There are numerous agile methodologies: Scrum, XP, Lean, Crystal, DSDM, etc. And they all agree on 4 fundamental things. They prefer:
- individuals and interactions to process and tools
- working software to documentation
- customer collaboration to contract negotiation
- responding to change to following a plan.
While there is value in the ones on the right, the ones on the left are more important.
It is especially hard to be agile at an FDA regulated company. Sometimes I think they prefer the ones on the right. In fact in a couple of cases I am sure of it. I know they value documentation over working software, because documentation has yet to harm anyone (other than perhaps the person writing it . I also think that they prefer processes to people, and following a plan rather than responding to change for the same reasons. And although the software won’t kill anyone, it is not likely to be usable by anyone either .
Despite the differences in opinion there are ways to make it work. Often this involves defining a plan that allows for change and using easier and lighter weight methods of documenting – like pictures and videos.