i4i Product Development Awards – Competition 24

Key Features

These awards support any stage of the translational research and development pathway, including the clinical development of laboratory-validated technologies or interventions.

Programme:     NIHR

Award:     No upper funding limit

Opens: 23rd Mar 2022

Closes: 10th May 2022

! This scheme is now closed

Overview

i4i Product Development Awards (PDA) support translational research and development of medical devices, in vitro diagnostics and high-impact patient-focused digital health technologies for ultimate NHS use. The research proposals may address any disease or health area, provided there is a clear unmet clinical need. There is no upper funding limit for Product Development Awards, but costs must be fully justified.

Award Specifications

All proposals must meet the essential requirements of the i4i programme.

  • Projects must have already demonstrated proof of concept as a minimum. Applicants are expected to have generated experimental data to support the case for further development and illustrate technical feasibility. Early stage research or discovery science is not fundable.
  • A collaboration comprising a minimum of two organisations must be involved from an NHS service provider, a Higher Education Institution (HEI) or a small-to-medium-sized enterprise (SME). Eligible collaborations must consist of at least two organisations from the above list (for example, an NHS service provider with an SME).
  • Lead applicants must be based in England.
  • Work packages must not include animal or animal tissue studies. If animal or animal tissue studies are required as part of the project, we expect applicants to seek parallel funding to cover such studies, details of which should be provided in the application form.
  • 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. Applicants should be aware of the recently published NHS MedTech Funding Mandate policy (.PDF) which came into effect on 1 April 2021 to help overcome the financial barriers to adopting medical devices, diagnostics and digital products in the NHS.
  • Projects can be of a maximum duration of 3 years. There is no upper funding limit, but all costs must be sufficiently justified and proposals must indicate good value for money.

Eligibility

For all i4i awards the lead organisation must be based in England. The lead organisation may be any of the types of eligible organisation listed below. The following types of organisations are eligible for funding:

  • SMEs (including start-up or ‘spin-out’ companies);
  • NHS service providers (including Trusts, community care providers, and tertiary care centres);
  • Universities, research institutes and not-for-profit organisations.

For projects to be eligible they must include a collaboration of at least two organisations. For example, applications which involve partnerships between a university and its associated NHS Trust, or an SME and an NHS service provider, are considered eligible collaborations. If support for a clinical trial is requested, one of the partners must be an NHS organisation which has agreed to be the sponsor of the trial.

Scope

  • 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 C of the NICE Evidence Framework for Digital Health Technologies, and that are focused on patient outcomes and intended for ultimate NHS use. Evidence that the NHSX Digital Technology Assessment Criteria (DTAC) has been considered should be demonstrated in your proposal.
  • 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. Please note that such AI technologies will classify as Medical Devices.
  • Product development required to enable a technology for clinical use; work packages may comprise all aspects of prototyping and manufacturing, engineering and performance testing, clinical evaluation, intellectual property protection, market analysis, business case development, health economic analyses, etc.
  • 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, including first-in-man and pivotal clinical studies.
  • 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.

Exclusions

  • 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, which have already been adopted within an NHS organisation or have a history of NHS use.
  • 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.

Interested in applying for this competition?

Book an appointment to speak to one of our advisors to discuss your eligibility to apply for this Grant Funding opportunity.