Nadim Daher of Frost & Sullivan interviews Dr Frank Rybicki on 3-D printing

M O V E R SS H A KE R S

A ConversAtion with Dr. FrAnk J. rybiCki

“We Accelerate Growth”

March 2016

Why 2016 may be the year medical 3d Printing crosses the chasm

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2 March 2016 | www.frost.com

Interview by Nadim Daher, Principal Analyst

Why 2016 may be the Year Medical 3D Printing Crosses the Chasm

February 2016

Dr. Frank J. Rybicki, professor and chair of the Department of Radiology at the University of Ottawa, chief of Medical Imaging at The Ottawa Hospital, and editor-in-chief for “3D Printing in Medicine,” speaks with Nadim Daher, principal analyst with the Transformational Health group at Frost & Sullivan, about the latest developments and the future of medical 3D printing.

Interview at a Glance

“Experience with many cases supports that the 3D model will increase surgical confidence and be desired for the next patient. Once a surgeon recognizes that this is possible for one patient, it becomes their personal standard.”

“I believe that we can learn from what we have accomplished thus far and capitalize on opportunities to generate win-win scenarios for medicine and the industry.”

“It is unlikely that a new group will buy more than one printer at a time. Most groups can and should start with surgical planning and use a few colors.”

“I cannot stress enough the need for a dedicated in-hospital ‘3D printing steering committee’ that will evaluate the needs of every department and eventually decide on the most balanced option for the institution, patient-wise and profit-wise.”

“The choice of an institution’s first 3D printer should largely consider the intended service.”

A Conversation with Dr. Frank J. Rybicki, professor and chair of the Department of Radiology at the University of Ottawa, chief of Medical Imaging at The Ottawa Hospital, and editor-in-chief for “3D Printing in Medicine,”

Dr. Frank J . rybicki , Department oF raDiology at the University oF ottawa

3www.frost.com | March 2016

“The models use materials that, while under $100USD per case, have accumulating expenses over time. There is no reimbursement for 3D printing at present.”

“Dedicated personnel should be also considered, including technicians’ and physicians’ full or part-time salary, as well as hardware replacements and technical support costs.”

“All in all a rough estimate would be around $200,000-300,000 USD for an institution aiming to utilize 3D printing in everyday clinical practice.”

“As radiologists, we deliver a very flat and very black-and-white ‘report.’ 3D printing offers something entirely different.”

“3D printing holds great promise toward patient-tailored medicine practice and has shown its feasibility, accuracy, reproducibility and the added value in almost every aspect of medicine.”

“[On the road to reimbursement], adding in a year buffer, I believe that we are looking at a roughly five-year horizon.”

“The fundamental question is, ‘Can we pay for the technology that physicians want to use to enhance patient care? Or will that technology ultimately pay for itself with improved outcomes and a better quality of life?’”

3D Printed Model from Dr Rybicki’s 3D lab at University of Ottawa

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Nadim Daher (ND): Dr. Rybicki, thank you very much for taking the time to speak with us today. As a pioneer of 3D printing in medicine, you have been experimenting with the technology and publishing scientific papers on it for some time. If you reflect on the past five years and consider where we are now, do you feel the case for 3D printing in medicine is advancing at the pace it should?

Frank J. Rybicki (FR): You are very welcome, and thank you for asking me to contribute to your excellent publications. I hope to accurately represent the voice of a growing, diverse, and innovative community. 3D printing is advancing at an expected rate, although not as fast as many members of the community would like. Favoring rapid advancement is opportunities.

3D printing has already revolutionized human well-being in some areas; individuals all over the world have 3D-printed dental prostheses. Similarly, maxillofacial reconstructions, how I was initially exposed to these technologies, have relied on 3D printing for many years. The difference is that in the last few years, other medical specialties have recognized how 3D printing can transform clinical care.

For example, the cardiovascular arena is now gravitating to 3D printing for adult valve disease, after a longstanding recognition that printed models are an essential part of surgical planning for complex congenital heart disease. Similarly, there are new oncology applications for 3D printing where multiple structures are printed—these include the tumor plus the surrounding healthy tissues that must be preserved, or are desirable to preserve, at surgical treatment for that patient. The 3D model that shows this to the surgeon, and that the surgeon can hold in his or her hand pre-operatively, is invaluable.

Once a surgeon recognizes that this is possible for one patient, it becomes their personal standard, and subsequent models are desired.

ND: You’ve mentioned some examples of current and promising new clinical use cases—from surgical guides and positioners, to patient-specific prostheses and biocompatible implants for regenerative medicine, to deformable models for surgical training… the possibilities seem endless. Which ones do you highlight as being ripe and robust enough for routine clinical use or will be soon?

FR: You have mentioned many of the possibilities that are in use now and on the short-term horizon. What you haven’t noted is some of the more straightforward applications for surgical planning.

For some time, radiologists have been eager to deliver ‘more’ than a simple report. In the U.S., Imaging 3.0, an initiative from the American College of Radiology, seeks to better define and add value to what radiologists can and should deliver to the healthcare system. As radiologists, we access intricate data on human anatomy and pathophysiology, and we deliver a very flat and very black-and-white ‘report.’

3D printing offers something entirely different. It gives radiologists the opportunity to deliver that anatomy and those disease processes to the community in the palm of their hands. This is an enormous opportunity, and we need to do it right. If we do, we will redefine how we think about imaging, modeling, and other new strategies and care algorithms that extend well beyond radiology.

Done right, patients will be better informed, trainees will be better trained, and a large variety of healthcare providers will have the tools to do their jobs better. On the contrary, if we do this the wrong way, we will simply



be introducing another expensive technology with little, or scattered, evidence that it improves patient quality of life. There will continue to be only niche applications and a small subset of care providers who benefit from the technology.

I believe that we can learn from what we have accomplished thus far and capitalize on opportunities to generate win-win scenarios for medicine and the industry.

ND: Those are really good points! As you said, 3D printing already has quite a strong position and clinical track record in dental applications—perhaps a 10-year head start. How do you explain that it is only now coming of age and gaining traction in mainstream clinical specialties; are there major road blocks like perhaps a lack of awareness, training, or cost justification?

FR: Let’s cycle back to the initial comments I made about the cancer surgeon who, for the first time, gets a model in her hands for surgical planning. Let’s say that model is for a lung cancer that is precariously positioned in the chest, so that the surgeon is challenged to re-sect the entire tumor and at the same time spare the major blood vessels and the airway, all necessary for survival, and the nerves in the region, critical for quality of life.

To date, experience with many cases supports that the 3D model will increase surgical confidence and be desired for the next patient. While many people debate personalized medicine, this is personalized medicine. In fact, the model can and should be shown to the patient so that the patient and their family can understand the disease and the state of their body before surgery, and optimize the process of informed consent.

Given this one example, one could hypothesize an exponential growth in 3D printing for surgical planning.

That exponential trend has been tempered, but not leveled, by pecuniary considerations. While a 3D printer can be acquired for well less than $100,000USD, a multi-purpose, multicolor printer is still more expensive than this. The models use materials that, while under $100USD per case, have accumulating expenses over time. There is no reimbursement for 3D printing at present.

ND: Considering that the 3D printer is only part of the total investment and given the current hardware, software and materials available, what kind of total ballpark investment are we talking about for a hospital wanting to adopt 3D printing?

FR: Again, this will also heavily depend on the intended use. Aside the cost of the 3D printer mentioned before, a hospital willing to adopt medical 3D printing should consider extra costs that include software, hardware, and materials. Certainly, dedicated personnel should be also considered, including technicians’ and physicians’ full or part-time salary, as well as hardware replacements and technical support costs. All in all a rough estimate would be around $200,000-300,000 USD for an institution aiming to utilize 3D printing in everyday clinical practice.

ND: In this context I learned at RSNA that each type of 3D printer is made to work with a different type of material. What does this mean for hospitals looking to set up a 3D printing lab; would they have to invest in several machines, or is there a particular type that seems most interesting right now?

FR: There are multiple considerations in choosing a printing technology. Important 3D printing parameters include time required to complete the print, availability, cost of printer and materials, choice of materials, color capabilities, biocompatibility, sterilization capability, material physical properties, and whether a 3D printer with multi-material capabilities is necessary.

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It is unlikely that a new group will buy more than one printer at a time. Most groups can and should start with surgical planning and use a few colors. The choice of an institution’s first 3D printer should largely consider the intended service.

ND: That makes complete sense. For a hospital wanting to get on-board with 3D printing, how should it be looking at the different deployment models that may be viable—like setting up an in-house 3D printing lab or signing up to a remote professional 3D printing service, or maybe a hybrid model based on the types of 3D models?

FR: Ideally, an in-house 3D printing lab should be incorporated in every hospital aiming to provide patient-centric, precision medicine-based care. Given the costs and the current lack of reimbursement for medical 3D printing, it is understandable that this cannot be yet realized.

Remote professional 3D printing services do exist, for example the service provided by Materialise that has been active and successful for some time now, and the decision on the service model should be made upon the projected application of this disruptive technology in each institution. However, I cannot stress enough the need for

a dedicated in-hospital 3D printing steering committee that will evaluate the needs of every department and eventually decide on the most balanced option for the institution, patient-wise and profit-wise.

As leaders in 3D printing assemble, it is important to recognize this need and form such groups.

ND: Radiology seems to want to hop on the 3D printing opportunity, and there seems to be good logic to it, but other specialties have good reasons to contend, too. What is your take on the rationale and the conditions for radiology to become the owner of the 3D printing opportunity?

FR: This technology provides radiologists with a new opportunity to offer an important value-added contribution to patient care. It also has tremendous potential for education and research. The radiologists’ combination of skill and experience in imaging anatomy, pathology and imaging technology places them in a unique position to create laboratories that translate 3D printing technology into clinical practice.

It is reasoned that other specialties would aim to be part of the medical 3D printing world that is unveiling.

3D Printed Model from Dr Rybicki’s 3D lab at University of Ottawa



3D printing has ushered in a new generation of imaging, offering a new perspective to physicians to comprehend normal anatomy and pathology. Medical imaging has been pioneered from radiologists, and distinct roles of medical specialties have long been established. I firmly state, though, that strong collaboration amongst colleagues from other specialties is not merely welcomed, but a prerequisite for this ground-breaking opportunity to be an incremental part of routine patient care.

ND: As adoption starts to pick up, the issue of quality is likely going to become increasingly important, and the regulatory bodies are probably starting to watch closely. What role do you foresee for the regulation of the software, the printers, and for the actual 3D-printed models?

FR: Indeed, medical 3D printing is currently undergoing a rapid transition from niche applications to more routine utilization. This increased utilization is secondary to lower costs and greater awareness that 3D printing can enhance patient care. Translating a new technology from the research to clinical domain first requires standardization and validation. Regulation committees that will establish standards of clinical practice are currently under way. There is also a lot of discussion on what the role of the FDA will be in regulating hardware, materials and software used for medical 3D printing.

ND: One of your presentations at RSNA 2015 had a slide titled, “The Road to Reimbursement,” where you explain that more and more clinical recognition and scientific validation of each clinical use case would ultimately lead the payers to consider reimbursement. What is a realistic model to expect down the road; for example, would we see a technical component and a professional component for 3D prints?

FR: Reimbursement poses currently one of the major obstacles for the wide adoption of medical 3D printing.

The straightforward path is to follow the example of earlier technologies that are now applied in patient care. Since the feasibility, the reproducibility and the added value of 3D printing have already been shown in the research field and in small clinical reports, large-scale retrospective and, importantly, prospective clinical studies that will establish the generalizability of the technology pose the first step. Once there, we expect that reimbursement will be inevitably considered by major health providers.

ND: What would you say is the kind of timelines we are looking at on this road to reimbursement, say in the most and least optimistic scenarios?

FR: Perhaps the best way to look at this is in reverse chronologic order. I believe that imaging reimbursement will eventually track with published guidelines. It is for this reason that I have spent a large part of my professional career volunteering for the American College of Radiology Appropriateness Criteria®, or the AC. These guidelines are implemented into clinical decision support tools, namely ACR Select, which is now the dominant platform that clinicians use for decision support.

One of the main reasons why I initiated 3D Printing in Medicine, an open-access peer review journal published by Springer, is to have an open forum and a dialogue for guidelines to be disseminated. This will take at least one year, although I would like to have some guidelines published, for example 3D printing nomenclature, within 2016. Guidelines themselves are based on trials that show quality and cost-effectiveness.

Right now, there are the beginnings of those studies that extend beyond case reports to include patient cohorts group by clinical indication for 3D printing. However, these will evolve over the next two to three years. Funding trials is essential, and I believe that there will be investigation-based resources dedicated to 3D printing.

Adding in a year buffer, I believe that we are looking at a roughly five-year horizon. I also remember being in the

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very same position in cardiac computed tomography about 13 years ago when I was completing my training. There was a new technology, ‘fast’ helical imaging—cardiac CT did not have a CPT code, but people knew that it was an emerging technology that was here to stay.

3D printing will likely avert many of the political obstacles encountered in garnering some reimbursement in the U.S. And it will avoid the patient radiation ‘hot potato.’ A former research fellow of mine recently published a paper noting that for printing bone, very low radiation doses in CT images are adequate using a novel patient-specific metric for 3D printing accuracy and quality.

We were able to show that these very low-dose CT images provide accurate 3D-printed models of bony structures in the maxillofacial region. However, for those patient-specific models to be accepted by the scientific community as well as the payers, it will require continued efforts to incorporate such elements into generic models, and to test them in other models such as the soft tissue, including the solid organs and the heart.

The fundamental question is, ‘Can we pay for the technology that physicians want to use to enhance patient care? Or will that technology ultimately pay for itself with improved outcomes and a better quality of life?’

ND: These are all really great insights. To wrap up, are there any recommendations, best practices or lessons learned that you would like to share with your peers who might be considering 3D printing?

FR: 3D printing holds great promise toward patient-tailored medicine practice and has shown its feasibility, accuracy, reproducibility and the added value in almost every aspect of medicine.

Since the role of imaging will remain incremental in the medical 3D printing world, the optimization and standardization of the imaging modalities used for the respective 3D printing application are yet to be determined. 3D printing has a large number of emerging and rapidly growing applications. It is important to determine the needs of your institution prior to establishing 3D printing programs. Once the program is established, expect exponential growth.

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Nadim Daher of Frost & Sullivan interviews Dr Frank Rybicki on 3-D printing

Healthcare

Transcript of Nadim Daher of Frost & Sullivan interviews Dr Frank Rybicki on 3-D printing