Integration Phase - AGILE vs. Regulatory

An AGILE software development process allows for adaptive development through incremental changes in the software. This means that there are more releases and upgrades of the software in the field. Within the AGILE process there is time allotted for the integration phase. This means after development and initial testing of software features the team decides which features will be integrated into the core software. This obviously has to happen after development and successful testing but prior to official V&V testing and release.

I think this method is great and makes a lot of sense for software development because the software is constantly being updated and improved. However lately I have seen this AGILE development process clash with certain fundamental regulatory elements that are necessary in the development of medical devices. For example, translations! Because the development of medical device software in an AGILE process happens so incrementally this results in quick and somewhat frequent releases of the software to market. The time between deciding to integrate a feature into the core software and the release to market of that new software is fairly short. However the time to get proper labeling and descriptions of the new features in the software translated can take much longer than the AGILE development process allows for. This causes conflict between the two processes of AGILE software development and software label translating.

So which process wins out, AGILE or translations? Is there a way to allow enough time for the validated translation process without holding up the release of the software?

--Jillian F. Walker