Invention for Innovation Challenge Awards - Scope for call 11
The NIHR Invention for Innovation (i4i) programme inviting applications for call 11 of its Challenge Awards, on 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 evidence typical of a technology recently placed on the market 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 newly CE/UKCA marked products or nearly CE/UKCA marked products (see Section on Regulatory Conditions for further information). For all self-assessed products (Class I & Class A) we expect a CE mark to have been obtained.
Digital health technologies in the Tier 3a category of the NICE Evidence Framework are eligible to apply, as long as they are intended for integration into the NHS and reasonable proof of safety and efficacy is provided in alignment with the NICE Evidence Framework and the NHS Digital Health Technology Standard. 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).
Please note that Tier 3b of the NICE Evidence Framework are treated as medical devices, as per the regulation, and thus evidently eligible for this funding.
Products should address a health priority such as those highlighted in the NHS Long Term Plan, 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, ICSs, STPs or CCGs). 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 Applied Research Collaborations (ARCs), 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.
- Products with existing CE certificates (under the MDD/AIMDD/IVDD or MDR/IVDR). The expiry dates of the certificates must exceed the proposed project completion date.
Please note that CE marking will continue to be recognised until 30 June 2023. From 1 July 2023 new devices placed on the Great Britain market will need to conform to the requirements for UKCA (UK Conformity Assessed) marking. UKCA marking will not be recognised in the EU, EEA or Northern Ireland and a CE mark would still be required for sale in these markets.
- The above bullet point excludes Class I products that are non-measuring, non-sterile, non-reusable and are currently certified under the MDD, as only conformity assessment under the MDR will be valid for such products.
- Products currently undergoing CE-marking will also be eligible 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.
- All proposals should indicate that the devices involved have been registered with the MHRA, or propose it as a deliverable in the project plan to ensure this is achieved before the end of the grace period permitted for your specific device, which is at the very latest the 31 December 2021. For further information read the Guidance Document published on 1 September 2020.
Please note that this is in alignment with the extended government guidance on device registration requirements, whereby from 1 January 2021 (to the 31 December 2021 at the very latest, depending on device type and classification), any medical device, IVD or custom-made device will need to be registered with the MHRA before being placed on the Great Britain market.
Key award specifications
- Applications are invited from SMEs, Higher Education Institutions (HEIs) or NHS Service Providers (e.g. NHS Trusts). A minimum of two organisations must be involved, and the proposal must include at least one collaborator from an NHS Service Provider.
- Lead applicants must be based in England, but co-applicants may be based outside of 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, the budget requested 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 be centred on a pragmatic evaluation of the technology in NHS settings, and must demonstrate clear customer and stakeholder engagement and competitor analysis. Due consideration of the NASSS Framework is expected.
- Projects are expected to be supported by a strong health economic case emphasising the clinical utility of the new technology.