Medical devices: the shift from embedded to connected

Five principles to help software architects walk the line between opportunity and threat.

Software architects in the medical device industry have never had it easy. Delivering innovation within a rigorous regulatory environment is no mean feat. This is compounded in the digital age: connected devices offer much potential, but they cannot be fully isolated from external risks. In this paper, Paulo Pinheiro and Anthony Hayward share five fundamental principles to mitigate risk and maximise opportunity in a connected world.

Driving advancements in medical devices for the benefit of patients can be inherently problematic. On the one hand, manufacturers are striving for seamless, frequent throughput of new products and product updates. On the other, their work must gain regulatory approval. In the digital age, the latter is increasingly complex, encompassing cybersecurity as well as user and patient safety. And this raises new challenges for medical device software architects.