# Addressing the 'Who, What, When' of Quality in the Medical Device Industry

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-09-08
- Length: 28m
- Episode: 227
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-08-addressing-the-who-what-when-of-quality-in-the-medical-device-industry
- Listen: https://podcast.greenlight.guru/episode/addressing-the-who-what-when-of-quality-in-the-medical-device-industry

## Summary

Christie Johnson, founder of Kasota Engineering, joins host Jon Speer to discuss quality management system (QMS) strategies for early-stage medical device startups. Johnson advocates for a 'teach mentality' over hiring senior QA veterans, arguing that researchers and engineers can be coached to build simple, usable quality systems from scratch. She critiques traditional consulting models that deliver static SOPs and emphasizes documenting the product development story to preserve tribal knowledge and reduce risk.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-08-addressing-the-who-what-when-of-quality-in-the-medical-device-industry#t=0) Introduction and Kasota Engineering Overview
- [3:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-08-addressing-the-who-what-when-of-quality-in-the-medical-device-industry#t=235) The Teach Mentality: Training Researchers for Quality
- [8:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-08-addressing-the-who-what-when-of-quality-in-the-medical-device-industry#t=486) Critique of Traditional Consulting and Static SOPs
- [13:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-08-addressing-the-who-what-when-of-quality-in-the-medical-device-industry#t=811) Baby-Stepping into Processes and Documenting R&D
- [16:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-08-addressing-the-who-what-when-of-quality-in-the-medical-device-industry#t=993) Preserving Tribal Knowledge and Risk Reduction
- [20:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-08-addressing-the-who-what-when-of-quality-in-the-medical-device-industry#t=1209) Product-Centric Quality and Final Advice

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)

## Most relevant to

early-stage companies

## Mentioned

- Kasota Engineering (company)
- Greenlight Guru (company)
- Prodct (company)
- RADx (other)
- ISO 13485 (other)
- FDA (other)

## Related episodes from other shows

- [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)
- [100 - PQMCoach, Our First Recording, Quality (Big Q/little q), Why Predictive Quality Management, and Communicating Quality with Larry Mager](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-30-100-pqmcoach-our-first-recording-quality-big-q-little-q-why-predictive-quality-m) (Let's Combinate)
- [128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t) (Let's Combinate)
- [037 - Reflections #1 - (Episodes 001-25)](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-15-037-reflections-1-episodes-001-25) (Let's Combinate)
- [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

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-08-addressing-the-who-what-when-of-quality-in-the-medical-device-industry. 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.