# Meet a Guru: Wade Schroeder

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-08-19
- Length: 26m
- Episode: 160
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-19-meet-a-guru-wade-schroeder
- Listen: https://podcast.greenlight.guru/episode/meet-a-guru-wade-schroeder

## Summary

Wade Schroeder, an electrical engineer and medical device guru at Greenlight Guru, discusses his background in IVD and product development, emphasizing the importance of early risk management and robust design inputs. He shares insights on helping startups navigate FDA design controls, citing examples of companies pivoting for the opioid crisis and COVID-19 while maintaining rigorous quality systems. Schroeder advises engineers to record and rationalize all decisions to ensure compliance and facilitate future audits or design changes. The conversation highlights Greenlight Guru's 'Guru Edge' of leveraging experienced professionals to mentor clients through complex regulatory landscapes.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-19-meet-a-guru-wade-schroeder#t=0) Introduction: Wade Schroeder and Greenlight Guru's Guru Edge
- [2:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-19-meet-a-guru-wade-schroeder#t=128) Wade Schroeder's Background: From Production Floor to Electrical Engineer
- [4:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-19-meet-a-guru-wade-schroeder#t=295) Mentoring Startups: Helping Engineers Navigate Medical Device Regulations
- [9:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-19-meet-a-guru-wade-schroeder#t=578) Design Controls: The Importance of Early Risk Management and Design Inputs
- [14:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-19-meet-a-guru-wade-schroeder#t=862) Customer Stories: Opioid Crisis Devices and COVID-19 Pivots
- [17:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-19-meet-a-guru-wade-schroeder#t=1070) Key Recommendations: Record, Rationalize, and Comply with 21 CFR 820
- [22:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-19-meet-a-guru-wade-schroeder#t=1324) Personal Life: Remodeling a House and Lessons from 'This Old House'

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [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

## Mentioned

- Greenlight Guru (company)
- Wade Schroeder (other)
- John Spear (other)
- IEC 610 (other)
- 21 CFR 820 (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)
- [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)
- [S1E23 A-Team Engineering, From Ireland to the United States | Ronan Jenkinson](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-07-24-s1e23-a-team-engineering-from-ireland-to-the-united-states-ronan-jenkinson) (Being an Engineer)
- [S1E13 A Holistic View on Product Development | Devon Campbell](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-09-s1e13-a-holistic-view-on-product-development-devon-campbell) (Being an Engineer)
- [S5E7 Matt Zachek | Medical Device Engineering Leaders 7](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-02-16-s5e7-matt-zachek-medical-device-engineering-leaders-7) (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/2020-08-19-meet-a-guru-wade-schroeder. 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.