Development of a software process framework to assist organizations developing mobile medical apps

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.