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 be to support developers of innovative medical devices, diagnostics and regulated digital technology to evaluate their product in a real world clinical setting.
You can choose from 2 options:
- Planning and preparation for a study. Project costs can be up to £50,000.
- A study to collect clinical performance and cost-effectiveness data. Project costs can be up to £250,000.
All projects must be business led.
This competition aims to provide support for micro, small and medium-sized enterprises (SMEs). Innovate UK are looking for studies that aim to develop an evidence base for products that address NHS priorities. This support will allow companies to collect and analyse clinical performance and cost effectiveness data in an NHS setting.
You can work alone or collaborate with others as unfunded partners or sub-contractors. Only the lead partner can claim grant funding.
If your project’s total costs or duration fall outside of the eligibility criteria, you must provide justification by email to support@innovateuk.ukri.org at least 10 days before the competition closes who then will decide whether to approve your request.
Your project’s total eligible costs can be up to £50,000 for option 1 and up to £250,000 for option 2. Projects must start by 1 July 2019 and be completed by the end of July 2020. They can last between 3 and 12 months.
Scope
This competition is aimed at SMEs that have developed and manufactured innovative healthtech, including medical devices, diagnostics and regulated digital healthcare products.
You must have gained a CE marking for your product but not marketed it 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 defined in ‘Next steps on the NHS 5 Year Forward View’
- provide evidence that you are working with appropriate stakeholders including NICE, NHS, NIHR and AHSNs
- outline how your study will allowing NICE to evaluate its data
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:
reduce cancellations or unnecessary appointments in primary and secondary care
reduce the number of people that need to use A&E services
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)
Who is this aimed at?
Lead applicant
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 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), National Institute of Health Research (NIHR) and Academic Health Science Networks (AHSNs), to demonstrate the feasibility of your proposal
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 funding.
What you will need to apply
Your answer to each question can be up to 400 words long.
Question 1: Need or challenge
What is the business need, technological challenge or market opportunity behind your innovation?
Provide evidence of:
the potential for your product to have a significant impact on patients or the efficiency of care delivery by the NHS
when the product was first marketed in the UK
summarise the current status of your evidence base
If you are applying for option 1 funding:
explain or justify why the study planning and preparation funding is necessary for you to keep developing your product
give details of any gap analysis you have already carried out into the clinical performance and cost-effectiveness of your product and include the output from the use of the NICE medtech early technical assessment (META) tool or an equivalent if appropriate
justify any further work needed to define the evidence gaps
summarise the evidence requirement you are trying to fill
If you are applying for option 2 funding:
show that you have performed an initial product evidence gap analysis using either the NICE META tool, a comparable approach or other product specific advice
explain how your proposed study will fill the identified gaps
tell us what evidence your study will gather and analyse
Question 2: Approach
What approach will you take?
If you are applying for option 1 funding:
tell us how you will use the funding to develop and execute plans for data collection
describe how you plan to contact and work with relevant stakeholders, including National Institute of Care Excellence (NICE), NHS, National Institute of Health Research (NIHR) and Academic Health Science Networks (AHSNs)
If you are applying for option 2 funding:
describe what work needs to be carried out during the study, and why
describe how the study data will be collected and analysed
describe how you plan to contact and work with NICE, NHS, NIHR, AHSNs and other stakeholders about the development of these plans
You can submit a single appendix as a PDF no larger than 10MB and up to 2 pages long to support your answer. The font must be legible at 100% zoom.
Question 3: Team and resources
Who is in the project team and what are their roles?
Describe or explain:
the roles, skills and experience of all members of the project team that are relevant to the approach you will be taking
the resources, equipment and facilities needed for the project and how you will access them
the details of any vital external parties, including sub-contractors, who you will need to work with to successfully carry out the project
(if your project is collaborative) the current relationships between project partners and how these will change as a result of the project
any gaps in the team that will need to be filled
You can submit a single appendix as a PDF no larger than 10MB and up to 4 pages long to support your answer. The font must be legible at 100% zoom.
Question 4: Market awareness
What does the market you are targeting look like?
Describe or explain:
the market opportunity you will address
how your product compares to the current standard of care or current practices
the markets (domestic, international or both) you will be targeting in the project and any other potential markets
the size of the target markets for the project outcomes, backed up by references where available
the structure and dynamics of the target markets, including customer segmentation, together with predicted growth rates within clear timeframes
the target markets’ main supply or value chains and business models, and any barriers to entry that exist
the current UK position in targeting these markets
the size and main features of any other markets not already listed
If your project is highly innovative, where the market may be unexplored, describe or explain:
what the market’s size might to be
how your project will try to explore the market’s potential
Question 5: Outcomes and route to market
How are you going to grow your business and increase your productivity into the long term as a result of the project?
Describe or explain:
how you will use the project’s clinical data
how you plan to develop the product further after your project is complete
whether the data generated will contribute to a NICE medtech or diagnostics guidance document, refinement of the product, or knowledge about the impacts to the care pathway
your current position in the markets and supply or value chains outlined, and whether you will be extending or establishing your market position
your target customers and/or end users, and the value to them, for example, why would they use or buy it?
your route to market
how you are going to profit from the innovation, through increased revenues or cost reduction
how the innovation will affect your productivity and growth, in both the short and the long term
how you will protect and exploit the outputs of the project, for example through know-how, patenting, designs or changes to your business model
your strategy for targeting the other markets you have identified during or after the project
Question 6: Wider impacts
What impact might this project have outside the project team?
Summarise the anticipated benefit of your product for one of the clinical or operational areas listed in the competition scope. Your product must address the clinical and service need priorities of the NHS, such as those described in the ‘Next steps on the NHS 5 year forward view’.
Describe, and where possible measure:
why and how this technology will lead to significant national healthcare benefits or savings
any expected impact on government priorities
any expected environmental impacts, either positive or negative
any expected regional impacts of the project
Describe any expected social impacts, either positive or negative on, for example:
- quality of life
- social inclusion or exclusion
- jobs, such as safeguarding, creating, changing or displacing them
- education
- public empowerment
- health and safety
- regulations
- diversity
Question 7: Project management
How will you manage the project effectively?
Describe or explain:
the main work packages of the project, indicating the total cost of each one
your approach to project management, identifying any major tools and mechanisms that will be used for a successful and innovative project outcome.
the management reporting lines
your project plan in enough detail to identify any links or dependencies between work packages or milestones
You may upload a project plan or Gantt chart as an appendix in PDF format no larger than 10MB and up to 2 pages long. The font must be legible at 100% zoom.
Question 8: Risks
What are the main risks for this project?
Describe or explain:
the main risks and uncertainties of the project, including the technical, commercial, managerial and environmental risks, providing a risk register if appropriate
how these risks will be mitigated
any project inputs that are critical to completion, such as resources, expertise, data sets
any output likely to be subject to regulatory requirements, certification, ethical issues and so on, and how will you manage this?
You can upload a risk register as an appendix in PDF format no larger than 10MB and up to 2 pages long. The font must be legible at 100% zoom.
Question 9: Added value
Describe the impact that an injection of public funding would have on this project.
Describe or explain:
if this project could go ahead in any form without public funding and if so, the difference the public funding would make, such as a faster route to market, more partners or reduced risk
the likely impact of the project on the business of the partners involved
why you are not able to wholly fund the project from your own resources or other forms of private-sector funding, and what would happen if the application is unsuccessful
how this project would change the nature of R&D activity you can undertake, and the related spend
Question 10: Costs and value for money
How much will the project cost and how does it represent value for money for the team and the taxpayer?
Describe or explain:
the total project cost and the grant being requested in terms of the project goals
how you will finance your 50% contribution to the project
how you will cover any costs, such as material costs, that are not covered under article 28 as listed on page 42 of the state aid manual
how this project represents value for money for you and the taxpayer
how it compares to what you would spend your money on otherwise
any sub-contractor costs and why they are critical to the project
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