During a week that began with widespread layoffs affecting thousands at the FDA and more at other government health agencies—and continued with new tariffs from the Trump administration threatening a global trade war—a group of medtech leaders looked to take stock of the situation and examine what the future may hold for patients, providers and the industry.
In a webinar hosted by the medtech development service provider NAMSA, the former longtime chief of the FDA’s Center for Devices and Radiological Health (CDRH), Jeff Shuren, M.D., said that the loss of 3,500 full-time positions through the agency’s recent reduction in force would assuredly impact the pace of its work—which, in some areas, has already fallen following initial waves of DOGE-led layoffs earlier this year.
“It would not be surprising if we saw longer review times, at least in the near term,” Shuren said.
“We know that some of the [early] terminations were rescinded for premarket review folks—and the administration has said that they're looking to protect the premarket review program—but some of those people have decided not to come back,” he continued. “Some people are taking the buyout. Some, of course, due to return-to-office or poor morale, have decided to move on … and that all of that has an impact.”
“Where do we go from here? Long term? Who knows?” said Shuren.
The workforce cuts come in the middle of a technological transformation effort at the agency—not only with the goal of better preparing it to assess the new artificial intelligence technologies that are making their way into the healthcare field but to also see how AI can be invested in the everyday work of the FDA’s staff.
“The administration has said they want to be able to do more with less … and there are lots of opportunities for efficiency,” Shuren said. “I don't know where they will go, but there are discussions around using AI tools to help in premarket reviews, and there are lots of opportunities there.”
“In fact, the center was already looking at those and starting to invest in tools to leverage that, and make it a more effective, efficient program … It'll be important to continue efforts on data management, because you have to make sure the data that's already there and coming in the door is cleaned up and consistent.”
“And we had an effort on the way to do that. It's not yet done. So hopefully, if anything, that gets expedited—but also, some of the people involved in that were part of the RIFs.”
That includes Vid Desai, the FDA’s chief information officer and head of its Office of Digital Transformation, who was laid off this week along with other senior members of the agency’s IT team.
“The reality is there is a lot of fear and there is a lot of uncertainty,” said Juan Granada, M.D., president and CEO of the Cardiovascular Research Foundation. “All these changes are deeply impacting what we do—with the slowdown in international companies that are concerned about whether we are going to have a functional FDA that can help us? Or companies that, right now, are at a critical point of development and are wondering what is going to happen next.”
“I'm an AI adopter. I really believe these are great initiatives, but we need to validate them first,” said Granada. “And to do the validation work, we need a valid AI group at the agency that we no longer have.”
“It's important that we are thoughtful and that we make these changes with a lot of care and strategy, because otherwise we're going to go back 20 years and essentially lose all the momentum that we had on innovation and progress in the United States.”
Martin Leon, M.D., director of the Columbia Center for Interventional Care at New York-Presbyterian Hospital and the Mallah Family Professor of Cardiology at Columbia University, said the FDA is also losing a major facet that sets it apart from other international regulatory agencies.
“I view the FDA as the supreme regulatory body in the world. In fact, there's nothing that's even close,” Leon said. “And I think that that has evolved dramatically over the past 15 years—and it's in how it’s favored innovation, it's embraced communication and it's developed a commitment to both safety and the efficient approval of new technologies that are meaningful to patients.”
“We've observed that the FDA no longer has a public-facing interaction capability,” he added. “What we were most proud of was the fact that we had open communication with the agency. We could discuss regulatory science, we could brainstorm new ways to be able to improve how we manage certain approval processes—and I think that dynamic of an open communication process was extremely helpful.”
“So it's painful for me to see that a lot of that has been erased very quickly,” Leon said. “To the extent that that can be restored, in a way that preserves the communication, I think would be very important going forward.”
The panel’s moderator, NAMSA Chief Medical Officer Adam Saltman, M.D., Ph.D., also pointed to the FDA’s presubmission and early engagement capabilities, calling it “one of the real jewels in our regulatory framework.”
“That doesn't exist in many other parts of the world. So as I'm talking to European clients or Asia-Pacific clients—they don't have the ability to have presubmission discussions. They don't have breakthrough designations, they don't have the Total Product Life Cycle Advisory Program, things like that,” said Saltman, who also spent 12 years at the CDRH.
“I'm a little bit worried that they would be threatened,” he said. “And if they are, it would obviously remove the advantages we have—which was a shift that has happened over 10 to 15 years to bring the U.S. to prominence.”
In terms of opportunities, Kenneth Ouriel, M.D., an executive VP at NAMSA, said the changes could lead to new ways of operating at the FDA.
“One thing that comes to mind in my recent experience—it’s not a workforce reduction, but it’s the changes that we saw during the early part of the COVID pandemic and the lockdown phase, where we couldn't do in-person monitoring visits,” said Ouriel, who is also chief medical officer of the CRO Syntactx. “And I said to myself, ‘Here it is, 2020 at the time, and we're still doing on-site monitoring,’ and it forced us to look at remote visits.”
“So that's one example of a change that was stimulated by something that wasn't a lot of fun, for sure, but maybe something we should have thought about earlier that was quicker and less expensive.”
“I hear all the time about the value of being able to engage with the folks in the center,” said Shuren. “That’s why we built those efforts. And it's not just for premarket reviews, it’s a whole host of activities. And, quite frankly, I also think it’s useful for the center.”
“Where we are today—it isn’t going to be shocking if we see a cut in the number of presubmissions, or the opportunities for them,” he added. “There’s a chance to rethink some of the engagements, and there are things that industry and others can do as well to take advantage of the opportunities when they are there—but be very targeted about what you’re asking about.”
“Do your homework in advance, and take some of that burden off of the staff … There are creative ways to go about it—but I would hate to lose the capability, at the end of the day, to have those interactions,” Shuren said.
“But that does require people’s time, and you need people to be able to do it.”
Regarding the costs of tariffs—with the latest round carrying no exemptions for medical devices—the panelists said their impacts would go much further than the bottom line.
“It affects the entire ecosystem of device development, prototype development and technology development,” said Granada. “If you have to bring in materials that are more expensive, or materials that will not be available, or if you damage relationships with countries that have certain areas of expertise—that is going to affect the entire ecosystem.
“It's going to make access even more complicated for other countries that need these technologies,” he added. “This is something that is going to affect, directly or indirectly, not only manufacturing costs, but also access to patient care.”
“We can't have our head in the sand and not interact with our colleagues around the world,” said Leon. “We learn so much from each other.”
“I'm concerned that tariffs really do fragment relationships, and those relationships have been forged over the course of decades—and they're so positive, in terms of us achieving a level of progress and collective wisdom.”
“I'm seeing an immediate reaction to the tariffs, as a symbol of an isolationist attitude of how we're going to be approaching the future,” Leon added. “I think that would be destructive. I think it would be negative.”
“Forgetting about the ability of being able to manufacture the same way, or having access to raw materials the same way … We have physicians, now, who won't come to the United States because they've been basically told by their governments or their institutions that the U.S. is not a friendly place.”
“This affects research fellows. This affects visiting physicians. This affects the exchange of science.”