Agile medical device software development: Introducing agile practices into MDevSPICE

Medical device software is usually embedded within the overall system as one of the sub-systems. It needs to be integrated with other sub-systems such as the electrical and mechanical for a functional medical device to be developed. In order to develop a working medical device system through integrating its sub-systems, the sub-systems' requirements have to be derived from the overall medical device system requirements. The system requirements are continuously collected, analysed and built from the needs of different stakeholders such as patients, health professionals and other companies offering relevant devices, interfaces and software related to the medical device system under development. Various regulatory requirements have to be achieved for a medical device to be allowed market access. We have developed and piloted a medical device software process assessment framework called MDevSPICEr that integrates the regulatory requirements from the relevant medical device software standards. This paper describes how the MDevSPICEr framework has been designed to enable medical device software developers to produce software that will be safe and easily integrated with other sub-systems of the overall medical device. We also describe the lessons learned from piloting MDevSPICEr in the medical device industry and introduce an agile methodology together with its benefits and challenges. This paper outlines how MDevSPICEr can be extended to include agile practices to enable medical device software development to be performed in a more flexible manner.