ACAPI - agile capability analysis and process improvement in highly regulated environments

Highly regulated environments such as the medical device domain are increasingly developing software within the context of a huge number of mandatory regulations. In these domains, the problem is inflexibility, which results in long release cycles, difficult changes, and inappropriate features. To deal with these problems, we are developing the ACAPI approach that analyzes a company's agile capability and then introduces the appropriate agile practices to improve the software development. This contribution introduces the domain, the problems, and agile development, and then gives an overview of our idea of how to combine them to solve the problems.