At AdvaMed’s annual MedTech Conference in San Diego, Scott Whitaker, President and CEO of the Advanced Medical Technology Association (AdvaMed), reaffirmed the organization’s focus on ensuring regulatory and economic stability for the U.S. medical device industry amid ongoing political and administrative uncertainty.
Speaking at a press conference that covered topics ranging from FDA operations and tariffs to ethylene oxide (ETO) sterilization and NIH funding, Whitaker emphasized AdvaMed’s collaboration with the Trump administration to preserve and, where possible, advance recent policy gains that have benefited medtech manufacturers and innovators.
“The key right now is stability,” Whitaker said. “We’re working hard with policymakers to make sure the progress we’ve made in the last few years isn’t lost, and that the framework for innovation in this industry remains strong.”
FDA operations and MDUFA stability
One of AdvaMed’s most immediate concerns involves the Food and Drug Administration (FDA), which continues to face strain following workforce losses and operational disruptions. Whitaker noted that the FDA — and specifically the Center for Devices and Radiological Health (CDRH) — had previously seen roughly a 20% reduction in staff due to layoffs and resignations. Still, he expressed cautious optimism that device review operations remain steady, even amid the government shutdown.
“We don’t know how much is in reserve, but there should be plenty to keep the FDA running for months,” he said, adding that AdvaMed has not observed a slowdown in review times or clearance activity.
Whitaker underscored that AdvaMed is closely monitoring how Medical Device User Fee Amendment (MDUFA) funds are being utilized. “We’re making sure the capital raised through MDUFA is being used for its intended purpose — to fund device review operations and not the agency at large,” he said. “That makes sense because we’re paying into the program for a specific purpose.”
The current MDUFA framework — a critical agreement that governs how the FDA collaborates with industry on device reviews — is set to expire in 2027. Whitaker said AdvaMed’s priority is to maintain continuity in the next reauthorization cycle. “We’d anticipate that the future framework will look a lot like what we have now,” he explained. “The system is working, and stability benefits everyone — regulators, innovators, and patients.”
ETO sterilization: balancing safety and access
Whitaker also addressed concerns surrounding the regulation of ethylene oxide (ETO), a key sterilant used for the majority of medical devices worldwide. Earlier this year, the Trump administration issued an executive order delaying stricter ETO emissions guidelines, a move aimed at giving the industry more time to adapt while protecting critical sterilization capacity.
Asked whether AdvaMed expects looser ETO regulation in the future, Whitaker struck a pragmatic tone. “It’s difficult to predict policy changes with different administrations every four years,” he said. “But what we’ve seen — from both the Trump and Biden administrations — is a broad recognition that ETO is essential for sterilizing medical devices safely and effectively.”
He added that over the past several years, the medtech industry has made significant progress in improving environmental safety around sterilization plants. “We’ve made a compelling case for why ETO is indispensable and how it can be managed responsibly,” Whitaker said. “Our goal is to ensure continued patient access to sterile devices while maintaining strong environmental standards.”
Tariffs and manufacturing
Turning to trade policy, Whitaker said AdvaMed continues to advocate for clarity and long-term certainty on tariffs to help companies make more reliable financial projections. He noted that medical device manufacturers already align with the Trump administration’s goals of strengthening domestic manufacturing and maintaining a healthy trade balance.
“I understand what the president is trying to accomplish, and he’s not wrong,” Whitaker said. “We should have a strong manufacturing base and a solid trade balance — but that already exists in our sector.”
Whitaker highlighted that the medical device industry maintains a trade surplus in nearly every region of the world, with the exception of Mexico — a key near-shoring partner under existing trade agreements. “Mexico is next door, and there’s a trade agreement in place,” he said. “Many companies have moved manufacturing there to ensure supply chain resilience and meet demand efficiently.”
As the medtech sector continues to adapt to shifting political priorities, AdvaMed is positioning itself as a stabilizing force — one that bridges government policy, industry innovation, and public health needs. Beyond regulatory and trade concerns, the organization is turning its focus toward sustaining innovation pipelines, supporting early-stage medtech companies, and reinforcing confidence in the financial and research environment that drives the next wave of U.S. medical technology breakthroughs.
Encouraging innovation through stability, not subsidies
Addressing questions about National Institutes of Health (NIH) funding and its impact on the medtech startup ecosystem, Scott Whitaker clarified that AdvaMed is not lobbying for the restoration of NIH grant programs recently reduced under federal budget constraints. Instead, the organization believes that market predictability — not direct government subsidies — is the most effective way to attract capital to new ventures.
“Our focus isn’t on replacing NIH funding,” Whitaker said. “It’s on ensuring the broader environment encourages investors to continue supporting early-stage medtech innovation. That means stable regulation, clear reimbursement pathways, and consistent trade policy.”
Whitaker noted that volatility in any of these areas — whether in FDA processes, tariffs, or capital markets — can stifle small innovators long before their technologies reach patients. By maintaining clear, reliable rules, he said, AdvaMed aims to create a level playing field where entrepreneurs can raise capital and bring novel therapies to market without being hindered by sudden policy swings.
“Venture investment thrives on predictability,” he added. “If investors believe that regulations or trade policies will drastically shift every few years, they’ll move to other sectors. Our job is to make sure that doesn’t happen.”
Sustaining medtech’s role in the U.S. economy
Whitaker emphasized that the medical device industry remains one of the few manufacturing sectors in the U.S. with a consistent trade surplus, employing hundreds of thousands of Americans in high-skill jobs. As such, AdvaMed continues to advocate for policies that reinforce domestic competitiveness — particularly around supply chain resilience, regulatory consistency, and global market access.
“The medtech sector is one of the healthiest examples of American manufacturing success,” Whitaker said. “We have a trade surplus in every major region except Mexico, which is a near-shoring partner that strengthens our regional supply chain. That’s a model of balance and stability we should be building on, not disrupting.”
He reiterated that AdvaMed supports a collaborative approach to manufacturing policy, one that recognizes the industry’s international integration while preserving its U.S. production base. “We’ve worked for years to make sure policymakers understand that medical devices are not a trade risk — they’re a trade asset,” he said.
A steady approach to long-term policy reform
Looking ahead, Whitaker said AdvaMed’s agenda for the next several years centers on maintaining continuity across FDA operations and user-fee negotiations. With the Medical Device User Fee Amendment (MDUFA) up for renewal in 2027, AdvaMed plans to work closely with the FDA to preserve the existing framework while exploring targeted improvements in digital health and AI-enabled device review processes.
“The MDUFA system works,” Whitaker noted. “It gives both industry and the agency the resources and predictability they need. What we’re focused on now is making sure it stays effective in a world where technology is evolving faster than regulation.”
He also cautioned against sweeping policy changes that could unsettle the progress made in recent years. “We’ve seen real advances in how quickly and safely devices reach patients,” he said. “The last thing we need right now is to destabilize the system with abrupt reforms.”
A message of continuity amid uncertainty
Whitaker closed his remarks with a message aimed at both policymakers and investors: stability, not disruption, is what will sustain America’s leadership in medical technology. “The medtech industry has always been about improving lives, but to do that we need a stable foundation,” he said. “Our focus at AdvaMed is to make sure that foundation doesn’t crack — no matter who’s in the White House or what global challenges arise.”
As AdvaMed continues its work with the Trump administration, the FDA, and global regulatory bodies, Whitaker’s message underscores a recurring theme throughout the conference: in an era defined by rapid innovation and political volatility, the path to progress lies in consistency, collaboration, and confidence.
Powered by Froala Editor