As Managing Partner at MedTech Impact Partners, Kwame Ulmer leverages over twenty years of experience evaluating medical technologies in the government and private sector to answer regulatory questions, develop comprehensive regulatory strategies, and support complex submissions (e.g., de novo, PMA, 510(k)) for companies working with the FDA. He has personally evaluated more than 1,000 medical technologies in his career, and he spent 12 years at the FDA in progressive leadership roles, including Deputy Director and Branch Chief. 

In addition to his work at MedTech Impact Partners, Kwame is a venture partner at Wavemaker Three-Sixty Health – the leading Southern-California based, early stage venture capital firm (Seed and Series A) focused on the healthcare industry – and is a lecturer and researcher in MedTech Innovation at the University of California, Los Angeles. 

During our conversation, Kwame shared his perspectives on the recent and significant changes at the FDA, particularly regarding staffing cuts, operational disruptions, and their impact on medical device companies, investors, and the broader medtech ecosystem. 

The FDA is experiencing a period of disruption and these disruptions are not business as usual, affecting all stakeholders across stages. As a result, FDA-risk has increased, demanding a greater allocation of time and resources from companies and founders. With continued turnover in the organization, companies should anticipate and budget for possible delays for different application types.

Despite regulatory uncertainty, Kwame believes investors will continue to fund medtech companies, with longer timelines and greater emphasis on de-risked regulatory pathways.

00:06:21 – The Current State of The FDA

09:07:10 – Investor Perspectives on FDA Changes

14:51:19 – MedTech Impact Partners

18:11:18 – Perspectives for Founders Navigating Changes at The FDA

37:05:14 – Conclusion