# What are the Opportunities for Improvement (OFI) for Quality?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-02-23
- Length: 42m
- Episode: 247
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality
- Listen: https://podcast.greenlight.guru/episode/what-are-the-opportunities-for-improvement-ofi-for-quality

## Summary

Jon Speer, founder of Greenlight Guru, hosts Mike Drues of Vascular Sciences to discuss the definition and implementation of quality in the medical device industry. They argue that regulatory quality is about consistency rather than subjective 'good or bad' outcomes, and that quality management systems should serve as a business philosophy rather than just a compliance checklist. The conversation highlights the disconnect between product design validation and manufacturing process validation, especially in Class 1 and 2 devices.

## Chapters

- [1:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality#t=95) Defining Quality: Consistency vs. Subjectivity
- [6:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality#t=396) Product Quality vs. Process Quality
- [13:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality#t=828) Responsibility for Quality Across the Organization
- [19:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality#t=1140) Negative Connotations and the 'Quality Police'
- [25:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality#t=1521) Integrating Quality into Design and Manufacturing
- [31:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality#t=1871) Design Controls and the Product-Process Gap
- [35:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality#t=2140) QMS as Business Philosophy vs. Compliance
- [39:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality#t=2345) Continuous Improvement and Conclusion

## 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)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- Vascular Sciences (company)
- FDA (other)
- ISO 13485 (other)
- 510(k) (other)
- PMA (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)
- [244 - 5 Critical Quality Differences Between Drugs and Devices](https://hardwarepodcasts.com/podcast/lets-combinate/2026-07-01-244-5-critical-quality-differences-between-drugs-and-devices) (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)
- [002 - “Seeing David in the Stone: Predictive Quality Management” with Larry Mager](https://hardwarepodcasts.com/podcast/lets-combinate/2021-10-14-002-seeing-david-in-the-stone-predictive-quality-management-with-larry-mager) (Let's Combinate)
- [065 - "8 Quality Lessons from Losing 100 Lbs " with Subhi Saadeh](https://hardwarepodcasts.com/podcast/lets-combinate/2022-12-28-065-8-quality-lessons-from-losing-100-lbs-with-subhi-saadeh) (Let's Combinate)

## 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/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality. 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.