Hardware Podcasts

#468: SaMD Issues, Defects & Detection | Shawnnah Monterrey

Global Medical Device Podcast · 10 Aug 2026 · 44m · Episode 468

What this episode covers

Shawnnah Monterrey, founder of Beanstalk Ventures and an FDA-accredited third-party reviewer, discusses post-market quality issues in medical devices, drawing on her experience at ZEISS and Illumina. She explains how inadequate upstream characterization, such as neglecting shipping stresses or subsystem-level DFMEAs, leads to costly 'dead on arrival' failures and field complaints. The conversation highlights the importance of robust unit testing, clear design documentation, and structural post-market surveillance to prevent catastrophic recalls, using a Class 1 ventilator case study to illustrate software-hardware interaction failures. Monterrey also addresses the challenges of integrating AI-generated code into maintainable systems and the critical need for open communication loops between R&D, manufacturing, and post-market teams to feed field intelligence back into product design.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Beanstalk Ventures, ZEISS, Illumina, COVIDian
Tools
MatLab, ChatGPT
Also
FDA, eStar, AWS

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