Uncertainty and confusion about the Trump administration’s approach to artificial intelligence pose a risk for medical device developers, AdvaMed Digital Health board members said during a Tuesday panel.
Members of the medical device lobbying group outlined their priorities for AI policies and explained how medtech companies are coping with limited information.
Companies have “some healthy anxiety,” but are moving forward with strategic plans, said Robert Cohen, a board member of AdvaMed Digital Health and president of digital, robotics and enabling technology for Stryker.
“No one's slowing up anything because of this current state of policy,” Cohen said. “We’re going somewhat at risk.”
After taking office, President Donald Trump signed an executive order rolling back Biden administration directives on AI technology. On April 3, the White House’s Office of Management and Budget followed up with a memo directing agencies to name a chief AI officer and to develop and retain AI talent.
Those policies conflict with other actions by the administration, such as the sudden firing of more than 1,000 probationary employees from the Food and Drug Administration in February, including AI device experts. Many were later offered their positions back, although it’s unclear how many returned. In March, Health and Human Services Secretary Robert F. Kennedy Jr. announced plans to cut 3,500 people at the FDA, part of a massive reorganization of HHS that included laying off approximately 10,000 employees.
A separate Trump executive order mandating the removal of 10 regulations, rules or guidances for each new one has also raised questions about how the FDA will approach AI policy.
Venk Varadan, a board member of AdvaMed Digital Health and CEO of digital diagnostics firm Nanowear, said the lobbying group is early in building relationships with the new administration.
“It’s difficult for us to pinpoint exactly what their priority number one [is] versus priority number five,” Varadan said.
Digital health, AI, access and home health are still big priorities for the new administration based on early discussions, Varadan added.
The board members emphasized that AdvaMed wants the FDA to keep its role as the lead regulator of AI-enabled devices. However, when asked about the issue, the panel did not directly comment on the Trump administration’s cuts of FDA workers.
Vardan said it’s important to have a “good mix” of people who understand AI and have clinical acumen. He added that “the traditional FDA person might look different in a year.”
The board members also raised concerns about Medicare coverage of AI technologies and privacy and data access.
Cohen said companies are moving forward with AI projects with the knowledge that a policy document could come out in a year that could derail that work. Risk mitigation strategies include looking at predicate devices, or products that have already been authorized by the FDA, and preparing for “every possible question.”
“If the FDA becomes more conservative, that puts more of a burden on where do you get the data from and how do you use the data to train your models,” Cohen added.
So far, AdvaMed has not seen a change in the quality of the FDA review process, Cohen said. He added that while the FDA could benefit from having more people who are knowledgeable on AI, “right now that’s not the limiting factor.”
