Experts told Medtech Insight that they expect the incoming Trump administration to focus on deregulation, which may provide new opportunities for business growth and reshape the judiciary. Health care fraud enforcement and supply chain diversification will remain areas of focus, and new opportunities may arise in chronic disease management. Proposed tariffs, meanwhile, could have major effects.
What are your expectations for the incoming administration?
George Breen, Chair of National Health Care and Life Sciences Practice, Epstein Becker Green
A second Trump administration suggests a continued effort at reshaping the federal judiciary through appointments of judges who are likely to be more “business friendly.”
From a regulatory perspective, I anticipate there will be an emphasis on deregulation, as well as a return to an effort to review, revise, and potentially terminate a number of existing rules and regulations that are believed to limit business growth and potential.
I also expect, separately, in light of the Supreme Court’s decision this past year in Loper Bright, overturning the Chevron doctrine, a continued and heightened effort by entities to challenge agency interpretations of ambiguous regulations, particularly in an era of the appointment of a judiciary likely to be more receptive to such arguments. This offers a key opportunity to defendants in FCA cases being pursued based on such interpretations, which will no longer have the deference previously afforded.
In terms of health care fraud enforcement, I expect the DOJ to continue to focus on its existing FCA Civil Cyber-Fraud Initiative and to focus more intently on the use of artificial intelligence in health care in attempting to bring cases under the FCA.
Matt Burton, strategic development director, IMed Consultancy
Both Trump and Robert F. Kennedy Jr, have named the FDA as a target for deregulation. There has been indication that cost cutting and increasing competition will be key drivers. Deregulation in the medical devices sector will strive for more streamlined approvals and potentially expedited time-to-market for new products but deregulation could become synonymous with deregulation of safety.
Trump’s proposed tariffs could affect 75% of all available US-marketed medical devices with negative trickledown effects. As manufacturers raise prices to protect tight margins, access to critical devices could be negatively impacted.
Reducing dependence on China could lead to diversification in the supply chain with greater competition and more opportunities. US manufacturers will need to ramp up production capacity and maintain competitive pricing to seize these fully.
Kennedy’s emphasis on addressing chronic diseases aligns with global healthcare trends toward preventive care and value-based models. Among the diseases in Kennedy’s sights are autism, attention-deficit/hyperactivity disorder, sleep disorders, infertility rates, diabetes, and obesity, which he claims have worsened due to federal inaction.
This shift creates opportunities for manufacturers of diagnostics, wearables, and remote monitoring systems designed to manage chronic conditions like diabetes, cardiovascular diseases, and respiratory illnesses. This could drive cross-industry collaboration, with device companies partnering with technology firms to develop integrated healthcare solutions.
Ahmed Elmouelhi, president and CEO, TRiCares
It’s too early to predict the impact of the new administration but we can certainly anticipate there will be changes to the process. Companies that can adapt will be in the best position to support their patients.
At the same time, I see a real opportunity for medtech companies in the evolution of the healthcare insurance model.
Kyle Faget, partner, Foley & Lardner
If Robert F. Kennedy Jr. is confirmed as the new Secretary of the Department of Health and Human Services, our approach to vaccination, and COVID vaccinations specially, may change. There has been a lot of clinical trial follow up to assess ongoing safety and efficacy issue of the COVID vaccine, but I wonder if we will see a re-litigation of the vaccine wholesale.
Adam Fine, founder and general partner, Windham Capital Partners
It remains unclear what the actual policies will be and how far they will go relative to statements made during the campaign. One possibility is that in order to pursue major tax cuts, the “safety net” and focus on health equity will be less prioritized and see lower funding. Vulnerable patients will face even greater needs around affordability and access to quality care. Thankfully companies like TailorMed, who we just led a $40m financing round for incidentally, are building out its affordability network at the right time.
Andy Fish, president, Medical Device Innovation Consortium (MDIC)
The transition to a new presidential administration will not alter MDIC’s role as a nonpartisan organization with a long history of catalyzing effective and essential collaboration. Regardless of shifting policy directions, MDIC unites medical device stakeholders to improve quality, advance clinical and regulatory science, enhance efficiency in regulatory pathways, and accelerate patient access to transformative technologies. MDIC remains committed to leading efforts that harness emerging technologies and place patient perspectives at the center of innovation.
Christoph Massner, principal, Earlybird Health
The new administration may streamline FDA regulations, reducing bureaucracy for faster processes. Meanwhile, I hope it maintains a strong commitment to innovation and scientifically grounded decision-making.
Marla Phillips, CEO and president, Pathway for Patient Health
I see the government being run more like a business, with expectations of measurable value. This will drive more efficiency. I believe the government and non-profits (including academia) absolutely need to recognize that they are running a business, irrespective of their IRS designation. However, I am concerned about large sweeping cutbacks without infrastructure in place to increase efficiency. As a result, work will have to be dropped, and product approvals will either be grossly delayed, or will be approved without thorough review. This is concerning for the patients our products are developed to serve.
Scott Trevino, senior VP of cybersecurity, TRIMEDX
While changes related to the incoming administration remain to be seen, I think it’s important to continue advocating for the changes and support to improve health care cybersecurity—for the betterment of health systems and, most importantly, the patients receiving the care.
I hope the incoming administration builds upon the progress we’ve seen in recent years and takes action to ensure hospitals can secure their medical devices. Medical devices are often overlooked or treated differently because they require unique protections to ensure they are secure from cyber-threats and operate properly for patient care. I also would encourage the administration and the new Congress to focus on rural health systems, which are particularly exposed to cyber-threats. These vulnerable health systems would benefit from targeted funding to help them bolster their cyber defenses and better serve patients.
Finally, “Right to Repair” continues to be a top priority. It’s essential to ensure health systems have the choice in how to repair their medical devices—whether it’s with the OEM or an independent service organization. This will ultimately improve patient safety by allowing qualified, on-site BMETs to fix medical equipment as soon as an issue arises.
Susan Van Meter, president, American Clinical Laboratory Association (ACLA)
ACLA always works in a bipartisan fashion. So, we’re going to continue to work closely with the administration across our priority areas, whether it’s preparedness for public health emergencies or appropriate regulation of diagnostics, rational reimbursement. We’re looking forward to having policy viewed through the lens of innovation.
