i4i Connect is aimed at small to medium-sized enterprises (SMEs) in need of a funding boost to reach the next stage in the development pathway. As long as the requirement for proof-of-concept evidence is met, innovations can be at any stage of the translational research and development pathway prior to implementation in the NHS. Research themes can be in any area of existing or emerging clinical need.
- Lead applicants must be from small-to-medium-sized enterprises (SMEs).
- Lead applicants must be registered in England.
- Projects must be £50,000-£150,000 in value.
- Projects must be 6-12 months in duration.
- Projects need to have proof-of-concept evidence.
- Projects need to address a clearly defined unmet clinical need.
- Upon acceptance of i4i Connect funding, applicants agree to be bound by the terms of the NIHR standard research contract and are expected to sign the contract within 4 weeks of the award notice or the award may be withdrawn.
- 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. Evidence that the NHSX Digital Technology Assessment Criteria (DTAC) has been considered should be demonstrated in your proposal.
- Generation of data to support an application to i4i Product Development Awards or any other funding stream.
- All areas of existing or emerging healthcare needs at any stage of the translational research pathway, including but not limited to:
- Product design – manufacturing and scale up, user requirement assessment
- Intellectual property strategy, including freedom to operate analysis, development of a commercialisation strategy and market analysis, business case development
- Small safety and efficacy studies including clinical validation/utility studies
- Health economic model development or analyses
- CE/UKCA marking, where applicable, and other regulatory requirements, including any associated preparation for a future clinical investigation application
- Activities associated with the adoption of new technology and any training associated with the implementation of new technology
- Please note that the proposed projects should include a Research and Development component. Projects solely focusing on activities outside of these will not be funded, e.g. if the proposed work only involves business case development.
The lead organisation must be an SME registered in England, have 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 Connect to be eligible for funding.
There is no requirement to have formed a collaboration prior to application.
The following types of organisations are eligible to collaborate with the lead SME:
- SMEs with a staff headcount no greater than 250 and annual turnover no greater than €50 million (including start-up or spin-out companies)
- NHS organisations (including NHS Trusts and NHS Foundation Trusts), and equivalent UK authorities
- Universities, research institutes and not-for-profit organisations
A collaboration of two or more of the above is accepted. Specialist services or expertise may be brought into the team through consultancy or sub-contract arrangements, however, appropriate justification must be provided. Sub-contractors may be based outside of England if the required expertise or service cannot be reasonably contracted from within England.
We cover 100% costs for SME and NHS trusts and 80% FEC for academic partners. There is no set rules on the split between collaborators, however, as the contracted organisation, the lead applicant will receive funding payments and would be required to distribute to co-applicants/contractors where applicable.
- Basic research
- Minor or incremental changes to technologies or interventions in current clinical use
- Projects involving small molecule drugs, stem cells or cosmetic products
- Projects that involve work on animals or animal tissue
- Evaluation or clinical trials of fully developed products or interventions, which have already been adopted within another NHS organisation or have a history of NHS use
- Studies on the impact of interventions on service delivery and management
- Products to be used only in hospital information, administration and infrastructure
- Methodologies clinically assessing or validating an existing or newly developed technique or technology
- Professional training
- Wellness and prevention apps or stand alone apps
- Products to be used only in hospital information systems, administration, infrastructure and other related software, as per the NICE Evidence Framework classification for digital health technologies:
- All Tier A digital health technologies
- All Tier B 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