As the medical device industry looks ahead to potential policies under the new administration, key decisions could shape the future of innovation, regulation and reimbursement in this sector.
Here are four factors to watch:
- During the first Trump administration, an executive order aimed to streamline Medicare coverage for FDA authorized "breakthrough devices" targeting life threatening conditions. These devices would have received four years of coverage to help manufacturers gather necessary evidence for permanent reimbursement. However, the policy was not implemented and was later scrapped by the Biden administration. As a result, industry advocates hope that the new Trump administration will revisit and expand Medicare coverage for breakthrough devices, The Wall Street Journal reported Nov. 14.
- If confirmed as secretary of HHS, Robert F. Kennedy Jr. is expected to have significant influence over medical device policies, particularly in areas such as safety, transparency and innovation, according to an Nov. 19 analysis by Medical Device Network. His push for more regulatory insight might enhance the safety and reliability of devices but could also lead to slower approval processes, potentially delaying market access for emerging technologies.
- Mr. Kennedy is likely to advocate for increased scrutiny of medical devices, potentially aligning U.S. approval standards with those in the European Union, according to the Medical Device Network report. This could result in safer and more reliable devices entering the market but may also slow down approval timelines.
- A key area of focus for the Trump administration could be strengthening the domestic supply chain for medical devices. While this may increase resilience and sustainability, it could raise costs, specifically for smaller manufacturers.