Medical device software development needs ‘risk compass’ for the digital age

30 July, 2019

The complex relationship between opportunity and risk in the connected world poses unprecedented challenges for medical device manufacturers, according to software specialists at product development consultancy Sagentia.

Software architects regularly contend with conflicting objectives when making technology choices. Acceleration of product development is a major goal, but so is the safety and security of patients and users. Upfront software decisions have a critical bearing on both product efficacy and the likelihood of achieving regulatory approval.

There is rarely an absolute right choice. Instead, software architects must consider all the available options, opportunities and repercussions, then make a pragmatic choice. Sagentia has developed a free whitepaper Medical devices: the shift from embedded to connected to help decision-makers develop a ‘risk compass’ to navigate this environment.

One of the paper’s authors, Paulo Pinheiro, Head of Electronics, Software and Systems at Sagentia, explains: “The new possibilities unlocked by connectivity and commodity software are hugely exciting. But they do come at a cost. With traditional medical devices, code is embedded and contained within a single functional unit. It’s isolated and relatively easy to protect. When devices are connected, you relinquish some of that control, and increase exposure to external threats. Software architects have to find the right balance between controlling the risks and maximising the opportunities. And it isn’t easy.”

Issues covered by the whitepaper range from risk-based decision making and future-proofing to usability. It considers how to apply the software classifications detailed in the IEC 62304 standard for medical device software. And it looks at software security guidance from the US Food and Drug Administration and the Association for the Advancement of Medical Instrumentation.

“Medical device development has to keep pace with the connected world, but decisions need to be underpinned by a high level of awareness,” Paulo continues. “With a solid understanding of the technology and regulatory landscape, backed by robust processes, the benefits of the connected digital world can be brought to medical devices, without compromising on patient safety.”

Medical devices: the shift from embedded to connected is available at

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