Lean and agile are frequently used terms in product development. The advantages of these techniques to improve time to market are well known. Some medical device companies feel that lean and agile techniques cannot be used because of design controls. However, the regulations don’t prevent the use of those techniques during product development.
In the US, when design controls were implemented in 1997, the FDA also released a guidance document that included a diagram showing typical waterfall development process. Many medical device product developers point to this diagram as evidence that the FDA expects them to use this waterfall type of process. However, upon reading the document in further detail, you find the wording recognizes that waterfall processes don’t reflect the iterative nature of product development.
In fact, the FDA doesn’t prescribe how to do product development. They do expect that you ‘Document what you are going to do, then do what you said you were going to do.’ This means that you can use product development processes that align with lean and agile processes, provided your quality system doesn’t prevent it. Just document how you are going to use lean and agile in your plan and follow it.
If you do decide to use agile methods and deliver incremental solutions over the development period, you need to document those deliverables as they occur. Going back to retrospectively document a product design is very difficult, adds extra time while you try to reconstruct what you did, and is a very poor design practice.
Outside the US, ISO 13485 is often used as an acceptable standard for the quality system, including design controls. A new version of ISO 13485 was released earlier this year and there is a 3-year transition period. However, any new accreditations after the 2nd year will be to the 2016 standard.
In the new version, the primary changes to the section on Product Realization, Section 7, are to:
- Strengthen the link with risk management
- Place a greater emphasis on the quality management system or QMS throughout the entire product lifecycle
- To more clearly specify the requirements.
Like the FDA regulations, ISO 13485 doesn’t specify how to run product development. So, there are no regulatory barriers to using lean or agile.