Frost & Sullivan feature on 3-Printing

1. MO V E R S
S H A KE RS
A Conversation with Dr. Frank J. Rybicki
“We Accelerate Growth”
March 2016
Why 2016 may be the Year Medical 3D
Printing Crosses the Chasm

2. Movers & Shakers
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,”

3. 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

4. Movers & Shakers
4 March 2016 | www.frost.com
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

5. Dr. Frank J. Rybicki, Department of Radiology at the University of Ottawa
5www.frost.com | March 2016
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.

6. Movers & Shakers
6 March 2016 | www.frost.com
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

7. Dr. Frank J. Rybicki, Department of Radiology at the University of Ottawa
7www.frost.com | March 2016
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

8. Movers & Shakers
8 March 2016 | www.frost.com
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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