In a new video feature, BioHealth Innovation’s Entrepreneur-in-Residence (EIR) Kwame Ulmer offers a candid and experienced take on the evolving FDA landscape and its impact on medical device innovation.
As Managing Partner at MedTech Impact Partners, Kwame brings more than two decades of regulatory expertise to the table. His experience includes twelve years in leadership roles at the FDA, culminating as Deputy Director and Branch Chief, where he personally evaluated over 1,000 medical technologies. Today, he advises startups on regulatory strategy, supports complex submissions including de novo, PMA, and 510(k), and helps medtech founders navigate an increasingly uncertain regulatory environment.
Kwame is also a Venture Partner at Wavemaker Three-Sixty Health, a leading early-stage healthcare venture capital firm, and serves as a lecturer and researcher in medtech innovation at UCLA.
In this conversation, Kwame discusses the FDA’s recent staffing and operational challenges, noting that the disruptions are far from routine. With increased application delays, higher turnover, and regulatory unpredictability, medical device companies must allocate more time and resources than ever before to clear the path to approval.
Still, Kwame remains cautiously optimistic. While timelines are lengthening and investors are scrutinizing risk more closely, the medtech investment landscape continues to move forward, with greater attention to regulatory clarity and strategic planning.
👉 Watch the full video here: https://www.youtube.com/watch?v=tMU7Y3PyasM
To learn more about BHI’s EIR program and how we support medtech startups, visit www.biohealthinnovation.org.