# Understanding the Value of a Medical Device Guru

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-05-26
- Length: 32m
- Episode: 208
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-26-understanding-the-value-of-a-medical-device-guru
- Listen: https://podcast.greenlight.guru/episode/understanding-the-value-of-a-medical-device-guru

## Summary

Tom Rish, Senior Medical Device Guru and manager of the Guru team at Greenlight Guru, explains how the company provides mentorship and regulatory support to medical device companies beyond its QMS software. He discusses the 'Guru Edge,' emphasizing a phased 'build as you go' approach to quality systems to help startups launch products and pass audits without being overwhelmed by paperwork. Rish highlights industry trends including the rise of wearables, software as a medical device (SaMD), and the impact of EU MDR and IVDR regulations on In Vitro Diagnostics (IVD).

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-26-understanding-the-value-of-a-medical-device-guru#t=0) Introduction: Tom Rish and the Greenlight Guru Team
- [3:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-26-understanding-the-value-of-a-medical-device-guru#t=214) The Role and Philosophy of the Guru Team
- [7:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-26-understanding-the-value-of-a-medical-device-guru#t=424) Hiring and Diversity of the Guru Team
- [13:14](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-26-understanding-the-value-of-a-medical-device-guru#t=794) Phased QMS Implementation and 'Build as You Go'
- [19:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-26-understanding-the-value-of-a-medical-device-guru#t=1148) Documentation Mindset and Design History Files
- [22:44](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-26-understanding-the-value-of-a-medical-device-guru#t=1364) Industry Trends: Wearables, SaMD, and Smart Orthopedics
- [27:15](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-26-understanding-the-value-of-a-medical-device-guru#t=1635) IVD, EU MDR/IVDR, and Pandemic Pivots

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Connected products & IoT](https://hardwarepodcasts.com/topic/connected-products-and-iot)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Greenlight Guru (company)
- Tom Rish (other)
- John Sphere (other)
- FDA (other)
- ISO (other)
- EU MDR (other)
- IVDR (other)
- NIH (other)
- RADx (other)

## Related episodes from other shows

- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (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)
- [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)
- [S6E19 Stuart Grant | MedTech Innovation](https://hardwarepodcasts.com/podcast/being-an-engineer/2025-05-09-s6e19-stuart-grant-medtech-innovation) (Being an Engineer)
- [015 - "Would You Use it on a Family Member?" with Monir El Azzouzi](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi) (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/2021-05-26-understanding-the-value-of-a-medical-device-guru. 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.