| Main topic of today is using Agile in an FDA regulated | | | | didn’t capture everything! Now, they realize |
| medical device context. Sounds like an impossibility I | | | | it’s a myth that all the req’ts can be defined |
| know, but the folks from Agiletek and Abbott | | | | upfront, and as the gentleman from Abbott stated: |
| presented a very interesting case study on how they | | | | "Your requirements are final when the product is |
| did it. They started off by presenting "the way it | | | | retired from market." |
| used to work", highlighting an older product | | | | - Software verification and validation (V&V) - |
| development cycle from the 1990s that had very | | | | they emphasized a risk-based approach. Run code |
| strictly defined dev phases, including a 10-12 week | | | | inspections and reviews on the most critical areas of |
| integration cycle - yikes! When they decided to | | | | code. Keep your requirements focused and high-level |
| implement Agile on a more recent project they broke | | | | so testers are testing the important stuff. |
| up their 3-5 year dev cycle in 6 week iterations. Here | | | | Anyway, here are the results they found by |
| were the biggest barriers they found to achieving | | | | modernizing their development with Agile: higher |
| this: | | | | visibility, lower costs (estimated schedule and team |
| - Documentation - they tackled this topic upfront. | | | | size reduction of 20-30%), higher quality product |
| There is a perception that the FDA wants truckloads | | | | (availability of working software allows for continuous |
| of docs from medical device manufacturers. The | | | | V&V), and overall the project had a steady |
| reality is, according to the presenters, that’s not | | | | pace to it rather than mad integration scrambles or |
| the case… the FDA wants "enough" documentation | | | | backend V&V chaos. |
| to demonstrate your process ("least burdensome" in | | | | The one big aspect of Agile they weren’t able |
| FDA-speak). The biggest area is of course | | | | to implement is the customer feedback component. |
| documenting requirements which they did through a | | | | This is mainly due to the limitations med device |
| Capability Matrix. | | | | companies have around "pre-marketing" their product. |
| - Requirements - this required a big culture shift. They | | | | All in all, a very interesting case study. Be interested |
| talked about past projects with 14 month | | | | to hear where anyone else has seen this done in a |
| requirements definition phases… which still | | | | highly regulated environment. |