TIDAL: Innovation

The impact of Brexit on Assistive Technologies Evidence Brief. March 2023.

Commissioned by TIDAL Network+, researched and written by Ailey McLeod, Megan Bowers, Thomas Moniz and Prof Cecilia Vindrola-Padros of the Rapid Research Evaluation and Appraisal Lab (RREAL).

This report provides an overview and understanding of the available evidence on the regulatory landscape for assistive technologies (AT) in the UK in the post-Brexit context. When it left the EU, the UK entered a transitional phase, seeking to dampen the impact on businesses and to allow the UK and EU to agree on a future trading relationship. That transition period ended on 31 December 2020, and since 1 January 2021, the regulatory landscape in the UK has changed and is characterised as complex and fragmented.

The UK regulatory framework for medical devices stems from a number of European Union (EU) directives. However, in the wake of Brexit, certain aspects of that framework are changing, as the EU makes regulatory advances, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) put in place transitional plans, including amendments, while establishing the UK’s new regime which will come into force in 2024. 

The report starts by providing a brief legislative context regarding disability rights, assistance, and accessibility as well as trade and manufacturing in light of the UK leaving the EU’s regulatory regime. This is followed by an overview of the regulations governing ‘Digital Assistive Technologies’. The report finally examines the regulations governing the use of medical devices.

Mapping the Mobility AT Ecosystem in Malawi: the case of Malawi Against Physical Disabilities (MAP) 2024

George Kayanga, PhD candidate, Loughborough University and Daniel Hajas, Innovation Manager, GDI Hub, UCL

This research report presents the findings of a mapping exercise carried out by George Kayanga, aimed at understanding Malawi's assistive technology (AT) environment. The mapping exercise in Malawi spanned two and a half months, from November 2023 to mid-January 2024. It focused on mobility assistive products (APs) and took the form of a case study of Malawi Against Physical Disabilities (MAP) owing to its significance to the local AT scene, particularly regarding the development and provision of mobility aids.

Daniel Hajas identifies lessons of value to the UK and opportunities arising from the case study to inform future research collaboration between Low and Middle-Income Countries (LMICs) and the UK.

Key findings of the mapping exercise included:

• A diffused network of service providers and unclear AT provisioning processes.

• The lack of a government ministry or central organisation essential to AT coordination.

• MAP's noteworthy contribution in offering mobility aids and medical rehabilitation treatments despite financial and technical challenges.

• A pressing requirement for a unified AT policy and heightened stakeholder cooperation to improve the AT ecosystem.

The report makes several recommendations to address the issues raised. These emphasise the potential for collaborative efforts to enhance Malawi's AT sector, and propose strategic approaches that involve capacity building, policy reform, and stakeholder engagement to expand access to efficient and effective AT services throughout the country, identifying roles for the Malawi government, the UK government, and other partners.

Finally, Daniel Hajas, GDI’s Innovation Manager asks, 'What is the role of the UK engineering and AT research community, and funding for that, in helping to solve the challenges of global AT provision, as exemplified by the Malawi case study?'

TIDAL training needs survey results 2023

Pilot study survey and data visualisation: Marisa Sargent, Loughborough University. 

Analysis and narrative report: Weiran Zhou, UCL.

This pilot study was carried out by Marisa Sargent at Loughborough University. It sought to identify the training needs of AT (assistive technology) researchers. Most respondents worked in universities or NGOs, with others from local government departments or agencies, health, social enterprises and other HE (Higher Education) institutions. The survey asked about training barriers, opportunities and gaps.  

Although it was a small, pilot survey, it does give some insight into current training barriers for AT researchers, the types of training available, and the range of training needs. It indicates a need for a larger study to evaluate training requirements for AT researchers; development of training programmes on a range of topics specifically geared towards them; and creation of sources to help AT researchers identify suitable training more easily and effectively.  

The study identified a desire and need for researchers to be able to interact more effectively with disabled people in order to design better for their needs. To support this need, we have created Disability Awareness content specifically aimed at researchers working with disabled people in a design or user testing context.  Some researchers expressed a desire to learn about upscaling designs for AT manufacturing, and for training on medical device regulation.

The TIDAL Accelerator provided an opportunity for ECRs to learn about the process for commercialising their designs, and included a workshop on medical device regulation.  Dissemination of the TIDAL rapid review, ‘The impact of Brexit on Assistive Technologies Evidence Brief. March 2023.’ Will also help to meet this need.

Assistive technology policies, products, and services: A review of the translation of UK university research into practice 2024

Authors: Niamh Gill Niamh, Laurence Kenney, Claire Horder, Catherine Holloway, Richard Bibb.

One pathway to impact is through the translation of university-based Assistive Technologies (AT) research into novel policies, products and services. The publication of the ‘impact case studies’ submissions to the 2021 UK Research Evaluation Framework (REF) exercise offered an opportunity to evaluate this. The aims were to review AT-related REF impact case studies and identify barriers and facilitators to the translation of academic research into products, policies and services. The REF Impact case study database was searched, and a two-stage screening process identified 57 case studies, from which details of the impact(s) were extracted. The types of impact spanned education, accessibility and mobility. Engagement with patients and/or users was commonly reported, but engagement with industry and/or the NHS less so.

Eight academic leads of case studies were interviewed about their experience, their product/service, and the role of funding bodies in the translation of their research. The barriers identified included multiple funding challenges, from the fragmented and ‘niche’ nature of funding bodies, to the time it takes to write a grant application which has very little chance of success, and the reluctance of funding bodies to fund research into ‘products’. 

EPSRC funding was highly valued and could enhance a researcher’s career prospects but their remit may not match what AT researchers need, especially in relation to the development of resources and services, even if that work will eventually inform products. Relationships with industry, as well as finance, were cited as key elements of getting through the notorious ‘Valley of Death’ (TRL 4-6 getting products from proof of concept to market) because it is, in effect, industry that commercialises ideas: having a good working relationship with them, from an early stage, was pivotal for success. Stakeholder engagement was found to be crucial for the adoption of a new technology, product or service, because it helps to ensure a fit with end-users’ needs. The need for regulatory approvals was another barrier identified, with many respondents feeling that funders should offer more support in this area, especially in relation to navigating the approval process for implementing products classified as medical devices in early-stage trials.

Despite the challenges, the report found that research has impacted on policy, and produced new products and services, but academics expressed a desire for better coordinated funding to support the translational pathways, and improvements to NHS and industry engagement.  

Translation of AT-research into novel products, policies and services is clearly a major challenge and the hurdles that the interviewees overcame were impressive. A spirit of tenacity, and an entrepreneurial approach, came out in some of the interviews as some of the key factors in determining success. While many positive comments on the role played by funding bodies came through in the interviews, there was a clear wish from some for more coordinated funding approaches which could support the translational pathway from early TRL products to commercialisation.  

This paper has been submitted for journal publication. We are not able to publish it until it has been published in the journal. In the meantime, please contact Laurence Kenney l.p.j.kenney@salford.ac.uk for further information.

Barriers and strategies to translate assistive technology research into practice in the UK  (2024) 

Authors: Weiran Zhou, Tigmanshu Bhatnagar and Catherine Holloway   

AT holds significant potential to improve the lives of disabled people. Rising global disability rates necessitate efficiently translating assistive technology (AT) research into accessible and assistive products and services. However, numerous challenges in translating AT research into practical, market-ready solutions remain.  This report examines the existing literature journey from an AT’s inception in research to its use with a disabled end user, identifying key factors and proposing improvements based on narratives within the existing academic literature. The findings from the literature are corroborated and further enhanced by a thematic analysis of interviews with stakeholders in AT research translation, including two researchers, start-up founders, AT users, and a technology transfer officer.

This report identifies critical areas where improvements are needed by analysing various barriers across TRLs. These include strengthening academic incentives for commercialisation, increasing funding support across all stages of development, and fostering stronger collaborations between researchers, industry, and end users.  Focusing this work on the UK, we find that academic systems need to train better, incentivise, and support the translation of lab-based research to real-world applications.

One of the most critical barriers is the “Valley of Death” faced during the transition from proof of concept to marketable products. Targeted funding, greater industry partnerships, and strategic user engagement are essential to overcome this. Long-term relationships with disability organisations can also significantly ensure that AT development is aligned with users' real-world needs. 

Furthermore, the regulatory hurdles, particularly for AT classified as medical devices, add complexity to the development process. A dual-track approach—focusing on non-medical AT first, where feasible, while preparing for regulatory approval for medical devices—can help to mitigate these delays and facilitate market entry. 

Based on the findings, the report presents practical strategies and critical insights for the different technology readiness levels (TRLs) and charts a comprehensive roadmap for future AT research translation into marketable products and impactful solutions, emphasising the need for multi-disciplinary collaboration, user-centred design, and the importance of policy and funding reforms.

By addressing these barriers, bringing innovative AT to market can be significantly streamlined, resulting in greater accessibility and improved quality of life for people with disabilities. 

Open-access Prosthetics Provision and Repairs Registry

Project team members:

• Dr Vikranth Harthikote Nagaraja (University Fellow, Salford University)

• Mr Runbei Cheng (Research Associate; DPhil Candidate at Oxford University)

• Prof Laurence Kenney (Professor of Rehabilitation Technologies, Salford University)

This mapping project was to co-create an open-access UK registry to help collect, organise, and share information about prosthetics provision and repairs, which is fragmented across different limb-fitting centres in a non-standardised manner. The registry will help researchers and innovators to understand how to better design, repair and manage prosthetics, benefiting healthcare providers, service commissioners, prosthetics manufacturers and patients. Preliminary work (pump-primed by Dr Nagaraja’s internal funding from March–August 24) involved semi-structured stakeholder interviews and a consensus survey.

The project scope was considerably influenced and shaped by the TIDAL Consensus Workshops on P&O, mobility aids, and wheelchairs co-organised by Dr Ben Oldfrey, Prof Kenney, and Dr Nagaraja in May/June 2024. Discussions were also held with various TIDAL Network members (Prof Alex Dickinson @ Southampton University; Prof Michael Berthaume @ King’s College London; and Dr Ben Oldfrey @ UCL London), as well as key limb-fitting centres.

TIDAL funding enabled the team to formally consolidate the work done to date, perform usability testing to develop the registry further, and preliminary deployment, performed with clinical partners at limb-fitting centres in Manchester and Oxford. It also enabled the production of research knowledge outputs in the form of a journal manuscript on the registry schema which was built with a co-creation and needs-led approach. The next stage will be to bid for follow-on funding in the form of an EPSRC New Investigator award, to build on the TIDAL-funded project. This will be submitted within 6 months of the end of the TIDAL-funded work.

The registry is intended to be a digital public good for the prosthetics research community that will impact manufacturers, start-ups, clinicians, and patients, as well as favourable environmental and cost implications, and spur much-needed efforts in alleviating poor prosthetic outcomes.

The UK NHS intends to achieve a “net zero” emissions service by 2040 and has identified specific targets to achieve this goal. Medical devices such as prosthetics - prone to poor outcomes, device abandonment, non/reduced use, and frequent repairs/breakdowns - have a considerable environmental impact (through carbon emissions, waste disposal, additional patient journeys, etc.) as well as imposing direct and indirect costs on patients and service providers. Frequent repairs and device breakdowns reduce user satisfaction and diminish the potential impact of prosthetic aids.

Providing a comprehensive database/registry for recording prosthetic provision and repair patterns will help drive future prosthetic designs, make devices more durable and reliable, reduce repair-related travel, etc. A common central databank is vital to help aggregate/crowdsource anonymised data at a national (or international) level on service provision, repair, and maintenance activities of prostheses linked to respective patient demographics. None of the existing regional or national databases facilitate systematic aggregation of data on prosthetic provision and, more importantly, repair/maintenance from different limb-fitting centres across the UK (and worldwide). A unifying effort like the registry supported by TIDAL will help to improve the evidence base and decision-making in device prescription and life-long care and is expected to integrate and amplify the UK’s efforts in becoming a global leader in the prosthetics field. Anticipated benefits include:

• informing future designs

• facilitating a 'big data' approach

• understanding device durability and reliability

• cost implications of device purchase and maintenance

• enabling in-depth analyses of the patient population and realising population-specific issues

• allowing for the optimisation of resource allocation in patient care and

• ultimately improving the overall quality of care and patient outcomes