# 014A - "The First P: Product" with Larry Mager

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-01-05
- Length: 1h 12m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014a-the-first-p-product-with-larry-mager
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/014A---The-First-P-Product-with-Larry-Mager-e1ccit5

## Summary

Larry Mager, Principal and Founder at Mgmt-Ctrl, explains the 'Product' phase of his Predictive Quality Management (PQM) framework, arguing that companies must first ensure their marketed devices are safe and effective before remediating broader quality systems. He details how to use post-market surveillance data, specifically FDA MAUDE and upcoming EU EUDAMED databases, to identify safety signals and compare them against competitive products to establish the 'State of the Art' (SOTA) benefit of patient safety. Mager describes a workflow where statistical analytics identify concerning product groups, triggering post-market risk assessments and CAPAs to improve risk control measures, thereby aligning the product with regulatory expectations and preventing recalls.

## Chapters

- [0:01](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014a-the-first-p-product-with-larry-mager#t=1) Introduction: Larry Mager and Predictive Quality Management
- [3:54](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014a-the-first-p-product-with-larry-mager#t=234) PQM Framework: The 3 Ps and Management Responsibility
- [8:38](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014a-the-first-p-product-with-larry-mager#t=518) Transformation vs. Remediation: Proactive Quality Strategy
- [15:23](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014a-the-first-p-product-with-larry-mager#t=923) Post-Market Data Sources: MAUDE and EUDAMED
- [23:15](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014a-the-first-p-product-with-larry-mager#t=1395) Establishing State of the Art (SOTA) Benefit of Patient Safety
- [29:28](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014a-the-first-p-product-with-larry-mager#t=1768) Statistical Analytics and Heat Map Tools for Signal Identification
- [36:28](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014a-the-first-p-product-with-larry-mager#t=2188) From Safety Signals to Post-Market Risk Assessments
- [44:39](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014a-the-first-p-product-with-larry-mager#t=2679) Implementing Risk Controls: Verification, Validation, and CAPAs
- [56:57](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014a-the-first-p-product-with-larry-mager#t=3417) Process Capability, Sigma Levels, and Predictive Monitoring
- [1:02:46](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014a-the-first-p-product-with-larry-mager#t=3766) Integrating Post-Market Clinical Follow-Up with Risk Management

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)

## Most relevant to

early-stage companies

## Mentioned

- Mgmt-Ctrl (company)
- MAUDE (other)
- EUDAMED (other)
- ISO 14971 (other)
- EU MDR (other)
- FDA (company)

## Related episodes from other shows

- [#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)
- [#410: Is the MAUDE Database Broken? An Insider’s Take on Adverse Event Reporting Failures](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-06-09-410-is-the-maude-database-broken-an-insiders-take-on-adverse-event-reporting-fai) (Global Medical Device Podcast)
- [#458: What the FDA Actually Says About AI in Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-05-04-458-what-the-fda-actually-says-about-ai-in-medical-devices) (Global Medical Device Podcast)
- [How does EU MDR impact your Quality Management System?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-22-how-does-eu-mdr-impact-your-quality-management-system) (Global Medical Device Podcast)
- [#422: ISO 14971 and the Road to Risk Management with Edwin Bills](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-05-014a-the-first-p-product-with-larry-mager. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.