NIHR Product Development Awards (PDA)

Contracting organisation

As specified on the i4i programme page.

Duration (months)

Between 24 – 36 months.

Co-applicants

As PDA requires at least one co-applicant from an organisation that is different from the contracting organisation, please ensure that all applicants have agreed and signed up for an AMS account as they will need to approve being included as an applicant.

Research plan

Please upload your research plan as a PDF. It should clearly include these sections:

• Background and rationale
• Aims and objectives
• Methodology/plan

 With this in mind please note the below requirements:

• Please ensure that the information is accurate, succinct, clearly laid out and provides sufficient methodological detail.
• Do not upload a research plan that is more than 7 pages for the outline application. We may not accept applications with a research plan that is more than the specified pages. Please ensure that your research plan uses Arial size 12 font, and shows page numbers within the document footer.
• Schematics, tables, illustrations, graphs, and other types of graphics can be embedded to clarify the research plan but they should not clutter the central narrative. Images containing any text need to be of high resolution quality and legible. Images that are illegible might be removed and not considered by the committee. Images may only be included within the ‘Research Plan’. Images included in other sections will be removed from the application and will not be seen by reviewers.

In addition to the research plan requirements outlined in the domestic funding guidance, please also ensure to cover the following specific PDA requirements:

Background and rationale

• Outline the anticipated value or contribution the intervention will provide, making a clear health economic case and indicating the anticipated timescales for any proposed impacts to be realised.
• Describe how the proposed solution may have an impact on patient, service user, or carer benefit (such as reduced mortality or morbidity, improved quality of life, reduced misdiagnosis, improved patient outcomes and experiences) and/or on future health care provision and long-term outcomes, comparing it with the existing standard of care and any other competing solutions in development or on the market. Describe why your approach is superior and what its benefit would be over existing NHS and/or social care practice.
• Describe the level of innovation of the proposed technology, clearly stating the current level of development of the proposed solution, including what technical and clinical validation (proof of concept) you have to date, and what challenges remain to be addressed and overcome.

Aims and objectives

• Include key measures of success.
• Describe the proposed project exit point, identifying end users and possible next steps. for implementation.

Methodology/plan

Timeline and milestones

• Include the individual work packages within your project and your project milestones. You may want to include approximate costs for each work package, to help the reviewers determine the project’s value for money. A Gantt chart could be attached in the supporting information.
• Include a description of the main hurdles to be overcome technically, clinically and commercially.
• Describe the key risks to your project (including financial, IP and implementation risks) and the steps you will take to manage and mitigate these risks. Ensure that these risks are considered when defining milestones (the go/no go points for your project).

Your research team

• An explanation of the role of key collaborators and sub-contractors involved in the research, as well as any patient, service user, carer and public leads (not previously listed as co-applicants). For those collaborating organisations that are SMEs, full details of the company need to be provided including company number, name, address and contact details. Sub-contractors provide external specialist services which cannot be provided by the organisation leading the project or its co-applicants or collaborators. Services include, for example, consultancy, design services, or the development and provision of specialist equipment. These costs can be requested for organisations providing these services in a territory that is outside the UK, but suitable justification is required.
• Include a named person with appropriate skills and experience who is responsible for working with people and communities during the project. This role should be an adequately costed and resourced team member who is able to manage the patient and public involvement and engagement plans and related activities.

Intellectual Property and commercialisation

• Provide details of any existing IP and ownership arrangements, including patents or patent applications that are relevant to the project.
• Indicate the procedure you used to evaluate your freedom to operate (FTO) position.
  • Please describe any FTO searches conducted to date and details of who carried them out.
  • Please list all related IP not owned by any of the applicants, including details relating to third party IP licensing requirements.
  • If no search has been conducted to evaluate FTO, please explain your rationale.
• Provide details of any IP which will be produced or improved during the proposed research by any of the partners.
• Provide details of how any new IP generated through the proposed research will be recognised, captured, managed and utilised, providing information on who will lead on dissemination and/or commercial exploitation.
• Describe any competitive technologies that exist on the market or are currently in development and how your proposed technology is different.
• Describe how long (in years) it will take from the project start date until the technology/solution is patient-ready, assuming that all necessary follow-on funding and commercial resources become available after the i4i project is successfully concluded.
• Explain how you will ensure that your technology is adopted in the healthcare service. Please outline your intended strategy including the current and future barriers which may hinder the adoption of this technology and how these will be overcome.
• Please outline the proposed route to market for your technology. Ensure that any regulatory hurdles arising are clearly indicated and how these may impact on the success of the technology. You should also indicate whether the project team or a third party (i.e. commercial partner) will be responsible for overcoming these hurdles.

Uploads

• As outlined on the domestic funding guidance, please upload (literature) references (mandatory, single-side A4 page PDF).
• You may upload either a flow diagram (illustrating the study design and the flow of participants) or a flexible upload (e.g., a Gantt chart, pictures, response to feedback from a previous submission, letter of support etc.). Please only upload one document and the upload should be a single side of A4. If submitting a flow diagram, applicants should also describe complex interventions and controls as accurately and fully as possible within their diagram. If proposing an RCT, we advise you to refer to the CONSORT statement and website for guidance. Alternatively, you may find the EQUATOR Network website useful.
• Please do not upload a logic model as this will not be considered by the committee during its review and may be removed.

Assessment criteria

In addition to the domestic assessment criteria, your application must:

●     Demonstrate how the proposed technology presents a significant level of innovation, providing an advance over currently available commercial products. 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. The proposal will need to articulate how the project will generate relevant data to drive adoption and how adoption of the technology would lead to a change in practice or better adherence to existing clinical guidelines.

●    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. For projects focusing on real-world evaluation, applicants will also be required to provide evidence of safety and efficacy of the technology, including evidence from the literature, to support the case for the evaluation study. Any claims or assertions made about the technology, including in the plain English summary, must have references provided.

●    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. Market opportunities, both domestic and global, and the expected impact of the proposed technology must be described. A strategy should be put forward as to how third party rights will be managed to allow for further development and commercial exploitation. IP arrangements between collaboration partners and with consultancies and sub-contractors must be regulated by appropriate agreements. A strategy for the commercial development of the technology must be presented, as well as a strategy for adoption of the technology into the NHS or other healthcare systems, or into the social care system. This should include a plan for the exploitation of the data produced during the project, the identification of the key stakeholders to engage, and potential sources for onward investment.  If the technology is in earlier stages of development, adoption and exploitation plans can be one of the project’s deliverables.

Frequently asked questions

A list of frequently asked questions is available for this funding opportunity.