Published: 03 November 2020
Version: 2.0 - November 2020Print this document
This document outlines answers to questions frequently asked by applicants to the Invention for Innovation (i4i) Product Development Awards (PDA). More information is available in our guidance for applicants to stage 1 and stage 2 of PDA funding competitions, and in our supporting information for applicants.
Is there any weighting assigned to the assessment criteria listed in the i4i PDA supporting information?
The application is assessed in its entirety against the eight assessment criteria in the supporting information for applicants; there is no specific weighting allocated to each criterion.
Do i4i PDA applications require a specific referencing style?
Please use the Vancouver or Harvard style format.
Can one organisation submit two different applications to the same i4i PDA funding call?
Yes, but you would have to clearly indicate the differences, and where applicable, potential synergies.
The application form indicates that there is potential for Joint Lead Applicants. Please clarify the implications of this and under what circumstances it would be acceptable.
An application might include Joint Lead Applicants for a number of reasons and is project dependent. Common examples are (but not limited to): if the intended Lead does not have experience of leading large projects; or if there are two co-applicants equally involved in the project from two different organisations. Justification for Joint-Lead applicants must be given.
Can an application to an i4i PDA be submitted whilst waiting for an outcome from another award (e.g. i4i Connect)?
Yes, but this must be explained in the application form. If the project is the same or very similar, applicants will not be awarded funding for both projects.
What evidence is required to demonstrate commitment from a collaborating party at Stage 1 of an i4i PDA application?
Letters of support would be welcomed at Stage 1 but are not a requirement.
Can a commercial SME be a joint lead?
Yes, provided as the joint lead, the SME is based in England. An explanation should be provided to justify why joint leads are required to lead the proposed research and how this brings value to the application.
How many collaborators or partners can be involved in the project? And how would the budget be separated between them? Under what criteria should we choose the lead applicant?
Up to 7 collaborators can be involved in the project but you would need to ensure that effective control of the project can be maintained. There would also need to be detailed collaboration agreements with all the collaborators to ensure this, particularly to protect what happens to intellectual property and the participants' freedom to operate. The budget will be attributed to each collaborator based on the lead applicant cost allocation based on the proposed work.
How long after the outcome of the submitted application is announced is the funding available for use?
The project can start as soon as the due diligence and contracting processes have been completed following the announcement of the outcome of the award. This can vary based on the project, but should not exceed four months from the date of receipt of the outcome letter.
Do contracts (for example a data sharing agreement with partner NHS organisation) need to be in place before an application is made or can this be completed when/if the PDA is awarded?
There is no requirement for any contracts to be in place prior to applying for PDA. We request copies of the draft collaboration agreement and any other agreements relevant to the project as part of our due diligence process.
Are i4i PDA Applications confidential?
i4i PDA applications are confidential. More information can be found in our document Confidentiality and disclosure - a guide for applicants, reviewers and commissioning committees. 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.
Scottish organisations cannot lead. Is there an equivalent mechanism for Scottish HEIs?
There is currently no equivalent mechanism for Scottish HEIs. However, CSO grant funding could be a suitable scheme.
Are you able to share a previously successful example application (appropriately redacted)? Where can applicants seek support with application writing?
Unfortunately, we are not able to share a previously successful example application. However, we would advise getting in touch with your local Research Design Service (RDS). The RDS provides support to health and social care researchers across England on all aspects of developing and writing a grant application including research design, research methods, identifying funding sources and involving patients and the public. Advice is confidential and free of charge.
What is a typical balance between product development and evidence generation within an i4i PDA?
i4i PDAs will fund the majority of activities associated with product development and evidence generation (excluding animal studies). There is no typical balance of these two aspects as this will depend on the stage of product development. i4i will also fund commercial activities. A full list of funded activities can be found in the i4i PDA supporting information.
Is product optimisation allowed or does this count as basic research?
Product optimisation can be funded as part of the product development activities as long as the technology fulfils the requirements of the award, i.e. there is proof of concept data. However, minor or incremental changes to technologies in clinical use will not be supported.
What is acceptable as demonstrated ‘proof of concept’?
Proof of concept refers to there being enough evidence to convince an Assessment Committee that a technology/intervention has a high potential to be developed into a tangible product. This will differ depending on the type of technology/intervention and applicants are encouraged to submit a pre-submission engagement form with their project idea if they require clarification.
If incorporating trials within an i4i PDA, what proof of ethical clearance is required at application stage?
Applicants are encouraged to discuss ethical approval requirements with their Local Clinical Research Network and the Health Research Authority (HRA). All necessary approvals must be sought during the course of the project or before, and this should be stated and/or planned for within the application.
For a medical device the first clinical study will be specific to the regulatory requirements for CE marking. So the study design is driven by that. Is this in scope of the PDA programme?
This would be within the scope of the i4i PDA funding stream, as technologies at any stage of development requiring work from preclinical to clinical evaluation are eligible for the award.
Can an application be for more than one activity, e.g. RCT for clinical effectiveness, CE/UKCA marking, and economic impact analysis?
Absolutely, as long as all the activities are directly relevant and support the development of the principal technology. In fact we expect to see varied work packages that link together for comprehensive product development.
Is there a preference for projects in specific clinical areas?
No. The i4i PDA programme is not based on themes. However, the relevance in terms of patient benefit and savings to the NHS will be an important factor in deciding which projects to fund.
Are there any examples of funded projects we could review?
The NIHR Funding and Awards website has a search tool to find information about past and present funded projects. You can also view a list of all active and complete NIHR i4i awards on this site.
Do you encourage early career researchers to apply with lesser track records of funding? Or are you looking to work with more established researchers?
Project team is part of our assessment criteria. We expect applicants to have the appropriate skills to ensure project success. You are welcome to apply as a lead and if you feel it is necessary to have a more established researcher in the project team they can be made co-applicant in your application.
I’m a fixed term researcher at a HEI. Do I need to have a full-time permanent contract to submit an application as a PI?
There is no rule stating that you need to be on the tenure track in order to submit an application. We encourage you to ensure that you have the necessary approvals from your research development office/faculty dean (or equivalent) as per your governance.
Is it possible for an application to change between Stage 1 and Stage 2, and if so, to what extent?
The overall aim of the project shouldn't change but it is possible to add or remove work packages if justified. In this situation, applicants would be advised to discuss the changes in advance of the submission of their Stage 2 application with their i4i Programme Manager.
As part of testing the technology and pathway we plan to develop we would like to perform a small multisite trial. Is there an expectation that a CTU would be involved?
Having a CTU on board would be advantageous as that would demonstrate that they are committed to supporting the trial.
We need to implement a QMS for an SME, who has been developing the technology to date but only has experience with health technologies (not regulated medical devices). Would this cost be eligible for funding as part of PDA?
Yes, regulatory activities are within the remit of PDA.
Is there a place that exists to link SMEs developing products with an NHS organisation who might have a need to trial it?
Yes. Please contact our Industry team, where you will be directed to the relevant clinical collaborators for your project. In addition, you can use the AHSN Network which will support you in connecting with an appropriate partner.
Finance and Intellectual Property (IP)
Is there a requirement for matched funding from the SME?
There is no requirement for matched funding from SMEs. 100% funding is available for SMEs.
Can early work conducted now, before funding is awarded, still be claimed and funded at a later date if successful, or are there restrictions on when costs are incurred i.e. this must be after the project start date?
Earlier work, prior to project commencement will not be funded and therefore should not be claimed. Project costs can only be incurred from the start date of the project.
What level of finance detail is required at Stage 1 for an i4i PDA application?
The estimated research cost and estimated NHS support and treatment costs must be included within the application form at Stage 1. Stage 2 requires a detailed breakdown of these costs.
Where can I find more information on what to include as NHS support and treatment costs?
Local Clinical Research Networks are there to advise on NHS support and treatment costs. A summary of what these costs include can be found in the i4i finance guidance.
What is the usual funding amount awarded to i4i PDA projects?
Funding for i4i PDAs is uncapped. Typically, awards range between £0.6m-£1.2m but applications do not have to be within this range. Applicants should make sure that they justify their costs and that their project offers value for money.
Is there a limit to subcontracting fees for e.g. IP/FTO searches and patent filings throughout the project?
There is no limit to the amount paid to subcontractors. However, these costs need to be fully justified. Please note that one of the criteria for assessing applications is whether the project would provide good value for money and high subcontracting costs may challenge this.
During the project, how are funds distributed to the Collaborators?
The Lead Organisation will be paid in arrears and is responsible for distributing agreed monies to Collaborating parties.
Can the cost of capital equipment be included in the grant application?
Capital equipment costing up to £5k, excluding VAT, will be considered. Costs of computers are normally restricted to a maximum of £650 each excluding VAT. For a more detailed overview please refer to the Finance Guidance.
Can rental of a piece of capital equipment be included?
Rental for a piece of capital equipment can be included within an i4i PDA application, but the need to do so must be justified.
What happens with arising IP if it is an improvement to existing IP owned by an SME partner?
Non-severable IP will be identified during the contract negotiation process. Ownership of non-severable background IP normally remains with the original owner.
I am unclear about the consent clause in the standard NIHR research contract. Since there is no equity in the company, a clause potentially stopping IP being used can cause problems for SMEs, in particular for future funding as it may limit the commercial strategy. Could you please elaborate on how post project commercialisation will work?
Please refer to section 15.2 of the i4i PDA guidance. 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 an income- or equity-based revenue share will be agreed. We may consider requests for early agreement of commercialisation terms. Consent for commercialisation/exploitation of NIHR funded research is granted on a case by case basis. We do not wish to prevent IP from being exploited since commercialisation is usually required to enable patient benefit from the research. Likewise, we consider SME growth and leveraging further investment to be a success metric of our programme. The consent clause within our contract is there as a safeguard to ensure any future terms are fair and reflect the investment made by the UK taxpayer.
Could you please confirm how the income/equity share works. Will the NIHR share any new IP and will it definitely want a financial return on any new IP created during the project?
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, cost savings to the NHS, public good and 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. IP ownership would normally lie with the Lead applicant, or in certain circumstances with a collaborating party. The funder will not own any IP created during a funded i4i PDA.
Does the applicant need to have secured a patent before applying for PDA? How can the applicant demonstrate the IP value of his proposal?
There is no requirement for having a patent granted at the time of submission of an application. However, we are looking for strong evidence that the level of innovation in the proposed technology is high. Providing competitor analysis and clearly describing how the proposed technology stands out from any similar ones or any alternative solutions to the same problem would be taken into account. Seeking a professional consultation with a patent attorney could be an additional way of supporting the strong IP position of the project further.
Can you say more about establishing Freedom to Operate? What evidence is needed for this?
The ideal evidence for clear FTO would be provided by a professional search conducted by an IP law firm. However, this is not a requirement for submitting an application for the programme and internal FTO searches are acceptable at this stage.