Lifecycle leadership. I have participated in and led cardiovascular device programs across the full development continuum — from patent‑stage ideation and prototype development through preclinical and animal studies, first‑in‑human and early feasibility work, pivotal registrational trials, PMA submission, and post‑approval evidence generation.

Enterprise impact. I have taken programs from completion of pivotal trials through publication and successful PMA submission, negotiated with FDA to develop new IDE pathways, presented strategy to boards and prospective investors, contributed to commercial launch planning through professional education and training oversight, and testified before the FTC in merger‑related proceedings. I have also initiated and directly overseen clinical operations for a 1,000‑patient multicenter trial.

Post‑market stewardship. I have led post‑approval studies and retrospective database research to address durability, generalizability, and implementation questions that emerge after broader adoption.