I have been asking a number of professional developer’s questions concerning requirements completeness and faster, more error-free development. Many responses demonstrate that the Software Development Industry believes that Agile or iterative mythologies are a panacea for all ills. But what about for those of us who due to regulation and safety concerns are committed to a more traditional waterfall lifecycle of development.
The difficulty with the proposal of using iterative development methods in Medical Software Development is that the required Design Controls dictates that Planning, Design Input, Design Output, Validation and Release happen in a lock-step linear fashion. Obviously anything affecting human health and safety has to be very well validated before it can be deployed. The amount of documentation and review overhead at each step precludes rapid cycles of the process. There is no prohibition of iteration within the steps or stages, but what about full-blown Agile Methodologies? If these methodologies really do deliver better results it makes no sense that they cannot be used in a way that provides faster and safer medical technologies as well.
I have seen enough discussion in the Blogosphere and Discussion groups to have hope that iterative methods could be successfully applied in even such a conservative environment as Medical Device Software development. Here is a list of links I have found to such discussions and proposals.
- Charlie Alfred proposes an approach in the discussion of my own post on Requirements and Architecture — https://ronrammage.wordpress.com/2010/10/23/better-requirements-require-architecture/
- Also see — http://malcsilberman.wordpress.com/2010/10/18/agile-in-healthcare/
- Dean Leffingwell has begun what promises to be a very informative series of articles on Agile Development under FDA regulation at — http://scalingsoftwareagility.wordpress.com/2010/10/14/agile-software-development-in-regulated-environments-example-medical-devices/#comment-2674
- This is a very interesting article describing reasons why Medical Software companies should be using Agile Methodologies. The article also suggests how Agile Methods can be used in compliance with FDA Design Controls. http://agile.dzone.com/articles/can-and-should-agile-be-used
- Bob Nadler has written some of the earliest blog articles I can find (2007) exploring the issues and challenges involved with implementing Agile methods in an FDA regulated environment.
- Big BioPharma companies such as Abbott Laboratories are beginning to use of Agile Methods in development.
The presentation may be found at: http://c-spin.net/2009/cspin200909Agile_In_Regulated_Experience_Report.ppt
Another early article on adoption of Agile Methods in Medical Software Development. Good overview of the principles behind the Agile Manifesto.