Episode 119: Regulatory & Investment Intersections for Healthcare Startups

Kwame Ulmer’s talk will discuss what role regulations play in a healthcare startup’s life. He will provide a deep dive into regulatory strategy with an overview of 5 categories that healthcare startups should consider to be prepared for the road ahead.

Bio: Kwame Ulmer
Kwame Ulmer brings nearly twenty years of experience evaluating medical technologies in the government and serving in senior operating roles at medical device companies. This experience allows him to help companies at all stages efficiently navigate global regulatory agencies. Kwame has particular expertise in all aspects of the USFDA, from premarket applications to postmarket compliance.

Mr. Ulmer previously served as Vice President, Regulatory Affairs and Quality Assurance at Implant Direct, a Danaher Corporation (Fortune 150) operating company. He led efforts to shorten global registration timelines, improved product quality by process optimization and achieve best-in-class department engagement scores. Kwame has in depth knowledge of the cross-functional activities needed to take a medical device from concept to product launch in markets including North America, EU, EMEA, China and LATAM.

Kwame has served in progressive leadership roles at the US Food and Drug Administration (FDA) and personally evaluated over 1,000 medical technologies. He has successfully overseen products through all FDA application types (IDE, 510(k), PMA, 513(g)) and advised over 100 early-stage medtech companies on regulatory path.

Mr. Ulmer is a member of Tech Coast Angels (LA), the world’s largest angel investing network and 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. Kwame earned his B.S. in Physics from Lincoln University (Pennsylvania) and both an M.S. in Materials Engineering and M.B.A. from the University of Virginia.

Twitter handle @kwameulmer