GMDN Agency and partners receive Innovate UK funding to research post-market medical device intelligence

The Global Medical Device Nomenclature (GMDN), along with several partners, including Guys and St Thomas NHS Foundation Trust, have announced funding from Innovate UK, part of UK Research and Innovation, to study how to improve the collection of post-market medical device information to improve patient safety in the UK.

The partners were funded as part of a six-month discovery phase of the project, “Transforming Post-Market Intelligence to Safely Accelerate Medical Device Innovation and Adoption.”

The project leader is Dr Emmanuel Akinluyi, Deputy Chief Medical Officer and Principal Biomedical Engineer at Guy's and St Thomas' NHS Foundation Trust. He is also a Consultant Clinical Scientist with a PhD in Health Systems Design and Head of Methodology and Deputy Director of the NIHR Healthtech Research Centre. As Principal Investigator, he will lead the network, particularly the NHS-related efforts.

“Medical devices affect every aspect of the public's interaction with the NHS, including disease prevention, screening, diagnosis, monitoring and treatment. The safety and effectiveness of these devices are critical to quality health outcomes. Traditionally, the majority of testing of medical devices has taken place before they are used on patients ('pre-market'). Manufacturers are required to monitor their devices in clinical use ('post-market'), but in practice this is primarily limited to voluntary reporting and feedback from users,” said Dr Emmanuel Akinluyi, project leader at Guy's & St Thomas' NHS Foundation Trust.

We call this ongoing information about medical devices in clinical use “post-marketing information.” The approach to post-marketing information has remained largely unchanged over the past few decades. However, recent technological innovations have the potential to transform post-marketing information.

“These innovations include advanced medical device software, connected devices, innovative sensors, and hospital medical device databases that are often managed by a staff of trained medical scientists. We believe connecting these new and enhanced sources of data on device safety and performance will create new opportunities.”

Read more: NHS Supply Chain and GMD Agency sign collaboration agreement

Partners on the project are King's College London, GS1 UK, UCL, GMDN Agency, Radar Healthcare, Panoramic Digital Health and Guy's and St Thomas' NHS Foundation Trust.

John Wilkinson OBE, chairman of the board of directors of the World Organisation for Medical Device Nomenclature and former director of devices at the MHRA, said: “Post-market surveillance has the opportunity to provide earlier warning of devices that don't work properly, are difficult to use, are unreliable or appear to be malfunctioning in some patient groups.”

“With this data, hospitals can better manage their patient services and feel more confident when introducing innovative devices into their services. Manufacturers can use the data to quickly detect and address any issues found with their devices. By changing the balance between pre-market and post-market safety and performance evaluations, regulators can provide a path to get innovative devices to patients more quickly.”

Our network of organisations will come together to explore this opportunity, including ways to encourage the adoption of this enhanced post-market surveillance by manufacturers and the NHS. Our network includes medical device manufacturers, companies and universities who specialise in developing standards and tools that bring organisations together, as well as NHS staff who may be managing data that could lead to improvements in how medical devices are developed, delivered and managed.

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