Europe – Medical devices: the shift from embedded to connected

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. Unfortunately, the software architecture that gets a product to market in the shortest timeframe isn’t necessarily one that regulators will accept. It takes
experience, detailed market & regulatory understanding and skill to develop a solution that marries regulatory approval with speed of delivery.

The rise of connectivity and commodity software presents a wealth of opportunity, but it’s a doubleedged sword. With discrete, unconnected devices, software code is embedded and contained within a single functional unit. It’s possible to own end-to-end code development and control risk with a top-down approach. But with connected devices, graphical user
interfaces (GUIs), web apps and mobile apps, there are multiple owners with distinct business, operational and regulatory concerns…