Development of a software process framework to assist organizations developing mobile medical apps
Kitija Trektere, Fergal McCaffery, Marion Lepmets · 2016
Despite mobile medical apps becoming an increasingly important part of the healthcare industry, developers still find it challenging to understand what exactly is required when a mobile healthcare application fulfils the definition of a medical device both in terms of safety and security. To date, the authors have developed and piloted a medical device software process framework called MDevSPICE®that integrates processes from various medical device software standards as well as generic software development best practice standards. This paper describes current research that extends the MDevSPICE®framework to assist organizations developing mobile application software that meets the definition of a medical device and therefore has to be developed in compliance with medical device regulations. This can be a challenge for developers of mobile applications as such applications are normally developed in a much faster and less documented manner than traditional prescribed and plan driven medical device software development. We will describe our approach that increases the flexibility of the MDevSPICE®framework through replacing rigid plan-driven practices with agile practices that are more suitable for the development of mobile medical applications.