Medical device manufacturers are facing ‘unprecedented’ challenges because of the relationship between opportunity and risk in the connected world, 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 can have a critical bearing on both product efficacy and the likelihood of achieving regulatory approval.
Sagentia has developed a paper: Medical devices: the shift from embedded to connected to help decision-makers develop a ‘risk compass’ to navigate this environment.
Paulo Pinheiro, head of electronics, software and systems at Sagentia, and one of the paper’s authors said: “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.
“Medical device development has to keep pace with the connected world, but decisions need to be underpinned by a high level of awareness. 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.”
Issues covered by the paper include 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.
