The NIHR i4i Challenge Awards Call 9 is inviting applications for the assessment of medtech nnovations in healthcare settings.
The aim is to shorten the evidence gap between the safety/preliminary efficacy typical of a newly CE marked technology and what is required for decisions by commissioners and regulators. At the same time, this will de-risk the product for follow-on investment.
Applications should focus on CE marked products. Digital technologies that are not regulated as medical devices but are going to be integrated into the NHS can also be included, as long as reasonable proof of safety and efficacy is provided.
Products should address one of the priorities defined by NHS England, focusing on a clinical need specific to the context where the technology will be tested. It is recommended for projects to be co-designed with the relevant stakeholders including those to whom the technology will be handed over (e.g. NICE, CCGs, other funding streams).
For this reason, NIHR encourages the establishment of highly multidisciplinary teams, with adequate expertise to address technical, health economic, managerial, regulatory and implementation challenges. Applicants are encouraged to seek the support of NIHR Medtech and In vitro diagnostics Co-operatives (MICs) and Collaborations for Leadership in Applied Health Research and Care (CLAHRCs), and to work closely with the Academic Health Science Networks (AHSNs), as they can provide important expertise and understanding of the current needs of the landscape.
- Applications are invited from SMEs, NHS Trusts, NHS service providers or Higher Education Institutions (HEIs). A minimum of two organisations must be involved, and the proposal must include at least one collaborator from an NHS Trust or NHS Service Provider.
- Lead applicants must be based in England.
- Projects may be up to three years in duration. An extension to five years could be considered for follow up research activities if fully justified in the application
- There is no upper funding limit, but costs must be fully justified. It is expected that awards will be in the region of £1.5m
- Proposals must describe pilot implementation evaluation in NHS settings, and must demonstrate clear customer and stakeholder engagement and competitor analysis.
- Projects must be supported by a strong health economic case emphasising the clinical utility of the new technology
- Teams are expected to have the appropriate skills for the delivery of the projects. Applications must take into account implementation and stakeholder management activities associated with the project besides clinical and technical aspects and the team proposed will have to demonstrate the relevant expertise in all these areas
- Proposals must include a realistic risk mitigation strategy