Invention for Innovation FAST - Guidance for Applicants

  • Published: 05 December 2022
  • Version: V6.0 - August 2024
  • 12 min read

Introduction

The Invention for Innovation (i4i) programme is a translational funding scheme which advances healthcare technologies and interventions for increased patient benefit in areas of existing or emerging healthcare need. It supports the research and development of medical devices, in vitro diagnostics and high-impact patient-focused digital health technologies (including AI) for ultimate NHS use, to a point where they are de-risked for follow-on investment.

The i4i FAST (Funding At the Speed of Translation) Awards are aimed at innovators in need of a small amount of funding to answer a single specific question to address an evidence gap across different development stages, from innovations with initial proof-of-concept (starting from TRL 3) to innovations which have demonstrated safety and efficacy. Successfully answering a single question could prove pivotal for the development of your technology. This may include validating a technology or developing or de-risking it to an extent to justify further research and investment by public or private funders. FAST awards operate a one stage application process and are designed to have a rapid turnaround from submission to award,

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. Awards made under FAST Call 4 may receive between £50k to £100k of funding for 6 to 12 months. The available budget for Call 4 is approximately £1.5m.

i4i FAST Awards

Key information

Scope: Preclinical and clinical product development of technologies for the prevention, diagnosis and management of and recovery from acquired brain injury (ABI)
Entry point: Experimental proof-of-concept or laboratory-validated technology (generally described as TRL3) up to technologies which have regulatory approval or demonstrated equivalent safety and efficacy
Exit point: Single question answered to address an evidence gap for developing an innovation
Lead applicant eligibility: HEI, SME, NHS or social care provider, not-for-profit organisation, based in the UK
Funding level: £50,000 to £100,000
Project duration: 6 to 12 months
Project start date: No later than 1 February 2025

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)

Technologies may be at any stage of the product development pathway, starting from demonstrated experimental proof-of-concept (TRL 3). It will be essential that you describe how the innovation works and, to the extent available, include experimental data to illustrate technical feasibility, the patient population that will benefit and the pivotal single question being answered to take the innovation to the next level, e.g. to progress research and development and/or to support the case for a funding application or future investment.

Some examples of questions that can be addressed through FAST funding include:

  • Developing, testing and validating a prototype
  • Obtaining patient and professional feedback on the acceptability and feasibility of an innovative approach
  • Conducting an early feasibility pilot of a new technology to provide evidence to support further funding applications (e.g. to the NIHR i4i or EME programme)
  • Undertaking a health economic and/or implementation analysis to determine how a proven technology can be integrated within existing services and pathways

Out of scope:

  • Generic health technologies not specifically addressing need in acquired brain injury

Who we fund

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.

We will cover the costs of specific requests in line with standard NIHR funding guidelines; 100% of costs for SMEs and not-for-profit organisations and 100% of direct research costs for NHS service providers; 80% of full economic costs for HEIs.

Applicants may wish to consider working with existing NIHR-funded infrastructure, which can provide a range of expertise and support for your research.

Each applicant may only submit one application as the lead applicant. Submissions by previous applicants (whether successful or unsuccessful) are allowed.

What we 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). We expect projects to focus on a single aspect of product development.

Proposals must involve one of the following:

For Fast Call 4, digital health technologies that fall under Tier A or Tier B of the NICE Evidence Standards Framework for Digital Health Technologies will also be considered if they specifically address one of the areas of interest that are in scope.

Proposed projects and activities must not overlap with or be incremental extensions of existing funded projects. However, funding may be requested to carry out work alongside an already funded research project in order to strengthen the commercial case or the case for implementation and adoption. This may, for example, include a market or healthcare pathway analysis, development of a regulatory strategy, a health economic analysis or a process evaluation. Reference to prior funding to support the case for development is expected.

The following activities may be supported by an i4i FAST award:

  • 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

Please note that any work which requires ethical and/or HRA approval is expected to have all the necessary approvals in place before the project start date and/or within the required timeframe to allow the timely start of the respective work. Failure to provide the required evidence may result in the withdrawal of the award. It is the applicant’s responsibility to understand what approvals are needed and to ensure that all the required approvals are in place. Please refer to the HRA website to understand what approvals are needed for your project.

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

Application and assessment process

Overview of the process

  • FAST operates a one stage application process.
  • Applications are accepted from 18 September 2024 through the Research Management System (RMS) and must be started by 16 October (after this date we cannot guarantee that the application will be considered).
  • The deadline for submitting an application is 23 October 2024 at 13:00.
  • Please note all new RMS users need to be validated to be able to start an application, which can take up to 48 hours upon registration.
  • Applications are treated as confidential, and all steps are taken to ensure confidentiality is maintained. Please refer to our Confidentiality Guidance for further details.
  • Applications will be reviewed by experts with a clinical, academic or commercial background.
  • Feedback on rejected applications will not be provided.

Completing the application form

The application form consists of three sections and each of them must be completed according to the guidance below. The maximum word count for each section is 500 words.

1. Please describe your innovation and the health problem being addressed, ensuring you describe how your innovation aligns with the scope of this FAST call. Please include the innovation's stage of development, evidence generated to date, and input from public and patient members.

  • What is the unmet health need being addressed and how does it align with the scope of the call?
  • What is the proof-of-concept and additional evidence in place for the innovation at the time of application and how will it be further explored to address an evidence gap?
  • What PPI activities have been conducted to date and how will it inform the development of the innovation?

2. Please state the single question to be addressed by this application, and describe the project plan and activities that will be conducted to answer this.

  • Please provide a clear description of the single question being answered. Please note, i4i FAST is not intended for projects that aim to answer multiple unrelated or distinct questions.
  • Please provide a description of the work packages or activities that will be conducted to answer the single question specified.
  • Please provide a high level description of potential risks and mitigation strategies.
  • Please ensure that the proposed activities are feasible to be delivered within the project duration.
  • Please ensure that you clearly articulate the involvement and engagement of patients and the public.

3. What are the next steps following the completion of the project and how will this funding get you closer to this goal?

  • How will this project de-risk the innovation or plug a specific evidence gap?
  • Once the proposed question is answered and the desired outcomes are achieved, what are the logical and realistic next steps for the innovation?
  • How will the proposed project plan put you in a position to apply for follow-on support or to leverage further investment?
  • In cases where the project is unsuccessful or the project hypothesis is disproved, what might you learn from this and how might it inform the next steps?

A Word version of the i4i FAST online Standard Application Form (.DOCX - Word) is available to be used as a template to prepare your answers. Please do not use this as an application form.

Completing the finance form

Applicants will need to complete the finance form integrated in the ‘detailed budget’ section of the i4i FAST application form. The finance form should be completed in line with the i4i Finance Guidance to ensure that all costs are eligible.

This section should only include eligible costs. Please make sure that costs are fully explained and justified for each budget heading in the application form and that it is clear how they will support the proposed research activities. It should be clearly described why the proposed research offers value for money, and a thorough, realistic and accurate review of the costing must be undertaken.

Please note that any costs for capital equipment over £5k will not be accepted.
Companies are required to provide their registration number on Companies House when applying. Other documents may be requested, as necessary, subject to funding being awarded.

Payments will be made to the contracted organisation only, and the contracted organisation will be responsible for distributing payments due to their partner organisation(s).

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

Post-award process

Once your application has been recommended for funding, you will be notified and provided with the due diligence requirements for the award. The terms and conditions under which the award will be made are set out in the i4i FAST Terms and Conditions, and are limited for use in this call. Please note that these T&Cs are subject to change and are non-negotiable. The contract will be concluded between the lead organisation and the Department of Health and Social Care, which will be managed by the NIHR.

Successful applicants are required to start their project by the date given in the funding notification, subject to satisfactory completion of due diligence and a fully signed contract. The Department of Health and Social Care reserves the right to withdraw the funding offer at any time up to six months after the funding notification.

i4i will oversee the management and progress of funded projects based on the reporting required as per the contract. Usually a mid-term interim report and end of project report will be required.

Payments will be made within one month of the start date (50% of the total award amount), after satisfactory completion of the interim report (40% of the total award) and after satisfactory completion of the end-of-project report (10% of the total award amount).

Requests for additional funding will not be considered. Time extensions will only be considered in exceptional circumstances, including delays which are out of the applicant’s control, and up to a maximum of 6 months.

Support and infrastructure for your application

The NIHR Infrastructure provides research expertise, specialist facilities, research delivery workforce and support services for delivering research and support to the life sciences industry. For more information on the industry offer and support, please contact the NIHR industry team.

Support with research design and forging partnerships is available to all prospective applicants through the NIHR research support services and wider, detailed below. All prospective applicants are encouraged to engage with these services at the earliest opportunity.

  • NIHR HealthTech Research Centres (HRCs): Can help medical device, digital technology and diagnostic companies (collectively known as healthtech) to develop, evaluate and validate new innovative health technologies to address pressing healthcare challenges. This includes help to generate evidence to demonstrate financial value (health economics) or improve operational efficiency in the NHS (real-world evidence generation).
  • NIHR's Research Support Service (RSS): Supports all aspects of developing and writing a funding application. Please note that the RSS is only available to applicants based in England, or with a project partner based in England. If that does not apply to you, you may wish to explore other services mentioned further down in this section.
  • NIHR's Business Development Team: Help with finding and making great partnerships to strengthen your work. This service is available to all UK-based applicants and you may wish to contact them if you are seeking a partner.
  • Applicants from Scotland may access NHS Scotland Innovation Hubs and/or NHS Research Scotland
  • Applicants from Northern Ireland may access The Northern Ireland Clinical Research Network
  • Applicants from Wales may access Health and Care Research Wales

Contact Details

If you have any queries about the application process, please contact the i4i FAST inbox (i4iFAST@nihr.ac.uk).

Frequently Asked Questions (FAQs)

For further information about i4i FAST Call 4, please see our i4i FAST FAQs page. This page includes answers to general queries as well as answers to queries on eligibility, the assessment process, finance and intellectual property.