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Results of a qualitative survey on the application of Computer System Validation in European SMEs of the Medical Device Industry
First findings of an ongoing research project
The Future of Entrepreneurship: Policy and Practice8-9 April 2019, Paris, France
Marius Schönberger
Prof. Dr. Tatjana Vasiljeva
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 2
Agenda
1. Introduction
2. Description of the problem
3. Related work
4. Research steps and methodology
5. Research findings
6. Limitation and outlook
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 3
Introduction
Software has become a significant economic factor
Software has thus become a significanteconomic factor not only in business,
science and technology, but also in the healthcare sector.
Medical device manufacturers
Software is necessaryto build devices that help patients lead
better lives.
With the benefits of software come the risk
of defects and bugs.
Software products are increasinglybecoming the central component of
complex electronic devices that controlor support technical or business
processes.
Source: Schönberger & Vasiljeva, 2018
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 4
Introduction
Software failures in the medical device industry
Source: Fu, 2011; AAMI, 2016
From 2002 to 2010, medical devices based on software resulted in over 537 recalls affecting more than 1.5
million devices.
11.3% caused by software failures
Medical devices are often subject to a high number of errors with
potentially catastrophic effects on the patients.
Medical errors are involved in more than 250,000 deaths each year in the US andaccount for nearly one in ten deaths.
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 5
Description of the problem
The need for computer system validation (1/2)
With the current technological possibilities of the software development …
… a considerable increase in the complexity of the devices and …
… major challenges for the reliability, patient safety and
security emerges.
The computer system validation are major means of avoiding defects and resultant recalls and is a requirement of the quality system for medical device manufacturers
Source: Fu, 2011; Alemzadeh et al., 2013; Bhusnure et al., 2015; FDA, 2002
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 6
Description of the problem
The need for computer system validation (2/2)
Source: FDA, 2002; Hrgarek, 2008
The implementation of computer system validation is necessary due to …
Legal regulations Economic, social and technological aspects
Problem: The regulations only determine that a computer system validation has to
be carried out, the exact scope of the validation as well as a structured approach
are not specified.
Challenge: All medical device manufacturers shall determine what needs to be validated and how muchvalidation is enough to ensure that regulatory requirements are met.
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 7
Related work
Approaches to Computer System Validation (1/2)
Author(s) Year Title Type Focused sector
Bendale et al. 2011 Computer software validation in pharmaceuticals Journal Pharmaceuticals
Bhusnure et al. 2015 Computer validation and ethical security measures for pharmaceutical data processing Journal Pharmaceuticals
Charan and Vishal Gupta 2016 GAMP 5: A quality risk management approach to computer system validation Journal Medical Device Industry
Esch et al. 2007 Good Laboratory practice (GLP) – Guidelines for the Validation of Computerised Systems Journal Laboratories
European Commission 2015 EU guidelines for good manufacturing practice for medicinal products for human and veterinary use EU Guideline Medical Device Industry
FDA 2002 General principles of software validation; Final guidance for industry and FDA staff US Guideline Medical Device Industry
Hrgarek 2008 A management approach to software validation requirements Proceeding Medical Device Industry
Huber 2005 Qualification and validation of software and computer systems in laboratories Monography Laboratories
McDowall 2016 Welcome to the brave new world of CSV? Journal Pharmaceuticals
Tracy and Nash 2002 A validation approach for laboratory information management systems Journal Laboratories
von Culin 2011 New approach to system validation Journal Medical Device Industry
Yogesh et al. 2015 Computer system validation: A review Journal Pharmaceuticals
Source: Schönberger, 2018
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 8
Related work
Approaches to Computer System Validation (2/2)
Source: Schönberger, 2018
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 9
Related work
Conclusions from the related work
No references to Small and medium enterprises 1
No differences to the general approach2
No description of recommendations for action3
Source: Schönberger, 2018
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 10
Research steps and methodology
Research questions
What is the status quo in European SMEs with regard to the implementation and application of the CSV?
RQ 1
RQ 2Do the results of the study reveal commonalities and differences in the implementation
and application of CSV?
Does the implementation and application of CSV have an impact on the firm performance of SMEs?
RQ 3
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 11
Research steps and methodology
Conceptual model
Source: Schönberger and Vasiljeva, 2019
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 12
Research steps and methodology
Development of measures for the questionnaireConstructs
DimensionsMeasures and reference to literature Items
IT assets (tangible)
Flexible IT infrastructure (FIT)Adopted from Van de Wetering et al., 2017; Garrison et al., 2015; Rockmann et al., 2015; Liu et al., 2013; Chen andWu, 2011; Kim et al., 2011; Prasad et al., 2010; Saraf et al., 2007; Ray et al., 2005; Byrd and Turner, 2001; Byrd andTurner, 2000.
10
Business applications (BAP)Adopted from Chen and Tsou, 2012; Chen and Wu, 2011; Kim et al., 2011; Pavlou and El Sawy, 2006; Chung et al., 2003; Byrd and Turner, 2000.
6
IT capability (intangible)
Human IT resources (HIT)Adopted from Chen and Wu, 2011; Kim et al., 2011; Chung et al., 2003; Byrd and Turner, 2001; Byrd and Turner, 2000.
6
IT management capability (ITM) Adopted from Chen et al., 2015; Kim et al., 2011; Bharadwaj et al., 1999. 6
Computer System Validation (CSV)
CSV approach (CAP) Newly developed based on indications of Elser, 2016; Dehghan-Dehnavi et al., 2015. 6
Risk assessment (RAS)Adopted from Dehghan-Dehnavi et al., 2015; Zou et al., 2009.Newly developed based on indications of McCaffery et al., 2010; Burton et al., 2006.
7
Firm performance
Product quality (PRQ) Adopted from Eikebrokk and Iden, 2017; Van de Wertering et al., 2017; Liu et al., 2013; Chen and Tsou, 2012. 2
Number of recalls (NOR)Adopted from Van de Wetering et al., 2017.Newly developed based on indications of Santos and Brito, 2012.
2
Competitive advantage (CAD) Adopted from Eikebrokk and Iden, 2017; Queiroz et al., 2017. 2
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 13
Research findings
Findings of the pre-test of the questionnaire (1/2)
Similarities
Characteristics Case study 1 Case study 2 Case study 3 Case study 4 Case study 5
Medical products Hearing protectionInjectors for imaging
methodsNutritional pumps Equipment for endoscopy Compression stockings
Respondents 1 CEO and 1 IT manager 1 CIO and 1 IT administrator 1 IT manager1 CEO and
2 IT administrators1 CIO
Staff 20 employees 146 employees 80 employees 72 employees 65 employees
Self-assessmentof IT skills
good very good very good good good
Employees are responsible for the maintenance of ICT within
the companies
Sufficient experience about the ICT used within the
companies could be recorded
All companies are located in the German-speaking area and
share cultural similarities
0
1
2
3
4
FIT01
FIT02
FIT03
FIT04
FIT05
FIT06
FIT07
FIT08
FIT09
FIT10
Diagrammtitel
Case study 1 Case study 2 Case study 3 Case study 4 Case study 5
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 14
Research findings
Findings of the pre-test of the questionnaire (2/2)
Results for Flexible IT Infrastructure (Selection)
Dimensions Case study 1 Case study 2 Case study 3 Case study 4 Case study 5
FIT01 2 4 3 3 4
FIT02 3 4 2 3 3
FIT03 1 3 3 4 2
FIT04 2 4 3 4 4
FIT05 2 3 4 3 3
FIT06 1 3 2 3 4
FIT07 4 4 3 4 3
FIT08 1 3 2 3 3
FIT09 2 4 2 2 3
FIT10 2 3 3 2 4
Note: All items use five-point Likert scales anchored at 1 (strongly disagree) and 5 (strongly agree).
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 15
Research findings
Evaluation of the case studies (Summary)
The work with ICT is absolutely necessary in all enterprises1
Overall, neither positive nor negative changes in the firm's performance could be registered6
Only a few enterprises stated that their IT infrastructure allows for rapid changes2
Only one enterprise has a risk-based CSV approach which is complaint to current regulations5
Overall, the IT personnel has a good knowledge about their IT systems and business applications3
Almost all enterprises lack in the ability to manage their IT resources to deliver business value4
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 16
Research findings
Conclusions (based on the case studies)
What is the status quo in European SMEs with regard to the implementation and application of the CSV?
RQ 1
RQ 2Do the results of the study reveal commonalities and differences in the implementation
and application of CSV?
Does the implementation and application of CSV have an impact on the firm performance of SMEs?
RQ 3
The majority of enterprises do not have CSV approaches. A risk analysis of the IT systems being used is also predominantly lacking.
Since only one company has a documented CSV process, this question cannot be answered at this time.
In all enterprises participating in the pretest, no significant changes in firm performance could be identified.
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 17
Limitations and outlook
Limitations of the research
The research does not addressthe validation of software in
medical products.
The legal regulations mentioned within the research are not
examined more closely for their necessity or correctness.
The research focusses on SMEsin the medical device industryand, therefore, does not claim
to be universally valid.
Such examinations are rather located in the field of software
engineering.
These regulations are rather regarded as general laws
according to which companies in the medical device industry
have to comply.
The application in largecompanies as well as in otherindustries, e.g. the pharmacy
industry, must first be checked.
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 18
Limitations and outlook
Further research steps and overall research methodology
Phase Process step Method and approach
Problemidentification State of research
Survey of medical devicemanufactures
Data collection and validation of the results
Expertinterviews
Impact of the computer system validation on the firm performance of small and medium enterprisesin the medical device industry
Development of a risk-basedmodel for CSV
Development and implementation
Evaluation of the resultsExpert
interviews
Systematic literature review
Questionnaire technique / pretest
Guided interview
CSV approaches / methodsRisk management approaches / methods
Conditions of international standards
Guided interview
Results of a qualitative survey on the application of Computer System Validation in European SMEs of the Medical Device Industry
First findings of an ongoing research project
The Future of Entrepreneurship: Policy and Practice8-9 April 2019, Paris, France
Marius Schönberger
Prof. Dr. Tatjana Vasiljeva
Results of qualitative survey on the application of CSV in EU SMEs of the Medical Device Industry | Marius Schönberger & Tatjana Vasiljeva 11.04.2019 20
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