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Invention for Innovation FAST - Guidance for Applicants

Published

07 March 2022

Version

1.0 - April 2022

Contents

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, active implantable devices and in vitro diagnostic devices to a point where they are de-risked for follow-on investment. 

i4i FAST (Funding At the Speed of Translation) 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 need/gap across many technology readiness levels. Research themes can be in any area of existing or emerging clinical need. 

Examples of questions that can be addressed through FAST are the following (please note the list is not exhaustive):

  • 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 and applications are always open for submission on a rolling basis, 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 i4i FAST scheme is a pilot programme and can close at any time subject to budget and evaluation requirements.

i4i FAST Awards Eligibility Criteria

Organisation

The lead organisation must be registered 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

  • 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. 
  • Resubmissions by the same lead applicant are not allowed following a rejection. 
  • Each applicant may only submit one application as the lead applicant.
  • Each applicant may only hold one active FAST award as the lead applicant.  
  • Project start dates must be within 4 weeks of receipt of the Award Letter.
  • Feedback on rejected applications will not be provided.
  • Requests for additional time or funding will not be considered.
  • It is expected that the contractor has appropriate authorisation to use background IP introduced to the research.
  • It is expected that all generated foreground IP will be owned by the contracting organisation

Applicants must review the NIHR i4i 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 the award notice or the award may be withdrawn. Please note that terms and conditions are non-negotiable.

i4i will fund:

  • 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.
  • Generation of evidence across all areas of existing or emerging healthcare needs at any stage of the translational research pathway, to support project progression and/or evidence generation in support of an application to other funding streams; 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.
    • Training associated with the implementation of new technologies.
  • Innovations at Technology Readiness Level (TRL) 3 at the time of application, which 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.

i4i will not fund: 

  • 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.
  • 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.
  • 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

Assessment criteria and Application form

i4i FAST applications will be assessed against the following criteria: 

  • Potential to address unmet patient needs
  • 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 a public reviewer; therefore, it is important that the need being addressed is well articulated and the descriptions are suitable for public reviewers.

Q1. What are your plans for the project, including the disease/health area that the plan would address, and why is it important to receive this funding now?

  • What is the unmet health need being addressed?
  • Why is the funding needed now to progress the activity?
  • Please provide a clear description of the activity/specific question being answered. How will the proposed project address an evidence gap?
  • How will this project overcome any proposed barriers to innovation / clinical adoption, de-risk the innovation, or plug a specific evidence gap?

Q2. What would you expect the success of the project to look like? How will you define impact? 

  • How will you ensure that this project is successful?
  • What measures will be put in place to ensure this project achieves the desired impact? 
  • Are planned outputs feasible and clear? Is it clear who is expected to benefit from the desired outputs?

Q3. How will this project, if successful, support what you are going to do next?

  • How will the proposed project plan put you in a position to apply for follow-on support or to leverage further investment?
  • Once you answer the proposed question, what are the next steps that you intend to take?

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 that are necessary and fully justified for the proposed research activities. The finance form should be completed in line with the i4i Finance Guidance to ensure that all costs are eligible.

Company Information

We ask that companies provide their registration number on Companies House on the application form. Other documents may be requested, as necessary, subject to awarding funding. 

Budget and duration

  • We will make an upfront payment, 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 and be appropriate to answer the proposed question/activity.

Application process

  • FAST operates a one stage application process.
  • Applications are always open for submission on a rolling basis through RMS, however the call may close at any time subject to budget and evaluation requirements.
  • 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 as soon as possible. We aim to do this within 6 to 8 weeks from application submission.
  • Applications are treated as confidential, and all steps are taken to ensure confidentiality is maintained. In line with the Department of Health and Social Care policy, i4i will publish summary minutes of the Selection Committee meetings. 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 Department of Health and Social Care; 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 the Final Project Summary will need to be completed through the Research Management System (RMS), no more than 2 weeks following the Award ending, to provide details of whether or not the specific activity or question was answered. 

Contact Details

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