# Knowing vs. Doing as Medical Device Professionals

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-04-19
- Length: 31m
- Episode: 197
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-19-knowing-vs-doing-as-medical-device-professionals
- Listen: https://podcast.greenlight.guru/episode/knowing-vs-doing-as-medical-device-professionals

## Summary

John Kapitan, CEO of Kapstone Medical, joins host John Speer to discuss the gap between knowing and doing in medical device quality systems. Kapitan categorizes professionals into three buckets: the ignorant, the antagonistic, and the apathetic, arguing that quality is a mindset rather than just a compliance burden. He warns that pre-revenue startups often neglect quality documentation, which can severely damage valuation during M&A due diligence by strategic acquirers. Kapitan advocates for a pragmatic, modular approach to building quality systems, cautioning against over-engineering processes for small companies.

## Chapters

- [0:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-19-knowing-vs-doing-as-medical-device-professionals#t=20) Introduction: John Kapitan and Kapstone Medical
- [4:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-19-knowing-vs-doing-as-medical-device-professionals#t=272) The Three Buckets of Quality Awareness
- [9:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-19-knowing-vs-doing-as-medical-device-professionals#t=578) Apathy and the Startup Mindset
- [13:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-19-knowing-vs-doing-as-medical-device-professionals#t=805) Investor Perspectives on Quality
- [16:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-19-knowing-vs-doing-as-medical-device-professionals#t=997) M&A Due Diligence and Valuation Risk
- [18:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-19-knowing-vs-doing-as-medical-device-professionals#t=1123) Kapstone Medical's Product Realization Services
- [22:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-19-knowing-vs-doing-as-medical-device-professionals#t=1336) The Danger of Over-Engineering Quality Systems
- [26:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-19-knowing-vs-doing-as-medical-device-professionals#t=1615) Pragmatic Implementation and Final Advice

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Growth, exits & acquisitions](https://hardwarepodcasts.com/topic/growth-exits-and-acquisitions)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies

## Mentioned

- Kapstone Medical (company)
- Green Light Guru (company)
- Medtronic (company)
- Boston Scientific (company)
- J&J (company)
- FDA (other)
- ISO 13485 (other)
- 510(k) (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)
- [071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-08-071-steel-industry-to-medtech-important-quality-systems-with-etienne-nichols) (Let's Combinate)
- [254 - Saying No Is the Easy Part of Quality](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-13-254-saying-no-is-the-easy-part-of-quality) (Let's Combinate)
- [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)
- [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/2021-04-19-knowing-vs-doing-as-medical-device-professionals. 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.