# S1E12 Simplifying Quality Management | Jon Speer

- Show: [Being an Engineer](https://hardwarepodcasts.com/podcast/being-an-engineer)
- Published: 2020-06-05
- Length: 37m
- Episode: 12
- Page: https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer

## Summary

Jon Speer, founder of Greenlight Guru, explains how his frustration with managing medical device quality via Excel spreadsheets led to the creation of a dedicated QMS software platform. He details the transition from chemical engineering to medical device systems, highlighting the specific pain points of manual data merging and the high validation burden for electronic records. The episode covers Greenlight Guru’s development, its focus on design controls and traceability matrices, and the regulatory challenges of FDA submissions and ISO 13485 certification for startups.

## Chapters

- [0:13](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer#t=13) Introduction: Jon Speer and Greenlight Guru
- [1:56](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer#t=116) Jon Speer's Engineering Background and Career Path
- [11:35](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer#t=695) The Origin of Greenlight Guru and the Excel Problem
- [15:01](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer#t=901) Early Development, MVP, and Funding
- [18:23](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer#t=1103) Medical Device Industry Challenges: Documentation and Risk
- [22:43](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer#t=1363) Regulatory Barriers and Validation of Software
- [27:14](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer#t=1634) User Workflow: Design Controls and Traceability Matrices
- [30:27](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer#t=1827) Success Story: From Startup to FDA Submission

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Mechanical engineering](https://hardwarepodcasts.com/topic/mechanical-engineering)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- FDA (other)
- ISO 13485 (other)
- CAD (tool)
- Global Medical Device Podcast (other)

## Related episodes from other shows

- [#431: Meet Alex Naber: Insider Insights on Quality Systems, Design Quality, and MedTech's Patient-First Ethos](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-11-03-431-meet-alex-naber-insider-insights-on-quality-systems-design-quality-and-medte) (Global Medical Device Podcast)
- [Meet a Guru: Sara Adams](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-17-meet-a-guru-sara-adams) (Global Medical Device Podcast)
- [Meet a Guru: Taylor Brown](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-01-meet-a-guru-taylor-brown) (Global Medical Device Podcast)
- [What are the Opportunities for Improvement (OFI) for Quality?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality) (Global Medical Device Podcast)
- [Meet a Guru: Karen Schuyler](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-03-08-meet-a-guru-karen-schuyler) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer. 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 Being an Engineer.