Funding competition SME support to evaluate innovative medical technologies: round 3

SMEs can apply for a share of £1.5 million to support the evaluation of innovative medical devices, diagnostics and regulated digital health products.

Start new application

Or sign in to continue an existing application.

Competition sections

Description

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:

  1. Planning and preparation for a study. Project costs can be up to £50,000.
  2. 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). We are looking for studies that aim to develop an evidence base for products that address NHS priorities. Our 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 our eligibility criteria, you must provide justification by email to support@innovateuk.ukri.org at least 10 days before the competition closes. We will decide whether to approve your request.

Funding type

Grant

Project size

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.

Who can apply

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.

Previous applications

Resubmissions

If Innovate UK judges that your proposal is not materially different from your previous proposal, it will be classed as a resubmission.

If we decide not to fund your proposal, you will be able to use it to apply once more.

Your reapplication can:

  • take into account the feedback received from the assessors
  • be for a later round of this competition or for another competition

Failure to exploit

If you applied to a previous competition as the lead or sole company and were awarded funding by Innovate UK or UK Research and Innovation, but did not make a substantial effort to exploit that award, we will award no more funding to you, in this or any other competition. You will not be able to contest our decision.

We will:

  • assess your efforts in the previous competition against your exploitation plan for that project
  • review the monitoring officers’ reports and any other relevant sources for evidence
  • document our decision, which will be made by 3 team members
  • communicate our decision to you in writing

Previous projects

Under the terms of Innovate UK funding, you must submit an independent accountant’s report (IAR) with your final claim. If you or any organisation in your consortium failed to submit an IAR on a previous project, we will not award funding to you in this or any other competition until we have received the documents.

Funding

We have allocated up to £1.5 million to fund projects in this competition.

You can apply for 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. It is expected this will involve discussion with appropriate stakeholders such as the National Institute for Health Research (NIHR) and National Institute for Health and Care Excellence (NICE).

Option 2: 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 must have been developed in discussion with appropriate stakeholders, such as those listed in option 1.

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

This competition provides state aid funding under article 28 of the General Block Exemption Regulation (GBER), ‘Innovation aid for SMEs’. It is your responsibility to make sure that your organisation is eligible to receive state aid. Further information, including eligible costs, can be found on page 42 of the state aid manual. It is important that you review these rules before you apply.

Your proposal

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 we 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)

Projects we will not fund

In this competition we 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 the NHS
  • digital health products not regulated as a medical device

22 November 2018
Applicant briefing event.
Please press play on the video.
23 November 2018
Applicant briefing event (short version).
Please press play on the video.
26 November 2018
Competition opens
30 January 2019 12:00pm
Competition closes
29 March 2019
Applicants notified

Before you start

Please read the general guidance for applicants. It will help your chances of submitting a quality application.

When you start an application you will be prompted to create an account as the lead applicant or sign in as a representative of your organisation. You will need an account to track the progress of your application.

What we will ask you

The application is split into 3 sections:

  1. Project details.
  2. Application questions.
  3. Finances.

1. Application details

Explain your project. This section is not scored, but we will use it to decide whether the project fits with the scope of the competition. If it does not, it will be immediately rejected.

Application details

The lead applicant must complete this section. Give your project’s title, start date and duration. Is the application a resubmission?

Project summary

Describe your project briefly, and be clear about what makes it innovative. We use this section to assign experts to assess your application. List any organisations you have named as collaborators. Your answer can be up to 400 words long.

Public description

Describe your project in detail, and in a way that you are happy to see published. Please do not include any commercially sensitive information. If we award your project funding, we will publish this description. This could happen before you start your project. Your answer can be up to 400 words long.

Scope

Describe how your project fits the scope of the competition. If your project is not in scope it will be immediately rejected and will not be sent for assessment. We will give you feedback on why. Your answer can be up to 400 words long.

Describe how your project fits the scope of the competition. If your project is not in scope it will not be eligible for funding. Your answer can be up to 400 words long.

2. Application questions

In this section, answers to these questions are scored by the assessors. Following assessment, you will receive feedback from the assessors for each question.

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

3. Finances

The finances section asks each organisation in your project to complete their own project costs, organisational details and funding details. For full details on what costs you can claim under ‘article 28: innovation aid for SMEs’, refer to page 42 of the state aid manual. These differ from the eligible costs set out in our general guidance for applicants.

Background and further information

The life sciences sector is critical for developing medicines, medical and digital technologies, and diagnostics that improve patients’ lives. It is one of the most important sectors for the UK economy with more than 5,000 companies, nearly 235,000 employees and a £70 billion turnover in 2017. It is a highly productive industry with employment distributed across the regions, in small, medium and global companies.

The government’s ambition is that NHS patients should be among the first in the world to get life-changing treatments. In autumn 2016, the independently chaired Accelerated Access Review (AAR) set out a vision of getting the best technologies to patients more quickly and more cheaply, in a system that is quick to adopt innovation.

More than 95% of companies in the UK life sciences sector are micro, small and medium-sized enterprises (SMEs). The AAR analysis revealed that SMEs are sometimes unable to provide sufficient real-world evidence to inform or support NHS commissioning and adoption decisions, preventing their innovations from helping patients.

In addition to the portfolio of support available through current research funding, the government is delivering a new £6 million scheme. This will help SMEs obtain an effective evidence base for their healthtech products, including in-vitro diagnostic medical devices (IVDs) and digitally enabled devices.

This Innovate UK scheme focusing on medtech is intended to support the collection and analysis of clinical performance and cost data within an NHS setting, often referred to as real-world evidence. This type of data will make it easier for the healthcare system to adopt those innovations that have the greatest potential to deliver savings or improve patient care.

If you need more information, email us at support@innovateuk.ukri.org or call the competition helpline on 0300 321 4357.

Need help with this service? Contact us