Amit Shah

Dr. Shah’s experience with medical technology spans R&D, clinical testing, regulation, standards-setting, investment, commercialization, and facility / end-user adoption. As the Founding Director of the office for technology commercialization for a $4 billion regional healthcare system in the Maryland and Washington, D.C. region, Dr. Shah vetted nearly 200 medical device and software inventions, ultimately fostering multiple academic-industry co-development initiatives and technology out-licenses. Serving as a Medical Officer at the Food and Drug Administration’s (FDA) Office of Device Evaluation, Dr. Shah led the FDA’s clinical review of multiple medical device applications including PMA, 510(k), and pre-IDE submissions. Dr. Shah’s formal training in and experience with clinical research (from trial design to execution to data analysis and presentation) added a unique depth to his reviews. Dr. Shah has also engaged with the Association for the Advancement of Medical Instrumentation to help safeguard patients through standards-setting in patient monitoring. Dr. Shah has served as a Clinical Partner at a leading healthcare venture capital investment firm and continues to advise angel investment groups. He is the Physician Representative to the Value Analysis / Technology Adoption Committee at one of the largest hospitals in the country, where he still practices emergency medicine and enjoys teaching resident physicians and medical students at the bedside.