NIHR – i4i Challenge Awards

Fund details

• Projects can be led by SMEs, NHS providers or higher education institutions (HEIs)
• A minimum of two organisations must be involved and at least one of the collaborators must be from an NHS provider (e.g. an NHS Trust)
• Technologies must have demonstrated safety and efficacy and must have obtained or be in the process of obtaining CE marking
• Project timelines can vary based on the required evidence for potential healthcare uptake and patient benefit. They can last up to 3 years, but a duration of up to 5 years will be considered if a longer period is needed to demonstrate long-term outcomes and a strong case is made
• Lead applicants must be based in England

The objectives of the i4i Challenge Awards are to:

• Accelerate the development and uptake of innovative products, technologies and interventions for the benefit of patients in the NHS
• Encourage the use of efficient methodologies for faster but still robust evaluation
• Support collaborative projects led by England-based organisations targeting unmet healthcare needs
• Provide translational funding for implementation research on technologies which have demonstrated safety and efficacy, and have a clear pathway towards clinical adoption and commercialisation
• Encourage engagement with a Local Authority, Sustainable Transformation Partnership or Integrated Care System, as appropriate, for the assessment of the product in the health or care setting, ideally involving both procurement and commissioning expertise
• Assess the clinical utility and health economic gains of transformative technologies, and generate meaningful evidence to support the decisions of NHS commissioners for effective deployment of the product
• De-risk projects and make them attractive to follow-on funders, investors and buyers, in particular NHS commissioners and national guidance bodies

Eligibility

Essential requirements

• Medical devices and in vitro diagnostics should have a CE/UKCA mark at the time of application
• Nearly CE marked medical devices and IVDs are eligible provided that the technical documentation has been submitted for Notified Body assessment and all mandatory testing has been completed
• Non-regulated digital technologies will need to have a potential application as products in the NHS, and reasonable proof of safety and efficacy should be provided in the application. These technologies must reflect the characteristics of the Evidence Tier 3 described in the Evidence standards framework for digital health technologies (.PDF) from NICE
• All digital technologies should comply with the Code of conduct for data-driven health and care technology and the NHSX Digital Technology Assessment Criteria (DTAC)
• A minimum of two organisations must be involved from a small-to-medium-sized enterprise (SME), an NHS Service Provider (for example, Trusts, community care providers, and tertiary care centres) or a Higher
• Education Institution (HEI), and the proposal must be led by or include at least one collaborator from an NHS Service Provider
• Lead applicants must be based in England
• Proposals must describe evaluations of technologies in healthcare settings. Evaluations must address an existing clinical problem and must be designed to inform decisions around its adoption
• Proposals must demonstrate that early engagement to identify stakeholders for the project has occurred, and that the product has provisional end user interest (for example, NICE, CCGs/ICSs, etc.). A delayed contract start date can be implemented to support formal project collaborations and improve the likelihood of successful innovation management
• Teams are expected to demonstrate appropriate skills for the delivery of the project, such as clinical and methodological approaches, an understanding of implementation science, health economics, regulatory requirements, project management, information governance and data management
• Work packages must not include animal studies. If animal 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

Applicants might want to consider including the following in their proposals:

• Patient input in the design of the trial and the delivery of the intervention
• Rigorous competitor analysis
• A strong health economic case for the clinical utility of the product
• An understanding of the pathway that will be disrupted by the product
• Implementation and sustainability strategy
• Plans for information governance
• A realistic risk-mitigation strategy
• Plans for stakeholder management
• Plans for adoption into the NHS or other care systems

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