New neurotechnologies are improving our understanding of the human brain and treatment for neurological conditions, such as those impacting movement, mood and cognition. 

Realising the potential of neurotechnology to improve health, advance scientific discovery, and deliver economic benefit, requires strong regulation to support safe research, adoption and use.

The partnership, also involving The Newcastle upon Tyne Hospitals NHS Foundation Trust and the Medicines and Healthcare products Regulatory Agency (MHRA), funded by the Advanced Research and Invention Agency (ARIA), will involve a full review of existing regulations and guidance for neurotechnologies, such as implanted brain-computer interfaces, neurostimulators and wearables.

Dr Luke Bashford, Lecturer in Neuroscience and Neurotechnology at Newcastle University, who is leading the partnership, said: “We will ensure the regulatory pathway for translating neurotechnology innovation to widespread patient benefit is relevant, appropriate, and easily accessible to all stakeholders.

“It demonstrates the UK as a neurotechnology leader from first-in-human and research studies to pivotal and post-market clinical trials. It should be seen as a global invitation to advance neurotechnologies here in the UK.

“Our team at Newcastle University and The Newcastle upon Tyne Hospitals NHS Foundation Trust are proud to lead this truly collaborative project and deliver the outputs openly and equitably.

“This work demonstrates the community’s continued commitment to research and ensuring people can access the latest clinical care for neurological conditions.”

Supporting the next generation

The partnership will strengthen the UK’s capacity to rapidly and safely support current and next generation neurotechnology innovation.

Expertise and insight will be sought from stakeholders throughout the UK and global neurotechnology ecosystem, including people with lived experience, academics, clinicians, charities and industry.

The partnership is led by principal investigator, Dr Bashford and co-investigators Professor Anne Vanhoestenberghe, Kings College London and Professor Tim Denison, University of Oxford.

Mark Grumbridge, Head of Clinical Investigations, Science Research & Innovation group, who leads the initiative within the MHRA, said: “The UK is uniquely positioned to lead in neurotechnology – combining world-class neuroscience and med-tech with the NHS, which provides an unparalleled platform for research and real-world application.    
 
To unlock the UK’s full potential, we must strengthen understanding of existing regulatory frameworks so that developers are clearer on how to get their products to market as quickly and safely as possible.  

This new partnership will help do exactly that, and I look forward to working with researchers, industry, policymakers, and patients to help create the conditions for a thriving neurotechnology ecosystem that delivers real benefit for patients.” 

The full press release can be read here