i4i Challenge Awards support market-ready innovations by addressing the translational gap between the clinical evaluation of technologies and their adoption, by funding the assessment of MedTech innovations in real-world healthcare settings. The expected output is a disruptive medical device or in vitro diagnostic test that can offer improved outcomes for NHS patients.
- Activities associated with the design and delivery of evaluations for innovations in healthcare settings. This includes any trial methodology aimed at demonstrating the real world clinical utility of the product. The following innovations are eligible:
- Medical devices and in vitro diagnostics as defined by the relevant EU Directives effective through the UK Medical Devices Regulations 2002.
- Digital health technologies that fall under Tier 3 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.
- Collection of effectiveness data if this is part of a clinical utility study.
- Health economic analysis.
- Work around market analysis and development of a business case for adoption.
- Project management and stakeholder engagement activities.
- Activities associated with data analysis, management and governance.
- Small changes to the technology that might be needed for its optimisation during the lifetime of the project, e.g. any adaptations deemed required for end user acceptance as part of this evaluation but not requiring any further regulatory approvals.
- Training associated with the implementation of the new technology, including the development of training resources, usage guidelines and other materials.
- Implementation research costs, including design of implementation strategy and management of studies associated with this, clinical pathway analysis, sustainability evaluation and data analysis.
- Activities associated with the dissemination of outputs.
The lead organisation must be based in England and may be any of the types of eligible organisation listed below. Overseas collaborators are permitted but will not be eligible to receive any funding. Their role must be clearly described in the application. 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, one of which must be an NHS service provider that will act as the site for the real world evaluation. 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.
The i4i challenge award will not fund:
- NHS support costs and excess treatment costs. Please refer to the AcoRD guidance for more information.
- Scale up manufacture of the devices that will be needed to carry out the project. Applicants must develop a plan for managing possible costs associated with these, and will have to describe it if invited to submit a stage 2 application.
- 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 work around 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 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.