Open Call: i4i FAST – “Funding At the Speed of Translation” Awards (United Kingdom)

Awards are designed to address an evidence gap and innovations must have demonstrated experimental proof of concept as a minimum. i4i FAST Call 4 will support the development of innovative healthcare technologies for acquired brain injury (ABI), including the prevention, diagnosis and management of ABI as well as recovery from ABI.

Scope

• The i4i FAST programme, in partnership with the NIHR HealthTech Research Centre in Brain Injury and the Defence Medical Services, invites applications to support the development of innovative healthcare technologies for the prevention and management of as well as the recovery from acquired brain injury (ABI) for the use in health and care settings or within the community where the ABI is incurred. ABI refers to any form of brain injury that has occurred since birth, including traumatic brain injury (TBI) and ABI as a consequence of stroke due to thrombosis/infarction, brain haemorrhage, tumours, infection and inflammation.
• Applications are encouraged for solutions covering all forms of ABI, including mild, moderate, and severe TBI from different aetiologies such as road traffic collisions, assault, sports-related concussion and blast injury.
• Funding will be provided to answer a specific question that is crucial for the further development of a medical device, in vitro diagnostic device or digital health technology (including AI-supported solutions) for use in health and care. Proposals must describe the benefits of the technology to the wider population, including underserved communities, and the involvement and engagement of patients and the public in the development of the proposal and the innovation is expected and must be clearly articulated.
• Technologies addressing one or more of the following areas of interest are in scope:
  • Prevention of brain injury and its impact
  • Improving diagnosis, stratification and monitoring of brain injury, including technologies for guiding the application of neuroprotective interventions
  • Enabling rehabilitation, support and continuing care after brain injury, including return to ‘normal life’ (work, sports, education, relationships)
• Out of scope:
  • Generic health technologies not specifically addressing need in acquired brain injury

Funding Information

• Funding level: £50,000 to £100,000
• Project duration: 6 to 12 months

What they fund?

• This funding supports activities associated with the research and development of technologies for use in health and care settings or within the community where the ABI is incurred. All activities must be carried out in the UK (with the exception of specific sub-contracted services). They expect projects to focus on a single aspect of product development.
• Proposals must involve one of the following:
  • Medical devices or in vitro diagnostic devices as defined by the Medical Device Regulations 2002
  • Digital health technologies that fall under Tier C of the NICE Evidence Standards Framework for Digital Health Technologies, and are focused on patient outcomes and intended for ultimate use in the NHS or social care system (Evidence that the NHS England Digital Technology Assessment Criteria (DTAC) have been considered should be demonstrated in your proposal)

Eligible Activities 

• Prototype development, including engineering, performance testing, design verification and validation, packaging and sterilisation
• Software/module design, API integration, data management and architecture
• Patient and public involvement and end user engagement
• Exploratory first-in-human and pilot clinical studies
• CE/UKCA marking and other regulatory requirements, including work towards QMS development
• Health economic analysis, such as a budget impact or market analysis to build or improve the economic case
• Competitive landscape and market analysis, development of plans for commercialisation
• Project management and stakeholder engagement activities
• Activities associated with data analysis, management and governance
• Training associated with the implementation of new technology, including the development of training resources, usage guidelines and other materials
• Activities associated with the dissemination of outputs

What i4i FAST awards will not fund?

• Work that involves animals, animal tissues or stem cells
• Any work related to early stage or basic research (TRL 1 or TRL 2), including the formulation of a technological concept and prototype creation without evidence to support its technical feasibility or potential benefits
• Minor or incremental changes to technologies in current clinical use
• Professional training, including PhD fees and stipends, although costed time of the individual is allowed
• Development of innovation or knowledge networks and healthcare technology cooperatives which aim to accelerate the development of innovative technology products
• Top-up funding for an ongoing study or clinical trial

Eligibility Criteria 

• The lead organisation must be based in the UK and must be one of the eligible organisations listed below:
  • Higher Education Institutions (HEI), including universities and research institutes
  • NHS and social care service providers, including Trusts, primary care providers, community care providers and tertiary care centres
  • Small and medium-sized enterprises (SMEs with a staff headcount no greater than 250 and an annual turnover no greater than €50 million, including start-up or spin-out companies; registration on Companies House is essential prior to applying)
  • Not-for-profit organisations, including charities and Community Interest Companies
  • Collaborators based abroad are allowed, however their participation must be justified and the benefit to the NHS or broader UK health and care system needs to be articulated.
  • Specialist services or expertise may be brought into the team through consultancy or sub-contract arrangements with appropriate justification. Sub-contractors may be based outside of the UK. The project team must be assembled at the start of the project with appropriate staffing posts in place.

Assessment Criteria

• Eligible i4i FAST applications will be assessed against the following criteria:
  • Potential to address an unmet patient need
  • Evidence to support the proposed question and project activities
  • Strength and feasibility of the project
  • Potential impact of outputs and the likelihood of future success and/or investment.

For more information, visit NIHR.