The i4i Programme will fund the generation of clinical evidence required for the implementation of technological innovations in the healthcare pathway, based on their use in a real-world context. In other words, the testing would be carried out as if the innovation was being used in service. This might include feasibility or effectiveness studies carried out in real-world settings that employ pragmatic study designs such as pathway and sustainability evaluations, qualitative assessments of the clinical burden, and assessments of broader downstream effects. Companies and NHS organisations may receive up to 100% of the requested funding, with no requirement for matched funding for commercial organisations.
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 that 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.
Requirements include the following:
- 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.
- 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.
- 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.
The i4i challenge award will not fund:
- NHS support costs and excess treatment costs.
- Scale-up manufacture of the devices that will be needed to carry out the project.
- Implementation costs other than those associated with research, including some of the costs incurred by the healthcare system in order to put in place the technology.
- Potential major workaround technology redesign (e.g. prototype optimisation and further CE marking activities) arising from the clinical evaluation undertaken with this award.
- Trials aimed solely at determining the efficacy of a product.
- Technologies falling in the Evidence Tier 1 and 2 categories described in the Evidence standards framework for digital health technologies (.PDF) from NICE, such as wellness and health-tracking apps.
- Any additional work packages related to early-stage or basic research.
- Evaluations of fully developed products or interventions, which have already been adopted within another NHS organisation or have a history of NHS use.
- Products to be used only in hospital administration, infrastructure and other related software.
- Professional training, including fees for PhD study.
- 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.