As additive manufacturing has made its way into the healthcare arena, the technology has opened up new possibilities in the creation of patient-specific medical products such as anatomical models and surgical guides. Due to the delicate nature of these devices and the critical care applications in which they may find use, the US Food and Drug Administration (FDA) has taken great interest in regulatory implications of the use of 3D printing. In early December 2017, the FDA issued guidance on 3D printed medical devices, a move that has major implications from a business perspective and one that builds on previous draft guidance and feedback leading up to the final document. The manufacture of medical devices is one that many agree should be closely regulated as new technologies emerge; some argue that even the 3D printers used to create medical devices should be regulated in addition to the parts that come off of them.
FDA senior research engineer Lieutenant Commander (LCDR) James Coburn has been examining the implications of 3D printing on medical device manufacture for some time now. About a year ago, Coburn spoke to the “Three Rs” of medical 3D printing: regulate, research, resource. As 2018 begins with the FDA’s guidance — Technical Considerations for Additive Manufactured Medical Devices: Guidance for Industry and Food and Drug Administration Staff — having recently been issued, Coburn was available again to speak to the agency’s position regarding these considerations at our Additive Manufacturing Strategies summit, held last week in Washington, D.C. Not the originally scheduled speaker, Coburn did an excellent job of presenting information during his time at the AMS summit, able to speak during the federal government shutdown going on that day because, he noted, “as a military officer, I can come today because I have to come to work anyway.”
“So far, there are about 100 FDA-cleared medical devices, and one drug aproved,” Coburn told us in opening. “Bioprinting research is going through the roof; we’re seeing a lot of work in that area.”
He mentioned prosthetics, dental applications, and anatomical models as other aspects where the FDA has noticed a great deal of attention in 3D printing. Noted as well was the issue of reimbursement, which “has some interest and needs more metrics.” He said that, “At the FDA, we’ve tried to interact a lot in this space in the last few years,” including a 2014 workshop that many of the AMS summit attendees had attended. As the summit and workshop illustrate, gathering experts together is an important step in disseminating information and encouraging conversation; Coburn also pointed to a joint meeting in August with RSNA as an example of such an event.
“I work in the science and engineering lab and run our core additive manufacturing facility there, which includes several industrial 3D printers and bioprinters. We have a gamut of technologies out there, so researchers and the people doing regulatory work understand what they’re getting into, and could leverage some of it to put out technical guidance in December,” he explained of the FDA’s wide-reaching interests and activities.
“One of our goals is to facilitate innovation; people don’t think of the FDA as an innovative organization. It is our business to know what’s in the small business sector. That’s our core demographic. About 75% of applications come from businesses with 50 or fewer people. We do a lot of outreach.”
As innovation and technology were the agenda for the day, Coburn kept a level head in reminding everyone that while there are many reasons to use 3D printed medical models, there are also reasons not to: “Every case isn’t going to need one.” The appropriate application of available technologies is a judgment call that must be made on a case-by-case basis, and while many difficult or complex procedures absolutely benefit from patient-specific anatomies made available to the medical team, they are not always necessary. Returning to the idea that when you have a hammer every problem can seem to be a nail, research is ongoing into best-use situations, and it is in these areas that the FDA is placing greatest priority.Concluding his time on the panel at the summit, Coburn looked ahead, noting that the FDA “typically doesn’t pointificate on the future,” but that he had a few bullet points to highlight, including the help from America Makes, of which the FDA is a Gold member.
“Education is one of these big things — finding out best practices, and how to disseminate that information, is big: we need to push that into the future. You have to show somebody that making a patient-specific guide improves care, that there’s some value to it,” he said, noting that the individual success rate increases, but the FDA does not have the metrics for that.
He underscored the importance of metrics and quantifying results, as hard data helps the FDA and other agencies to better understand and evaluate new technologies for regulation. While new developments such as the use of haptics can, Coburn said they’d heard, feel better in use, “it’s hard to put a number to ‘it feels better’ and until that happens it’s hard for people like the FDA to look at it in a quantitative way.” He noted a recent post from FDA Commissioner Scott Gottlieb, MD, about updating 510(k) criteria to include safety and performance review that “would look at performance criteria rather than conducting comparison testing with a specific predicate to say a device is marketable.”
“We need these metrics,” he said, adding that they “would be very useful to move things forward, and especially to help the FDA in that area.”
To gain a fuller picture of the FDA’s involvement with 3D printing and stance on 3D printed medical devices, I later sat down with Coburn for a chat.
We’ve been following the FDA’s activities in 3D printing for some time, including issued approvals and the development of the guidance; how long, though, I asked, has the FDA been active with additive manufacturing?
“We’ve had 3D printed devices coming in for at least a decade; we had a database search, retrospective analysis, all in some form or other for about a decade now. We really started ramping up in the last, say, five years now,” Coburn told me.
“Everything today’s speakers have noted about how trensds are increasing, we’ve seen a corollary increase in Class 2 devices. In the research area, we notice these sorts of trends, and also started using 3D printing for our research purposes, for functional performance, and it’s nice to prototype with 3D printing. We did some work in the 2012-2013 range, and we always knew it would be a big thing — we pushed grassroots for more involvement. Luckily, senior management thought it would be a good idea. We have a cross-agency working group; I’m the lead for our core 3D printing research facility. It’s a really nice collaborative effort.”
We turned next to the guidance, as I asked how the response has been since its issuing in December.
“People so far have been responding positively. The major response was when it went draft. There were a couple changes, but for the most part it was well-received. We had comments from industry, from stakeholders, and tried to incorporate as much as possible,” he explained.
“You’d have to ask the companies for their perspective, but everything we’ve seen has been positive and we think it’s helping people.”
With the guidance now live for over a month, I would certainly be curious to hear more from the companies working with 3D printing for medical devices; any comments are always welcome as we look to present a diverse range of voices from the industry.
As we wrapped up our chat, I asked Coburn about applications that the FDA is keeping a keen eye on, and the applications they see as key to their attention to 3D printing.
“What I really want to accomplish, and think we’ve built into our program, is this outreach we’re building with the industry. To make sure we can foster innovation in a way that is beneficial for everybody, and that the FDA is helping to advance things rather than reacting,” he told me.
The US FDA will continue to work with and keep an eye on the latest developments with 3D printing as the technology continues to impact human healthcare.
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