Episode Thumbnail
Episode 200  |  38:29 min

Waterfall vs. Agile: Battle of the Product Development Methodologies

Episode 200  |  38:29 min  |  04.28.2021

Waterfall vs. Agile: Battle of the Product Development Methodologies

00:00
00:00
This is a podcast episode titled, Waterfall vs. Agile: Battle of the Product Development Methodologies. The summary for this episode is: <p><span style="background-color: transparent; color: rgb(0, 0, 0);">Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice?</span></p><p><span style="background-color: transparent; color: rgb(0, 0, 0);">The waterfall methodology used to be the industry norm for medical device product development until an alternative approach known as the agile methodology emerged, leading to competing opinions over which product development approach is best.&nbsp;</span></p><p><span style="background-color: transparent; color: rgb(0, 0, 0);">In this special 200th episode of the Global Medical Device Podcast, </span>host Jon Speer and his guest Devon Campbell, founder and CEO at Prodct, discuss the waterfall and agile methodologies for medical device product development, how they&nbsp;were first introduced and how they are interpreted and used today, while also dispelling common myths about the two approaches.</p><p><span style="background-color: transparent; color: rgb(0, 0, 0);">Listen as the battle between the methodologies is finally laid to rest by Jon and Devon, with one key theme emerging: the name of your chosen methodology is not nearly as important as the defined processes you follow during product development and throughout the course of your medical device project.</span></p><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Some highlights of this episode include:</strong></h3><ul><li><span style="background-color: transparent;">The FDA’s Design Control Guidance for Medical Device Manufacturers is outdated and includes the waterfall design process. However, medical device manufacturers do not have to follow the waterfall approach.&nbsp;</span></li><li><span style="background-color: transparent;">Industry norm? Read the entire guidance before making an incorrect assumption. The waterfall approach is one way, but the guidance offers other approaches and best practices to consider or follow.&nbsp;</span></li><li><span style="background-color: transparent;">The waterfall approach was not revolutionary, but it did serve a lot of good for a lot of people. It helped companies establish infrastructure and understand how to develop medical devices in a safe and efficacious manner to meet patient needs.</span></li><li><span style="background-color: transparent;">The term, ‘agile,’ as far as a product development methodology, didn’t exist until 2001 with the </span><em style="background-color: transparent;">Agile Manifesto</em><span style="background-color: transparent;">. There were huge gains in efficiency, productivity, and customer satisfaction for software companies using this shiny new approach.</span></li><li><span style="background-color: transparent;">What does a good prototype look like? It might be a misconception that one approach is slower or faster than the other. Embrace and acknowledge the idea of continuous change and iteration. Document early, revise often.</span></li><li><span style="background-color: transparent;">However, a certain order of operation needs to be followed for verification, validation, traceability, and flow of requirements, regulations, and other factors.</span></li></ul><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Memorable quotes from this episode:</strong></h3><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“The big confusion about medical device product development is exacerbated by the infamous waterfall diagram that’s published in the FDA guidance.”</em><span style="background-color: transparent; color: rgb(0, 0, 0);"> Jon Speer</span></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“Incorrect impression: Well, the FDA says we have to do this, and therefore, we shall do this. They’ve given us a model. This is the way we have to do it. It doesn’t say that.”</em><span style="background-color: transparent; color: rgb(0, 0, 0);">&nbsp; Devon Campbell</span></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“People, they just see this waterfall approach and use it. Kind of blindly, almost.”</em><span style="background-color: transparent; color: rgb(0, 0, 0);"> Devon Campbell</span></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“You start seeing huge gains in efficiency and productivity and customer satisfaction for software companies where they are using this approach.”</em><span style="background-color: transparent; color: rgb(0, 0, 0);"> Devon Campbell</span></p><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Links:</strong></h3><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-control-guidance-medical-device-manufacturers" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">FDA - Design Control Guidance for Medical Device Manufacturers (Waterfall Diagram)</a></p><p><a href="https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">FDA - Quality System Regulation, Part 820</a><span style="background-color: transparent; color: rgb(0, 0, 0);">&nbsp;</span></p><p><a href="https://agilemanifesto.org/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Agile Manifesto</a></p><p><a href="https://www.scaledagileframework.com/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Scaled Agile Framework (SAFe)</a></p><p><a href="https://less.works/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Large-Scale Scrum (LeSS)</a></p><p><a href="https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Software as a Medical Device (SaMD)</a></p><p><a href="https://www.iso.org/iso-13485-medical-devices.html" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">ISO 13485 - Medical Devices</a></p><p><a href="https://www.prodctdev.com/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Prodct LLC</a></p><p><a href="mailto:dcc@prodctdev.com" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Devon Campbell’s Email</a></p><p><a href="https://www.linkedin.com/in/devonccampbell/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Devon Campbell on LinkedIn</a></p><p><a href="http://twitter.com/devonccampbell" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Devon Campbell on Twitter</a></p><p><a href="https://open.spotify.com/episode/38QBAVgJw5Y5lB3chXFSpG" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Project Medtech Podcast with Duane Mancini</a></p><p><a href="https://podcast.easymedicaldevice.com/116/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Easy Medical Device Podcast with Monir El Azzouzi</a></p><p><a href="https://www.greenlight.guru/academy" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru Academy</a></p><p><a href="https://www.youtube.com/channel/UCYfQsPqHW8H8mZ4xpM4gn1Q" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru YouTube Channel</a></p><p><a href="https://www.greenlight.guru/podcast-mtqs" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">MedTech True Quality Stories Podcast</a></p><p><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru</a></p>

Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice?

The waterfall methodology used to be the industry norm for medical device product development until an alternative approach known as the agile methodology emerged, leading to competing opinions over which product development approach is best. 

In this special 200th episode of the Global Medical Device Podcast, host Jon Speer and his guest Devon Campbell, founder and CEO at Prodct, discuss the waterfall and agile methodologies for medical device product development, how they were first introduced and how they are interpreted and used today, while also dispelling common myths about the two approaches.

Listen as the battle between the methodologies is finally laid to rest by Jon and Devon, with one key theme emerging: the name of your chosen methodology is not nearly as important as the defined processes you follow during product development and throughout the course of your medical device project.

Some highlights of this episode include:

  • The FDA’s Design Control Guidance for Medical Device Manufacturers is outdated and includes the waterfall design process. However, medical device manufacturers do not have to follow the waterfall approach. 
  • Industry norm? Read the entire guidance before making an incorrect assumption. The waterfall approach is one way, but the guidance offers other approaches and best practices to consider or follow. 
  • The waterfall approach was not revolutionary, but it did serve a lot of good for a lot of people. It helped companies establish infrastructure and understand how to develop medical devices in a safe and efficacious manner to meet patient needs.
  • The term, ‘agile,’ as far as a product development methodology, didn’t exist until 2001 with the Agile Manifesto. There were huge gains in efficiency, productivity, and customer satisfaction for software companies using this shiny new approach.
  • What does a good prototype look like? It might be a misconception that one approach is slower or faster than the other. Embrace and acknowledge the idea of continuous change and iteration. Document early, revise often.
  • However, a certain order of operation needs to be followed for verification, validation, traceability, and flow of requirements, regulations, and other factors.

Memorable quotes from this episode:

“The big confusion about medical device product development is exacerbated by the infamous waterfall diagram that’s published in the FDA guidance.” Jon Speer

“Incorrect impression: Well, the FDA says we have to do this, and therefore, we shall do this. They’ve given us a model. This is the way we have to do it. It doesn’t say that.”  Devon Campbell

“People, they just see this waterfall approach and use it. Kind of blindly, almost.” Devon Campbell

“You start seeing huge gains in efficiency and productivity and customer satisfaction for software companies where they are using this approach.” Devon Campbell

Links:

FDA - Design Control Guidance for Medical Device Manufacturers (Waterfall Diagram)

FDA - Quality System Regulation, Part 820 

Agile Manifesto

Scaled Agile Framework (SAFe)

Large-Scale Scrum (LeSS)

Software as a Medical Device (SaMD)

ISO 13485 - Medical Devices

Prodct LLC

Devon Campbell’s Email

Devon Campbell on LinkedIn

Devon Campbell on Twitter

Project Medtech Podcast with Duane Mancini

Easy Medical Device Podcast with Monir El Azzouzi

Greenlight Guru Academy

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

More Episodes

How Mindset Training Can Help Your Team Operate at Peak Performance

Examining the HHS Proposal for Premarket Notification Exemptions

Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead

Building your Brand as a Medical Device Professional

Understanding the Value of a Medical Device Guru

Meet a Guru: Etienne Nichols