# Determining User Needs for Your Medical Device

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-01-14
- Length: 42m
- Episode: 300
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-14-determining-user-needs-for-your-medical-device
- Listen: https://podcast.greenlight.guru/episode/determining-user-needs-for-your-medical-device

## Summary

Jesseca Lyons, a mechanical engineer and regulatory expert at Greenlight Guru, discusses the common pitfalls of defining user needs in medical device design controls. She explains how to distinguish true user problems from premature solutions using root cause analysis and emphasizes the importance of cross-functional input to identify who the actual users are. Lyons also clarifies the relationship between user needs and design inputs, noting that not every design input requires a corresponding user need and that design inputs should define performance requirements rather than specific solutions.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-14-determining-user-needs-for-your-medical-device#t=0) Introduction and Guest Background
- [4:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-14-determining-user-needs-for-your-medical-device#t=242) Defining User Needs and Ownership
- [9:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-14-determining-user-needs-for-your-medical-device#t=545) Identifying the True User and Problem
- [11:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-14-determining-user-needs-for-your-medical-device#t=670) Determining Scope and Stopping Divergent Thinking
- [16:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-14-determining-user-needs-for-your-medical-device#t=1015) Pitfalls: Retroactive Needs and Standalone Design Inputs
- [21:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-14-determining-user-needs-for-your-medical-device#t=1282) Broadening the Definition of 'User' to Include Packaging and Logistics
- [23:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-14-determining-user-needs-for-your-medical-device#t=1387) Validation Pitfalls and Continuous Validation
- [27:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-14-determining-user-needs-for-your-medical-device#t=1636) Using Root Cause Analysis to Find True Needs
- [31:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-14-determining-user-needs-for-your-medical-device#t=1889) Avoiding Technical Jargon and Fear of FDA Scrutiny
- [36:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-14-determining-user-needs-for-your-medical-device#t=2182) Design Inputs vs. Solutions and Final Advice

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- FDA (other)
- ISO 13485 (other)
- 510(k) (other)

## Related episodes from other shows

- [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)
- [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)
- [074: Medical Device Product Development Best Practices](https://hardwarepodcasts.com/podcast/product-startup/2021-05-05-074-medical-device-product-development-best-practices) (Product Startup)
- [Dakota Welker | User Needs, Design Inputs, Verification & Validation](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-09-25-dakota-welker-user-needs-design-inputs-verification-validation) (Being an Engineer)
- [A Look Inside Medical Device Manufacturing with Philips’ Natalia Mendez](https://hardwarepodcasts.com/podcast/manufacturing-happy-hour/2022-09-27-a-look-inside-medical-device-manufacturing-with-philips-natalia-mendez) (Manufacturing Happy Hour)

## 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/2023-01-14-determining-user-needs-for-your-medical-device. 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.