Recommendations hailed as “a timely call to action”

A new report from the Regulatory Horizons Council has said that reform of medical devices regulation is urgently needed given the “enticing opportunities” available.

The report highlights the health and economic benefits of reform, in particular the role medical devices can play in pandemic preparedness and how medical devices can ensure the UK becomes a “science superpower.”

Professor Sir Bruce Keogh, former Medical Director, NHS England, said in a foreword to the report, it was “A timely call to action.”

He points out, the complexity of new medical devices is “mind boggling” and is driven by the speed of advances in technology and material science and their potential application to solve debilitating or life-threatening human conditions.

In turn this brings enormous personal benefits and greater individual risks.

It offers a route to more effective safety assurance through mechanisms that consider the whole product lifecycle, how we detect adverse events which occur rarely or a long time after use of the device and how we trace and recall patients when needed.

“Importantly this report is firmly patient-centred: accelerating innovation, assuring safety, and increasing engagement of patients with the process of development and regulation.

“The report also considers a number of ways we can be smarter in our use of data and technology to join up digital systems.”

Examples include more effective use of unique device identifiers on medical devices, and collection of lifelong data in a systematic way will improve detection of adverse events and our ability to intervene earlier.

There is also a role for ensuring better joining up of the human systems – ensuring that disparate health providers and regulators communicate effectively with each other and with patients.

The 10 recommendations are based on include recognising:

• There is a need to build a regulatory system for medical devices that works for patients.
• There is a need to increase capacity to address present needs and emerging opportunities.
• There is an opportunity for the UK in international leadership and partnership in medical devices.
• There is an opportunity to use medical devices as a template to help enable regulatory innovation that improves patient safety, system efficiency and UK growth, and there is a need to build resilience and prepare for future threats.

Sir Bruce says: “The opportunities are enticing. Effective implementation of the recommendations will bring tangible economic benefits and enable our patients to benefit from the very best of UK and global innovations more rapidly than at present.”

*Read Future Care Capital’s project report Helping through haptics: Innovation pilots in care homes