Weekend FDA Purge Hits Device Center Hard, Many AI And Digital Health Staffers Gone

A flurry of firings as part of the Trump administration’s pledge to shrink the federal government hit the FDA over the weekend. While the exact number of staff let go is unclear, the agency’s device center took the brunt of it.

(Shuttersock)

While the Trump administration’s Department of Government Efficiency, or DOGE, spearheaded by tech billionaire Elon Musk, claims to have already saved the taxpayers a billion dollars by slashing government waste, it’s also now removed scores of employees at the Food and Drug Administration working on artificial intelligence and digital health.

Over the weekend, the DOGE ax fell across several federal agencies, including the Department of Health and Human Services.

Those fired were told that their “ability, knowledge and skills” were no longer needed and that their performance could no longer justify their continued employment, according to an HHS letter obtained by CBS News.

Though the FDA did not respond to requests for a breakdown of those let go, Andrew Nixon, director of communications at HHS, said in a statement to Medtech Insight that the department was following the administration’s guidance and taking action to support Trump’s broader efforts to restructure and streamline the federal government.

“This is to ensure that HHS better serves the American people at the highest and most efficient standard,” he said.

The statement also included government statistics showing that HHS employment grew between fiscal years 2019 and 2024 at 17%. According to the statement, the FDA has 1,979 more employees than it did in FY 2019. (For a more detailed count, see graphic below.)

However, multiple sources said the firings seemed to disproportionately impact the Center for Devices and Radiological Health (CDRH). The tally is said to have included about 200 device reviewers as well as some 40 statisticians and others in the center’s research division.

The most senior CDRH employee cut during the purge appeared to be Ross “Rusty” Segan, director of the Office of Product Evaluation and Quality. Segan, a minimally invasive surgeon with extensive device industry experience, took over from longtime FDA leader William Maisel in September 2024. Like many of those cut, he was still in a probationary period during which federal employees can be fired more easily.

Reviewers who had worked with vascular, dental, radiological and diabetes devices were among the many posting to LinkedIn that they had been laid off and were now looking for work. The 20 staffers cut from the office of neurological and physical medicine devices included several working on a brain implant produced by Musk’s Neuralink, Reuters reported.

Neuralink is trying to make a device that will allow people with quadriplegia to operate technology with their thoughts. However, the company has faced numerous regulatory challenges, including delays in getting FDA approval for human trials as well as a Department of Agriculture investigation into alleged poor treatment of monkeys used in research.

Industry Says Blow Significant

In a social media post, Julia Sullivan, division director for radiological imaging and radiation therapy devices at CDRH, confirmed the center took a significant blow.

“We lost some really excellent people in the radiological health space who are now looking for work,” she posted, adding that the center lost expertise in AI and machine learning (ML), x-ray imaging, radiation therapy including carbon ion therapy, and software.

Those let go, she added, were “adaptable, innovative, and hardworking.”

“DOGE dilettantes have dismissed some of the FDA’s most talented medical device experts, including people with difficult to find skills for assessing AI and ML enabled medical devices.”

Brendan O'Leary

The Alliance for a Stronger FDA, a coalition of more than 150 FDA stakeholders, including consumer and patient groups, research advocates, health professions societies, industry, and trade associations, has “deep concerns” about the cuts, organization executive director Cartier Esham said.

“We share the goal of having a federal government that is effective, efficient, can protect the public and advance innovation,” she said. “We are committed to working with the administration and Congress to ensure the FDA has the resources and flexibility necessary to maintain the level of expertise needed to achieve those goals.”

In a similar statement, AdvaMed president and CEO Scott Whitaker said he too understands the goal of ensuring a more efficient and accountable federal government across the board.

He added, however, that it was critical that the process of getting the latest and most promising US medical technologies into the hands of our doctors and patients isn’t put at risk. Many have speculated that the cuts to review teams could slow the device review process.

“Patients’ lives, as well as our nation’s global leadership in medtech innovation, manufacturing, and jobs are potentially at stake.”

In a later statement posted on LinkedIn, Whitaker noted that the most recent FDA user fee agreements include incentives encouraging agency review staff to be more efficient, transparent, and predictable.

The cuts, he said, are costing the FDA its “best and most innovative” hires.

Still others were less diplomatic.

Brendan O’Leary, former deputy director at the agency’s Digital Health Center of Excellence, was more pointed in a LinkedIn post.

“DOGE dilettantes have dismissed some of the FDA’s most talented medical device experts, including people with difficult to find skills for assessing AI and ML enabled medical devices,” O’Leary said. “If you’re a technology developer or investor, this administration may have just blown up your plans and your time-to-market estimates. If you’re one of the many people who would stand to benefit from new and improved medical device technologies, those benefits are that much less likely to be realized now. For what?”

“These cuts were planned before Secretary Kennedy was even sworn into office. I am sure this latest action would not align with his goal of making America healthy again.”

Scott Whitaker

Until the dust settles, it will be hard to define the full scope of the cuts, especially to the device center.

However, due to the rise of AI and the growing importance of digital health, it’s likely the impacts could be severe. Those who received the pink slips worked on life-saving technologies, which means the ripple effect could be massive.

Even prior to the cuts or the ascendancy of Musk, the FDA has struggled to find and maintain talent, as David Maislin, president and CEO of Biomedical Statistical Consulting (BSC), noted on LinkedIn.

“The agency has long faced challenges in attracting and retaining talent, and this loss will have lasting effects on data-driven healthcare innovation,” he wrote. “These cuts hit close to home for those of us in statistics and data science. Biostatisticians, data scientists, and quantitative researchers in healthcare are more important than ever. Losing experienced professionals in these fields could slow progress in medical devices, digital health, and real-world evidence generation,” Maislin continued, “areas that depend on rigorous data analysis and interpretation.”

Whitaker’s post also addressed the growing importance of AI, citing its ability to diagnose diseases more accurately and quickly, which, he said, means earlier treatments and better outcomes for patients as well as lower costs to patients and to the nation’s health care system overall.

“Eliminating FDA’s recent critical new hires in the AI space will dramatically slow review times and require reassigning non-experts already at FDA to review these technologies who will inevitably make slower and potentially inappropriately conservative decisions,” Whitaker said. “These cuts were planned before Secretary Kennedy was even sworn into office. I am sure this latest action would not align with his goal of making America healthy again.”

A source close to the FDA told Medtech Insight the layoffs could have a devastating effect on the agency’s morale and will also prevent the best and brightest from wanting to work at the FDA.

The source was also surprised CDRH was a target.

“I thought the device center would be safe. They’re not circulating abortion devices, there’s no major DEI initiatives, or anything like that that’s perceived as controversial,” the source said. “But I was 180 degrees wrong.”

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