# Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-11-18
- Length: 35m
- Episode: 168
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-18-are-you-spending-enough-time-defining-and-managing-requirements-for-your-medical
- Listen: https://podcast.greenlight.guru/episode/are-you-spending-enough-time-defining-and-managing-requirements-for-your-medical-device

## Summary

Devin Mack, mechanical engineer and owner of Enqual, discusses the critical importance of defining and managing requirements in medical device product development. He argues that companies should spend approximately one-third of their project time on this phase to avoid chaos and ensure market fit. Mack advocates for early cross-functional involvement from quality, manufacturing, and regulatory teams, rather than siloed engineering efforts. He also shares his 'stoplight' methodology for tracking progress against customer specifications and emphasizes the need for usability models to get it right the first time.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-18-are-you-spending-enough-time-defining-and-managing-requirements-for-your-medical#t=0) Introduction and Guest Background
- [5:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-18-are-you-spending-enough-time-defining-and-managing-requirements-for-your-medical#t=334) The Challenge of Defining Requirements
- [9:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-18-are-you-spending-enough-time-defining-and-managing-requirements-for-your-medical#t=540) Cross-Functional Collaboration Pitfalls
- [15:44](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-18-are-you-spending-enough-time-defining-and-managing-requirements-for-your-medical#t=944) The Stoplight Methodology for Tracking Specs
- [25:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-18-are-you-spending-enough-time-defining-and-managing-requirements-for-your-medical#t=1527) Agile vs. Waterfall in Medical Devices
- [28:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-11-18-are-you-spending-enough-time-defining-and-managing-requirements-for-your-medical#t=1713) Investing in Usability Models and Communication

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)

## Most relevant to

established companies

## Mentioned

- Enqual (company)
- Greenlight Guru (company)
- FDA (other)
- ISO 13485 (other)
- EU MDR (other)

## Related episodes from other shows

- [176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski](https://hardwarepodcasts.com/podcast/lets-combinate/2025-02-19-176-the-fastest-way-to-ruin-drug-device-development-and-how-to-avoid-it-with-eri) (Let's Combinate)
- [Requirements Engineering, part 2:  A Practical Process for Safety-Critical Development](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2026-05-27-requirements-engineering-part-2-a-practical-process-for-safety-critical-developm) (The Pragmatic Embedded Podcast)
- [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)
- [S7E19 Ryan Schoonmaker | How to Take A Structured Approach to Solving Engineering Problems](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-05-01-s7e19-ryan-schoonmaker-how-to-take-a-structured-approach-to-solving-engineering) (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)

## 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/2020-11-18-are-you-spending-enough-time-defining-and-managing-requirements-for-your-medical. 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.