NIHR – i4i Product Development Awards

Fund details

The expected focus of a PDA is product development required to enable a technology for clinical use or use in social care and/or the clinical development of a laboratory-validated technology or intervention. The research proposals may address any area of unmet need. Projects must have a clear pathway towards adoption and commercialisation.

Proposals must involve one of the following:

• Medical devices or in vitro diagnostic devices as defined by the Medical Device Regulations 2002
• 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

Eligibility

• Scope: Preclinical and clinical product development
• Entry point: Experimental proof-of-concept or laboratory-validated technology
• Exit point: Laboratory and/or clinically validated technology
• How much: No upper funding limit, but all costs must be fully justified
• How long: Maximum project duration is 3 years

PDA will fund the preclinical and clinical development of innovative technologies, gathering the required evidence for regulatory approvals and follow-on studies. Projects must have demonstrated proof-of-concept as a minimum, which is generally described as TRL3. 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. A strong element of patient and public involvement and end-user engagement is a prerequisite for PDA.

Proposals must also set out a commercial strategy that takes into account the regulatory pathway, IP management, commercial barriers, health economics and route to market. A plan for future adoption of the technology into the NHS or social care system should be presented. Applicants should be aware of the NHS MedTech Funding Mandate policy, which came into effect in April 2021 to help overcome the financial barriers to adopting medical devices, diagnostics and digital products in the NHS, as well as other government policies as updated.

Projects may last up to 3 years, and SMEs and NHS organisations may receive up to 100% of the requested funding, with no requirement for matched funding for commercial organisations. Higher Education Institutions are entitled to up to 80% of the full economic costs (please refer to the Finance guidance for more details).