027 - "Become a Historian of the Problem" with Duane Mancini
Duane Mancini, CEO and Managing Partner of Project Medtech, discusses his transition from medicinal chemistry to medical device regulatory strategy at NAMSA and LabCorp. He explains the critical importance of integrating reimbursement strategy early in the development of combination products to avoid commercialization failures, noting that regulatory choices like 510(k) can negatively impact reimbursement pathways. Mancini details how Project Medtech supports startups through its podcasts, Startup Symposiums, and consulting services, focusing on capital raising, milestone mapping, and navigating the complexities of drug-device combinations like insulin patches.