# 205 - Why Less Than 20% of Companies Have Started Quality 4.0

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-09-11
- Length: 35m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-11-205-why-less-than-20-of-companies-have-started-quality-4-0
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/205---Why-Less-Than-20-of-Companies-Have-Started-Quality-4-0-e37ssjj

## Summary

Larry Mager, Founder of MGMT-CTRL, explains why fewer than 20% of companies have started Quality 4.0 despite 63% believing it will transform operations. He introduces his Quantum Quality Management (QQM) framework, a five-phase roadmap that prioritizes people, process, and technology to move beyond compliance. Mager argues that legacy Electronic Quality Management Systems (EQMS) fail because they are pre-programmed, whereas modern solutions use 'digital twins' to model workflows and ensure digital continuity. He emphasizes that successful implementation requires a strategic roadmap, cultural change, and management control rather than just installing software.

## Chapters

- [0:07](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-11-205-why-less-than-20-of-companies-have-started-quality-4-0#t=7) Introduction: The Quality 4.0 Gap
- [1:39](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-11-205-why-less-than-20-of-companies-have-started-quality-4-0#t=99) The Role of Quality Professionals in Life Sciences
- [4:04](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-11-205-why-less-than-20-of-companies-have-started-quality-4-0#t=244) Implementing Quality 4.0: People, Process, and Tech
- [7:30](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-11-205-why-less-than-20-of-companies-have-started-quality-4-0#t=450) Digital Twins vs. Legacy EQMS
- [13:34](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-11-205-why-less-than-20-of-companies-have-started-quality-4-0#t=814) The Importance of a Strategic Roadmap
- [30:28](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-11-205-why-less-than-20-of-companies-have-started-quality-4-0#t=1828) Quantum Quality Management (QQM) Framework

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Factory operations & automation](https://hardwarepodcasts.com/topic/factory-operations)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)

## Most relevant to

early-stage companies

## Mentioned

- MGMT-CTRL (company)
- Quantum Quality Management (other)
- FDA (other)
- EQMS (other)

## Related episodes from other shows

- [#462: Implementing an eQMS: The Ultimate Move-In Guide for MedTech Leaders](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-06-29-462-implementing-an-eqms-the-ultimate-move-in-guide-for-medtech-leaders) (Global Medical Device Podcast)
- [Digitizing Quality Management](https://hardwarepodcasts.com/podcast/the-manufacturing-executive/2022-08-09-digitizing-quality-management) (The Manufacturing Executive)
- [Quality Management in a Changing Manufacturing Environment w/ Naveen Poonian](https://hardwarepodcasts.com/podcast/the-manufacturing-executive/2024-08-27-quality-management-in-a-changing-manufacturing-environment-w-naveen-poonian) (The Manufacturing Executive)
- [Understanding the 'Compliance Manager' Role](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-09-understanding-the-compliance-manager-role) (Global Medical Device Podcast)
- [#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)

## Citing this page

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