Medical Devices Meet 3D Printing!

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Medical Devices?
Meet 3D Printing!
How to Seize an ‘Almost Unfair’ Competitive Advantage
A Special Report for Medical Device and 3D Printing Marketing Managers
Chuck Sanders
Sandprops Communication
2/2/2015

Sandprops Communication I Medical Devices? Meet 3D Printing!
Table of Contents
Executive Summary ....................................................................1
3D Printing..................................................................................2
Imagination + the Human Spirit = Innovation + Opportunity...2
Medtech Faces New Major Headwinds....................................4
The Almost ‘Unfair’ Competitive Advantage............................5
How does 3D Printing work?....................................................6
A Range of 3D Printing Applications.........................................7
Major Hurdles Still Exist..............................................................9
Value Marketing .......................................................................10
Conclusion ................................................................................12
© 2015 by Sandprops Communication
Readers are free to distribute this report within their own organizations, provided the Sandprops
Communication footer at the bottom of every page is also present.

Sandprops Communication 1 Medical Devices? Meet 3D Printing!
Executive Summary
Medtech has had a great run. The industry has seen decades of growth and success. However, major
healthcare consultancies are sounding an eye opening alarm. From their view, two major challenges
could threaten that momentum.
Yet rarely in business does a proactive ‘antidote’ present before the market totally consumes the
‘poison’. 3D Printing, also known as additive manufacturing, does just that.
Moreover, despite the media hype, one great revelation is the variety and flexibility of 3D Printing
technologies.
Even more, for medical device manufacturers and marketers, incorporating 3D Printing yields
an almost ‘unfair’ competitive advantage.
Indeed, additive manufacturing provides an irreplaceable dimension. It grants the ability to
customize, personalize, and add patient value to new and existing product lines.
Nevertheless, there are still challenges to overcome.
The first major hurdle, The Patient Protection and Affordable Care Act (ACA) changed everything. The
customer changed. The payer changed. Indeed, even the patient changed.
Even more, changes from ACA had a specific impact for medical device manufacturers and marketers.
The ACA changed how payers justify payments, the reimbursement model.
Instead of traditional fee-for-service, ACA encouraged a move to a value-based system. This shift usually
highlighted some form of quality improvement paired with reduced cost to the patient.
Likewise, ACA influenced provider consolidations. Therefore, physicians saw an advantage in joining
larger hospitals or organizations. The result reduced the influence of the individual physician, the
traditional buyer of medical devices.
In addition, ACA and technology granted patients more information about the products and services
they receive. They now can compare and choose.
The second major hurdle resulted from chance. The unexpected interaction of economic events had
profound impact.
Here ACA did not act alone. Instead, it increased the speed of other downward pricing trends. According
to analysts, this price pressure has exposed devices to a devaluing of unique product features. The
result, according to major consultants, is the real risk of commoditization in many product lines.

Commoditization is the process by which products become undifferentiated and therefore
interchangeable in customers’ perceptions.
With these market challenges, two imperative remain.
How do manufacturers differentiate their products?
Simultaneously, how do manufacturers and marketers create greater value for the patient?
3D Printing aligns perfectly with these Medtech priorities. This technology has a unique capacity. 3D
Printing creates custom devices. It therefore adds value by meeting the individual personal needs of the
user. That this often occurs at reduced costs represents an added benefit.
As mentioned, a key attribute of 3D Printing is its flexibility and variety of uses. Consequently, there are
many groundbreaking 3D Printing success stories in the medtech industry and medical device sector.
Yet for broad acceptance, 3D Printing still faces major impediments. These include governmental
regulation, available biocompatible materials, and intellectual property issues.
Even so, the future for 3D Printing in the medical device sector is nothing less than stunning. Yet the
market environment is dynamic and changing. Clear effective communication will be the key in market
success.
Indeed, we propose three synergistic marketing tools. These tools hold promise for broad effectiveness
in this new marketing environment.
It would be our honor to tell your stories.
______________________________
“...About merging the human spirit with technology…as if my DNA becomes a part of the
technology itself.”
3D Printing
Imagination + the Human Spirit = Innovation + Opportunity
Imagine you could not get out of bed this morning. Yesterday you walked and ran. Today your legs
simply do not work.
Imagine all that moves your life and brings you joy…your spirit, your fire, your gifts…forced to sit
immobile…confined to a chair.

What would life look like for you?
Amanda faced that reality. Twenty-two years
ago Amanda Boxtel fell, breaking her back in
a horrific skiing accident. She lost all
sensation and movement, left paralyzed
below her pelvis.
Yet, Amanda never gave up. Instead, she
asked, “What if technology could improve
your quality of life, give you freedom of
mobility, but also become an extension of
your senses?”
Working with design engineers at 3D Systems
and Ekso Bionics, she then helped create the
first hybrid 3D printed exoskeleton. Indeed,
some call this medical miracle a
‘technological-biological fusion’.
Today, after falling 22 years ago, with high-
tech assistance, Amanda walks again. But
even more, her spirit takes wing.
“I’ve broken my back about 21 years
ago”, she said. “I’ve never broken my
spirit.”
For Amanda’s device, the 3D printed parts are light enough to be comfortable. Yet, they are strong
enough to give full support to hold Amanda in various postures.
“The 3D printed parts, the white parts, follow the curvature of my spine. It raps around me,
around my body, around my kidneys, just like it’s giving me a hug.”
“I feel as if the exoskeleton is truly one with me. It’s as if it’s an extension of my body, as though
my own DNA has been imprinted into the design itself.”
For Amanda Boxtel, her dreams and her spirit inspired 3D printing innovation. It changed Amanda’s life
from ‘disabled’ to inconvenienced yet doable.
Yet Amanda’s story, while exceptional, need not be unique. Indeed, could Amanda’s story be just one of
many examples?
This is a time of tremendous change and unprecedented challenges in healthcare.
3D Printing provided a custom personal product for Amanda. Yet the value she feels is truly priceless.
Figure 1: Amanda Boxtel: Photo courtesy of 3D Systems
Figure 2: Amanda Boxtel: Photo courtesy of 3D Systems

Could 3D Printing provide this almost ‘unfair competitive advantage’ for many other medical device
manufacturers?
_______________________________________
Medtech Faces New Major Headwinds
Medtech has had a tremendous run. The industry has been a marvel of innovation and growth. Even
more, the industry has helped improve man’s material well-being worldwide.
However, some healthcare analysts, looking at the business environment, have raised major warnings.
They argue that market changes wrought by healthcare reform and other market forces could upend or
slow Medtech’s growth.
Are they right? You be the judge. Moreover, if so, what does it all mean? Even more, how best can
medical device manufacturers and marketers respond?
Here is their argument.
Ernst and Young argue that The Affordable Care Act (ACA) changed everything. This goes well beyond
the onerous 2.3% tax placed on medical device manufacturers, they argue. The ACA affected how and
with whom manufacturers do business. The buyer changed. The payer changed. According to EY, even
the patient changed.1
However, without doubt, ACA’s greatest impact was on how payers figured payments, the
reimbursement model. ACA scrapped the old traditional fee-for-service model, payment for the volume
of procedures. In its place is a still evolving range of value-based systems. These new models have some
basis in affordable patient outcomes and customer satisfaction.
The
Customer:
Provider consolidations changed who decides on purchases
from individual providers to hospital administrators, hospital
Value Analysis Committees (VAC), or Group Purchase
Organizations (GPO)
The
Payers:
Reimbursements and justifications for major purchases
changed from the volume of procedures done to the
demonstration of the value of service to the patient.
The
Patient:
Patients have greater access to information about care and
more choices of services and providers. Also they are often
now responsible for greater portions of their healthcare costs.

Then, as if adding seismic tremors to known fault lines, Ernst and Young went on to highlight another
potential quake. They looked at market trends in their reports dating to 2011. The outcome, the results
of those trends, was alarming.
They described:
 Trend #1: The emphasis on value and the necessity to demonstrate improved outcomes
to payers and providers
 Trend #2: Patient empowerment: their capacity to access critical knowledge from
connected devices, e.g. smartphone apps, social media, and sensor-imbedded objects
o Patients AND payers now have greater power
 Trend #3: The ACA compels manufacturers to demonstrate measureable improvements
in patient outcomes. At the same time, market forces are driving reduced costs.
 The Outcome: EY warns the high potential risk exists, in some products, of
commoditization.2
Commoditization
Commoditization is the process by which products become undifferentiated and
therefore interchangeable in customers’ perceptions.
________________________________
The Almost ‘Unfair’ Competitive Advantage
No one knows the future; crystal balls do not work. Indeed, the future is complex and unknown.
However, that does not blind our ability to see trend lines and respond to changing priorities. 3D
printing does just that.
As with Amanda Boxtel’s case, 3D Printing aligns perfectly with a new healthcare culture. That culture
stresses affordable patient outcomes and customer satisfaction.
Yet 3D Printing, also known as additive manufacturing, is far from ‘one-size-fits-all’. Embracing several
different additive techniques, the technology has flexible capabilities. That capability gives the
technology its one singular advantage, adaptability.
3D Printing also respects the bottom line. It can cost-effectively create custom products.
Deloitte Consulting highlighted this alignment when they noted that the medical device sector:

1. Serves a broad geographic population of providers and an even larger and more
dispersed market of customers,
2. Produces many medical devices that are quite small. Therefore, they fit well within the
assembly envelope of current additive manufacturing systems.
3. Most medical device products are ‘value-dense’, possessing a relative high value and
small volume.3
How does 3D Printing work?
3D Printing creates devices by depositing
(adding) materials layer-by-layer. The
process of making the device begins with
creation of a digitized model of a device.
The reproduction uses computer-aided-
design (CAD) software.
The digital format selected allows the
computer to ‘slice’ the software model
into layers. The computer then sends
instructions to the 3D Printing device to
guide the layering of material.
This mimics the ‘sliced’ software, to create
the actual physical device.
3D Printing, aka additive manufacturing
process, is somewhat akin to inkjet printers.
In truth, 3D Printing, as a category, represents several different additive techniques.
The deposition processes differ. Yet the critical distinction in these differing processes is the materials
used. Instead of ink, the machines create layers of polymers, metals, and plastics in forming the device.4
Figure 3: Stereolithography Apparatus:
By Materialgeeza via Wikimedia Commons

Additionally, 3D Printing has other unique benefits:
5
___________________________________________________
A Range of 3D Printing Applications
A lot of hype and ‘wow’ has surrounded the introduction of 3D Printing. Sadly, this may have done a
disservice, trivializing its real and tangible potentials.
For instance, there are the stories of 3D printed guns that have added new fuel to a heated gun control
debate.
On the other hand, maybe you saw the recent story of NASA ‘emailing a wrench’ (actually the software
plans) for a 3D printed ratchet wrench to the crew on the International Space Station.
Yet many manufacturers have already begun significant applications using 3D Printing. Indeed, these
devices range from creative improvements of existing usages to fundamental scientific advances.
3D Printing:
Other
Major
Advantages
the capacity to produce devices with intricately precise dimensions
while reducing initial tooling costs
the capacity for enormous reductions in waste and scrap materials
while increasing manufacturing efficiency
the capacity to customize production by making small batches at
much lower costs, often due to the reduction or elimination in
tooling costs
the capacity for rapid prototyping that supports far faster speed in
bringing new innovations to market.

Figure 4: OsteoFab Patient-Specific Cranial Device/Courtesy of Oxford Performance Materials
For example, Oxford Performance Materials has a record of breakthrough clinical accomplishments.
Oxford Performance Materials (OPM) is an advanced materials and additive manufacturing company. In
2013, OPM received FDA 510k approval of their additive manufactured cranial polymer implant.
OPM then announced its use in a surgical procedure replacing 75% of a patient’s skull. It marked the
first FDA approval of an additive manufactured device.
In addition, Organovo is a San Diego based company established in 2007. It achieved one of the most
significant new science achievements. Organovo pioneered a technology for 3D Bioprinting functional
living tissue.
Organovo’s NovoGen Bioprinting™ platform takes living cells and puts them into a 3D matrix that grows
the tissue. Their technology layers the tissues in the right architectural position. Their technology allows
for the cells, having internal programming, to finish the process.
Amazingly, Organovo is able to produce tissue outside of the body. The tissue produced has the same
architecture and composition as similar tissue inside of the body.
The technology shows great promise for drug companies by providing more cost effective ways to test
new drugs.
Why is this important?
Unfortunately, animal testing often gives poor results. This process fills the cost and time-consuming gap
between animal testing and the actual clinical trials in humans.
According to Eric Davis, M.D., J.D, Organovo Chief Strategy Officer, “It has the promise of more drugs,
faster drugs, and safer more effective drugs.”

Possible future uses include surgical replacement of diseased and damage tissue. The technology also
has potential major impact in the implant arena, as well.
_______________________________________
Major Hurdles Still Exist
If one follows trade publications, it is hard to miss the scores of rosy projections for 3D Printing.
However, there is no rose petal strewn pathway in 3D Printing’s future. In fact, as in most things, the
truth is more of a nuance.
In fact, a more sober assessment entails attention to major hurdles that remain unresolved.
Healthcare remains an industry with intense regulatory scrutiny. However, regulatory protocols for 3D
Printing remain unclear. The Food and Drug Administration (FDA), as we write, has yet to make final
approval for the evaluation process for future 3D Printing submissions.6
Michael Drues, president of Vascular Sciences, voiced what may be one of 3D Printing’s most limiting
concerns. In a Med Device Online article, Drues warned of the scarcity of bio-friendly materials. He
focused on the inadequate numbers of substances suitable for implantable devices.7
Drues also had concerns about a rather unspoken but obvious question.
“How do we test 3D printed medical devices”, Drues continued.
Regulation
•Products must
first meet
regulations and
statutes that
mandate
compliance
before being
allowed to face
the competitive
marketplace
IT and Data
Security
•Complex CAD
software, 3D
Printing's
intellectual key,
represent major
potential targets
of industrial
piracy
Scarcity of bio-
friendly materials
•Inadequate
current number
of substances
suitable for
implantable
devices

The FDA also shares Drues’ concerns. The FDA’s Office of Science and Engineering (OSEL) recently gave
two labs new investigating roles. Their challenge is to find how 3D Printing affects future medical device
manufacturing.
The Functional Performance and Device Use Laboratory now works to develop computer-modeling
methods. Their job is to track the effect of design changes on device safety and performance in various
patient populations.
In addition, the FDA’s Laboratory for Solid Mechanics now studies the effect of different additive
manufacturing techniques. Their concern is to know 3D Printing’s effect on the durability and strength of
materials used in medical devices.
The FDA expects this will contribute to setting standards and parameters. They are looking for the scale,
materials, and other factors affecting device safety and innovation.8
Moreover, Deloitte Consulting’s Mark Cotteleer highlighted major concerns with data management in
3D Printing. CAD software, not the design product, is the key intellectual resource. As such, it also
becomes the potential target for industrial piracy.
The design products, being customizable and reproducible, represent far less potential value.4
“With 3D Printing, the capital requirements of counterfeiting will fall dramatically. One challenge CIOs
and their teams will face is finding a new means of identifying their companies’ products.”
-Mark Cotteleer, Research Director, Deloitte Consulting
_____________________________________
Value Marketing
This is an exciting time to be in healthcare. Yet from whatever vantage point one views, the market for
healthcare has changed for everyone.
Your vantage point may be that of marketing for an additive manufacturing concern. Maybe you wish to
increase exposure in the medical device sector.
Maybe your viewing point is that of a medical device marketing or product manager. Possibly, you have
interest in or are currently using 3D Printing.
On the other hand, maybe your aims are more customary. Maybe you wish to increase interest or
demand for your medical device, product, or service.

Even so, the buyer groups, their makeup, and their concerns have changed. Buyers are now a diverse
lot. For example, the buyer group makeup often ranges from staff clinicians to supply chain heads of
large health care systems. The groups may often even include patient advocacy groups, as well.9,10
To market products and services in this changed market requires smart effective well-crafted tools.
Figure 5: MedTech Sales Funnel
Sandprops Communication recommends
1. Case studies (CS):
With the new focus on value to the patient, Case Studies serve a unique and pervasive role.
More often, they range from 750 to 1200 words in length. Case Studies are effective
testimonials of real patient/customer experience. They tell the actual story of how your product
or service brings real world value to your customers.
2. White Papers with Case Studies (CS):
White Papers are cogent essays about your specific product, service, or technology. On average,
they range from 3000 to 5000 words. White Papers present detailed technical material using
irrefutable facts and logic in an easy to understand format.
Case Studies used within the White Paper format convey your product’s value. It demonstrates
your product's technical effectiveness in the real world for your patient or customer.
3. Brochure/Sale Sheets with Case Studies (CS):

Brochures/Sale Sheets are traditional sales documents that create interest and desire. However,
Brochures/Sale Sheets have a unique versatile capacity. They change, individualize, and target.
They place focus on the specific challenges, needs, and interests of specific buyer group
members.
Brochure/Sale Sheets are colorful documents that support product introduction. When paired
with Case Studies, they serve a dual function of value communication.
These marketing tools owe their potential effectiveness to their pairings. These innovative pairings
provide both synergy and flexible messaging. They also respond to changing buyer group compositions.
_________________________________
Conclusion
The Medtech industry has seen decades of growth and success.
However, healthcare consultants warn of two major challenges on the economic horizon stemming from
the Patient Protection and Affordable Care Act (ACA).
1. How do manufacturers differentiate their products?
2. How do manufacturers and marketers create greater value for the patients?
3D Printing, despite the hype, offers the solution to these challenges.
3D Printing, known as additive manufacturing, offers enormous variety and flexibility for the medical
device sector.
Unfortunately, major hurdles stand in the way of the broad acceptance of 3D Printing. These are
government regulation, biocompatible materials, and issues of intellectual property.
Even so, the future in the medical device sector is stunning. At Sandprops Communication, we propose
three synergistic marketing tools. These tools have promise for broad effectiveness in this new
environment.
1. Case Studies
2. White Papers with Case Studies
3. Brochures/Sales Sheets with Case Studies
To find out more about how Sandprops Communication can help your team create marketing winners,
call us at (360) 930-9565. It would be an honor to tell your stories.

1
Pulse of the Industry: Medical Technology Report 2013: Redefining Innovation:
http://www.ey.com/US/en/Industries/Life-Sciences/Pulse-of-the-industry---medical-technology-report-2013
2
Pulse of the industry: Differentiating differently: Medical technology report 2014:
http://www.ey.com/Publication/vwLUAssets/ey-pulse-of-the-industry-report/$FILE/ey-pulse-of-the-industry-
report.pdf
3
3D Opportunity in Medical Technology: Deloitte University Press: http://dupress.com/articles/additive-
manufacturing-3d-opportunity-in-medtech/
4
3D Printing: Data, Data Everywhere - Deloitte CIO – WSJ : http://deloitte.wsj.com/cio/2013/06/25/3d-printing-
data-data-everywhere/
5
The 3D Opportunity Primer: The basics of Additive Manufacturing; http://dupress.com/wp-
content/uploads/2014/03/DUP_718-Additive-Manufacturing_Overview_FINAL.pdf
6
Public Workshop - Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical
Considerations of 3D Printing, October 8-9, 2014:
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm397324.htm
7
3D Printing In Medicine: 4 Questions That Need To Be Answered: http://www.meddeviceonline.com/doc/3d-
printing-in-medicine-questions-that-need-to-be-answered-0001
8
FDA Goes 3-D: http://blogs.fda.gov/fdavoice/index.php/tag/laboratory-for-solid-mechanics/
9
Deloitte | 2014 outlook on life sciences | Interview with Terry Hisey :
http://www.deloitte.com/view/en_US/us/Industries/life-
sciences/be0d25719bb8b310VgnVCM1000003256f70aRCRD.htm
10
1. Chilukuri S, 2. Gordon M, 3. Musso C, 4. Ramaswamy S.: Design to value in medical devices [Internet]. Florham
Park (NJ): McKinsey and Company; 2010 [cited 2012 Aug 2]. Available from:
http://www.mckinsey.com/~/media/mckinsey/dotcom/client_service/Pharma%20and%20Medical%20Products/P
MP%20NEW/PDFs/774172_Design_to_value_in_medical_devices1.ashx

Medical Devices Meet 3D Printing!

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