Funding competition SME support to evaluate innovative medical technologies: round 2

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

Competition opens: Monday 2 July 2018
Competition closes: Wednesday 22 August 2018 12:00pm

This competition is now closed.

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Description

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.

This competition aims to provide support for small and medium-sized enterprises (SMEs). We are looking for an evidence base that can evaluate products that address NHS priorities. Our support will allow companies to collect and analyse clinical performance and cost effectiveness data in an NHS setting.

There are 2 options for applicants in this competition:

1.Study planning and preparation. Project costs up to £50,000

2.Collection of clinical performance and cost-effectiveness data study. Project costs up to £250,000

All projects must be business led.

Projects can be collaborative but this is not mandatory. Only the lead partner can claim grant.

Find out if your business fits the EU definition of an SME.

If your project’s total costs or duration fall outside our eligibility criteria, email us at support@innovateuk.gov.uk at least 10 days before the competition closes.

Funding type

Grant

Project size

Total project costs of up to £50,000 for option 1. Up to £250,000 for option 2. Projects must start by 1 January 2019 and be completed by the end of December 2019.

Who can apply

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

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

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.

Your proposal

SMEs are encouraged to get involved in the development and manufacture of innovative medical devices, diagnostics and regulated digital healthcare products. This competition is to collect supporting clinical evidence on the performance and impact of their product in the NHS.

We encourage projects to support the development or design of plans for the collection of clinical data. These can include projects to define evidence gaps and design performance evaluation studies.

Priority will be given to products that address the priorities outlined in the Next steps on the NHS 5 year forward view. 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 projects that:

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)

Project types

This competition is being run under Article 28: Innovation Aid for SMEs as described in the State Aid Manual (see page 41). It is important that you review the rules under innovation aid for SMEs before you apply.

Your work should focus on understanding evidence gaps, and testing product performance to explain the operational impact of your product on NHS service provision.

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

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 NHS England in the NHS 5 Year Forward View
digital health products not regulated as a medical device

2 July 2018: Competition opens
3 July 2018: Recording of briefing event .
22 August 2018 12:00pm: Competition closes
19 October 2018 4:09pm: Applicants notified

Before you start

Please read the general guidance for applicants. It will help your chances of submitting a quality application. Please note that there are differences in the funding rules and eligible costs as this competition is being run under Article 28: Innovation Aid for SMEs.

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 contribute to the application
other organisations to participate in the project as unfunded collaborators if your application is successful

Unfunded partner organisations can be other businesses, research organisations, public sector organisations or charities.

What we will ask you

The application is split into 3 sections:

Project details
Application questions
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 doesn’t, it will be immediately rejected.

Application details

The lead applicant must complete this section. Give your project’s title, start date and length. List any partner organisations you have named as collaborators.

Project summary

Describe your project briefly. We use this section to assign experts to assess your application.

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 be before you start your project.

Project 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. Applicants must demonstrate how their products are aligned with the competition’s specific priority areas as described in the competition scope.

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, citizen challenge, 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, as only products that have been marketed for less than 5 years are eligible for support

Give a summary of 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 carried out into the clinical performance and cost-effectiveness of your product
include the output from the use of the NICE medtech early technical assessment (META) tool or an equivalent
provide any specific advice you have received on evidence gaps
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 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 NICE, NHS England, NIHR and 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 England, NIHR, AHSNs and other stakeholders about the development of these plans

You may submit a single appendix as a PDF no larger than 1MB 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 may submit a single appendix as a PDF no larger than 1MB 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

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 (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 given 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 1MB 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 may upload a risk register as an appendix in PDF format no larger than 1MB 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 faster to market, more partners and 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 please refer page 41 of the specific guidance related to the eligible costs under Article 28: Innovation Aid for SMEs as described in the State Aid Manual. These differ from the eligible costs set out in our standard guidance for applicants. Please note that you will need to enter a grant percentage of 50%.

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 £63.5 billion turnover in 2016. 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 percent 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 medtech products, including in-vitro diagnostic medical devices (IVDs) and digitally enabled devices, or medicines qualifying for the Early Access to Medicines Scheme (EAMS). 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, contact the competition helpline on 0300 321 4357 or email us at support@innovateuk.gov.uk.

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