Agile Development in a Medical Device Company

This article discuss the experience of the software development group working in Cochleartrade with introducing Scrum as an agile methodology. We introduce the unique challenges we faced due to the nature of our product and the medical device industry.These are long validation cycles, strict regulatory standards and a high level of dependence on physical devices among others. We then show how we managed to overcome these by adapting Scrum and mapping it unto our current process in such a way as to continue to satisfy the strict standard and regulations. We show how we automated the testing of physical devices to overcome our dependence on manual testing. We present the tools we used for managing requirement, validation, reporting and performance metrics. Finally we briefly look at the implications of the proposed IEC62304 standard on software development with Scrum.