Introduction
The NIHR Invention for Innovation (i4i) Programme Connect Call is aimed at small and medium-sized enterprises (SMEs) developing medical technologies in need of a funding boost to reach the next stage in their development pathway. The following document provides guidance for applicants completing the Expression of Interest form.
i4i Connect operates a two stage application process:
Stage 1 – Expression of Interest
Stage 2 – Business Plan (up to 15 pages) and a 3 minute video pitch
Your objective in completing the NIHR i4i Connect Expression of Interest is to generate enough interest in your project to get invited to the second stage of the application process. Think of it as your business pitch on paper.
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
For more information on the assessment criteria and the information we would like to see in the application please see Connect Supporting information for applicants.
Application Form
Section 1: Research Details
Research Title
The programme title should state clearly and concisely the proposed research. Any abbreviations should be spelled out in full.
Lead Organisation
Host or lead organisation is the organisation that will be the contractor if the project is funded. Please provide details.
Research Duration (months)
Ensure you include sufficient time to complete all aspects of the research including applications for regulatory approvals (where required) and the final report. Please note, i4i Connect projects can be between 6 and 12 months long.
Proposed Start Date
Note this should be from the 1st of the month regardless of whether this is a working day or not. Please be realistic about your possible start date taking into account the necessary contracting, and staff recruitment prior to starting your project.
End Date
This field will automatically populate once you have entered the start date and research duration information.
Estimated Research Costs
Enter the total amount of research costs requested (not including NHS Support & Treatment costs). NHS Support & Treatment Costs will not be met by any i4i award but will be taken into account by the i4i committee when assessing the overall value for money provided by the proposed research project.
Estimated NHS Support & Treatment costs or external (not NHS) intervention costs
Enter the total amount of NHS support and treatment costs associated with this proposal.
Section 2: Lead Applicant Details
Complete your name, contact details and other requested information.
Section 3: Expression of Interest
- Unmet patient or social care need
- Proposed solution
- Benefits to patients or service users and to the health or social care system
- Project and Spending plan
- Applicant and team details
- Company information
Expression of Interest is the main part of your application which will be considered by the reviewing panel. You should ensure that the information is accurate, succinct, clearly laid out and provides sufficient methodological detail. Each of these sections must be addressed according to the guidance below. The maximum word count for each of these sections is 300 words.
This guidance includes questions that should help you think about the critical aspects of your project in order to develop a compelling case. We do not expect you to have all of the answers, but please ensure you address the headings highlighted in bold; your narrative should include only those points relevant to your project proposal.
Unmet Patient or Social Care 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.
- How do you know there is an unmet need for your technology? Remember that i4i Connect will fund the development of technologies at any stage of their translational pathway as long as proof-of-concept has been demonstrated.
- What is the evidence base for the unmet need (e.g. literature/NICE guidelines, market research)?
- What is the scale of that need in the UK, and globally?
- How are patients or service users currently treated/diagnosed/monitored, and what are the limitations of this approach? How will your innovation change this?
- How would the implementation of your technology into the healthcare or social care system address this unmet need? We do not expect a health economic model but use of published figures can be useful to argue your case.
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.
Briefly explain your commercialisation plans and how you propose to develop your medical technology into a market ready product.
- How significant is the level of innovation of your technology? For example:
- In what ways is it breakthrough or transformative?
- What is its competitive advantage?
- What is its potential to change technology, clinical or social care practice?
- How are you going to get your technology adopted in the NHS?
- What are the UK and global markets for your product? Who are the key players? What penetration do you realistically expect to achieve?
- Do you have Freedom to Operate, and what is the evidence for this? Are there any third party rights to your technology?
- Who will own the foreground IP and what relevant background IP is associated with your technology (e.g. copyright, patents, trademarks, trade secrets)?
- What are your plans after the Connect project? Do you intend to apply for another NIHR award or funding from another organisation? What are your long term commercialisation plans?
Benefits to patients or service users and the health or social care system
Please provide a clear case of how the proposed device, technology or intervention will change clinical practice and provide benefits to patients or service users (such as reduced mortality or morbidity, improved quality of life, reduced misdiagnosis, improved outcomes and experiences). Potential cost savings for the NHS or social care system should also be provided, along with details of the expected involvement of patients, service users and/or public representatives during the product development process.
- What evidence do you have that your medical technology is feasible?
- What is the demonstrable benefit of your technology? Does it reduce mortality or morbidity, improve quality of life, reduce misdiagnosis, improve patient or service user outcomes and experiences, or connect patients with the healthcare or social care system?
- What patient or service user groups will benefit from your innovation?
- How will you involve patients, service users and/or the public with your medical technology? Patient and public representatives can provide essential lived experience, insight and advice.
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.
- Why is Connect funding essential for the development of your technology?
- Describe your project plan with clearly defined work packages, timelines and deliverables. It might be useful to provide a summary of each work package and its approximate cost.
- How will you ensure that the project will be managed effectively?
- If applicable to your technology, have you considered regulatory and ethical aspects?
- What are the risks associated with your project? How will you mitigate against them?
- Explain why your projected spend offers value for money.
- Show the projected cash flow forecast for the year of the Connect award and its impact on the financial health of the company.
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.
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.
- Who are the key players in your project team? Who will lead which work package, and why did you choose them? If you lack expertise in a particular area, how will you fill the gap?
- If relevant, briefly describe your experience in successfully applying for funding and delivering projects. Please note that this is not a prerequisite.
- Highlight recent formal/informal collaborations that are relevant to your application.
- Please note that while a formal collaboration is not part of the eligibility requirements for Connect, applicants interested in applying for post-award i4i PDA funding would be expected to identify collaborators as a deliverable during the project.
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.
Section 4: Validation Summary
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.