Hardware Podcasts

S2 E2: Demystifying Medical Device and System Development with Alan Cohen

The Builder Circle · 12 Dec 2023 · 1h 11m

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Texas Instruments, Droplet, Mass General Hospital, Harvard Med School, VA, CMS
Also
Alan Cohen, Prototype to Product: A Practical Guide for Getting to Market, FDA, ISO 14971, ISO 13485, ISO 9001, IEC 62304, CPT codes, REACH, RoHS

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