Project to research medical device intelligence

The Global Medical Device Nomenclature (GMDN) Agency alongside several partners including Guy’s and St Thomas’ NHS Foundation Trust has been funded through Innovate UK as part of a six-month discovery phase on a project called transforming post-market intelligence to safely accelerate medical device innovation and adoption. The project lead is Dr Emmanuel Akinluyi, Deputy Chief Medical Officer and the Chief Biomedical Engineer at Guy's & St Thomas' NHS Foundation Trust and a consultant clinical scientist.

“Medical devices impact every aspect of the public's interaction with the NHS, for prevention, screening, diagnosis, monitoring and treating of diseases and the safety and effectiveness of these devices is critical to the quality of health outcomes,” said Dr akinluyi. Traditionally, while the great majority of medical device testing is done pre-market, manufacturers are also required to monitor their devices in clinical use, although in practice this is mainly limited to voluntary reporting and feedback from users.

“We refer to this ongoing information about medical devices in clinical use as "post-market intelligence" The way we approach post market intelligence, has barely changed in decades. However, recent technological innovations mean that post-market intelligence could be transformed. These innovations include sophisticated medical device software, connected devices, innovative sensors and growing hospital medical device databases, which are often managed by trained healthcare scientific staff. We believe that new opportunities can be created by connecting these new and enhanced sources of data about device safety and performance.”

John Wilkinson OBE, Chairman of the Board of Trustees at the Global Medical Device Nomenclature Agency and former Director of devices at MHRA, said:

“There is an opportunity for post-market-intelligence to provide much earlier warnings about devices that are not operating as they should, are difficult to use, unreliable, or seem to function poorly in sub-groups of patients. This data could be used by hospitals to better manage their services to patients, while manufacturers could use data to rapidly detect and address any identified issues with their devices.”

Regulators could provide pathways that enable innovative devices to get to patients more quickly, by changing the balance of pre-market and post-market safety and performance evaluation, he added.

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