How 3D printing will shatter the medtech supply chain

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.

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 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 now—how 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.