Balancing agility and discipline in a medical device software organisation

Agile development techniques are becoming increasingly popular in the generic software development industry as they appear to offer solutions to the problems associated with following a plan-driven Software Development Life Cycle (SDLC). However, agile methods may not be suited to all industries or organisations. For agile methods to succeed, an organisation must be structured in a way to accommodate agile methods. Medical device software development organisations are bound by regulatory constraints and as a result face challenges when they try to completely follow an agile methodology, but can reap significant benefits by combining both agile and plan-driven SDLC such as the Waterfall or V-Model. This paper presents an analysis of a medical device software development organisation based in Ireland, which is considering moving to agile software development techniques. This includes the performing of a Home-Ground Analysis to determine how agile or disciplined the organisation currently is. Upon completion of the Home-Ground Analysis recommendations were made to the organisation as to how they could tailor their existing structure to better accommodate agile development techniques. These recommendations include adopting agile practices such as self-organising teams to promote a culture of “chaos” within the organisation.