The Deepest Cut: The looming disaster from the assault on the FDA

With a PhD in biochemical engineering on her resume, Dr. Kristy Katzenmeyer can speak with authority on the lifesaving ramifications of medical research.

As a former product reviewer in the medical device division of the Food and Drug Administration, she knows the incalculable benefits of new and improved medical equipment as well as the potential consequences of bringing unsafe devices to market.

And as the owner of KP Medical Device Consultants, she is on the front lines of the Trump administration’s blitzkrieg against the medical and medical research industries, as well as the FDA itself. 

She can talk at length about the devastating long-term impacts of all this to the livelihoods of people who have dedicated their whole lives to demanding and highly specialized work, to the US economy and, most ominously, to people’s quality of life and long-term health outcomes.

Whether it’s mass firings without cause at the FDA or the National Institute of Health or drastic cuts to medical research, the damage, Katzenmeyer asserts, is enormous.

“It’s an immediate impact,” Katzenmeyer says. “It’s hitting right now. It’s affecting universities. They’re not taking on new graduate students. So that’s engineers and scientists and that will impact new technologies, new therapies that could be used to help the general public.”

She notes, too, that the military is a special case, requiring very specific and esoteric medical devices for when access to a hospital is not possible. So our soldiers, too, might suffer as a result of these cuts.

Unjust and Arbitrary 

Donald Trump appears to be enacting virtually every plank of the policy prescription he distanced himself from during the campaign, Project 2025. Project 2025 is the Heritage Foundation’s fever dream for radically dismantling government institutions.

The newly established Department of Government Efficiency, headed by the unelected Elon Musk, has made highly dubious claims – many that have since been quietly retracted – regarding government waste and inefficiency. Ironically, the administration rushed to get rid of the very people whose careers as civil servants were dedicated precisely to ferreting out this waste and inefficiency. More ironically yet, some of those people were watchdogs for the various industries in which Musk himself has received multi-billion dollar contracts.

Yet rather than take a scalpel to alleged waste, Trump and Musk are creating mass disruptions across all spectrums with an arbitrary, sledgehammer approach. Katzenmeyer says the firings at the FDA have been totally without judgment –  or justification – because the administration flagged anyone with a “probationary” tag for removal.

“So it’s not just that they’re decimating the numbers, they’re letting some of the best people go,” she says. “So you hear the word ‘probationary’ and you think, oh, they’re new or they’ve done something wrong. But that’s almost never the case. Probationary usually means they’ve been recently promoted because they’re so good at what they do so that just makes them new at that job.”

Furthermore, DOGE destroyed the personnel files of these workers before attempting to justify their removal for “poor performance reviews.” Needless to say, without access to their personnel files, which one assumes usually come with glowing commendations, workers have no way to appeal.

“So this is just so very wrong, in my opinion,” Katzenmeyer says. “And now they’re cut without severance pay. Some of these people have moved across the country to take these jobs. These are people with young children, maybe. People who could have made twice as much money working in the private sector. And If this happened in the private industry, the folks doing the firing would be looking for attorneys.”

And because the degrees required to work in this profession are so demanding, many of these people are paying back huge student loans.

A Bottlenecked Approval Process

Interestingly, the medical device industry itself has been screaming bloody murder at the administration to stop with the cuts. (DOGE has since attempted to rehire staff but stunningly misplaced some of the contact information and is struggling to reach them. Still others are, understandably, hesitant to reclaim jobs that can just as easily be taken from them again). The reason the industry is clamoring for rehiring of FDA staff is, without FDA guidance and approval, these businesses can’t develop their products nor can they get the approval they need to bring these cutting edge devices to market.

“So it might be new devices but it might be existing devices that need upgrades to keep up with innovation,” Katzenmeyer says. “And once these things get bottlenecked it just takes forever to get it unstuck. In the meantime, people aren’t getting the best health outcomes they should be getting.”

Ironically, many people who work for the FDA – including most medical device reviewers – aren’t even taxpayer-salaried, but rather get their salaries from private-industry user fees, meaning these cuts aren’t even saving taxpayers any money.

With the FDA now woefully understaffed, medical device companies are in limbo with how to proceed on either a new project or a project that is in the end stages but still requires FDA guidance and approval. 

“What’s concerning is that a lot of these (medical device) reviewers that were let go are just very highly skilled and trained people,” Katzenmeyer says. “So it’s a lot of, say, toxicologists who, if you place a device in a body, can tell you what type of chemicals that might be least harmful and is it going to affect you. You  need very specific, trained people with years of experience.

“Another huge growth industry is Artificial Intelligence,” she continues. “And a lot of the people who were cut were AI experts. So what happens is you’re going to have non-experts looking at devices that use AI, which is a very scary thought.”

When we hear the words “medical device” we might not give it another thought. But Katzenmeyer says we interact with them all day every day. It’s anything from a toothbrush to a stent to an MRI to a knee replacement. The more complex of these never happen without a company being willing to take the risk, to invest in research and development for a device that might never come to market. So the government incentives that have driven this for the past 80 years are critical to the industry.

‘They Really Don’t Know What This Means’

Furthermore, the United States leads the world in medical device technology, capturing close to 40 percent of the market. Losing a percentage of that will have an impact on our overall economy and put us behind where we’d otherwise be, effectively ceding the technological advances and market share to other countries.

And it bears repeating just how vital the medical research and medical device industries are in advancing the best medical outcomes and, therefore, how warranted government investment in those industries seem given the real-life, very human returns.

Katzenmeyer also points to huge recent innovations in non-invasive surgery, which allows a surgeon to insert a long tubular device into a small incision point to do any number of things, including removing or inserting objects that otherwise might have required opening up the patient. That  not only makes for better outcomes – and an easier recovery – it saves a lot of money.

Robotics is another great advance that allows surgeons to operate from what looks like a video game booth. It is much more exact and ergonomically much friendlier to a surgeon whose hands after a long day in surgery might begin to cramp.

While Katzenmeyer has been minimally affected thus far by Trump policy, she says she still feels outrage at everything that’s happening.

“I’ve been trying to figure out good ways of expressing that,” she says. “Not a lot of people understand what is happening. They hear ‘government layoffs’ but they really don’t know what it means. Or even who is being laid off. 

“But when you explain it to them, they sort of go, ‘oh, so this means no new medical devices are going to get through and there aren’t going to be safety updates and there goes all the clinical trials.’ Then they start to realize what it all means.”