The i4i FAST Call closed on the 1st December 2023.
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.
i4i FAST (Funding At the Speed of Translation) Call 3 is aimed at innovators in need of a small amount of funding to answer a specific question to support the development of innovative healthcare technologies applying genomics, pharmacogenomics, phenomics or artificial intelligence for primary care settings. FAST awards are designed to address an evidence gap across different development stages, from innovations with initial proof-of-concept (starting from TRL 3) to innovations with demonstrated safety and efficacy.
The i4i FAST awards operate a one stage application process, providing between £15k to £50k of funding for projects that can last from 3 to 6 months. 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 are designed to have a rapid turnaround from submission to award.
The available budget for the i4i FAST Call 3 is approximately £1.5m.
i4i FAST Awards
Key information
Scope: Preclinical and clinical product development of technologies applying genomics, pharmacogenomics, phenomics or artificial intelligence for primary care settings.
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 evidence gap for developing an innovation
Applicant eligibility: HEI, SME, NHS or social care provider, not-for-profit organisation, based in the UK
Funding level: £15,000 to £50,000
Project duration: 3 to 6 months
Project start date: No later than 1 April 2024
Scope
The i4i FAST programme invites applications to support the development of innovative healthcare technologies applying genomics, pharmacogenomics, phenomics or artificial intelligence for primary care settings (including general practice, community pharmacy, dental and optometry services), to enable earlier or more accurate diagnosis and patient stratification, leading to more effective use of therapies or therapy monitoring.
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 healthcare solutions) for use in primary care. Proposals need to describe the benefits of the technology to the wider population, including underserved communities.
Only technologies addressing one of the following areas of interest for use in primary care settings are in scope:
- Early screening for disease prevention to tackle long term conditions
- Rare diseases screening
- Disease diagnosis and/or treatment stratification through a personalised approach
- Targeted interventions for the prevention of future ill-health in specific at-risk groups
- Management of long-term illnesses, including multimorbidity
- Identification of high-risk patients and prevention of hospital admission
- Management of patient demand or patient triage in general practice
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 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:
- To seek patient or user feedback on whether an innovative approach would be acceptable
- To conduct a health economic analysis to build or develop the health economic case, identify the focus of future research efforts or to determine cost-effectiveness or budget impact
- To develop a regulatory plan to seek approval for a technology for a specific healthcare application
- To conduct user acceptance testing on a proof-of-concept diagnostic device
- To understand routes for reimbursement and procurement of a technology in a primary care setting
Out of scope:
- Technologies developed exclusively for secondary care
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 and community care providers and tertiary care centres
- Small and Medium 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
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, 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 primary care settings. 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:
- 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)
- Artificial Intelligence regulated as a medical device (.PDF)
Digital health technologies that fall under Tier A and Tier B of the NICE Evidence Standards Framework for Digital Health Technologies will only be considered if they specifically address management of patient demand or patient triage in general practice.
Proposed projects and activities must not overlap with or be incremental extensions of existing funded projects. However, reference to prior funding to support the case for development is helpful.
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
- 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 must have all the necessary approvals in place before the project start date. Failure to provide the required evidence will 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
Application and assessment process
Overview of the process
- FAST operates a one stage application process.
- Applications are accepted from 2 November 2023 through the Research Management System (RMS) and must be started by 24 November.
- The deadline for submitting an application is 1 December 2023 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 300 words.
- 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 to apply genomics, pharmacogenomics, phenomics or artificial intelligence to primary care settings?
- What is the proof-of-concept and additional evidence in place for the innovation at 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 co-development of the innovation?
- 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.
- 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?
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 unmet patient needs
- 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 (90% of the total award amount) 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 and up to a maximum of 3 months.
Contact Details
If you have any queries about the application process, please contact the i4i FAST inbox (i4iFAST@nihr.ac.uk).