Funding competition SME support to evaluate innovative medical technologies: Round 4

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

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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 support developers of innovative medical devices, diagnostics and regulated digital technology to evaluate their product in a real world clinical setting.

All projects must be led by a UK based SME. You can choose from 2 options:

  1. Planning and preparation for a study, for which total eligible project costs can be up to £50,000.
  2. A study to collect clinical performance and cost-effectiveness data, for which total project costs can be up to £250,000.

Applications for funding to cover the costs of material or capital usage will not be eligible. Leave these sections blank in your application.

This competition provides support for micro, small or medium sized enterprises (SMEs) 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 non grant claiming partners or sub-contractors. Only the lead partner will be eligible to claim grant funding.

Applications are highly encouraged from SMEs from across all regions of England, Scotland, Wales, and Northern Ireland.

If there are any questions about funding levels and costs please email support@innovateuk.ukri.org. If your project’s total costs and/or duration fall outside of our above mentioned eligibility criteria, you must provide justification at least 10 days before the competition closes by email to support@innovateuk.ukri.org. We will decide whether to approve your request.

This competition closes at midday 12pm UK time on the deadline stated.

Funding type

Grant

Project size

The total eligible project costs can be up to £50,000 for option 1 and up to £250,000 for option 2, of which applicants can apply for up to 50% grant funding.

Who can apply

State aid

Any UK business claiming funding must be eligible to receive state aid at the time we confirm you will be awarded funding. If you are unsure please take legal advice. For further information see our general guidance.

Your project

The total eligible project costs can be up to £50,000 for option 1 and up to £250,000 for option 2.

You can apply for funding of up to 50% of the total eligible project costs. Therefore, option 1 applications can claim a grant of up to £25,000. Option 2 applications can claim a grant of up to £125,000.

Projects must start by 12 December 2019 and must be completed by the end of December 2020.

Projects must have a total duration of between 3 and 12 months.

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 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.

If your project does not fulfil these eligibility criteria, or you have not yet reached the point of delivering a detailed and feasible plan for the collection of relevant data in a clinical setting, you may wish to look to consider the NIHR i4i competition Challenge Awards 2019: real world implementation. The deadline for submission for stage 1 is 1pm on 12 June 2019.

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. We will accept resubmissions in this competition.

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 total eligible project costs.

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.

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

It is important that you review these rules before you apply as they are different to other Innovate UK run competitions, in particular the percentage of funding available.

Your proposal

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 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 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

Options

You must choose one of these.

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

Projects we will not fund

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
  • any cost for materials or capital usage as part of the application case

23 April 2019
Competition opens
1 May 2019
Online briefing event recording.
3 July 2019 12:00pm
Competition closes
6 September 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.

As the lead applicant you will be responsible for:

  • collecting the information for your application
  • representing your organisation in leading the project if your application is successful

You will be able to invite:

  • colleagues to make contributions
  • other organisations to collaborate with you as non-grant claiming partners

What we will ask you

The application is split into 3 sections:

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

1. Project 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 team

Invite colleagues to contribute to your application and other organisations to collaborate on your project.

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.

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. 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.

2. Application questions

The assessors will score your answers to these questions. You will receive feedback from them for each question.

Your answer to each question can be up to 400 words long. Do not include any URLs in your answers unless we have explicitly requested a link to a video.

In this section, answers to these questions are scored by the assessors, except for question 1. 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: Funding options

Tell us which funding option your project fits into. This question is not scored.

Question 2: 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 3: 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 4: 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 5: 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 6: 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 7: 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 reviewed in the NHS Long Term Plan

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 8: 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 9: 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 10: 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 11: 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?

If costs for materials or capital usage are included in the ‘your project costs’ section of your application it will be ruled as ineligible and will not be funded. Do not list these costs here either but do explain how they will be covered.

Describe or explain:

  • the total project cost and the grant being requested in terms of the project goals. This cannot exceed 50% of total project costs
  • how you will finance your 50% contribution to the project
  • how you will cover any costs, such as material and capital usage 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 healthtech 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.

NICE has published new evidence standards framework for digital products called evidence standards framework for Digital Health technologies, which may help companies develop their applications.

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

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