Trump tariff plan and FDA layoffs: The medtech industry is concerned

President Donald J. Trump © Courtesy of the Library of Congress Prints and Photographs Division

This week, President Donald J. Trump unleashed regulator layoffs and then global tariffs. The medical device industry is not happy.

Here's a roundup of what's happened and how the industry is reacting.

Calls for tariff 'exemption'

Trump announced his tariff plan during a White House ceremony on April 2. It includes a baseline tariff of 10% on most countries and “reciprocal” tariffs on a long list of select countries such as China, the European Union and others.

The medical device industry has spoken out against tariffs throughout the early days of the Trump administration, calling for exemptions for the industry. On Wednesday, Scott Whitaker, the President and CEO of AdvaMed, the Medtech Association, again expressed his disappointment and called for an exemption.

“I am disappointed in the news of the Administration’s intent to levy broad tariffs that will negatively impact American medical technology and innovation,” he said in a statement. “If implemented as proposed, broad-based tariffs of this nature would act much as an excise tax. It will have a negative impact on innovation, cost jobs, and increase overall costs to the health care system. Historically, industries with a meaningful humanitarian mission have been exempted from broad tariffs, and as a result we have seen no to low tariffs on medtech from all key trading partners.”

Whitaker went on to say conversations with the administration will continue.

Scott Whitaker, President and CEO, Advamed

Credit: Advamed, the Medtech Assocation

“While disappointed in this initial announcement, we look forward to continuing our conversations with the White House to help them understand the important role the medtech industry plays in our health care ecosystem, the value it provides to patients, and the importance of the industry to continued U.S. economic growth,” he said. “The medtech industry should be exempted from these tariffs.”

Tariff price impacts

What impact tariffs will have on the industry’s outlook remains to be seen as they are imposed. Rohit Harve, a health care operations expert and a partner at PA Consulting, said in a previous interview with Medical Economics that tariffs will impact device prices based on whether they are life-saving or discretionary, with devices required for care seeing price increases passed on to payers, physicians and patients, while devices related to discretionary care seeing less price impact, as makers worry about lower demand.

“Broadly speaking this is going to impact health care costs,” Harve said.

FDA layoffs hit device office

Tariffs aren’t the only concern the medical device industry has with the early days of the Trump administration.

Also this week, Trump’s Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. took sweeping action to reduce the size of the HHS staff, impacting thousands of employees across the FDA, CDC, NIH and more. Leaders were reassigned or fired, and regulators were let go.

Media reports say the FDA is reducing its staff by 3,500, including regulators in the FDA’s Center for Devices and Radiological Health (CDRH). The Wall Street Journal reports that Michelle Tarver, M.D., Ph.D, CDHR’s leader, is one of the few senior leaders still in place at the FDA.

Former FDA Commissioner Robert Califf, MD, FACC, put it bluntly on a social media post: “The FDA as we’ve known it is finished.”

Former Medtronic CEO Bill George said in a LinkedIn post the pharma and medical device companies are “facing a quadruple threat” from RFK’s leadership, including less drug and device innovation, slow down of approvals, and more.

“Some staff reductions are likely warranted, but these are far more dramatic changes than appropriate,” he said.

One result of all this chaos? Device clearances have slowed. Here’s some data according to a search of FDA databases on approvals between Jan. 1 and April 2:

• De novo device clearances: So far in 2025 only three novel, or de novo, devices have been cleared by the FDA, compared to 13 during the same period in 2024.
• Premarket approval: Four original devices have received approval in 2025, compared to eight in the same period in 2024.