Introduction
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 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 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. Offering between £50,000 - £150,000 over a 6 - 12 month period, the primary aim of Connect is to help SMEs get to a point where they can apply for further funding, in particular for a full i4i Product Development Award (PDA), or to further de-risk projects for follow on investment. This will enable accelerated development of promising medical technologies, in line with recommendations from the Government’s Accelerated Access Review.
You may also be interested in the supporting information.
Essential Requirements
- 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. Time extensions of active awards will not be considered.
- Projects need to have proof-of-concept evidence.
- Projects need to address a clearly defined unmet clinical need.
- Project start dates must be between 01 May 2023 and 01 July 2023.
- 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to sign the contract within 4 weeks of the award notice (subject to satisfactory due diligence) or the award may be withdrawn.
Eligibility
i4i Connect 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. 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.
i4i Connect will not fund:
- 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
- Methodologies clinically assessing or validating an existing or newly developed technique or technology
- Professional training
- Wellness/wellbeing 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
Applicant Eligibility
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.
Assessment Criteria
Expression of interest applications will be assessed against the following criteria:
- Clinical need, health economic case and impact on the NHS and patients
- Level of innovation
- Quality of the project plan, including the technological content, and risk mitigation strategy
- Strength of the project team and management arrangements
- Intellectual Property (IP) & commercialisation strategy
- Value for money
- Consideration of Patient and public involvement
Expression of Interest application forms include the following sections:
- Unmet patient need
- Proposed solution
- Benefits to patients and the healthcare system
- Project and Spending plan
- Applicant and team details
- Company information
Each of these sections must be addressed according to the guidance below. The maximum word count for each of these sections is 300 words.
Unmet Patient Need
Please provide details on the scale of the clinical problem to be addressed both in the UK and globally and on the limitations in current clinical practice.
Proposed Solution
Please provide a clear explanation of the device, technology or intervention and the benefits it provides over competing technologies. A consideration of the proposed barriers to clinical adoption must also be clearly articulated, as well as a description of the level of innovation of the proposed technology and Intellectual Property (IP) position.
Benefits to Patients and the Healthcare System
Please provide a clear case of how the proposed device, technology or intervention will change clinical practice and provide benefit to patients (such as reduced mortality or morbidity, improved quality of life, reduced misdiagnosis, improved patient outcomes and experiences). Potential cost savings for the NHS should also be provided, along with details of the expected involvement of patient/and or public representatives during the product development process.
Project and Spending Plan
Please provide details of the work to be conducted and how funds will be allocated. This section must adequately address the main objectives of the project. Project objectives must be realistic in terms of time and resources requested.
Applicant and Team Details
Arrangements for managing the project must be adequate and roles of team members must be clearly described. Project teams are expected to have included expertise in all areas relevant to develop the proposed device, technology or intervention to the expected project end point.
Company Information
Full details of the company are to be provided including company number, name, address and contact details. A summary of the company’s activities should be provided, including, if applicable, other products in development, any synergies of the proposed project with an already existing portfolio, or any other relevant information.
Application Process
i4i Connect operates a two stage application process:
- Stage 1 – Expression of Interest
- Stage 2 – 15 page (maximum) Business Plan and a 3 minute video pitch
The first stage requires applicants to submit an Expression of Interest form. Applicants shortlisted for Stage 2 will be required to submit a business plan with a maximum of 15 pages and a 3 minute video pitch which will be reviewed by our i4i Connect Selection Committee. The i4i Connect Committee comprises commercial, clinical and academic experts.
Please note that this guidance document is for Expression of Interest applications only. Shortlisted applicants must refer to the i4i Connect Business Plan guidance document which will be made available in the invitation outcome letter, linking the NIHR i4i webpage prior to Stage 2 launch.
Registration and Creating an Application
Applications to both stages of the process must be submitted online using the NIHR Research Management System (RMS). For Stage 1 Expressions of Interest, the lead applicant must register on the RMS, providing contact details and a CV, in order to be able to create and complete the application. The team of co-applicants will also need to register on the RMS and have their accounts validated.
To update your ORCID ID number, log in to the research management system, go to 'Manage my details' and select 'Update CV'. In this section you will be able to login to the ORCID ID site and create an account if you do not already have one. Your unique number will automatically pull through to your Connect application form
Validating and Submitting your Application
When the application form is complete it must be validated prior to submission. This will highlight any omissions in the form and allow these omissions to be corrected. After successful validation the lead applicant may submit the application. Once you have submitted your application, an i4i specific reference number will be generated. The application will be automatically considered for funding once the funding call closes.
Shortlisting
Assessment of EoI applications is carried out by the i4i Connect funding committee. Applications are scored against the EoI assessment criteria. EoI applications will be shortlisted and successful applicants will be invited to Stage 2 of the process. Guidance for creating and submitting your business plan for Stage 2 of the application process will be made available in the invitation outcome letter, linking to our i4i webpage at this time.
Confidentiality
Applications are treated as confidential and all steps are taken to ensure confidentiality is maintained. In line with Department of Health and Social Care policy, i4i will publish summary minutes of Selection Committee meetings. Please refer to our Confidentiality Guidance for further details.
Post Award Process
Funding Offer
Once your application has been recommended for funding, we will provide feedback agreed with the Committee. Successful applicants are expected to start their project between 01 May 2023 and 01 July 2023, subject to satisfactory completion of due diligence and a fully signed contract.
Due Diligence
Due diligence is carried out by the i4i Secretariat as part of the funding process to highlight any potential areas of risk or weakness within a project. This allows for recommendations to address risks or weaknesses in the project and to identify the level of project monitoring that will be required. Projects recommended for funding will have to satisfy all conditions imposed by the Committee and the i4i Secretariat before the funding agreement can be put in place.
In addition to any changes to the work plan that may be requested by the Committee, further information may be requested on project finances, project management, intellectual property and commercialisation. Funded applicants may be required to engage with an independent advisor for the revision of the project plan or any other project elements.
A face to face meeting between funded applicants and an i4i Secretariat member is strongly encouraged to address key questions and allow quick conclusion of the funding contract.
Finances
The project finances will be scrutinised to ensure that all requested costs meet the NIHR finance guidelines, any costs that cannot be fully justified may have to be adjusted. The Department of Health and Social Care reserves the right to negotiate the price it is prepared to pay for the work, based on the cost of the application and its operating constraints.
For collaborative partnerships where a partner is providing in kind contributions, the exact nature of the commitment of each partner must be clearly detailed. SMEs and/or early-stage companies may be required to provide accounts and cash flow forecasts in order to demonstrate their capability to support a project throughout its lifetime.
Contracting
Once due diligence has been completed, the NIHR standard 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 NIHR Coordinating Centre. Applicants should refer to the terms and conditions under which the award will be made prior to applying for funding. These terms are set out in the NIHR standard contract and are non-negotiable. Upon acceptance of i4i Connect funding, applicants agree to be bound by the terms of the NIHR standard contract. It is the Contractor’s responsibility to arrange payments with collaborators and subcontractors under the appropriate agreement.
As part of the contracting process, a reporting and a payment schedule will be negotiated with the lead organisation, based on the proposed deliverables and milestones. The contract will be managed by the NIHR Coordination Centre; all i4i projects will be actively monitored.
Post Award Monitoring
Progress and Financial Reports
i4i will oversee the management and progress of funded projects based on the deliverables agreed in the contract through progress reports and meetings with the project team. An i4i Programme Manager will be assigned to your project to evaluate progress and the achievement of deliverables. Payments will be made in arrears, and you will also be required to provide an annual statement of expenditure. Lead applicants are required to issue invoices at the end of each payment period; any deviation from the scheduled payment in the contract must be thoroughly explained. Any funding not spent at the end of the financial year may be recovered by the Department of Health and Social Care or set off against any future payments. In such situations, a new payment schedule will be issued.
Return on investment
The NIHR funds a wide spectrum of health research and is keen to support the exploitation of products or treatments developed under its funded research to ensure that the benefits are not lost to UK patients and there is a return on its investment. The return on investment will depend on the nature of the funded project and the level of funding provided and will be agreed as part of the NIHR commercialisation agreement. Potential forms of return on investment include:
- Patient benefit, such as reduced morbidity or mortality, and improvements in quality of life
- Cost savings, resulting from innovative practice methods developed within the public health and social care systems funded by the NIHR
- Commercial return in the form of a share of revenues generated through IP licensing or consultancy, taking shares in new businesses created, or seeking product or service discounts, thereby generating cost savings
- Public good, such as a demonstration of the impact of NIHR funding on the health and prosperity of the nation
When a project team wants to make commercial use of any IP generated during an i4i project, whether during the life of the project or at any time after the project has ended and is ready for commercialisation, written consent must be obtained by the Department of Health and Social Care and an income and/or equity-based revenue share will be agreed. We may consider requests for early agreement of commercialisation terms. At this time, the terms as set out in a NIHR commercialisation agreement will form the basis for negotiation.
Key Dates
The key dates for i4i Connect Call 7 are shown below:
| Event | Date |
|---|---|
| Stage 1 (Expression of Interest) Launch | 06 December 2022 |
| Stage 1 Submission Deadline | 18 January 2023 |
| Stage 2 (Business Plan) Launch | 07 February 2023 |
| Stage 2 Submission Deadline | 28 February 2023 |
| Submission Outcome | April 2023 |
Contact Details and Further Information
We wish to ensure that potential applicants fully understand what is needed in their applications before they submit them. We encourage discussion of proposals prior to the deadline, although we cannot advise on the specific content of an application.
Enquiries may be made by contacting the i4i Secretariat on +44 (0)20 8843 8080 or by emailing i4i@nihr.ac.uk.