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Table of Contents

  • 1. Summary
  • 2. An old story: innovation here, implementation elsewhere 
  • 3. The opportunity cost is just getting bigger
  • 4. Recommendations
  • 5. Acknowledgements
  • 6. Authors
  • 1. Summary
  • 2. An old story: innovation here, implementation elsewhere 
  • 3. The opportunity cost is just getting bigger
  • 4. Recommendations
  • 5. Acknowledgements
  • 6. Authors

Summary 

  • Neurotechnologies are devices that interface with our brain, either recording signals or sending carefully targeted stimulation. Implantable neurotechnologies, which sit beneath the skull, offer much richer data and more precise therapy than wearable devices, opening the door to transformative therapies.
  • Established neurotechnologies already have a transformative impact, benefitting thousands of people each year – for example helping restore function for Parkinson's patients and those with hearing impairments.
  • Opportunities for the future are even greater: there is potential for the next generation of technologies to address many neurological diseases, including paralysis and intractable depression.
  • Research is progressing rapidly, with an acceleration in clinical trials for the next wave of therapies, especially implantable brain-computer interfaces (iBCIs).
  • Accelerating the adoption of neurotech will not only bring clinical benefits, but also support economic growth. In the UK, a recent analysis estimated the total economic burden of ten selected neurological conditions was at least £96 billion in 2019, the equivalent of 4.3% of GDP. This comprises both the indirect costs of lost productivity for patients and carers, and the direct economic impact of the burden of these conditions. Optimising the delivery of existing interventions could cut this burden by more than £30 billion.
  • Despite fundamental research contributions, the UK is falling behind peer nations on two key fronts. First, we aren't doing enough to scale current treatments and get them to the patients who need them. Second, the UK's R&D ecosystem is structurally misaligned with the demands of next-generation neurotech development.
  • To become a leader in neurotech development and adoption, the UK must:
  • 1. Scale today's breakthroughs:
    • Pilot an integrated conditional commissioning pathway: Accelerated Adoption Mandates for cost-saving therapies, and time-limited managed access for highly cost-effective therapies targeting the NHS opportunity cost of £15,000 per QALY, with risk-sharing partnerships where manufacturers supply devices at evaluation prices
    • Fund clinical fellowships to support service delivery and clinical research
    • Establish Neurotech Clinical Leads to boost referrals
  • 2. Unlock tomorrow's innovations:
    • Develop a dedicated MHRA route for early iterative first-in-human device studies, analogous to the FDA's Early Feasibility Study
    • Launch an MHRA-held reference file mechanism (akin to FDA master files) so unchanged, previously reviewed components aren't re-assessed
    • Establish a Clinical Trial Support Programme via NIHR to reimburse NHS Trusts for service costs, with sponsors providing investigational devices free-of-charge
    • Pilot at least 3 NHS Neurotechnology Hubs with UKRI-funded pathway stewards and aligned UKRI/MRC/Innovate UK strategic priorities
  • While accelerating access to neurotechnology for the UK is essential, we recognise that the rapid evolution of these therapies presents some ethical risks. In addition to delivering on the recommendations set out here, policymakers must address these broader concerns to manage the privacy, transparency, and access concerns these technologies raise.

An old story: innovation here, implementation elsewhere 

Despite significant contributions to the fundamental science that underpins neurotechnologies, the UK now lags far behind international comparators, particularly the United States and China, in developing and deploying these innovative technologies. This analysis focuses on the clinical, regulatory, and commissioning barriers behind this shortfall. Detailed engineering and manufacturing challenges, though vital, lie beyond its scope. If left unaddressed, this growing neurotechnology gap threatens to undermine both our economic interests and our ability to address critical healthcare needs.

Brain disorders are the leading cause of disease burden worldwide

Neurological disorders are now the leading cause of ill health globally, surpassing even cardiovascular diseases in their impact on people’s quality of life and longevity. The impact on UK health and social care is staggering, with 600,000 people diagnosed each year, 850,000 providing care, and 12.7 million hospital bed days used. As the population ages, this burden on the NHS is set to grow even further.

The economic toll is similarly substantial. In the US, brain disorders are estimated to cost 8.8% of GDP per year. In the UK, a recent analysis estimated the total economic burden of ten selected neurological conditions was at least £96 billion in 2019, the equivalent of 4.3% of GDP. This aggregate burden comprises both the indirect costs of lost economic productivity for patients and carers, and the direct costs of healthcare for treatments and services. The same analysis suggests that optimising the delivery of existing interventions for these disorders could cut this burden by more than £30 billion, yet many high-burden conditions remain classified as untreatable.

The opportunity cost is just getting bigger

The clinical potential of existing devices is already profound. Implantable neurotechnologies have emerged as transformative interventions for a variety of neurological disorders, from deep brain stimulation (DBS) for Parkinson’s disease to cochlear implants for hearing impairments. These devices can restore lost bodily functions and significantly improve quality of life for thousands of patients each year. 

Yet these technologies represent just the beginning of what is possible. Failure to promote innovation now risks compounding disadvantage in the years ahead. New waves of device therapies are emerging, including implantable brain-computer interfaces (iBCIs) for paralysis and DBS for intractable depression. Increasingly, concerns are being raised about inequitable access to this next wave of transformative neurotechnology, given the extent of US leadership.

Looking even further ahead, neurotechnologies will likely be applied outside of healthcare, with discussions of transhumanism and cognitive enhancement now commonplace. Whether such developments are ultimately desirable or ethically sound is the subject of intense debate, but the potential for neurotechnology to evolve in this way underscores the immense stakes – and the need for the UK to influence the trajectory of technological development. As things stand, our community could have much greater potential to shape the future of these technologies.

1) The UK lags behind comparable nations in the pace of neurotechnology adoption

Despite examples of early leadership, the UK has struggled to match the rate at which patients are able to access devices as standard of care, compared to other advanced healthcare systems. Whilst direct comparisons are complicated by significant variation between systems     , the data reveals clear patterns. Two of the most widely used neurotechnologies – deep brain stimulation and cochlear implants – illustrate how far the UK  has fallen behind, despite early successes.

Case Study: Deep Brain Stimulation

1980s: A collaborative effort in groundbreaking research. 

Foundational preclinical and clinical studies begin, led by researchers in France and the US. The UK is an early contributor, contributing three of the 23 clinical trial sites used to test the Medtronic Activa (TM) system - the first example of a commercially successful DBS system.

1990s: Europe takes the lead with regulatory approval. 
Regulatory approval for DBS is obtained early in Europe (including the UK), with approval for use to treat essential tremor and Parkinson’s tremor secured as early as 1993-1995. In contrast, the FDA in the US only approves DBS for the same conditions in 1997.

2000s: The UK falls behind. 
By 2004, a major gap in DBS implementation between the UK and US appears, with procedures performed nearly ten times more often per capita in the US than in the UK. An estimated 0.76 implantations per 100,000 people are performed in the US versus just 0.08 per 100,000 in the UK.

2010s: The UK tries to catch up.
By 2019, the UK manages to narrow the gap somewhat, but implementation remains low (2.3/100,000 in the US compared to 0.4-1.0/100,000 in the UK). Differences in clinical eligibility and patient preferences partially contribute to this gap, but the latest data shows that the majority of UK patients who are eligible still do not access DBS therapies.

2020s: Early adoption of adaptive deep brain stimulation
Clinical outcomes from DBS stand to be improved by switching from standard DBS to adaptive DBS (aDBS), whereby brain stimulation is given in response to specific features of brain activity. UK clinical sites are among the first in the world to switch on this new therapy in clinical trials and implement the devices in clinical practice.

Case Study: Cochlear Implants

Early 1980s: Pioneering device development in the UK.
A team at University College Hospital, London, uses charity funding to develop and translate a single-channel cochlear implant, one of the first in the world. Whilst this UK-manufactured device did not achieve commercial success, it provided early clinical experience and exemplifies the UK’s strengths in clinical research. 

Late 1980s: The UK starts to trail the US.
The US takes the lead in 1985 when FDA approval was obtained for the Cochlear Nucleus-22 system. But the UK is not far behind, and the first UK implants occurred as early as 1988. 

2000s: The UK falls behind the US and Europe.
Despite decades of progress following initial translation, the UK’s per capitadevice implantation rate remains roughly half that of comparable European countries such as Germany or Austria, and about one-third that of the US.

2) The UK imposes barriers which prevent proven therapies from reaching patients 

Often, slow uptake of novel therapies in the UK is blamed on slow regulatory approval. Yet these case studies reveal a more complex reality. The UK has typically secured regulatory approval rapidly, sometimes ahead of the US. The true failure points lie further down the innovation pipeline: first in the uncertainty of the commissioning pathway, and second in the chronic lack of capacity to deliver treatments at scale.

  1. Failure to commission

Compared to the US and European peers, the UK system is very onerous when it comes to device commissioning: the process through which the NHS decides whether to fund and make a treatment available to patients. After a device has been judged as safe and effective and received market access approval by the UK’s health regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), it must still pass another hurdle: a detailed cost-effectiveness review by the National Institute for Health and Care Excellence (NICE) that often requires additional study data. Until this step is completed, the device cannot be routinely funded or made available to patients through the NHS. This often causes long delays in access, even for proven technologies that may well end up proving to be cost-effective.
In the US, such cost-effectiveness calculations are not universal across different healthcare providers. Furthermore, the US Centers for Medicare & Medicaid Services (CMS) can grant a transitional pass-through payment, giving new FDA-approved devices additional reimbursement for two to three years while CMS gathers real-world cost data – effectively underwriting early adoption while the economic case is still being built. CMS is also piloting Transitional Coverage for Emerging Technologies, whereby breakthrough devices approved by the FDA can finalise national coverage determination within 6 months, providing coverage for years of evidence development.  

In France and Germany – nations facing constraints on healthcare spending more comparable to the UK – patients can often begin accessing new devices while economic evaluations are still underway. France, for instance, offers a Prise en Charge Transitoire (PECT): devices approved by the health regulator that address an unmet clinical need can receive provisional reimbursement for up to twelve months, provided the manufacturer files for full reimbursement listing within that period and continues gathering the large-scale trial data needed for permanent inclusion. These countries allow initial reimbursement to proceed in parallel with health-economic analysis, avoiding unnecessary delays.

The core problem in the UK is that the commissioning pathway places the entire burden of generating this post-approval evidence on innovators, while offering insufficient assurance that a technology will be adopted at scale even if it proves cost-effective. This high-risk, low-certainty environment deters investment in UK-based trials, leaving many neurotechnologies stuck in limbo – approved as safe, but not accessible to patients.

Historically, this post-clearance, pre-commissioning phase has delayed patient access:

  • In the case of DBS for Parkinson’s, there were substantial delays after regulatory approval in the mid-1990s. A UK-specific commissioning study did not start until the 2000s, due to an absence of funding mechanisms to evaluate the therapy that had already demonstrated general safety and performance.
  • Similarly, despite cochlear implants receiving regulatory approval, they were only available for UK patients through charity funding for several years. Eventually, a consortium including clinicians and the British Cochlear Implant Group successfully lobbied the Department of Health to fund the essential study to support commissioning.

These barriers to commissioning neurotechnology for use in the NHS persist. Newer therapies like responsive neurostimulation and DBS for epilepsy remain uncommissioned in the UK, even though patients can access these treatments in the US, France, Germany, and Italy. For one subtype of epilepsy, a DBS device was approved for use in Europe as early as 2010, and positive clinical outcomes were published in 2015. Yet NICE did not issue its appraisal until 2020 – ten years after regulatory approval – ultimately concluding that more evidence was required to support commissioning. Despite stronger efficacy data emerging in 2021, no further evaluation has been performed in the four years since.

This illustrates the central challenge for innovation. There is  ongoing debate about the appropriate threshold level for NICE’s cost-effectiveness, as well as deep misunderstanding of its interpretation. The application of this framework involves complex and nuanced judgements that can be hard to predict. For example, while the standard threshold is £20,000-£30,000 per QALY, treatments like DBS for Parkinson’s can be approved at higher ratios by applying modifiers for factors like the severity of the condition. This creates significant commercial uncertainty for companies deciding whether to invest in the expensive UK-specific studies NICE requires. A more collaborative and predictable evidence-generation pathway is needed, one that provides innovators with greater clarity upfront on the real-world data required to secure a positive recommendation.

  1. Failure to scale uptake: 

Once a treatment has been commissioned for use in the NHS, there are yet more barriers preventing these technologies from being deployed at scale. This failure to scale can be largely attributed to three blockages: capacity constraints, delayed referrals, and talent shortages.

The UK has approximately half the number of neurologists compared to the European average, and about one-quarter the number found in peer countries such as France or Germany. The UK ranks 44/45 in Europe for neurologists per capita. Specialist nurses and neuropsychology support are also in short supply. As a result, neurological evaluation and referral of eligible device candidates is often delayed. One neurologist leading the DBS service at a major UK tertiary centre reported that Parkinson’s patients eligible for DBS now wait over a year from initial presentation at a neurology clinic to surgical evaluation, with waiting times for urgent neurology referrals also extending to 6 months (compared to just 4 weeks in 2008).

Whilst systemic challenges in the NHS create profound capacity constraints, it is important to ensure the limited available resource is used as effectively as possible. Focused, targeted interventions can help optimise referral pathways and patient uptake, ensuring the right patients get access to these high-impact treatments. For example, failure to scale neurotechnology adoption is also partly due to failures in clinician and patient education, which depress referral rates. One neurosurgeon reported to us that after hosting targeted educational sessions for referring neurologists, the number of appropriate DBS referrals rose temporarily each year, enabling more eligible patients to receive treatment. This suggests that a relatively straightforward targeted intervention – structured training sessions – can significantly improve patient selection and treatment rates. Patient education and engagement have also been shown to influence uptake of effective therapies. At one centre, only 28% of patients identified as good candidates for DBS chose to attend further evaluation at DBS centres. After providing patients with clear educational materials about the risks and benefits of DBS, that number rose to over 43%.

In health systems where procurement is more decentralised – for example, in much of the United States and parts of continental Europe — manufacturers compete for individual hospital or insurer contracts. That commercial incentive pushes companies to fund clinician education days, device-demonstration workshops, and patient outreach campaigns as part of their marketing effort. The result is a faster diffusion of technical know-how and higher clinician awareness of emerging therapies, albeit alongside well-known risks of promotional bias. The UK’s highly centralised purchasing model changes this dynamic entirely.

Once a device has national approval from NICE, the commercial challenge shifts. To achieve actual uptake, a company must individually persuade each of the 42 local commissioning bodies (Integrated Care Boards or ICBs), as well as the clinical and managerial teams within individual hospital trusts. The immense effort required to navigate these separate budget priorities and build dozens of local business cases makes the return on investment for local training and education commercially unattractive. Consequently, front-line clinicians receive fewer updates on novel neurotechnology therapies, and referral pathways remain under-utilised.

3) The UK environment is ill-suited to developing next-generation neurotechnology

Slow adoption of existing therapies is only part of the story. The UK also lags behind its peers in its ability to spearhead research into the neurotechnologies of the future, as evidenced by:

  1. The scale of funding: Major global competitors have made neurotechnology a national priority, with government commitments including the US BRAIN Initiative ($6 billion up to 2025) and the China Brain Project (estimated at $1 billion). Other peers like Japan and Korea have also launched centralised initiatives with upwards of $300 million in funding. The EU’s Human Brain Project represented an investment of €607 million over its ten-year lifespan (2013-2023). In comparison, the UK’s primary commitments are a £69 million programme from the Advanced Research and Invention Agency (ARIA) over four years, and a £50 million MRC consortium over fourteen years.
  2. Patents: The US accounts for nearly half of new neurotechnology patent applications (47%), followed by South Korea (11%), China (10%), Japan (7%), Germany (7%), and France (5%).
  3. The maturity of the commercial ecosystem: The US dominates the commercial neurotechnology landscape, with a 54% share of the companies and recent iBCI funding rounds alone topping $1 billion. Although UK startups such as Amber Therapeutics, Mint Neurotech, and Coherence signal a growing commercial ecosystem, Britain’s neurotechnology industry still underperforms relative to its scientific potential, with fewer late-stage financing rounds, pivotal studies, and companies not being retained long term in the UK .
  4. Trials of novel invasive therapies: Pioneering early-stage trials, such as first-in-human DBS for treatment-resistant depression or implantable BCIs to restore movement in paralysis, are seldom conducted in the UK. Whilst dozens of patients overseas have received these investigational implants, the most prominent of these pioneering studies have been conducted outside the UK.

Several obstacles are impeding the development of novel therapies in the UK:

Regulatory roadblocks

  • First-in-human studies: Early implanted-neurotechnology studies are often slowed less by regulations themselves than by experience gaps among investigators and knowledge gaps among reviewers. These gaps and limited knowledge of cutting-edge neurotechnologies can result in protracted re-working of documents and responses to low yield queries, which contributes to exploratory studies involving a single patient that can take more than 18 months to gain the necessary permissions. Comparable US studies typically receive approval in under half the time, aided by greater investigator experience with device trial requirements and more established regulatory familiarity with cutting-edge neurotechnologies.
  • No dedicated early-stage pathway: Unlike the US FDA’s Early Feasibility Studies and Breakthrough Devices Program, which offer adaptive trial designs, ongoing regulator dialogue, and interim reimbursement routes, the UK does not yet have a dedicated, small-scale early-iterative pathway that formally enables proportionate non-clinical evidence and structured regulator dialogue for very small-N, first-in-human work. 
  • No reference-file mechanism: Unlike the FDA’s master-file approach, the UK lacks a system that allows previously reviewed, unchanged device components or data packages to be referenced in subsequent submissions. This absence means each study often requires a full re-assessment, even for elements regulators have already evaluated, adding duplication and avoidable delay.

Resource constraints

  • Long-term funding: Short-term grant cycles of 3-4 years are misaligned with the decade-long development timelines needed for complex neurotechnologies. Recognising these challenges, decade-long funding timelines have long been supported by the US Brain Initiative. The UK government’s recent pledge of decade-long funding for R&D funding and infrastructure in key sectors is encouraging, but it remains unclear whether neurotechnology falls within its scope.
  • NHS resources: The NHS often lacks dedicated spaces for clinical trial follow-up, operating theatre capacity, access to imaging suites, and spare capacity among clinicians and research nurses, making it difficult to schedule and run device studies alongside the provision of routine care.
  • Dwindling primate capacity: Pre-clinical, behavioural studies with non-human primates is often an essential step in the development of novel neurotechnologies. With one of the UK’s largest non-human primate breeding colonies potentially slated for closure, researchers must either pay premium prices for the dwindling domestic stock, or import animals from abroad. This jeopardises supply security, potentially inflates costs, and risks lower welfare standards under foreign breeding regimes.

Bureaucratic friction

  • Protracted IP negotiations: A lack of standard IP agreements for multistakeholder research and clinical studies can produce delays in the UK that may not be seen in the US, where pre-negotiated IP frameworks and one-stop regulatory models clear the path for implantable device studies. Whilst examples like the MRC’s Industry Collaboration Framework offer a foundation, they could be broadened and strengthened to cover a wider range of partnerships.

Partnership challenges

  • Complexity deters private investment: The lengthy pathway from clinical trials through NICE approval to NHS adoption creates unpredictable timelines for investors, with unclear cost-effectiveness thresholds compounding uncertainty for private investment in UK innovation. 
  • Facilities draw expertise elsewhere: Only a handful of UK centres possess the specialised expertise and facilities needed to support advanced neurotechnology trials. As a result, individual academics and startups may relocate overseas to train and work.

Case Study: Startup Relocation During Preclinical Device Development 

One early-stage UK company making implantable neurotechnology has recently opened a lab in the US, and shifted key roles overseas, to keep its preclinical device development on schedule. They report that ethical approvals and protocol amendments for rodent studies have proceeded roughly three times faster than in the UK, enabling rapid prototyping and animal testing. 

Although UK lab space and labour costs are competitive, lengthy approval timelines are such a significant factor that they are sufficient to relocate critical R&D.

Case Study: The Inaugural UK Human Neuropixels Study

The Neuropixels probe is a high-density neural recording device developed by an academic consortium in the 2010s, where the UK’s Wellcome Trust and UCL were key partners. 

Although developed as a cutting-edge tool for animal studies, the probe has been temporarily implanted in volunteer neurosurgical patients at several US centres, yielding new insights about human brain function. 

The extended timeline reflected two main challenges: the extensive preparation required for a novel ethics application and the complexities of securing local governance approvals in an area with limited precedent. Because the project sits outside the MHRA’s remit, since it is non-commercial, single-use research hardware, the site may have also struggled to identify the most appropriate compliance pathway.

This lack of clear templates and limited prior experience in navigating the approvals contributed to delays, while in the meantime US groups were able to publish early landmark human data.

Recommendations

Britain’s capacity to develop and deliver neurotechnologies stalls at multiple points across the innovation pipeline, from technical developments to first-in-human studies to building robust efficacy data and securing NHS commissioning. To unlock its latent potential, the UK must pursue two complementary objectives:

  1. Remove barriers to scaling proven therapies
  2. Create new pathways for catalysing next-generation device research

Remove barriers to scaling proven therapies

An immediate priority for the UK Government should be to create a predictable pathway to scale proven therapies that can demonstrate both their clinical and cost-effectiveness. This is essential to ensure those who are eligible under the NHS receive the most advanced treatments possible – especially in cases where UK patients are yet to access treatments being used routinely abroad.

Reform commissioning through research

  • Coverage with evidence development: NHS England should pilot an integrated “conditional commissioning” pathway to accelerate access for promising therapies. This pathway would allow innovators to generate the real-world outcomes and cost-effectiveness data required for a final NICE decision, while providing early, managed access for patients. The scheme would have two distinct routes based on a therapy’s projected value:
  1. For therapies with robust early evidence of being net cost-saving: The pathway would provide an Accelerated Adoption Mandate immediately following MHRA approval, ensuring these high-value technologies are scaled rapidly across the NHS.
  2. For therapies with plausible evidence of being highly cost-effective: This route would grant time-limited access in a limited number of specialist centres. The explicit goal would be to collect the real-world data needed to prove the therapy can be delivered at a cost-effectiveness at or below the NHS opportunity cost of £15,000 per QALY.

To manage this, a ring-fenced, centrally held budget would cover the associated NHS service costs (the procedure and follow-up), protecting local budgets from risk.

Crucially, this would be a risk-sharing partnership. In exchange for this managed access to generate data, manufacturers would be required to supply their devices at a minimal evaluation price or agree to a full rebate if the therapy subsequently fails to meet the pre-agreed £15,000/QALY endpoint. This ensures that innovators are rewarded for success, while the taxpayer is protected from paying for technologies that do not demonstrate exceptional value for money in a real-world NHS setting.

Accelerate patient recruitment and referral 

  • Clinical fellows: NHS England, in partnership with UK Research and Innovation, should establish and fund 10 seven-year neurotechnology fellowships embedded within NHS neurology and neurosurgery teams. These fellowships would combine day-to-day patient care with trial recruitment and research responsibilities – specifically focused on scaling access to advanced neurotechnologies. By embedding clinician-researchers within existing NHS neurology teams, the scheme would enhance service capacity and trial readiness without requiring structural changes to the system. Fellows could also serve as local champions for referral education and pathway optimisation. Given their dual clinical and academic function, these roles can be supported at relatively low cost through joint NHS and research funding models already in use for Academic Clinical Fellowships, and the more recently announced Future Leaders Fellowships. 
  • Referral champions: NHS England should pilot the designation of a “Neurotech Clinical Lead” in at least three major neuroscience centres. Each lead would be an existing NHS consultant in a relevant speciality (e.g., neurology, neurosurgery, or neuropsychiatry), tasked with driving regional uptake of advanced neurotechnologies. Responsibilities would include:
    • Quantifying and mapping local patient cohorts who may be eligible for neurotech therapies based on clinical criteria.
    • Leading regional outreach and coordinating referral education, such as running structured workshops for referring clinicians to improve pathway awareness and referral quality.
    • Tracking key performance indicators, including the rates of appropriate referrals over time, the proportion of eligible patients offered implantation, and treatment rates.
    • Acting as a public-facing contact for volunteer enquiries, supervising a coordinator to field emails and calls from individuals with neurological diseases who wish to participate in research. This would involve providing up-to-date information on ongoing neurotechnology studies and directing them to the correct trial teams, thereby offering an ad hoc volunteer‐registry function in the absence of a formal database.

These responsibilities would be integrated into the consultant’s existing roles through the allocation of specific dedicated time within their job plans, in line with current mechanisms for funding clinical leadership responsibilities. The pilot would run for an initial 12–18 months, with outcome data used to assess feasibility, impact, and cost-effectiveness prior to national expansion.

Create new pathways for next-generation research

Most of the greatest benefits to individual patients and society      will come from therapies that have yet to be developed. There is therefore a clear imperative to pursue policy reforms that enable research into next generation neurotechnologies – attracting both leading research talent and private investment to the UK.

Regulatory innovation

  • Early feasibility pathway: The Department of Health and Social Care should instruct the MHRA to develop and pilot a dedicated early feasibility pathway to accelerate first-in-human studies of novel implantable neurotechnologies. This would adopt features of the US FDA’s Early Feasibility Studies (EFS) and Investigational Device Exemption (IDE) programmes, creating a formal framework for small-N studies. This would include structured pre-submission meetings tailored to first-in-human studies, pre-agreed change control plans for minor device/protocol refinements during the study, and acceptance of proportionate non-clinical evidence. 
  • Reference file mechanism: The MHRA should introduce a reference file system, analogous to the FDA’s master-file approach. This would allow previously reviewed, unchanged components or data to be referenced across submissions, reducing duplication whilst keeping risk-based scrutiny where it matters.
  • A Neurotechnology Clinical Trial Support Programme: The Department for Health and Social Care, via the National Institute for Health and Care Research (NIHR), should establish a pilot programme to support early-stage neurotechnology trials. This programme would reimburse NHS Trusts for the additional service support costs associated with hosting an MHRA-approved clinical investigation, on the clear condition that the sponsor provides the investigational device itself free-of-charge. Eligibility would be restricted to serious, high-need indications, with a pre-agreed evidence plan aligned with NICE. To ensure a strong pipeline of UK innovations can benefit from this programme, UKRI should align its strategic funding priorities through the Medical Research Council and Innovate UK with this NIHR focus on neurotechnology. This would lower the financial and administrative barrier for NHS trusts to participate in high-cost implantable neurotechnology trials, de-risking the process for sponsors and bringing earlier access for eligible UK patients.

Neurotechnology Hubs

To catalyse next-generation neurotechnology research and ensure rapid, coordinated translation from bench to bedside, the UK should pilot at least 3 Neurotechnology Hubs, each anchored in an existing NHS-university clinical neuroscience partnership and linked by a national consortium. Each Hub would:

  • Pathway stewards (systems engineers): The Hubs should be provided with dedicated funding from UK Research and Innovation (UKRI) to pilot pathway-steward roles. These posts would be embedded in each Hub to coordinate study approvals, contracting, procurement, scheduling, and training, working with the MHRA and HRA to reduce avoidable back-and-forth and shorten the time from application to first patient.
  • Disease-Specific Patient Registries: Build and maintain digital registries for priority indications (e.g., spinal cord injury, post-stroke paralysis, treatment-resistant depression), supporting efficient study recruitment. Outcomes may also be followed up across these cohorts to serve as comparators to demonstrate economic effectiveness.
  • Multidisciplinary Incubators: Co-locate at each Hub a shared innovation space with co-working labs, offices, prototyping facilities, clinical stimulation theatres, and programming/events, such as design sprints and an annual demo day. Incubators may take inspiration from models such as Stanford Biodesign or London’s Institute for Healthcare Engineering.
  • Fellowships and Translational Grants: Host a stream of UKRI-funded Neurotech Fellowships (MRC-led with EPSRC co-funding) that provide salaried clinical or engineering placements within each hub, alongside hub-managed £100k–£250k seed awards from existing UKRI translational seed-funding routes to de-risk early-stage concepts through to first-in-human studies.
  • Collaboration: Establish a consortium of Hubs to share protocols, frameworks and templates, coordinate multi-centre studies, aggregate data, and to share resources and specialist labour based on variable study demands.

Acknowledgements

Some of the evidence cited in this report was originally compiled for an independent study commissioned by ARIA in 2024 – on the potential barriers to translating clinical neurotechnologies in the UK – to inform the development of their Precision Neurotechnologies programme. All the analysis and policy recommendations in this Centre for British Progress report are the independent views of the authors and do not represent the views or positions of ARIA.

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