A Snapshot of the State of Practice in Software Development for Medical Devices

The medical device industry is a constantly growing domain which makes use of more and more software products. Given the importance to this industry of dependable software components, rigorous software engineering techniques would seem to have an important role to play. However, in a recent survey of the industry we found a lower than expected rate of adoption of certain sound software engineering practices. To ensure and improve the quality of developed software products, whether they are standalone applications or embedded in complex systems, both the medical device industry as well as software engineers have to take action. Our survey is a first step in this direction and may help in identifying appropriate programs and future research topics.