# Leaning into Lean Documentation

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-06-07
- Length: 55m
- Episode: 322
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-07-leaning-into-lean-documentation
- Listen: https://podcast.greenlight.guru/episode/leaning-into-lean-documentation

## Summary

Steve Gompertz, a partner at QRX Partners with experience at St. Jude Medical, Boston Scientific, and Medtronic, explains the concept of lean documentation in medical device Quality Management Systems (QMS). He argues that documentation should be written for employees, not auditors, using hierarchical structures like flowcharts and appendices to improve usability. Gompertz details how to build effective Standard Operating Procedures (SOPs), manage CAPA execution, and prove the ROI of a well-architected QMS by reducing audit findings. He also outlines the essential early-stage components for a new medical device company, emphasizing design controls and management responsibility.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-07-leaning-into-lean-documentation#t=0) Introduction: Steve Gompertz and QRX Partners
- [3:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-07-leaning-into-lean-documentation#t=225) Defining Lean Documentation and Writing for Employees
- [6:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-07-leaning-into-lean-documentation#t=391) Building Effective SOP Templates and Flowcharts
- [14:15](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-07-leaning-into-lean-documentation#t=855) Document Ownership and Collaborative Production
- [18:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-07-leaning-into-lean-documentation#t=1136) The Importance of Process Thinking and QMS Architecture
- [24:12](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-07-leaning-into-lean-documentation#t=1452) Proving ROI on Quality Systems and Maturity Models
- [31:57](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-07-leaning-into-lean-documentation#t=1917) Using Guidance Documents and Managing Ambiguity
- [42:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-07-leaning-into-lean-documentation#t=2549) Building a QMS for Early-Stage Medical Device Companies

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)

## Most relevant to

early-stage companies, companies scaling up, large enterprises

## Mentioned

- QRX Partners (company)
- St. Jude Medical (company)
- Boston Scientific (company)
- Medtronic (company)
- Vital Images (company)
- Control Data (company)
- Greenlight Guru (company)
- ISO 13485 (other)
- ISO 14971 (other)
- FDA (other)
- BSI (other)
- G2 (other)

## Related episodes from other shows

- [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)
- [215 - Why Aren’t Technical People Leading Drug-Device Audits?](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-26-215-why-arent-technical-people-leading-drug-device-audits) (Let's Combinate)
- [185 - ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder](https://hardwarepodcasts.com/podcast/lets-combinate/2025-04-23-185-iso-10013-document-control-in-pharma-devices-sops-work-instructions-and-raci) (Let's Combinate)
- [Living Documentation and Test Automation with Paul Massey](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-07-15-living-documentation-and-test-automation-with-paul-massey) (The Pragmatic Embedded Podcast)
- [S1E12 Simplifying Quality Management | Jon Speer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer) (Being an Engineer)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-07-leaning-into-lean-documentation. 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 Global Medical Device Podcast.