Board-Certified Surgeon, Former FDA Office Director
Enterprise Partnerships
On-Call FDA Expert for High-Consequence Device Decisions
I help leading device companies navigate moments where regulatory strategy, clinical evidence, and market timing must align. Drawing on two decades leading FDA review and policy, I identify risks and pathways your team may miss.
Failed clinical trials, emerging safety issues, or uncertainty about FDA expectations—I help companies navigate these inflection points. Drawing on twenty-five years of FDA leadership and surgical practice, I identify the path forward when internal teams are stuck.
