Global Medical Device Podcast powered by Greenlight Guru Waterfall vs. Agile: Battle of the Product Development Methodologies
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- The FDA’s Design Control Guidance for Medical Device Manufacturers is outdated and includes the waterfall design process.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
Software as a Medical Device (SaMD)
Project Medtech Podcast with Duane Mancini
Easy Medical Device Podcast with Monir El Azzouzi
Greenlight Guru YouTube Channel