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

- Show: [The Builder Circle](https://hardwarepodcasts.com/podcast/the-builder-circle)
- Published: 2023-12-12
- Length: 1h 11m
- Page: https://hardwarepodcasts.com/podcast/the-builder-circle/2023-12-12-s2-e2-demystifying-medical-device-and-system-development-with-alan-cohen
- Listen: https://rss.com/podcasts/thebuildercircle/1261616

## Summary

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.

## Outline

1. Introduction and Guest Background
2. Identifying Medical Application Needs and Reimbursement
3. Regulatory Pathways and FDA Classifications
4. Risk Assessment: Fault Tree Analysis vs. FMEA
5. Documentation, Process, and FDA Audits
6. Testing, Validation, and Clinical Trials
7. Funding Challenges and Innovation Barriers
8. Supply Chain and Manufacturing for Startups
9. FDA vs. EU Regulatory Convergence
10. Final Advice and Key Takeaways

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

early-stage companies

## Mentioned

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

## Related episodes from other shows

- [269: Ultra-Precise Death Ray](https://hardwarepodcasts.com/podcast/embedded-fm/2018-12-06-269-ultra-precise-death-ray) (Embedded.fm)
- [269: Ultra-Precise Death Ray (Repeat)](https://hardwarepodcasts.com/podcast/embedded-fm/2021-07-02-269-ultra-precise-death-ray-repeat) (Embedded.fm)
- [#427: Medical Device Reimbursement - Pitfalls to Avoid](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-10-06-427-medical-device-reimbursement-pitfalls-to-avoid) (Global Medical Device Podcast)
- [#369: Advice to Medical Device Inventors](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-23-369-advice-to-medical-device-inventors) (Global Medical Device Podcast)
- [Best Practices for Clinical Evidence Management](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-09-22-best-practices-for-clinical-evidence-management) (Global Medical Device Podcast)

## Citing this page

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