NIHR i4i Product Development Awards

Fund Details

Funded activities include the following:

• Research and development of medical devices, in-vitro diagnostic devices as defined by the relevant EU Directives, across all areas of existing or emerging healthcare need.
• Digital health technologies that fall under Tier 3 of the NICE Evidence Framework for Digital Health Technologies (.PDF), and that are focused on patient outcomes and intended for ultimate NHS use.
• Artificial Intelligence (AI) technologies including Augmented or Ambient Intelligence, applied in areas of health and social care including health promotion and prevention, diagnosis and treatment.
• Product development required to enable a technology for clinical use.
• Research and development of techniques or technologies from a different industry sector, which could have a potential impact if applied in a healthcare setting.
• Feasibility studies if a technology from a sector other than health is being developed.
• Studies to provide data relating to safety and effectiveness of a device.
• Clinical utility studies, looking at the technology’s usability, tolerability and user acceptance.
• CE/UKCA marking and other regulatory requirements, including work toward QMS development and the Clinical Evaluation Report.
• Activities associated with the technology’s market access strategy.
• Training associated with the implementation of new technology.

All proposals must meet the essential requirements of the i4i programme, including:

• Projects must have already demonstrated proof of concept as a minimum. Early-stage research or discovery science is not fundable.
• Proposals must set out a commercial strategy that takes into account the regulatory pathway, IP management, commercial barriers, health economics and route to market.
• Proposals must present a plan for future adoption of the technology into the NHS.

Eligibility

• Projects can be led by small-to-medium-sized enterprises (SME), NHS providers or higher education institutions (HEIs).
• Projects must be collaborative between any two of the eligible types of organisation.
• Projects can last a minimum of 24 months and a maximum of 36 months.
• The lead organisation must be registered in England.

The i4i programme will not fund:

• Minor or incremental changes to technologies in current clinical use.
• Projects involving small molecule drugs and biologics, including vaccines and gene therapies.
• Projects involving stem cells.
• Projects that involve work on animals or animal tissue.
• Early-stage or basic research.
• Product ideation.
• Clinical evaluations of fully developed products.
• Studies to improve the understanding of biological processes such as mechanism-of-action or exploratory studies.
• Technologies intended only for hospital information, administration, infrastructure, patient flow or hospital beds management and other related software.
• Methodologies clinically assessing or validating an existing or newly developed technique or technology.
• Wellness and wellbeing mobile apps.
• Software aimed at healthcare professional training.
• Development of innovation or knowledge networks and healthcare technology cooperatives which aim to accelerate the development of innovative technology products.

Talk to us today if you would like to apply for this opportunity.