Dr. Duane Pinto is a cardiovascular physician‑executive with experience spanning the full medical device lifecycle, from patent‑stage innovation and preclinical validation through pivotal trials, regulatory approval, commercialization, and post‑market evidence generation.
He currently serves as a Global Chief Medical Officer within structural heart technology, where he has guided programs through completion and publication of pivotal trials, successful Premarket Approval (PMA) submission, negotiation of subsequent Investigational Device Exemption (IDE) pathways with the FDA, and initiation of large‑scale multicenter clinical studies, including oversight of a 1,000‑patient prospective trial. He has presented clinical and regulatory strategy to corporate boards and prospective investors and has testified before the Federal Trade Commission in the context of merger‑related regulatory review.
Dr. Pinto’s experience includes early‑stage product conception, prototype development, animal studies, first‑in‑human evaluation, Early Feasibility Study design, and post‑approval studies and real‑world database research.
He is an Associate Professor of Medicine at Harvard Medical School (20+ years faculty) and holds a Master of Public Health in Clinical Effectiveness from the Harvard School of Public Health. He has authored nearly 200 peer‑reviewed publications (H‑index 52), including work published in The New England Journal of Medicine, The Lancet, Circulation, and JACC.