# Waterfall vs. Agile: Battle of the Product Development Methodologies

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-04-28
- Length: 38m
- Episode: 200
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-28-waterfall-vs-agile-battle-of-the-product-development-methodologies
- Listen: https://podcast.greenlight.guru/episode/waterfall-vs-agile-battle-of-the-product-development-methodologies

## Summary

Jon Speer, host of the Global Medical Device Podcast, interviews Devon Campbell, founder and CEO of Prodct, to debunk myths surrounding waterfall and agile methodologies in medical device development. They argue that the FDA's Design Control Guidance is often misinterpreted as mandating a rigid waterfall process, when it merely illustrates one possible approach. Campbell and Speer emphasize that successful product development relies on defined processes, traceability, and hybrid models rather than adherence to a specific named methodology. They advocate for 'documenting early and revising often' to manage the high costs of late-stage changes in electromechanical hardware.

## Chapters

- [0:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-28-waterfall-vs-agile-battle-of-the-product-development-methodologies#t=21) Introduction: Jon Speer and Devon Campbell on Episode 200
- [6:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-28-waterfall-vs-agile-battle-of-the-product-development-methodologies#t=411) The Misinterpretation of FDA Design Control Guidance
- [10:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-28-waterfall-vs-agile-battle-of-the-product-development-methodologies#t=655) The History of Stage-Gate and the Rise of Agile
- [15:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-28-waterfall-vs-agile-battle-of-the-product-development-methodologies#t=921) Addressing the Myth That Agile Is Always Faster
- [19:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-28-waterfall-vs-agile-battle-of-the-product-development-methodologies#t=1142) Applying Agile Principles to Electromechanical Hardware
- [24:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-28-waterfall-vs-agile-battle-of-the-product-development-methodologies#t=1471) Hybrid Approaches and Team Culture
- [27:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-28-waterfall-vs-agile-battle-of-the-product-development-methodologies#t=1657) Defending Quality Systems Against Agile Pushback
- [32:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-28-waterfall-vs-agile-battle-of-the-product-development-methodologies#t=1975) The Importance of Traceability and Version Control

## 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)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Green Light Guru (company)
- Prodct (company)
- FDA (other)
- Agile Manifesto (other)
- SAFe (other)
- ISO 13485 (other)

## Related episodes from other shows

- [Agile Manifesto Pt. 1](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2022-03-08-agile-manifesto-pt-1) (The Pragmatic Embedded Podcast)
- [269: Ultra-Precise Death Ray (Repeat)](https://hardwarepodcasts.com/podcast/embedded-fm/2021-07-02-269-ultra-precise-death-ray-repeat) (Embedded.fm)
- [Agile vs. V Model](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2023-03-30-agile-vs-v-model) (The Pragmatic Embedded Podcast)
- [269: Ultra-Precise Death Ray](https://hardwarepodcasts.com/podcast/embedded-fm/2018-12-06-269-ultra-precise-death-ray) (Embedded.fm)
- [Lean and Agile at a Product Development Consultancy](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2021-06-28-lean-and-agile-at-a-product-development-consultancy) (The Pragmatic Embedded Podcast)

## 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/2021-04-28-waterfall-vs-agile-battle-of-the-product-development-methodologies. 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.