# 100 - PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-08-30
- Length: 30m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-30-100-pqmcoach-our-first-recording-quality-big-q-little-q-why-predictive-quality-m
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/100---PQMCoach--Our-First-Recording--Quality-Big-Qlittle-q--Why-Predictive-Quality-Management--and-Communicating-Quality-with-Larry-Mager-e28mb5a

## Summary

Larry Mager, Principal at Mgmt-Ctrl and founder of PQMCoach.com, discusses his evolution from a Fortune 500 quality engineer to a startup operator who built a Quality Management System (QMS) from scratch for a cardiovascular device. He explains the shift from 'Big Q' compliance to 'Little Q' operational excellence, detailing how he navigated an FDA consent decree at a large manufacturer and later moved into consulting to address communication barriers in quality management. Mager advocates for Predictive Quality Management (PQM) and the Plan-Do-Check-Act (PDCA) cycle as universal tools for improving business performance across pharma, medical devices, and CROs.

## Chapters

- [0:01](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-30-100-pqmcoach-our-first-recording-quality-big-q-little-q-why-predictive-quality-m#t=1) Introduction and Episode 100 Milestone
- [4:09](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-30-100-pqmcoach-our-first-recording-quality-big-q-little-q-why-predictive-quality-m#t=249) From Fortune 500 to Startup: Building Quality from Scratch
- [14:10](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-30-100-pqmcoach-our-first-recording-quality-big-q-little-q-why-predictive-quality-m#t=850) Navigating FDA Consent Decrees and Corporate Remediation
- [18:43](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-30-100-pqmcoach-our-first-recording-quality-big-q-little-q-why-predictive-quality-m#t=1123) The Frustration of Compliance-Only Consulting
- [21:06](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-30-100-pqmcoach-our-first-recording-quality-big-q-little-q-why-predictive-quality-m#t=1266) Predictive Quality Management and PDCA in Pharma
- [24:07](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-30-100-pqmcoach-our-first-recording-quality-big-q-little-q-why-predictive-quality-m#t=1447) Communication Failures and Engaging People
- [29:16](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-30-100-pqmcoach-our-first-recording-quality-big-q-little-q-why-predictive-quality-m#t=1756) Advice to Younger Self and Closing Thoughts

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

companies scaling up, established companies

## Mentioned

- Mgmt-Ctrl (company)
- PQMCoach.com (other)
- Da Vinci robot (product)
- FDA (other)
- EUMDR (other)

## Related episodes from other shows

- [#329 The Right Way to Start a QMS: When, How, & What](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what) (Global Medical Device Podcast)
- [#420: MedTech Synergy: The Project Manager and Quality Professional Relationship](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-08-18-420-medtech-synergy-the-project-manager-and-quality-professional-relationship) (Global Medical Device Podcast)
- [#444: Scaling Your QMS: What the FDA Really Expects for MedTech Startups](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-01-30-444-scaling-your-qms-what-the-fda-really-expects-for-medtech-startups) (Global Medical Device Podcast)
- [#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-11-07-390-building-a-non-bs-qms-4-core-principles-for-medtech-success-with-ashkon-raso) (Global Medical Device Podcast)
- [S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements) (Being an Engineer)

## Citing this page

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