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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2026-08-10
- Length: 44m
- Episode: 468
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-10-468-samd-issues-defects-detection-shawnnah-monterrey
- Listen: https://podcast.greenlight.guru/episode/post-market-software-and-medtech-quality-shawnna-monterrey

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-10-468-samd-issues-defects-detection-shawnnah-monterrey#t=0) Introduction: Shawnnah Monterrey and Beanstalk Ventures
- [2:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-10-468-samd-issues-defects-detection-shawnnah-monterrey#t=131) Manufacturing Transfer and Software Deployability
- [2:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-10-468-samd-issues-defects-detection-shawnnah-monterrey#t=131) Dead on Arrival (DOA) Failures and Shipping Reliability
- [7:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-10-468-samd-issues-defects-detection-shawnnah-monterrey#t=446) Software Defect Isolation and Unit Testing
- [10:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-10-468-samd-issues-defects-detection-shawnnah-monterrey#t=647) Class 1 Ventilator Recall and Root Cause Analysis
- [15:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-10-468-samd-issues-defects-detection-shawnnah-monterrey#t=934) Field Upgradeability and Regulatory Trade-offs
- [18:12](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-10-468-samd-issues-defects-detection-shawnnah-monterrey#t=1092) Complaint Root Cause Analysis and Systemic Issues
- [26:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-10-468-samd-issues-defects-detection-shawnnah-monterrey#t=1584) Feedback Loops and Technical Debt
- [29:19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-10-468-samd-issues-defects-detection-shawnnah-monterrey#t=1759) AI-Generated Code and Maintainability
- [39:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-10-468-samd-issues-defects-detection-shawnnah-monterrey#t=2362) End User Expectations and Usability

## Topics

- [Debugging & failure analysis](https://hardwarepodcasts.com/topic/debugging-and-failure-analysis)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Embedded firmware](https://hardwarepodcasts.com/topic/embedded-firmware)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)

## Most relevant to

early-stage companies

## Mentioned

- Beanstalk Ventures (company)
- ZEISS (company)
- Illumina (company)
- FDA (other)
- eStar (other)
- AWS (other)
- COVIDian (company)
- MatLab (tool)
- ChatGPT (tool)

## Related episodes from other shows

- [217 - 5 Fixable Problems Holding Back Drug–Device Programs](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-10-217-5-fixable-problems-holding-back-drug-device-programs) (Let's Combinate)
- [024 - "Operating Under Constraints "with Naveen Agarwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-16-024-operating-under-constraints-with-naveen-agarwal) (Let's Combinate)
- [123 - Uncovering HUGE Quality Issues, Inspection Readiness in 2024, Data Integrity, AlCOA+/PIC/S and Critical Thinking in Quality Management with Peter Baker](https://hardwarepodcasts.com/podcast/lets-combinate/2024-02-14-123-uncovering-huge-quality-issues-inspection-readiness-in-2024-data-integrity-a) (Let's Combinate)
- [Photon Rich, Cash Poor](https://hardwarepodcasts.com/podcast/the-amp-hour/2016-10-14-photon-rich-cash-poor) (The Amp Hour)
- [S2 E8: Quality Engineering and Strategy for Hardware with Matt Lipsitz](https://hardwarepodcasts.com/podcast/the-builder-circle/2024-03-05-s2-e8-quality-engineering-and-strategy-for-hardware-with-matt-lipsitz) (The Builder Circle)

## Citing this page

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