Tariffs, FDA user-fee programs, clearer payment and coverage rules and cybersecurity are top of mind for AdvaMed, according to Scott Whitaker, president and CEO of the organization.
Whitaker made these comments at the AdvaMed MedTech Conference in Boston on Monday. AdvaMed is a trade association representing medical technology manufacturers, diagnostic companies and digital health innovators.
The organization’s policy priorities include:
1. Tariffs: AdvaMed would like to get to a zero-tariff model, and if not a zero-tariff model, then a low-tariff model, Whitaker said. He added that he would like tariffs to be more predictable.
“The back and forth of it — is it 10%, is it 5%, is it 25% — is not helpful to anybody who runs a global business because you need predictability, hard predictability,” he said.
2. Medical Device User Fee Amendments (MDUFA): AdvaMed sees renewal of the FDA’s medical device user fee program as a key legislative priority. Under MDUFA, medical device companies pay fees to the FDA when they submit a premarket submission or register their facilities. The fees help the FDA improve efficiency of regulatory processes. MDUFA VI, the proposed agreement between the FDA and the medtech industry for fiscal years 2028–2032, outlines updated user-fee structures and FDA performance goals and is awaiting congressional action.
“I think the biggest issue is just maintaining the quality of the process that exists right now, and making sure that continues,” he said.
3. Payment policy: Whitaker argued that there needs to be more transparency when it comes to the payment and coverage of medical technology. He noted that there is predictability with the Food and Drug Administration, but there is very little predictability with the payer side.
“Coverage is important,” he said. “A payment is important, but probably even more important than that is to understand what federal payers need in order to get your product covered today. … If we can get a global market that is steady and predictable, we have an FDA that’s steady and predictable, and then a payment environment that allows us to understand how to navigate payment and coverage, this is an industry that’s going to just take off.”
4. Data access and cybersecurity: AdvaMed considers secure data access a key priority as healthcare becomes more connected. Whitaker included “data access, cybersecurity, and all that goes around connected care” among the group’s priorities.
Photo: metamorworks, Getty Images
