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

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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.

http://www.wired.com/2014/05/3d-printed-guns/

http://www.washingtonpost.com/news/speaking-of-science/wp/2014/12/19/nasa-just-emailed-a-wrench-to-space-for-the-first-time/


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.”

http://www.oxfordpm.com/

http://www.organovo.com/


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

http://www.meddeviceonline.com/doc/3d-printing-in-medicine-questions-that-need-to-be-answered-0001


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.

http://sandprops.com/

http://sandprops.com/


1Pulse 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/PMP%20NEW/PDFs/774172_Design_to_value_in_medical_devices1.ashx

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