# S2 E8: Quality Engineering and Strategy for Hardware with Matt Lipsitz

- Show: [The Builder Circle](https://hardwarepodcasts.com/podcast/the-builder-circle)
- Published: 2024-03-05
- Length: 1h 01m
- Page: https://hardwarepodcasts.com/podcast/the-builder-circle/2024-03-05-s2-e8-quality-engineering-and-strategy-for-hardware-with-matt-lipsitz
- Listen: https://rss.com/podcasts/thebuildercircle/1374062

## Summary

Matt Lipsitz, Head of Quality at Formlabs, explains that quality is a culture of managing risk to meet customer expectations, starting with Failure Modes and Effects Analysis (FMEA) in the design phase. He details how startups can build a low-touch quality infrastructure by defining clear specifications, validating them through testing, and implementing proactive control points in the supply chain to catch defects before they reach the field. Lipsitz emphasizes that successful quality requires deep knowledge transfer, often involving on-site supplier partnerships, and treating every downstream partner as a customer to ensure alignment on critical-to-quality metrics.

## Outline

1. Introduction: Matt Lipsitz and Formlabs Background
2. Defining Quality and Risk Management via FMEA
3. Proactive vs. Reactive Quality in the Product Lifecycle
4. Knowledge Transfer and Supplier Partnerships
5. Managing Supplier Performance and Trade-offs
6. Common Pitfalls: Prototypes, Misuse, and Measurement
7. Hardware Horror Stories: Measurement Disagreements and Foreign Objects
8. Design for Manufacturing and Supplier Alignment
9. Conclusion: Quality as a Culture

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Prototyping & iteration](https://hardwarepodcasts.com/topic/prototyping)
- [Test & measurement](https://hardwarepodcasts.com/topic/test-and-measurement)

## Most relevant to

companies scaling up

## Mentioned

- Formlabs (company)
- Keurig Dr. Pepper (company)
- FMEA (tool)
- Formlabs printers (product)

## Related episodes from other shows

- [Building a Culture of Quality](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-20-building-a-culture-of-quality) (Global Medical Device Podcast)
- [#412: How to Build a QMS That Actually Works: From Startup to Scale in MedTech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-06-23-412-how-to-build-a-qms-that-actually-works-from-startup-to-scale-in-medtech) (Global Medical Device Podcast)
- [#384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-09-26-384-insights-from-an-ex-fda-investigator-compliance-quality-systems-and-medtech) (Global Medical Device Podcast)
- [Addressing the 'Who, What, When' of Quality in the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-08-addressing-the-who-what-when-of-quality-in-the-medical-device-industry) (Global Medical Device Podcast)
- [#468: SaMD Issues, Defects & Detection | Shawnnah Monterrey](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-10-468-samd-issues-defects-detection-shawnnah-monterrey) (Global Medical Device Podcast)

## Citing this page

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