Invention for Innovation Challenge Awards - Scope for Real World Implementation call
The NIHR i4i Challenge Awards Call 10 is inviting applications for the assessment of medical device and in vitro diagnostic innovations in healthcare settings. The aim is to shorten the evidence gap between the safety/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. However, nearly CE marked products will be considered where evidence can be shown that the technical documentation has been submitted for Notified Body assessment, and whereby all of the mandatory testing has been completed. For self-assessed products (Class I & Class A) we expect a CE mark to have been obtained. Digital health technologies that are not regulated as medical devices but are going to be integrated into the NHS will also be eligible, as long as reasonable proof of safety and efficacy is provided. We strongly encourage such technologies to have obtained a relevant professional body endorsement from organisations such as ORCHA, NHS Apps Library, or have obtained NICE Advice (e.g. Medtech Innovation Briefings).
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, we encourage 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 last up to 3 years but could be considerably shorter, or if a strong case is made, may last up to 5 years (for example if extended patient follow-up is required to demonstrate improved outcomes). Timelines will need to be commensurate with the requirements of the project and the delivery of outputs, in terms of potential healthcare uptake and patient benefit.
- There is no upper funding limit, but costs must be fully justified.
- Proposals must describe 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.