Assessing the suitability of agile practices for medical device software development

The adoption of agile software development methods is growing rapidly in many industries. The reason for this is because they promise to solve many obstacles which are consistently linked with a plan-driven or waterfall software development, such as lack of flexibility and long time to market. However, the adoption rate of agile practices in the regulated healthcare industries has remained at a very low level. This is especially true for the development of medical device software. The reason for this is that software for medical devices includes compliance challenges not faced with the development of non-safety critical software (Hugh, Caffery, Casey, & Pikkarainen, 2012). Previous research has shown that agile practices can be traced to the software development process. Therefore, this study will focus on agile development of medical device software in compliance with the IEC 62304:2006 international standard for medical device software. The objective is to identify which agile practices can be incorporated in the existing lifecycle processes of the IEC 62304:2006. For this purpose, a literature review was conducted to identify where agile practices have been successfully implemented by medical device software practitioners. The results were combined into a conceptual framework which provided a foundation for the empirical study conducted in the later part of this study. The empirical study was conducted to validate the findings of the literature review by means of a questionnaire-based survey. The key findings of this mapping study result in a verified conceptual framework containing agile practices mapped to the eight IEC 62304:2006 life cycle processes.