Medical Device Development: Two perspectives
Gloria Kolb, PhD, Gloria Kolb is an inventor with a dozen patents, and an entrepreneur with over 20 years of experience in product development and commercialization, mainly in the field of medical devices. In one endeavor, Ms. Kolb founded Fossa Medical to bring innovative endourology devices to market, and included securing funding and advisors, building the team, and managing the founding years within budget. Her creative designs and ability to solve unmet clinical needs has led to prestigious awards including Boston’s “40 under 40”, MIT Technology Review’s “World’s Top Innovators under 35”, and Fortune Small Business’ 14 Hot Startups. Ms. Kolb’s consulting work included technology and clinical market evaluations of acquisition targets. She has been trained in NSF’s I-Corps program as an adjunct. Her part-time job as the Director of Venture Development at the University of Connecticut, Technology Commercialization Services, allows her to review and vet new University inventions and help with startup companies.
Fred Schoen, MD, PhD has contributed over a 40+ year career to the evolution of mechanical and biological heart valve substitutes through the science and engineering of biomaterials coupled with sound pathological principles and practice. Dr. Schoen is currently Professor of Pathology and Health Sciences and Technology, Harvard Medical School; and Director of Cardiac Pathology and Executive Vice-Chairman in the Department of Pathology at the Brigham and Women’s Hospital (BWH). He is Director of the BWH Biomedical Research Institute (BRI) Technology Innovation Program and BWH liaison to (Site Miner for) the Center for Integration of Medicine and Innovative Technology (CIMIT). He is author or co‐author/editor of over 470 manuscripts in journals and books. In 2015, he was awarded the highly prestigious Technology, Innovation & Development Award by the Society for Biomaterials.