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How 3D printing will shatter the medtech supply chain

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By Norbert Sparrow
Published: April 24th, 2015

The 3D-printing medical breakthroughs of the year

(so far): BIOMEDevice

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Available materials limit vast medical potential of

3D printing

Make no mistake: 3D printing is a disruptive technology, one of the most transformative processes we have seen in a long
time that will fundamentally change manufacturing from top to bottom. How it will affect the supply chain in medical
manufacturing is a topic that Jim Joyce, Specialist Leader - Supply Chain Practice, Deloitte Consulting (Boston), will
address at the forthcoming BIOMEDevice Boston event. He recently shared some insights in advance of the conference
and exhibition with PlasticsToday.

Researchers 3D print airway stents

An FDA perspective on the use of 3D printing in
medical applications

From its origins in rapid prototyping, where additive manufacturing, a term that is
used synonymously with 3D printing, shaved off months of labor and significant
expense from conventional methods, to the next frontier of printing final parts and
bringing mass customization to the marketplace, 3D printing is affecting everything
from moldmaking to off shoring. It will make regionalized manufacturing viable, as
micro factories are set up near the point of purchase. Going a step further, car
dealerships one day will "print" spare parts, as needed. The possibilities are
endless. And as the cost of printers and materials plummet, "the factors that have
made China the workshop of the world will lose much of their force," writes Richard
A. D'Aveni in "3D Printing Will Change the World " in the Harvard Business
Review. The supply chain, as we know it, will undergo massive change.
3D printing is an enabling technology that is driving change in supply chain
practices in two fundamental ways, says Joyce: removal of assets and changes in
Jim Joyce, Deloitte Consulting
required skills and capital. "A small company or even a consumer will be able to
participate in the supply chain," he says. "You won't need scale or a significant
investment." The maker movement is the avant garde of this transformative process.
Healthcare delivery systems will set up maker spaces, predicts Joyce, radically decentralizing medical manufacturing.
"Practitioners and hospital personnel will be able to 'print' stents, tubes and valves for individual patients on the spot. As the
cost of equipment and materials collapses, we will be going from a landscape of startups and large companies to front-line
healthcare delivery providers making the devices," says Joyce.
Before we reach that bold new age, however, one must reckon with the regulatory process, not a small matter, and IP
issues.
Right now, FDA makes exceptions to the normal regulatory pathways via investigational device exemptions and such. The
FDA may need to think more along those lines, as the benefits of 3D printing become increasingly manifest while current
regulatory practices reveal themselves to be inadequate for allowing the technology to come to market in a timely manner.
FDA will need to come up with new regulations and new pathways that are appropriate for this technology, says Joyce.
"The patient is on the table and we need a custom part that can be printed here and nowhow do you get that approval?"
Equally important is the unsettled law surrounding 3D printing and intellectual property (IP), says Joyce. "Let's say you're a
doctor who has been working with Medtronic stents for a long time and you decide to print a straight copy of that stent.
That's a clear violation of the patent. But what if you modify that design and it becomes a whole new product and revenue
stream. Should you talk to Medtronic about joint IP? Or is the device sufficiently different?" asks Joyce.
Given these unresolved issues, how far away are we from seeing the routine use of 3D printers in the healthcare delivery
system? "Well, if you're asking if the machine quality and consistency are there, the answer is, clearly, yes, because 3D
printing in these types of situations is already being done in some places," says Joyce. PlasticsToday has reported on
some examples: "3D printing could revolutionize meniscus repair" and "Researchers 3D print airway stents," to name two
recent articles.
The 3D printing machines and the materials are not the obstacles. "It comes down to the regulatory issues and institutions
willing to take risks in terms of liability and ownership," says Joyce.
BIOMEDevice Boston, co-located with PLASTEC New England, will feature two tracks devoted to innovations in 3D printing
on May 6 and 7. Joyce is scheduled to speak on the impact of 3D printing on supply chains on May 7 at 1 PM. For more
information about the conference and to register to attend, go to the event website .

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