Invention for Innovation - Connect Supporting Information for Applicants

Introduction

The NIHR Invention for Innovation (i4i) Programme is a translational research funding scheme aimed at the research and development of medical devices, in vitro diagnostic devices and digital health technologies addressing an existing or emerging health or social care need.

Examples of funded projects can be found on the NIHR Funding and Awards website.

i4i Connect key information

Scope: Innovations at any stage of the translational research and development pathway prior to implementation in the NHS

Entry point: The minimum entry point is experimental proof-of-concept or a laboratory-validated technology

Exit point: Reaching the next stage in the development pathway

Applicant eligibility: UK-based SME

Funding level: £50,000 to £150,000

Project duration: 6 to 12 months

Scope

i4i Connect is aimed at small to medium-sized enterprises (SMEs) in need of a funding boost to reach the next stage in the technology 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 an i4i Product Development Award (PDA), or to further de-risk projects for follow on investment. This will enable accelerated development of promising medical technologies.

Proposals must involve one of the following:

• Medical devices or in vitro diagnostic devices as defined by the Medical Device Regulations 2002 (please see Regulating medical devices in the UK for details).
• 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

Projects must have demonstrated proof-of-concept as a minimum, which is generally described as TRL 3. As part of demonstrating proof-of-concept, applicants are expected to have already generated experimental data to support the case for further development and illustrate technical feasibility or have concluded a robust review of existing literature. 

Pre-award support

Prospective applicants are encouraged to attend launch webinars, which are arranged for each competition and advertised on the i4i website. If you have any queries about whether your proposal is eligible for i4i funding, please send an email with specific questions to the i4i Programme team at i4i@nihr.ac.uk.

Who we fund

Applicant eligibility

The lead organisation must be an SME registered in the UK, 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. 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.

We cover 100% of the eligible research costs within the budget limits with no requirement for matched funding. The lead applicant organisation will receive funding payments and will be required to distribute them to co-applicants/contractors where applicable. 

Tips for assembling a strong team

• Project teams must have demonstrable expertise and experience in all areas relevant to deliver the project, which may include scientific research, product development, clinical research, patient and public involvement, project management, intellectual property management, regulatory strategy and health economics.
• For projects with a clinical emphasis, it is expected that project teams encompass all relevant expertise required for the design and delivery of the clinical study, such as clinical trial methodologists, statisticians, research nurses, allied health and/or social care professionals. The involvement of an accredited Clinical Trial Unit (CTU) in the design of clinical trials is strongly encouraged.
• We expect the day-to-day running of projects to be handled by a project manager, which could be the lead applicant or a dedicated project manager if appropriate.
• Overseas collaborators may be involved, however, their involvement must be justified and the focus must be on demonstrating ultimate patient benefit in the UK.
• Large industry collaborators may also be involved but they will not be eligible to receive any funding, and their role in the project must be clearly described.
• Any in-kind contributions must be clearly detailed.

What we fund

i4i Connect will fund:

• Generation of data to support an application to i4i Product Development Award or any other funding stream.
• All areas of existing or emerging health or social care needs at any stage of the translational research pathway, including but not limited to:
  • Prototype development and manufacturing, including engineering, performance testing, design verification and validation, 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:

• Early stage or basic research
• Projects that involve work on animals or animal tissue
• Minor or incremental changes to technologies or interventions in current clinical use
• Projects involving small molecule drugs, stem cells or cosmetic products
• Evaluation or clinical trials of fully developed products or interventions, which have already been adopted within an NHS organisation or have a history of NHS use
• Studies on the impact of interventions on service delivery and management
• Professional training, including PhD fees and stipends, although costed time of the individual is allowed 
• Digital health technologies that fall under Tier A and Tier B of the NICE Evidence Standards Framework for Digital Health Technologies, including wellness and wellbeing apps, technologies intended only for hospital information, administration, infrastructure and other related software

Tips for preparing a strong application

To help prepare your application, please see the Connect Expression of Interest guidance for applicants (stage 1) and the Connect Business Plan guidance for applicants (stage 2).

Applicants are encouraged to consider the following aspects, which address the assessment criteria of the programme, when preparing a project proposal:

The clinical or social care need, health economic case and impact on the NHS or social care system, patients or service users, must be clearly articulated. The proposed research must be highly relevant to the needs and priorities of the NHS and/or social care system and must respond to an existing clinical or social care need. The need and advantages over the current gold standard must be clearly articulated. Evidence must be presented that a novel technology will be the ultimate output of the project, delivering a clear benefit to patients or service users and practice within the NHS or social care system.

Applicants must demonstrate how the proposed technology presents a significant level of innovation, providing an advance over currently available commercial products. 

Applicants will need to provide evidence to support the case for further development based on work to date and/or evidence from the literature. Details of key data generated in previous studies that support the project should be clearly described. 

The quality of the project plan, including the technological content and risk mitigation strategy, is integral to any application for funding. The proposed project must be focused on a specific clinical or social care application. The project plan must adequately address aims and objectives, with a clear description of work packages, deliverables and milestones, and identify the main technical and regulatory barriers. Key risks to successful completion of the project should be clearly described, and appropriate steps to mitigate these risks must be proposed. If ethical approval for any part of the project is required, the timelines must be clearly indicated. Applicants are encouraged to discuss ethical approval requirements with their local Clinical Research Network and the Health Research Authority.

The strength of the project team and project management arrangements must be clearly articulated. Arrangements for managing the project must be adequate, and the roles of costed team members must be clearly described. Project teams are expected to have included expertise in all areas relevant to develop the proposed technology. 

The application must also include an intellectual property (IP) and commercialisation strategy. All background and any potentially arising foreground IP must be described in the application. An initial freedom to operate opinion must be provided. A strategy for the commercial development of the technology must be presented. 

Taking into account the expected benefits of the proposed work and the level of funding requested, the proposal must provide value for money. All requested costs must be sufficiently justified and essential for the proposed work. Guidance on how to complete the finance section of funding applications is available in the Finance Guidance.

The NIHR expects active involvement of patients and the public (PPI) in the projects it supports. Applicants should identify the relevant patient or user group(s) for their application and engage with those groups at an early stage. A plain English summary is required to make the contents of your application and the implications of your project clear to members of the public, but also commissioning boards and reviewers.

Application process

Applications should be submitted to the Research Management System (RMS) before 1pm on the advertised closing date. We encourage early registration on the RMS as the system requires registration and validation of all co-applicant accounts. The terms and conditions under which the award will be made are set out in the NIHR standard research contract 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.

Applications are treated as confidential and all steps are taken to ensure confidentiality is maintained. If funded, the plain English Summary, Chief Investigator/Co-Investigator(s) names, award amount, start date and end date will be published on the NIHR funding and awards page. In line with the Department of Health and Social Care policy, i4i will publish summary minutes of committee meetings. Please refer to our Confidentiality Guidance for further details.

The i4i programme operates a two-stage application process, Stage 1 - Expression of Interest and Stage 2 - Business Plan.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. Assessment of applications is made by an expert committee, which comprises academic, clinical and commercial expertise (see the Connect Committee here).

Applications are scored against the following assessment criteria:

• Clinical or social care need, health economic case and impact on the NHS or social care system, patients and service users
• Level of innovation
• Case for further development based on work to date and evidence from the literature
• Quality of the project plan, including the technical content, research methodology and risk mitigation strategy
• Strength of the project team and management arrangements
• Intellectual property (IP) and commercialisation strategy, including plans for adoption
• Value for money
• End user engagement and patient and public involvement (PPI)

Post-award process

Once your application has been recommended for funding, we will provide feedback as agreed with the i4i funding committee and undertake appropriate due diligence. Successful applicants are expected to start their project within the time frame 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.

In addition to any changes to the work plan that may be requested by the i4i funding committee, further information may be requested, for example, on project finances, the project plan, project management, intellectual property and commercialisation. Funded applicants may be required to engage with members of the i4i funding committee or an independent advisor for the revision of the project plan or any other project elements.

i4i will oversee the management and progress of funded projects based on the deliverables and milestones agreed in the contract. An i4i programme manager will be assigned to your project and will use regular progress reports and communication to evaluate progress and the achievement of deliverables and milestones.

Payments will normally be made monthly, and you will be required to provide an annual statement of expenditure. Commercial organisations are required to issue invoices at the end of each payment interval; and deviation from the scheduled payment in the contract must be explained.

When a scheduled payment is linked to a funding stage gate, the project team must clearly demonstrate that the contractually defined milestone has been achieved before any payment will be released. If a milestone is not achieved, payments may be withheld until the milestone has been achieved or an appropriate contingency plan has been agreed.

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.

Contact Details and Further Information

Enquiries may be made by emailing the i4i Secretariat on i4i@nihr.ac.uk.

Key dates for Connect and other i4i competitions can be found on the NIHR website.

Privacy and data protection

The Research Management System (RMS) is hosted by Pulsant and managed by the NIHR Coordinating Centre (NIHRCC). The Data Controller for the website is the Department of Health and Social Care (DHSC). The Data Processor is the NIHRCC, based at LGC. 

The purpose for which personal information is collected through the RMS is to deliver the work of the NIHRCC in relation to the operation of research programmes, faculty and infrastructure workstreams. Data will not be used for any other purpose without the consent of the supplier.

Use of the registration and application facility on the RMS is entirely voluntary and the personal information stored will be used solely by the NIHRCC, its subcontractors and partners in order to respond to your enquiries and send information relevant to its work.

To prevent unauthorised access, maintain data accuracy, and ensure the correct use of information, the NIHRCC has put in place appropriate physical, electronic, and managerial procedures to safeguard and secure the information it collects online. The information you provide will be held securely and in accordance with the Data Protection Act 1998. The Department of Health and Social Care, National Institute for Health and Care Research (DHSC NIHR) is the Data Controller. Your personal details provided on registration will not be disclosed to third parties. Details that are provided on research application forms must necessarily be shared in confidence with third party individuals involved in making funding decisions.

Your information may also be shared with other DHSC NIHR bodies for the purposes of statistical analysis and other DHSC NIHR management purposes, including targeted communications with selected groups of researchers. In addition, information collected is used by the NIHRCC, its subcontractors and partner organisations:

• To administer the grant application process
• To identify peer reviewers for grant applications
• To notify users about funding opportunities by email
• To notify relevant users about application deadlines by email
• To notify users of any issues of service interruptions, holiday closures and other situations affecting the operation of the RMS.

If we change our privacy policy, for example, in response to changes in legislation, we will post details of any changes on our website. This will help ensure that you are always aware of what information we collect, how we use it, and under what circumstances, if any, we share it with other parties. In some circumstances, explicit consent to continue the use of the Services may be required. Otherwise, your consent to changes will be implied by your continued use of the Services. If you do not consent to the changes, then you must terminate your agreement as set out in section 12 of the Research Management System Terms and Conditions.

Equality and diversity monitoring information

NIHR is committed to promoting equality, diversity and inclusion in research and asks applicants to provide Equality and Diversity Monitoring Information (age, sex, ethnicity and race, and disability).  By answering these Equality and Diversity Monitoring Information questions, you will help us to better understand the different groups of people that apply to us for funding and their experiences of the funding process – particularly the groups protected by UK equality legislation.  Although it is mandatory to answer these questions, it is possible to select “prefer not to say” as a response.  However, the more information you provide, the more effective our monitoring will be. This information will not be used to make decisions about funding.

Support and infrastructure for your application

The NIHR Infrastructure provides research expertise, specialist facilities, research delivery workforce and support services for delivering research and support to the life sciences industry. Below are some examples of the support available should the support be relevant to your research plan proposal.

For more information on the industry offer and support, please contact the NIHR industry team.

Research Support Service

Applicants may wish to seek advice on the content of an application via their NIHR Research Support Service (RSS). It is advisable to make contact as early as possible to allow sufficient time for discussion and a considered response.

NIHR Medtech and In vitro diagnostics Co-operatives (MICs)  

Applicants may wish to seek support from a relevant NIHR Medtech and In vitro diagnostics Co-operative (MIC) which build expertise and capacity in the NHS to enable evidence gathering for new medical devices and in vitro diagnostic (IVD) tests.

Clinical Trials Units (CTUs)

CTUs are regarded as an important component of any trial application and can advise and participate throughout the process from initial idea development and design through to project delivery and reporting. CTUs may not be essential for all types of research studies. 

If you are looking for a CTU to collaborate, the Research Support Service can signpost you to one. The UKCRC CTU Network provides a searchable information resource on all registered units in the UK and lists key interest areas and contact information.

Resubmission policy

Although we do not prohibit the submission of applications which were submitted unsuccessfully in previous application rounds, applicants should recognise that the original applications were judged to be uncompetitive in that round, or significantly flawed, and are therefore likely to need substantive modification to have a realistic chance of being funded in future competitions. 

Submissions to more than one NIHR programme

NIHR will not accept the same or substantially similar applications to more than one NIHR programme. If two similar applications are submitted, once the overlap is identified, the application that is most advanced through the funding process will continue and the second will not be taken further.

Similar applications will only be considered by two programmes concurrently if:

• The aims and research proposals are substantially different
• If successful, NIHR would be prepared to fund both proposals
• The successful delivery of one project is not dependent on the other

Public involvement

NIHR has issued guidance for researchers about involving patients and the public in research. 

Information and resources to assist you can be found on the NIHR website, including: Briefing notes for researchers on how to involve patients/service users, carers and the public, which defines involvement, engagement and participation; and Payments Guidance for researchers and professionals with information on budgeting for involvement.

There are a number of organisations that may be able to provide useful resources, advice and support on patient and public involvement in research:

The Research Support Service (RSS) provides advice and support to researchers developing research proposals for submission to the NIHR and other national funding organisations for health and social care research.

The NIHR Centre for Engagement and Dissemination (CED) provides advice and a range of resources on patient and public involvement in research.

Learning For Involvement provides a wealth of training programmes and resources for public involvement in research. 

For best practice in PPI please see UK Standards for Public Involvement.

Ethics/Regulatory approvals

Guidance on the application process for ethical and other approvals can be found on the HRA website. Please note that if your study is led from England or Wales and involves NHS sites you should apply for HRA and HCRW approval. If your project is led from Northern Ireland or Scotland and involves NHS/HSC sites you should apply through the appropriate NHS/HSC permission process for that lead nation. Studies with sites in Northern Ireland or Scotland are supported through existing UK-wide compatibility systems where each country accepts relevant centralised assurances from national coordinating functions to avoid duplication. Guidance is available on IRAS.

If you are using patient information from an existing database, you should check whether the patients have given their consent for their data to be included in that database for research purposes, or if not whether the database is exempt under Section 251 of the NHS Act 2006.  Where exemptions are not already in place, approval to use confidential patient information without consent must be requested from the HRA which makes decisions with advice from the Confidentiality Advisory Group (CAG).

NOTE: The programme is interested in taking advantage of the growing utility of routine data (such as HES, GP records etc.), and would like investigators, where appropriate, to ask study participants to consent to long term follow up (e.g. beyond the outcomes to be collected in the funded trial) using routinely collected data, and appropriate linkage to allow this data to be best used.

Carbon reduction guidelines

Researchers applying for NIHR funding are asked to consider the carbon footprint of their research and take steps to reduce carbon emissions where appropriate. Advice on how to do this can be obtained from the Carbon Reduction Guidelines.

Transparency agenda

In line with the government’s transparency agenda, any contract resulting from this tender

may be published in its entirety to the general public. Further information can be found in the Transparency agenda.

Appendix: Guidance on completing the application form

To submit an application, you must complete all the relevant sections of the online form available within the NIHRCC Research Management System (RMS).

The ‘System Help’ document found on the NIHRCC RMS’s web pages provides extensive step by step instructions on how to make use of the NIHRCC RMS.

The following is a practical guide. For more help preparing your application, please see the Connect Expression of Interest guidance for applicants (stage 1) and the Connect Business Plan guidance for applicants (stage 2).

Registration

Only registered users of the NIHRCC RMS can apply. Applicants new to using the NIHRCC RMS should register as a new user. Once logged into your account the RMS home page is the starting point for creating applications, accessing applications and updating contact information and professional details.

Please ensure RMS accounts are created and validated in good time before the submission deadline.

Managing my details

Lead applicants and co-applicants can manage their basic contact information and curriculum vitae (CV) through the ‘Manage my Details’ link on their RMS home page. Lead and co-applicant contact information and CV details are integrated by the RMS into the relevant fields during the application process. Please note that only lead applicant CV details are mandatory at Stage 1. At Stage 2, lead and co-applicant CV details are mandatory. 

Creating an application

The lead applicant must initially create a new application. Clear instructions on how to start a new application can be found in the ‘System Help’. At Stage 2, the research team can collaborate with the lead applicant to edit the content of the application by being invited to be a co-applicant through the co-applicant section of the application form. 

The lead applicant can use the search tool to find co-applicants and then invite them to join the application. The RMS will automatically dispatch an email inviting the co-applicant to confirm their participation in the application. Co-applicants can then decide whether to accept the invitation and consent to the application being submitted jointly in their name. They will need to log into the RMS and follow the links to ‘Confirm’ their involvement on the co-application summary page. Once confirmed, the co-applicant will be granted access to edit the online application form.

All co-applicants must ‘Confirm’ their invitation to participate in the application electronically on the co-application summary page in advance of the submission deadline.

Completing an application

From the application summary page, the application can be edited by clicking on the ‘Edit’ button. The different sections of the application form can then be accessed via the list of hyperlinked buttons on the left-hand side of the RMS webpage. You can move from page to page either by using the ‘Previous’ and ‘Next’ buttons or using the list on the left-hand side of the web page.

Most questions are associated with contextual help buttons and clicking on them will open up pop-up windows containing brief guidance notes that supplement the published guidance for applicants. It is strongly advised that applicants refer to the published guidance first and then use contextual help as they complete and review each question. Contextual help is not designed to replace guidance. Mandatory questions are flagged with a red dot.

The system will prevent your co-applicants from accessing your application at the same time as you. This stops applicants and co-applicants from inadvertently making changes to the same part of the application at the same time and overwriting each other’s work.

Remember to save your work

You will be prompted to save your work if you leave the browser in application editing mode. We recommend you save your work regularly to minimise the risk posed by any local computer or internet problems. You can save and return to the application form as often as you like prior to submission.

Exiting and returning to work on your form

Should you wish to exit your form, you can return at any time; simply log in using your username and password and select ‘My Applications’ from the menu. You will then be presented with a list of all the applications you are currently involved with as well as providing details as to their stage in the submission process.

Validation and submission of the form

The lead applicant can review the progress of their application at any time by selecting the ‘View/Print’ option on the application summary page to generate the application as a PDF File.

When the application form has been completed, the lead applicant must use the ‘Validate form’ tool within the online application form. The validation step is a check run by the RMS to assess whether all the mandatory questions contain information. It will provide a list of links to any parts of the form where corrections or additional content are needed. 

Once the application has been validated successfully and no further corrections are needed, the lead applicant can submit the application by clicking on the ‘Submit’ button on the lower right-hand side of the application summary page.

Following submission

A programme specific reference number will be assigned to the application once it has been submitted. After the relevant competition round closes, the application will automatically enter the process of being considered for funding.