Brexit May Present ‘Huge Opportunity’ for Device Makers


November 12, 2020

Categories: AAMI News, Clinical, Early Career, Education & Academia, Executive , Health Technology Management, Individual Contributor, Information Technology, Manager or Director, Medical Device Manufacturers, Medical Device Manufacturing

Although medical device makers will face challenges following Brexit, the UK’s withdrawal from the European Union also offers potential opportunities for the industry, according to Graeme Tunbridge, director of the Medicines and Healthcare products Regulatory Agency (MHRA).

Tunbridge was a keynote speaker at the BSI/AAMI International Medical Device Standards & Regulation Conference, held virtually on Nov. 3–4. During his address, Tunbridge noted the success of the UK’s rapid development of ventilators at the beginning of the COVID-19 pandemic, as well as the expedited deployment of a COVID-19 antibody test at a time when “the antibody test market was flooded with tests.” He also emphasized patient safety issues, the importance of listening to the patient voice, and the need to be less reliant on safety data from manufacturers.

“We have a huge opportunity to step into the global space,” said Tunbridge, adding that a new UK registration system needs to be flexible, truly transparent in terms of decision-making processes, and involve clearly developed regulations. He addressed the need to be less reliant on manufacturers to generate safety data and depend more on the valuable data generated by the National Health Service (NHS).

“We need to generate our own data,” he said, adding that he was excited about the potential for having more comprehensive data, which is essential to increasing effectiveness in the UK medical device market.

Tunbridge emphasized that using NHS data would offer tremendous benefits, making the UK the safest place to bring medical devices to market and providing high-quality data both pre- and postmarket.

In developing new regulations post-Brexit, Tunbridge emphasized the need for “thinking about the big picture” and making regulations “as simple and coherent as possible” while improving transparency.

“So much of what was done before was done behind closed doors,” he told virtual conference attendees. “We want open dialogue with those affected and with everyone able to have their say.”

He recognized that complying with a new system will be a big change for manufacturers but also said that in vitro diagnostic medical devices would be “neglected no more,” as the current framework has been “long overdue for revision” given the inefficiency of the system.

Tunbridge cited the publication of an independent report titled First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review. Published in July 2020, the report examines how the UK healthcare system responds to reports about adverse effects from medications and medical devices and considers how to respond to them more quickly and effectively in the future.

Tunbridge characterized the report as “sobering reading” for those interested in patient safety, given its accounts of adverse outcomes of two medications and one medical device (a pelvic mesh). With that report in mind, he advocated a system that was designed to be in the best interest of patients—one that understands the patient point of view and avoids tokenism involving patients.

“For too long, patient voices have not been heard,” he said.

Further, Tunbridge recommended that risk should be foreseen, measured, and monitored and that its consequences should be managed.

“Without some risk, there can be no innovation,” he suggested. “We need a medical device regulation system that encourages new technologies.”