Invention for Innovation FAST - Guidance for Applicants

Published: 05 December 2022

Version: 2.0 - December 2022

Purpose

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) Pilot 2 is a new funding scheme aimed at innovators in need of a small amount of funding to answer a specific question or to fund a single piece of activity. These awards are designed to address an evidence gap across different developmental levels, from innovations with initial proof-of-concept (starting from TRL stage 3) to mature innovations. Research themes can be in any area of existing or emerging clinical need.

Examples of questions that can be addressed through FAST funding are the following (not an exhaustive list):

To develop a code, algorithm, or programme, hiring relevant staff where needed.
To conduct user acceptance testing on a proof-of-concept diagnostic device.
To seek patient feedback on whether an innovative approach would be acceptable.
To develop a regulatory plan to seek approval for a technology in a health area.
To understand the routes for reimbursement and procurement of a health technology in a bespoke setting.
To conduct market research and develop a pricing strategy, and determine whether a proposed innovation could be cost-effective.
To validate a sterilisation method or protocol.

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. This may include consolidating the innovation’s foundation, and developing or de-risking it to an extent to justify further research and investment by public and/or private funders. FAST Awards are designed to have a rapid turnaround, and decisions to fund will be made within 6 to 8 weeks.

The available budget for the i4i FAST Pilot 2 is approximately £1.5m. The scheme will close on 15 February or earlier if a high number of applications have been received and/or the available funding has been allocated. Applicants are therefore encouraged to apply as soon as possible.

i4i FAST Awards Eligibility Criteria

Organisation

The lead organisation must be located in England and must be one of the eligible organisations listed below:

SMEs with a staff headcount no greater than 250 and annual turnover no greater than €50 million (including start-up or spin-out companies). Companies must be registered on Companies House prior to applying to i4i FAST to be eligible for funding.
NHS organisations (including NHS Trusts and NHS Foundation Trusts), and equivalent UK authorities
Higher education institutions (including universities and research institutes).
Not-for-profit organisations (including charities and Community Interest Companies).

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

Projects

Innovations must be at Technology Readiness Level (TRL) 3 at the time of application and have demonstrated experimental proof of concept as a minimum. Applicants are expected to have generated experimental data to support the case for further development and to illustrate technical feasibility. Reference to relevant technologies developed should be provided where appropriate to support technical feasibility.
Projects must be between 3 to 6 months in duration.
Funding requests must be between £15,000 and £50,000 in value.
All activities must be carried out in England.
Proposed projects and activities must not overlap with or be incremental extensions of existing funded programmes.
Projects must be designed to answer a specific question or to fund a single piece of activity.
Submissions by those rejected in pilot 1 are allowed.
Each applicant may only submit one application as the lead applicant.
Project start dates must be within 4 weeks of receipt of the award notification, but no later than 31 March 2023.
Feedback on rejected applications will not be provided.
Once awarded, requests for additional time or funding will not be considered.
It is expected that the lead organisation has access to background IP necessary for the project.
It is expected that all generated foreground IP will be owned by the lead organisation.

Please note that clinical studies or any work which requires ethical and/or HRA approval or excess NHS treatment and support costs are outside the scope of this Pilot 2.

Applicants must review the NIHR i4i FAST Research Contract prior to application submission. Upon acceptance of i4i FAST funding, applicants are expected to agree to NIHR Research Contract terms and conditions within 2 weeks of receiving the award outcome or the award may be withdrawn. Please note that terms and conditions are non-negotiable.

i4i will fund activities which fall under these areas:

Research and development of medical devices and in vitro diagnostics as defined by the EU Medical Device Directive MDD (please see Regulating medical devices in the UK for details).
Digital health technologies that fall under Tier C of the NICE Evidence Framework for Digital Health Technologies and that are focused on patient outcomes and intended for ultimate NHS use. This may include interventions for active monitoring or diagnosis or for interventions that provide or guide treatment.
Artificial Intelligence (AI) technologies including Augmented or Ambient Intelligence, applied in areas of health and social care including health promotion and prevention, diagnosis and treatment. Please note that such AI technologies will classify as Medical Devices.Generation of evidence across all areas of existing or emerging healthcare needs, including evidence to support a future application to other funding programmes. Fundable activities may include:

Product design and development; user requirement assessment.
Intellectual property strategy, including freedom to operate analysis, development of a commercialisation strategy and market analysis, business case development.
Health economic model development or analyses.
CE/UKCA marking, where applicable, and other regulatory requirements.
Activities associated with the adoption of new technology
Training associated with the implementation of new technologies

i4i will not fund:

Early stage research projects relating to TRL 1 or TRL 2, including the formulation of a technological concept and prototype creation without evidence to support its technical feasibility and potential benefits.
Projects involving small molecule drugs or biologics, including vaccines, gene or stem cell therapies and cosmetic products.
Projects involving animals, animal tissues or animal cells.
Studies to improve the understanding of biological processes such as mechanism-of-action or exploratory studies.
Technologies to support or enhance research quality and efficiency, which do not provide direct patient benefit.
Studies on the impact of interventions on service delivery and management.
Development of methodologies for the purpose of assessing or validating another new or existing technology.
General professional training or fees for PhD students.
All Tier A or B digital health technologies, which may include:

Innovations to be used only in hospital information systems, administration or infrastructure;
Wellness/wellbeing Apps (where there is no professional input);

Standalone training devices/platforms where the product is focused on providing training for staff and/or patients;
Other related software, as per the NICE Evidence Framework classification for digital health technologies.

Some Tier C digital health technologies that work to support preventative behavioural change, without the input of a healthcare professional, or which aid self-management of a condition but do not claim to influence clinical outcomes.

Assessment criteria and Application form

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 likelihood of future success and/or investment

Each of the sections in the application must be completed according to the guidance below. Applicants are encouraged to consider the points below when completing the application. The maximum word count for each of these sections is 300 words.

Fundable applications will be reviewed by technical, clinical and public reviewers; therefore, it is important that the application is written in a way which is suitable for reviewers of differing expertise.

Please describe your innovation and the health problem being addressed. Please include the innovation's stage of development, evidence generated to date, and input from public and patient (PPI) members.

What is the unmet health need being addressed?
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 what activities would be conducted to help you 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?

Finance

Applicants will also be expected to complete the finance form integrated in the ‘budget section’ of the i4i FAST application form. Further details on how to complete this section will be provided on RMS as well as on the NIHR website.

This section should only include eligible costs. Please make sure that costs are fully explained and justified in the application form and it is clear how they will support the proposed research activities.

The finance form should be completed in line with the i4i Finance Guidance to ensure that all costs are eligible.

Budget and duration

We will make an 90% upfront payment, subject to DHSC supplier requirements, with 10% of the total award retained until satisfactory completion of the Final Project Summary.

We will cover the costs of specific requests in line with standard NIHR funding guidelines; 100% costs for SMEs, not-for-profit organisations and 100% direct research costs for NHS service providers; 80% FEC for HEIs.
Costs for specialist services or expertise may be requested through consultancy or sub-contract arrangements; however, it must be explained why their contribution is essential for answering the specific question proposed. Sub-contractors may be based outside of England if the required expertise or service cannot be reasonably contracted from within England.
The contracted organisation will receive funding payments and will be required to distribute predefined payment shares where applicable.
All costs must be fully justified in the application form and be appropriate to answer the proposed question and activity.

Application process

FAST operates a one stage application process.
Applications are open for submission on a rolling basis through RMS.
The call will close on 15 February 2023. However, the call may close earlier if a high number of applications are received or once all available funding has been allocated. Therefore, applicants are encouraged to apply as soon as possible.
Applicants are invited to submit an application via RMS that will be reviewed by a pool of reviewers. The i4i FAST reviewers are composed of experts from clinical and/or academic backgrounds and public and patient reviewers
Applications are scored against the i4i FAST assessment criteria.
Applicants will be notified of the funding decisions around 6 to 8 weeks from application submission.
Applications are treated as confidential, and all steps are taken to ensure confidentiality is maintained. Please refer to our Confidentiality Guidance for further details.

Contracting

Subject to a satisfactory response to outstanding questions from the i4i FAST secretariat, the NIHR Research Contract will be put in place between the lead organisation and the DHSC; this process will be managed by the i4i secretariat.

Applicants should refer to the NIHR terms and conditions of the Research Contract prior to applying. These terms are non-negotiable. Upon acceptance of an i4i FAST Award, applicants agree to be bound by these terms.

Post Award Monitoring

The i4i secretariat will oversee the management and progress of funded Awards.

Submission of an interim report approximately midway through the Award and a Final Project Summary, no more than 2 weeks following completion of the Award, will be required.

Contact Details

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