comprehensive design framework is formulated. Formalization and standardization is also sig-

nificant to facilitate the implementation of MDR into development process and ‘to ensure qual-

ity levels and predictable outcomes’ (Schilling, 2017, p. 218). It is also advisable to prepare or

recruit medical writing teams responsible for extracting data and documenting the development

of PSIMs as well as a quality control specialist for reviewing the final document.

There is also the need for building an implementation team that will meet regularly, preferably

a multidisciplinary team. Meetings should have clear goals with well-defines tasks, roles, and

responsibilities. A possible composition of the implementation team would be to include a ra-

diologist for the image acquisition and analysis, a surgeon that will be the representative or the

champion of the medical discipline in which the innovation is going to be implemented. For

example, if the innovation is going to be integrated into the craniomaxillofacial discipline then

the champion should be a craniomaxillofacial surgeon. Other valuable members would be med-

ical writers to document and review the development process making sure that is consistent

with regulatory requirements and design engineers with experience in clinical applications or

with basic medical knowledge so that the designed models are relevant to the clinical case.

This will not only improve communication but also enhance the quality of development process

(Chen & Gariel, 2016).

For integrating the development process into a clinical setting it is necessary to formulate an

implementation plan which will specify the different operating tasks, the person who will be

responsible for each task, the deliverables, time-line and required resources (Cooper, 2011, p.

204). Therefore the recommendation here is to include implementation advisors to develop an

implementation plan that will be tailored to the local needs; will map key stakeholders and pre-


123

calculate the consequences of implementation (i.e. workload or structural changes, frequency

of machine maintenance) and include strategies on how to deal with the low degree of technol-

ogy’s trialability. Implementation advisors have also the tools for evaluating implementation

processes. They can help hospitals develop policies and systems for monitoring and assessing

the implementation process. ‘These systems may inform audit and feedback strategies’

(Powell, et al., 2015).

7.4 Final conclusions Research question 1 Research question one was about finding the drivers and barriers for the

delivery of custom-made implants in the market. It was found out that 3DP is disrupting the

medical device industry by enabling the potential of producing custom-made implants on site

at a low cost. Custom-made implants have attracted the interest of health care providers due to

its benefits in surgery and to the patient. The market of medical device is driven by the in-

creased aging population and increased number of trauma accidents, birth marks and cancer

indicating the rising demand for more reconstructive surgery and the growing complexity of

surgical practices in craniomaxillofacial and orthopaedic disciplines (Asanova, et al., 2017;

Mason, et al., 2019). The market is also driven by the customer demand for more personalised

health care treatment and by healthcare providers who are looking for medical technologies

that will increased their autonomy; improve surgical quality in terms of predictability, outcome,

time, cost and accuracy; facilitate working process; enhance staff experience and competen-

cies, expand market share and increase patient satisfaction. Other factors that are in favour of

the delivery of additive manufactured custom-made implants are the technological advance-

ments in surgical planning (i.e. digitalization), market competition and the scarcity of resources

which indicate the need for medical technologies that are value based and reducing treatment

costs. To be able for the hospital to respond to these demanding challenges it is necessary to

invest in medical technologies that will promote personalized treatment, improve the efficiency

of surgical procedures and hence the quality of the treatment, simplify complex pathologies,

enhance physicians working experience and provide competitive advantage.

The market of medical device is however heavily regulated and currently the industry is under

adaptation due to new medical device regulations. At macro level, regulatory impediments such

as sparsity of qualified notified bodies and scale-up restrictions coupled with the lack of reim-

bursement are creating marketing approval delays and increased health care costs making

PSIMs accessible only to customers with high income and forcing hospitals to use PSIMs only

as a last resort. At meso and micro level, it is difficult to draw any conclusions since only few

of the factors that were found in literature review were related to patient specific implants

(PSIMs). Existing literature studies do not provide a comprehensive view of the implementa-

tion challenges related to custom-made implants. Furthermore, current literature is focusing

mostly on the views of medical doctors rather than capturing the views of hospital managers

and research engineers. To understand the factors acting at meso level – and consequently at

micro level as well – it is requisite to conduct more research that will include the perspectives

of stakeholders who are involved in the implementation of PSIMs. It is also necessary to spec-

ify suitable implementation frameworks and theories that identify the main implementation

factors at organizational level and explain the correlation among them in order to develop better

implementation strategies related to the integration of 3DP for the development of patient


124

specific implants. There is a need for consolidated implementation related knowledge in the

field of 3D printing and medical applications.

Research question 2 According to stakeholder views and practices, custom-made implants

in surgery have the potential of increasing surgical quality and outcomes minimizing surgical

time and hence hospital costs. However, there are several implementation barriers that are act-

ing at a hospital level which makes difficult their implementation. The implementation imped-

iments were segmented into regulatory, financial, contextual, competence, procedural, strategic

and structural complications. Regulatory complications are mainly caused by the insufficient

experience in the life cycle of patient specific implants and their long-term consequences on

the patient which forms a regulatory content that is filled with ill-defined areas possibly related

to the lack of long-term product performance and safety standards; consequently making diffi-

cult the development of a comprehensive guideline on how to operationalize the MDR into the

development process of PSIMs. Regulatory uncertainty indicated the need for MDR support

and administrative simplification. Financially, there is the belief that developing PSIMs in a

clinical setting will have long term benefits for the hospital. In practice however, it is difficult

to provide evidence of the innovation’s cost-effectiveness due to transfer and scale-up regula-

tory restrictions, high implementation costs and lack of accurate costing information. Regard-

ing the contextual complications, there is an indication that clinicians’ receptivity to the inno-

vation depends on the implementation climate and organizational commitment to employ the

innovation. If clinicians do not have time and access to knowledge on how to incorporate the

innovation into work tasks; do not see management commitment; have little understanding of

the necessity to implement the change and its consequences on the status quo; are working in

a risk-averse cultural environment with high degree of formalization, then clinicians will be

reluctant to engage in implementation initiatives. When it comes to complications related to

competence, there is shortage in qualified manpower indicating the limited educational support

and training opportunities in 3DP and medical applications. At strategical level, the lack of

communication, the limited insight into local and clinicians’ needs and use of unsuitable busi-

ness models to introduce disruptive innovations are at the heart of the reason for why manage-

ment commitment is perceived insufficient. Structural complications denoted the need for an

autonomously centralized in-house 3D Printing facility to effectively incorporate the interven-

tion into the hospital and accelerate the development workflow and therefore its delivery. Nev-

ertheless, due to the scarcity of resources in terms of available premises and funding and the

fragmented supporting services for building and sustaining the 3D Printing unit there is an

uncertainty of whether the hospital can afford making the necessary adaptations to establish a

manufacturing unit. Finally, procedural complications denoted the need for standardized pro-

cedures and proper design frameworks to accommodate the development process; advisors to

implement change; implementation policies and tools to monitor change procedures and im-

plementation strategies on how to cope with the low trialability of the intervention.

Research question 3 In section 7.3, recommendations were provided on how to cope with

implementation impediments mentioned in section 7.2. The question that is raised here is how

these recommendations can be prioritized and consolidated to provide an overview of the pos-

sible alternatives assisting clinicians in the integration of custom-made implants into clinical


125

practice. The answer to this question lies in Rogers’ assertion who describes the process of

innovation in five steps: agenda setting, matching, redefining, clarifying and routinizing. Fig-

ure 19 illustrates Rogers’ model slightly modified to meet the study needs. The suggested

framework for prioritizing the recommendations comprises six phases: agenda setting, building

a business case, restructuring, clarifying, evaluating and routinizing.

Figure 19: Suggested framework for prioritizing recommendations.

Phase 1: Agenda setting. The initial stage before implementing custom-made implants should

focus mainly on three things: conducting a local needs assessment to identify ‘organizational

problems that may create a perceived need for the innovation’ (Rogers, 1995, p. 393), identi-

fying early adopters who can help fulfil the adoption chasm based on their experience from

previous innovations and engaging key stakeholders such as implementation advisor, MDR-

experts and managers. As it was mention in subsection 7.2.3, the stage of agenda setting is

important to find conditions that will create a sense of urgency at a later stage of the implemen-

tation and reduce internal resistance.

Phase 2: Building a business case. This stage involves concept definition, financial justifica-

tion and an implementation plan with the purpose of justifying the establishment of a 3D print-

ing business. During the concept definition the ‘problem from the organization’s agenda is fit

with the innovation’ (Rogers, 1995, p. 394) and the value proposition of the innovation is de-

fined. The suggestion here is to use disruptive business models coupled with implementation

drivers mentioned in section 7.1 and perceived relative advantages of PSIMs (i.e. high degree

of observability and adaptability) to create the value proposition for patient and for hospital.

During financial justification, the economic rationale of the investment is specified. The rec-

ommended financial action here was to seek for new funding, conduct resource sharing agree-

ments, seek for political support for better resource allocation and negotiations with govern-

ments and other payers to develop new funding formulas and use an economic framework for

assessing the cost of the procedures related to the development of PSIMs providing a holistic

view of the financial impact from implementing the technology.

Finally, the implementation plan will specify the different operating tasks, the person who will

be responsible for each task, the deliverables, timeline and required resources. This means


126

mapping the alliances and building collaborative network, preparing management support in

terms of premises, funding and training, engaging MDR experts to develop a guideline on how

to comply to MDR based on the local workflow and developing educational materials and

training opportunities.

Phase 3: Restructuring. At this stage, the innovation will be tested in a small scale to promote

adaptation and build gradually the 3D Printing Lab. The purpose with the small-scale testing

is to see if staff can cope with the consequences of the innovation. One of PSIMs consequences

is the increased time in surgical planning since the perfect implant fit requires many iterations

allowing only one chance to get everything right. Therefore, spending more time in surgical

planning is critical. Another adaptation is for the hospital to provide premises for the 3D Print-

ing Lab. The location of premises should offer optimal observability and accessibility to clini-

cians. Other adaptations are related to the infrastructure capacity, use of design frameworks

and establishment of quality monitoring systems to reduce errors and technological uncertainty

during development process.

Phase 4: Clarifying. At the clarifying stage organizational members want to know how the

innovation works, how it will affect their status and why it is necessary (Rogers, 1995, p. 399).

Resistance to change may also be anticipated, therefore it is important to provide ongoing train-

ing and consultation, conduct educational meetings to demonstrate the benefits of the technol-

ogy and follow up implementation progress, communicate at different organizational levels

about the forthcoming change work and provide a platform where clinicians will be able to

leave feedback on the ongoing implementation.

Phase 5: Evaluating. To achieve a sustain implementation, it is significant to monitor the

progress of implementation, reflect, improve strategies, and adjust the implementation plan that

was developed during phase two. The focus here is specifically to consider clinicians’ feedback

and evaluate the change program developed in the implementation plan by assessing which

strategies and assumptions in the implementation plan work and which ones need change and

why.

Phase 6: Routinizing. Rogers (1995 p. 399) support that ‘routinization occurs when the inno-

vation has become incorporated into the regular activities of the organization and the innova-

tion loses its separate identity’. At that point the implementation stage is completed. This study

supports that routinization of PSIMs will be achieved through a constant adaptation of the in-

tervention and assimilation of the 3D printing services into the hospital structure. This means

that phases three to five will have to be iterative until routinization is achieved (Figure 19).

7.5 Study Limitations This research study is qualitative in nature based on an interpretive philosophy in which the

generated data are affected by the author’s own interpretation of reality. Although the analysis

of empirical data is theory based, the translation of empirical data, the choice of theoretical

concepts to interpret the data and the described correlation between barriers are, at some de-

gree, influenced by the authors intellectual capacity and perception of the events occurred dur-

ing the interviews. Furthermore, the empirical data was collected by a very small sample size.

Therefore, the conclusions of this research are not expected to be generalized. Instead the


127

anticipation was to generate findings that will benefit any hospital that has encountered similar

issues described in this work or is keen on implementing 3DP for the development of PSIMs

adding incremental knowledge to the field of 3DP and implementation science.

Conducting semi structured interviews provided in depth information and better understanding

of the respondent’s viewpoint. However, semi structured interviews coupled with the CFIR

framework led to massive amount of information making the data analysis immensely time-

consuming. The CFIR model was very helpful for the development of relevant interview ques-

tions, coordination of interviews and interpretation of collected data. The choice of constructs

was based partly on the findings from the literature review which were relatively limited re-

garding the factors that affect the hospital internally and therefore constructs or determinants

such as compatibility, culture, employee’s identification with the organization, and organiza-

tional size, were overlooked. On the other hand, it was noted that new constructs could be

added such as business model and stakeholders’ aim and needs.

The outbreak of corvid-19 led to some difficulties that limited the accessibility to research

participants and the control over the selection of them, significantly extending the time for the

completion of the empirical research. Despite these challenges and with the help of the medical

community, different health care professionals, middle managers and research engineers were

included in this study to reveal several views. The main advantage is that most respondents

were at the forefront of 3D printing and patient specific implants. In fact, some of them were

also public speakers or characterized as champions from their co-workers and peers. Therefore,

their knowledge and expertise were relevant to the study aim. Malterud et al. (2016) underline

that theoretical saturation can be achieved with lower number of participants as long as partic-

ipants’ experience and characteristics are specific for the study aim. Based on the authors’

criteria, the sample size of this study, although small, is sufficient to gain an understanding of

the various implementation issues related to 3D printed patient specific implants.

Another limitation that should be considered is that this study does not show the significant

influence of each barrier namely if there are barriers that are more important than others creat-

ing thus a sense of priority among them. To provide such information would require conducting

a quantitative study that would measure the dimensions of each factor. This study, as mentioned

before is qualitative in nature and what it does accomplish to provide is a presumed correlation

among barriers based on empirical and theoretical data.

7.6 Future research From this study several projects for future research can be initiated. Conclusion one stated that

there is limited research regarding the implementation of MDR into the workflow of patient

specific implants as well as the factors which affect PSIMs implementation at meso level (hos-

pital setting). From conclusion one, the first recommendation to be made is to conduct studies

on the MDR and how to develop a comprehensive implementation framework that will guide

the integration of regulatory requirements into the development process of PSIMs in a clinical

setting. Another recommendation for future research related to conclusion one, is to conduct a

study that this dissertation was initially set out to do but due to COVID-19 was unable to

achieve. A mix of qualitative and quantitative case study in a hospital setting to identify


128

implementation barriers and facilitators of PSIMs. The study should comprise the views of

stakeholders at different organizational levels including patients and top management as well

as key stakeholders formulating funding and policy legislations such as payer and policy mak-

ers or regulators. Current studies on contextual factors affecting implementation and routiniza-

tion of PSIMs reviewed from a multi-stakeholder perspective are limited.

From conclusion two, it is recommended to investigate further available business models for

building a manufacturing unit in a hospital setting. What would be the adequate business

model? Christensen’s disruptive innovation theory coupled with other organizational theories

could produce valuable knowledge in the field of implementation science related to medical

devices.

Another recommendation concerns clinicians’ resistance to change which showed to be one of

the major obstacles in the implementation of PSIMs. Ergo, a proposal for future research would

be to conduct a case study exploring the available strategies to effectively manage implemen-

tation change in relation to 3D printing and patient specific implants based on the traits towards

staff development.

Research on quality control technologies to accurately monitor and control several aspects of

the development and production process of implants is also another topic to be considered. This

recommendation would have the benefit of developing an implementation plan and policies

that will accommodate evaluation of implementation and development procedures.

Lastly, designing and developing an educational program related to 3DP and its medical appli-

cations and how to integrate this program into the academic training of future physicians could

be another interesting area for research. Initiating training opportunities should not only be the

responsibility of physicians, but also be the accountability of academic institutions and com-

munities.

REFERENCES

129

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APPENDIX A

Appendix A: Literature review

APPENDIX A

APPENDIX B

Appendix B: Interview questions Domain 1: Individual/adopters’ characteristics

1. What is your current professional role in the organization you work for? (skills)

2. How many years of experience do you have within 3D printing? (experience)

3. What motivated you to get involved with 3D printing and patient specific implants?

(motives)

4. How 3D printing changed your role as a doctor or engineer? (personal beliefs on the

tech)

Characteristics of 3D printed patient specific implants

Relative advantage

1. What are the main relative advantages of 3D printed patient specific implants in com-

parison to standard ones? Are there any drawbacks compared to standard implants?

2. What are the main relative advantages of AM compared to traditional methods? Are

there any limitations?

Complexity

1. Is it easy to implement 3D printed patient specific implants in-house? How complicate

is it to develop them and produce them in-house?

2. What kind of skills are necessary to cope with the challenges of implementing 3D

printed custom-made implants?

Trialability

1. How easy do you think it is (was) to test patient specific implants for the first time in

your setting?

Cost

1. What are the main costs that are considered when deciding to implement the 3D printed

custom-made implants? Which of these costs are high?

2. In scientific articles, it has been reported the need for detailed cost analysis of patient

specific implants due to the inconclusive statements of whether or not 3D printed im-

plants are more cost-efficient than standard ones. What is your opinion? Do you agree

or disagree with theses statements and why?

Outer setting

External policies and incentives

1. One of the factors that hinders the implementation of patient specific implants is the

requirement of Medical Device Regulations (MDR). More specifically, there are scien-

tific reports mentioning how difficult it is to operationalize the Medical device Regula-

tions (MDR) into the workflow. What is your opinion? What is necessary to be done to

overcome the problem?

APPENDIX B

2. Are there other external forces that can influence implementation? What kind of finan-

cial or other incentives influenced the decision to implement the intervention?

Inner Setting


1. What kinds of infrastructure or structural changes will be needed to accommodate the

implementation of 3D printed PSIMs?

2. What kinds of changes or alterations do you think you will need to make to the inter-

vention so that it will work effectively in your setting?

Networks and Communication-collaboration

1. How is the communication with the engineers (alternatively doctors)?

2. What could facilitate communication in a multidisciplinary team?

3. Are meetings, such as staff meetings, held regularly?

Implementation Climate

Tension for change

1. Is there a strong need for 3D printing and implants?

2. Do you think employees at the hospital are ready to cope with challenges?

3. Are there any efforts to implement the innovation in the hospital?

4. What are your colleagues say about patient specific implants? Have you encoun-

tered any resistance?


1. Does the hospital provide any rewards to encourage implementation of patient spe-

cific implants?

2. What do you think would encourage practitioners to engage with patient specific

implants?

Readiness for Implementation


1. What kind of support or actions can you expect from leaders/managers in your or-

ganization to help make implementation successful?

2. What can be improved?

Available resources

1. Do you expect to have sufficient resources to implement and administer the intervention?


1. What kind of training is planned for you? For colleagues? Does the hospital in gen-

eral have plans training for its practitioners?

APPENDIX B

Implementation Process

Implementation plan

1. Do you have an implementation plan? What can be improved?

2. What are the success factors?

Engaging

1. Who were the main stakeholders in the implementation of 3D Printing Lab?

2. Who are involved in the development process of patient specific implants?

Reflecting and Evaluating

1. How do you assess the progress of implementation? To what extent has the hospital

set specific objectives or implementation goals?

APPENDIX C

Appendix C: CFIR constructs

APPENDIX C

APPENDIX D

Appendix D: Informed consent Participant's Informed Consent Form – 55XXX

3D Printing in Healthcare: An exploratory qualitative study of implementation barriers and facilita-

tors of 3D printed custom-made implants in orthopedic and cranio-maxillofacial surgery

The following is an informed consent form for a research project carried out by Antonia Evgenia Nioti

from Uppsala University. The interviewer should have the interviewee read this form carefully and

answer any questions the interviewee may have. Before any interview starts, approval of this consent

form from the interviewee is required. Informed consent can be obtained in one of the following ways:

either in written form by signing this document, orally by phone or simply replying via email with the

following statement: I (name) approve the informed consent form – 55XXX provided by the student

Antonia Evgenia Nioti from Uppsala University.

Consent for Participation in Interview Research I volunteer to participate in a research project conducted by the student Antonia Evgenia Nioti from

Uppsala University. I understand that the project is designed to gather information about the factors

that hinder or facilitate the implementation of 3D printing in orthopedic and cranio-maxillofacial sur-

gery for the development of high-risk custom-made implants.

1. I understand that my participation in this study is voluntary and I may withdraw participation at any

time without any reason. If I decline to participate or withdraw from the study, my data will not be

used.

2. I understand that participation in this study involves me being interviewed by Antonia Evgenia Nioti

from Uppsala University and I agree to this interview being audio-recorded. If I do not want the inter-

view to be taped, I must state my wish before the interview starts. The interview will last approxi-

mately 45-60 minutes.

3. I understand that my name and job title will not be revealed to people outside of this study and will

not be used in any reports, web pages, publications, and other research outputs. Data collected about

me during this interview will be used only for educational purposes and will be anonymized before it

is submitted for publication. My confidentiality as a participant in this study will remain secure. How-

ever, if I do want my identity and contribution to be acknowledged I must inform the interviewer

about it.

4. I understand that this research study has been approved by the division of Industrial Engineering

and Management at Uppsala University. For research problems or questions regarding this study, the

department may be contacted through contact information that is being provided at the end of this

consent form.

5. I have read and understand the explanation provided to me. I have been given the opportunity to

ask questions about this study and all my questions have been answered to my satisfaction.

6. I have been given an electronic copy of this consent form as well as adequate time to consider it.

______________________________________ ________2020-XX-XX________ My printed name Date _____________________________________

____Antonia Evgenia Nioti_________

My signature Signature of the researcher

APPENDIX E

Appendix E: Comprehensive overview of empirical results

APPENDIX E

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