SME support to evaluate innovative medical technologies: Round 4

Overview

The Office for Life Sciences (OLS) will work with Innovate UK, as part of UK Research and Innovation, to invest up to £1.5 million in innovation projects. These will support developers of innovative medical devices, diagnostics and regulated digital technology to evaluate their product in a real world clinical setting.

Scope

This competition is aimed at SMEs that have developed and manufactured innovative medical devices, diagnostics or regulated digital healthcare products.

You must have gained a CE marking for your product and it must already be available for the NHS to purchase, but not marketed in the UK for more than 5 years. You must collect supporting clinical evidence of its performance, cost effectiveness and impact in the NHS. If Innovate UK decide to fund you, this evidence may help increase uptake of your product within the NHS.

The competition will support the development or design of plans for the collection of clinical data in a real-world setting, and also support the running of these studies.

Your proposal must:

• describe the innovative or CE-marked device
• show how your product is likely to have a significant impact, including increasing patient access to innovative technologies where appropriate
• demonstrate how the product meets the priority needs, such as those reviewed in the NHS Long Term Plan
• provide evidence that you are working with appropriate stakeholders including NICE, NHS, NIHR and AHSNs
• outline how your study will allow NICE to evaluate the data you collect

Your project must:

• focus on understanding evidence gaps and testing product performance to explain the operational impact of your product on the NHS
• add data to the evidence base that can contribute to the health technology appraisal process, for instance by comparing the use of the new product with the current standard of care
• involve potential breakthrough technologies
• help improve methods and systems

Priority will be given to projects that are related to:

• ageing well
• cancer
• digital transformation
• learning disabilities and autism
• mental health
• personalised care
• prevention
• primary care
• starting well
• stroke
• workforce

Eligibility

To lead a project or work alone you must:

• be an SME based in England, Scotland, Wales or Northern Ireland
• carry out your project within the NHS
• have a product that is aligned with at least one of the NHS’s priority healthcare areas, such as those reviewed in the NHS Long Term Plan
• have a product that is already available for the NHS to purchase, but that has been marketed in the UK for less than 5 years
• outline relevant discussions you have had with the main stakeholders, such as the National Institute for Health Research (NIHR), National Institute for Health and Care Excellence and Academic Health Science Networks (AHSNs), to demonstrate the feasibility of your proposal
• have gained a CE marking for your product

SMEs can work alone or in collaboration with other businesses or research organisations as non grant claiming partners or sub-contractors. Only the SME leading the project will be eligible to claim grant funding.

Funding Costs

Up to £1.5 million has been allocated to fund projects in this competition. You can apply for funding of up to 50% of your total eligible project costs.

Material and capital usage costs are ineligible. If these costs are included your application will be ruled as ineligible and will not be funded.

Option 1: total project costs of up to £50,000

SMEs can apply for support to develop detailed and feasible plans for the collection of relevant data in a clinical setting. It is expected that such planning and evidence collection will involve discussion with appropriate stakeholders such as the NIHR, NICE and AHSNs.

Option 2: total project costs of up to £250,000

SMEs can apply for support to collect and analyse real world data that helps evaluate the impact of a product. Plans for the collection and analysis of real world data must have been developed in discussion with appropriate stakeholders, such as NIHR, NICE and AHSNs.

You can use the funding to:

• access innovation and advisory support services, including consultancy
• support costs related to the collection and analysis of clinical data beyond that required for standard clinical care

Exclusions

Projects will not be eligible for funding under this competition if they involve:

• CE marked products that are not currently available to the NHS or have been marketed in the UK for more than 5 years
• medical devices and diagnostics that do not focus on priority areas for the NHS
• digital health products not regulated as a medical device