Agile challenges within regulated healthcare environments

Abstract

Agile methodologies has had an increasing popularity within healthcare software development due to many advantages over more traditional waterfall-like methodologies. However, there are still many challenges and uncertainties facing practitioners working with, or wanting to adopt an agile methodology within the regulated domain. In this thesis we perform a case study to identify challenges perceived by practitioners when working with, or adopting agile within the regulated healthcare environment. This is done through interviews with a total of 9 practitioners from 5 Sweden-located companies. The interviews produced a set of 37 challenges, summarized into 10 challenge categories based on similarity. The challenge categories are put into three areas indicating where the cause for the challenges lie: either at the practitioners; at the regulatory bodies; or somewhere in between the two. Given the encountered challenges, this study investigates if they are common to all software healthcare companies and further try to resolve the challenges while still keeping to an agile approach. This study, however, finds no literature which treat the challenges caused by the regulatory bodies, and as such many challenges are missing suggestions for solutions. This study concludes by identifying three needs in order for companies to be able to work with agile in regulated healthcare environments. Firstly, there needs to be more research done in the field. Secondly,there is a need for more resources and guidelines explaining how to work agile in regulated healthcare environments. Lastly there is the need for an improvement of the existing regulatory documents to better emphasize support for the agile way of working.