SAN DIEGO — Since the beginning of the year, the medtech industry has grappled with the threat of tariffs, Food and Drug Administration staff cuts and regulatory uncertainty. Last month, the Trump administration announced it was opening a Section 232 investigation into medical equipment, a process the administration has used to impose tariffs for the steel, automotive and pharmaceutical industries.
While it’s not clear if President Donald Trump intends to impose industry-wide tariffs on the medtech sector, AdvaMed CEO Scott Whitaker said his team “is focused solely right now on the 232 investigation and the process around that.”
Speaking to press at The MedTech Conference, Whitaker said the lobbying group will file comments this month, and aims to make the case that medtech already has a strong U.S. manufacturing footprint. He added that medtech has a trade surplus in every region, except Mexico, which many companies have turned to as a nearshoring option because of the U.S.-Mexico-Canada Agreement.
“Tariffs is probably not the right tool for us in this industry, given where we are right now, to make sure we continue to be really, really strong,” Whitaker added.
Medtech companies can mitigate the risk to their supply chains by onshoring and nearshoring as much as possible, and having production and supply chains in “friendly shores,” or allied countries, Whitaker said.
As tariff rates remain uncertain, Whitaker said AdvaMed has called for more clarity in private conversations with the administration. He added that levies as high as 45% or 50% would create a “huge problem” for the industry and impact jobs.
Whitaker added that the uncertainty of the current policy environment has caused people to pause while they look to better understand how things might play out.
“Just give us some certainty,” Whitaker said. “What is the tariff going to be for the next three years? And then let us manage to that.”
FDA staff cuts
In February and April, the Trump administration made mass staff cuts to the FDA, including its medical device center. AdvaMed voiced concerns in February that the cuts would affect staff whose work is funded by user fees and delay device reviews. The February firings were reversed but the April reductions in force remained in effect.
ProPublica reported that as of August, the Center for Devices and Radiological Health had lost 22% of its workforce, which includes cuts and attrition.
AdvaMed has not yet noticed performance issues regarding product review times, Whitaker said.
“It’s not like we like what has happened,” Whitaker said. “But it’s the reality of what has happened. And we’re glad to know, at least for now, things seem to be pretty stable, at least on the review side.”
He acknowledged that some staff have left, but is encouraged that CDRH Director Michelle Tarver is still at the FDA. Many other FDA center directors have left, or been removed or replaced, including the leaders of programs around biologics, drugs, tobacco products and food.
Shutdown not a concern — yet
The federal government shutdown has been ongoing since Oct. 1. The FDA has said it will not take new device submissions requiring user fees during the lapse. However, some other activities, such as surveillance for “significant safety concerns,” and other work funded by user fee carryover balances, will continue.
Whitaker said he is not particularly concerned about the shutdown in the short term, but emphasized that money collected from user fees should be used for the device program.
While he doesn’t know exactly how much the FDA has in reserves, Whitaker said, “We believe there’s enough in there to last for a little while.”
