The demands of safety-critical medical device software development

In the main, software development is a business which is frequently challenged with quality concerns, with the overwhelming majority of software users having experienced some level of difficulty using software at some point in time. One of the primary reasons for such issues is the very nature of software and its development process. Odd as it may sound to a non-software savvy audience, it can in practice be difficult to accurately and completely identify even the requirements for a software development product. And defining the requirements is only the initial hurdle, with the implementation on various platforms and the need to integrate with sometimes unforeseeable additional systems looming large on the product development horizon. For safety critical domains, such as the medical device and healthcare sectors, these hurdles are amplified. Whereas a failure in a desktop application may be resolved through a restart with no harm incurred, a failure in a medical device can – and has – resulted in serious injury and death. Our work in the Regulated Software Research Centre (RSRC) aims to support medical device producers in the production of safer medical device software while also taking account of economic considerations such as cost and duration of development. In this article, we discuss the MDevSPICE® project and how it successfully addresses both the economic and the safety concerns faced by medical device producers.