# Meet a GURU: Jesseca Lyons

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-07-15
- Length: 37m
- Episode: 155
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-15-meet-a-guru-jesseca-lyons
- Listen: https://podcast.greenlight.guru/episode/meet-a-guru-jesseca-lyons

## Summary

Jesseca Lyons, a Senior Medical Device Guru at Greenlight Guru with a mechanical engineering background from Rose-Hulman and experience at Beckman Coulter, discusses the critical role of design controls and risk management in medical device development. She explains how she transformed her view of risk management from a tedious burden into an engaging process by using relatable analogies like ice cream and Sharknados to explain probability and hazardous situations. Lyons emphasizes the importance of documenting design decisions early to avoid costly remediation and shares her passion for helping customers navigate audits and regulatory hurdles to improve patient quality of life.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-15-meet-a-guru-jesseca-lyons#t=0) Introduction and Jesseca Lyons' Background
- [13:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-15-meet-a-guru-jesseca-lyons#t=780) The Importance of Design Controls and Documentation
- [17:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-15-meet-a-guru-jesseca-lyons#t=1075) Reframing Risk Management with Analogies
- [26:57](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-15-meet-a-guru-jesseca-lyons#t=1617) Tips for Early-Stage Companies and New Customers

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

companies scaling up

## Mentioned

- Greenlight Guru (company)
- Beckman Coulter (company)
- Rose-Hulman (other)
- ISO 14971 (other)
- FMEA (other)

## Related episodes from other shows

- [S1E17 Precise Speech, Customer Success, & General Engineering Love | Jesseca Lyons](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-26-s1e17-precise-speech-customer-success-general-engineering-love-jesseca-lyons) (Being an Engineer)
- [157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-09-157-design-inputs-that-dont-suck-risk-control-measures-and-problems-with-verific) (Let's Combinate)
- [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)
- [S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-02-06-s7e6-bob-hankins-medical-device-engineering-leadership-working-with-the-fda) (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)

## 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/2020-07-15-meet-a-guru-jesseca-lyons. 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.