S2 E2: Demystifying Medical Device and System Development with Alan Cohen
Alan Cohen, author of 'Prototype to Product' and a systems engineering manager specializing in radiation therapy devices, explains the complexities of medical device development to host Sera Evcimen. Cohen emphasizes that successful startups often emerge from collaborations between engineers and clinicians, and he details the critical importance of understanding reimbursement models, specifically CPT codes, before building a product. He advocates for using Fault Tree Analysis over FMEA for complex systems to manage risk efficiently and advises founders to balance lean documentation with rigorous process adherence to satisfy FDA requirements without over-engineering.