FDA Software Verification and Validation

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Main topic of today is using Agile in an FDA regulated medical device context. Sounds like an impossibility I know, but the folks from Agiletek and Abbott presented a very interesting case study on how they did it. They started off by presenting “the way it used to work”, highlighting an older product development cycle from the 1990s that had very strictly defined dev phases, including a 10-12 week integration cycle – yikes! When they decided to implement Agile on a more recent project they broke up their 3-5 year dev cycle in 6 week iterations. Here were the biggest barriers they found to achieving this:

Anyway, here are the results they found by modernizing their development with Agile: higher visibility, lower costs (estimated schedule and team size reduction of 20-30%), higher quality product (availability of working software allows for continuous V&V), and overall the project had a steady pace to it rather than mad integration scrambles or backend V&V chaos.

The one big aspect of Agile they weren’t able to implement is the customer feedback component. This is mainly due to the limitations med device companies have around “pre-marketing” their product.

All in all, a very interesting case study. Be interested to hear where anyone else has seen this done in a highly regulated environment.  Signing off from Agile 2009… be sure to follow us on Twitter

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