On Thursday, April 10, 2025, in its Boston office of Foley & Lardner LLP hosted and participated in a MedTech round table of investors and business leaders, including chief executive officers, partners, directors, innovation leads, investment funds managers and partners, and general counsels. There was collective interest in understanding how these MedTech leaders are adjusting to the changing business and regulatory environment under the second Trump administration.
Specific concerns addressed included:
- The reduction in force (RIF) observed at the U.S. Food & Drug Administration (FDA) and the impact the RIF will have on medical device clearances and approvals. The expectation is that review periods will be prolonged, which will impact commercialization timelines.
- The overall investment landscape where the group concluded that a more risk averse approach to investing is preferred. The net result is that investors are more likely to invest in products with strong research and development, clear regulatory pathways, and clinical profiles that are addressing an unmet clinical need.
- How artificial intelligence can be incorporated into clinical trials to reduce the cost of clinical research and to expedite the clinical trial process, especially in light of anxiety regarding delayed regulatory reviews.
Based on the robust and timely discussion and because the effects of the administration transition will be realized more concretely over time, Foley & Lardner LLP plans to host another MedTech roundtable in the fall.
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