Published: 03 November 2020
Version: 3.0 - April 2023Print 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 i4i PDA Sporting 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 assessment criteria in the i4i PDA 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. Overlap for activities and costs would not be allowed.
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. Please note only one organisation (the lead organisation) will be party to the funding contract with DHSC.
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?
You can provide a letter of support, however that is not a requirement at Stage 1. We advise that you make clear in the application what role and responsibilities the collaborators will contribute.
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. Please note we do not expect foreground IP generated from the research to be jointly owned.
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. We expect a single collaboration agreement 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.
Can both organisations be of the same type e.g. two universities?
Yes, both collaborating organisations can be of the same type, as long as they are from the list of our eligible organisations. If support for a clinical trial is requested, one of the partners must be an NHS organisation.
Can the SME be a new spin-out startup from the NHS organisation or university?
Yes, spin-outs and start-ups can be the lead organisation or collaborating organisation at the start of the project. However, do ensure that individuals are not costed across multiple organisations (e.g. PI time costed at university and also SME).
Can we request funding to support work at NIHR MedTech and In Vitro Diagnostics Co-operatives (MICs), i.e. for PPIE activities? Similarly, can a MIC be a partner and lead that aspect of a proposal?
Yes, funding can be requested to support work planned to be delivered by MICs. You can list a MIC as your collaborating organisation and explain what aspect of your proposal is supported by them. There are 11 NIHR MICs that work in partnership with innovators to help them successfully translate innovative ideas into the clinical setting, and cover a broad range of expertise including, PPI, patient care pathway analysis, user testing and human factors and regulatory advice. See the NIHR MICs website for more details. It is encouraged that engagement with NIHR support services occurs as early as possible in developing the project.
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 depending on the complexity of the queries, but ideally, should not exceed four months from the date of receipt of the outcome letter.
Do contracts (for example a data sharing agreement with a 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 would expect initial discussions with collaborating partners and data access relevant to the project to have started and to reflect their commitment in the application. We request copies of the draft collaboration agreement and any other agreements relevant to the project as part of our due diligence process. Where prior agreements are already in place with partners, this should be explained in the proposal and provided during due diligence.
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.
Can Devolved Nations and organisations based abroad be involved?
The Lead organisation must be based in England. Collaborators based in devolved nations or abroad are allowed, however they must be justified and demonstrate clear patient benefit to the NHS or broader UK-wide Health System.
Are you able to share a previously successful example application (appropriately redacted)? Where can applicants seek support with application writing?
You may refer to the NIHR funding and awards page for examples of funded projects. Unfortunately, we are not able to share a previously successful example application. 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 between 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 for applicants.
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 the assessment Committee that a technology/intervention has a high potential to be developed into a tangible product. 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. Applicants are encouraged to submit an Enquiry 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.
Is there a way that we should evidence our Tier C status if we are a digital health technology (DHT)?
Applicants must evidence that their DHT meets and satisfies the Tier C criteria as set out in the NICE Evidence Standards Framework for Digital Health Technologies and it must be evident in the proposal that the innovation falls into Tier C classification. Tier C covers DHTs for treating and diagnosing medical conditions, or guiding care choices and includes those with direct health outcomes, or that are likely to be regulated medical devices.
The i4i Programme does not support DHTs that fall into either Tier A or Tier B classification, including those that help patients to manage their own health and wellness, or that intend to save costs or release staff time with no direct patient, health or care outcomes.
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?
Yes, 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, and not a single activity
If the technology needs further trials to gather data for training and validation of an AI algorithm, which would directly help to improve the prototype, would this be in scope?
Projects that include studies which are looking to collect clinical data for the improvements of prototypes with existing proof of concept t, such as further training and validation of AI algorithms, are within scope. Please see the i4i PDA Supporting information for applicants for examples of funded activities.
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 are funded.
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 or joint-lead applicant in your application.
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. This also applies to budget changes over 10% from Stage 1.
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.
I currently don't have a collaborator on my project. Do you have advice on how to find suitable NHS or university collaborators?
Yes. Please contact the NIHR 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.
How are the funds paid out? What is the percentage of total costs budgeted usually granted on average? How are funds distributed to the Collaborators?
PDA provides funding for 100% of research costs, normally paid quarterly according to a payment schedule defined at the contracting stage. For HEIs, up to 80% of Full Economic Cost will be paid, provided that TRAC methodology has been used. For applications where the contractor is an NHS body or a commercial organisation, up to 100% of costs will be paid. For more information see the i4i Finance guidance.
Payments will be made to the contracted organisation only and the contracted organisation will be responsible for passing on any money due to their partner organisation(s). Appropriate sub-contracts must be put in place for any element of the research which is to be paid to another organisation.
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 £0.5m-£1.5m 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.
Are University staff costs funded, such as a PostDoc salary or time?
The appropriate amount of a PostDoc salary for their time contribution to the project is eligible. The Awards are for projects, so costs are looked at on that basis.
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 subcontracting costs may be considered as part of this.
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?
Contracting organisations must disclose any encumbered background IP which is required for the purpose of the NIHR funded project. As with any NIHR funded foreground IP generated in the project, the ownership of improvement to any background IP will need to be agreed upon during the contracting stages.
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 from 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 the NIHR Intellectual Property and Commercialisation 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 Social Care. We may consider early consent requests if appropriate. Consent for commercialisation or exploitation of NIHR funded research is granted on a case by case basis. The consent process is to ensure exploitation is maximised to ensure patient research. 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, the level of innovativeness 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 or Patent law firm. However, this is not a requirement for submitting an application for the programme and internal FTO searches are acceptable at this stage.