SME support to evaluate innovative medical technologies: round 2

Overview

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

All projects must be business led.

Scope

Developers of medical devices, diagnostics and regulated digital healthcare products must have gained a CE marking. However, you must not have marketed the product in the UK for more than 5 years. Your proposal must:

• describe the innovative medicine or CE-marked device
• show how your product is likely to have a significant impact, including increasing patient access to innovative technologies where appropriate
• include any up to date evidence of the product’s clinical performance and cost effectiveness
• demonstrate how the product meets the priority needs defined in ‘Next steps on the NHS 5 Year Forward View’, and how it is expected to deliver significant cost savings, health gains or beneficial service impacts if quickly adopted across NHS England
• provide evidence that you are working with appropriate stakeholders including NICE, NHS England, NIHR and AHSNs
• include the development or implementation of plans for data collection within the NHS
• outline how studies will generate data on the costs and benefits of a product, allowing evaluation by NICE

Your project must:

• focus on understanding evidence gaps and testing product performance to explain the operational impact of your product on the NHS
• produce evidence of the impact of your technology
• expand the evidence base by adding data 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
• support identification of potential breakthrough technologies
• support the establishment of improved methods and systems, and demonstrate how the product combined with health care system adaptation delivers better outcomes at lower cost

Priority will be given to products that address the priorities outlined in the ‘Next steps on the NHS 5 year forward view’, such as:

• reduce cancellations or unnecessary appointments in primary and secondary care
• reduce the burden on A&E services, for example by diverting footfall
• improve patient safety and avoid patient harm
• speed up diagnosis, such as improving the scope of lower cost diagnostic imaging
• enable earlier diagnosis of cancer
• support the management of long term conditions, such as diabetes, chronic pain management cardiovascular disease, asthma and chronic obstructive pulmonary disease (COPD)

Eligibility

To apply for funding you must:

• be a UK based SME
• carry out your project within the NHS
• have a product that is aligned with the specific priority healthcare areas defined in the ‘Next steps on the NHS 5 year forward view’
• involve products that have been marketed in the UK for less than 5 years
• be able to outline relevant discussions you have had with the main stakeholders, such as the National Institute for Health and Care Excellence (NICE), NHS England, National Institute of Health Research (NIHR) and Academic Health Science Networks (AHSNs), to demonstrate the feasibility of your proposal

SMEs are encouraged to work with the NHS in England. If you want to work with healthcare systems in other parts of the UK you must provide evidence that your project is aligned with the eligibility criteria.

SMEs can work alone or in collaboration with other businesses or research organisations as unfunded partners or sub-contractors. Only the SME leading the project can claim grant.

SMEs can only submit one application to this round of the competition.

Funding Costs

You could get funding of up to 50% of your eligible project costs.

Option 1: 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. This must involve discussion with appropriate stakeholders in NIHR, NICE and NHS England.

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

SMEs can apply for support to enable the collection and analysis of real world data that helps evaluate the impact of a product. Plans must have been developed in discussion with NICE and NHS England.

You can use the funding to access innovation and advisory support services, including consultancy. You can also use it to support costs related to the collection and analysis of clinical data beyond that required for standard clinical care.

Projects must start by 1 January 2019 and be completed by the end of December 2019.

Exclusions

In this competition Innovate UK are not funding projects involving:

• CE marked products that have been marketed in the UK for more than 5 years
• medical devices and diagnostics that do not focus on the specific priority areas for NHS England in the NHS 5 Year Forward View
• digital health products not regulated as a medical device