Funding competition SBRI: Digital Regulatory Navigation Platform (Health Products)

Organisations can apply for a share of £3 million, inclusive of VAT, to develop a digital regulatory navigation platform for health product innovators.

This competition is now closed.

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Competition sections

Description

This is a Small Business Research Initiative (SBRI) competition funded by Innovate UK.

The aim of the competition is to support proof of concept projects to develop an intuitive medical device digital regulatory navigation tool.

Projects must:

  • demonstrate the principle of an intuitive digital platform that enables users to understand and explore the regulatory pathways for the healthcare product they are developing
  • provide users with information and access to UK support structures that are relevant to their commercial R&D, for example, standards, UKAS accredited test labs and Notified Bodies

This is phase 1 of a potential 2 phase competition.

A decision to proceed with phase 2 will depend on the outcomes from phase 1, availability of further funding and assessment of a separate application into a subsequent phase 2 competition.

The potential phase 2 will support extended data collection and beta testing activity with end users.

Adoption and implementation of a solution from this competition would be subject to a separate, possibly competitive, procurement exercise. This competition does not cover the purchase of any solution.

In applying to this competition, you are entering into a competitive process.

This competition closes at 11am UK time on the date of the deadline.

Funding type

Procurement

Project size

Projects can have total costs from £250,000 to £1 million inclusive of VAT.

Who can apply

Your project

Projects must:

  • start by 1 November 2021
  • end by 31 March 2022
  • last up to 5 months
  • have total eligible project costs from £250,000 to £1 million inclusive of VAT
  • demonstrate a deep understanding and expertise of the regulation of health products within the UK and EU
  • understand challenges facing innovators or businesses seeking to bring innovative products to market

Applicant

To lead a project, you can:

  • be an organisation of any size
  • work alone or with others from business, research organisations, research and technology organisations or the third sector as subcontractors

Contracts will be awarded only to a single legal entity.

However, if you can justify subcontracting components of the work, you can employ specialist consultants or advisers. This work will still be the responsibility of the main contractor.

Funding

A total of up to £3 million inclusive of VAT, is allocated to this competition.

In this competition, phase 1 feasibility study R&D contracts will be awarded from £250,000 to £1 million inclusive of VAT, for each project for up to 5 months. We expect to fund up to 5 projects.

The total funding available for the competition can change. The funders have the right to:

  • adjust the provisional funding allocations between the phases
  • apply a ‘portfolio’ approach

Research and development

Your application must have at least 50% of the contract value attributed directly and exclusively to R&D services, including solution exploration and design. R&D can also include prototyping and field-testing the product or service. This lets you incorporate the results of your exploration and design and demonstrate that you can produce in quantity to acceptable quality standards.

R&D does not include:

  • commercial development activities such as quantity production
  • supply to establish commercial viability or to recover R&D costs
  • integration, customisation or incremental adaptations and improvements to existing products or processes

Subsidy control

SBRI competitions involve procurement of R&D services at a fair market value and are not subject to Subsidy Control criteria that typically apply to grant funding.

Your proposal

The aim of this competition is to:

  • demonstrate the value of an intuitive digital platform that enables users to understand and explore the regulatory pathways for the product developed
  • provide users with information and access to UK support structures that are relevant to their commercial R&D, for example, standards, UKAS accredited test labs, and Notified Bodies

Your project must deliver an intuitive proof of concept digital regulatory navigation tool for medical devices that specifically includes UKCA requirements. These are outlined in Medicines & Medical Devices Act 2021 along with EU CE Mark requirements set out in Regulation (EU) 2017/745 and Regulation (EU) 2017/746

You must consider how externally maintained nomenclatures will be used. Examples of relevant nomenclatures include Global Medical Device Nomenclature (GMDN), Notified Body Operations Group (NBOG), Systematized Nomenclature of Medicine (SNOMED), International Classification of Diseases (ICD) and Anatomical Therapeutic Chemical (ATC) code.

Your project must:

  • demonstrate a credible and practical route to market
  • include a plan to commercialise your results
  • utilise externally maintained nomenclatures
  • focus on healthcare products for the UK and EU

The initial focus of the platform should be on healthcare products for UK and EU but the platform should be scalable to other sectors and global markets in the future.

At the end of the phase 1 contract period you must deliver a functioning proof of concept digital regulatory navigation platform.

You must demonstrate a credible and practical route to market, so your application must include a plan to commercialise your results.

Specific themes

Your project can also include any of the following:

  • medicines
  • products that combine medicines and medical devices
  • health related products such as cosmetics, nutritional products, biocidal products, PPE
  • other sectors such as aerospace, automotive, finance
  • regulatory requirements for other geographies, for example, US, China, Japan, India
  • creation of ‘trusted service provider’ marketplace
  • training and education resources that underpin the platform and provide granular information to users that is specific to their product.

Research categories

Feasibility studies
This means planned research or critical investigation to gain new knowledge and skills for developing new products, processes or services.

Projects we will not fund

We will not fund projects that

23 August 2021
Competition opens
25 August 2021
Online briefing event: watch the recording
20 September 2021 11:00am
Competition closes
5 October 2021
Applicants notified
1 November 2021
Phase 1 contracts awarded

Before you start

By submitting an application you agree to the terms of the draft contract which is available once you start your application. The final contract will include any details you have agreed with the funding authority and will be sent to you if your application is successful.

The contract is binding once the contract is returned by the applicant and signed by both parties. The terms and conditions included in the draft contract should not substantially change.

When you start an application on the Innovation Funding Service 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 from your organisation to contribute to the application.

What happens next

A selected panel of assessors will review and score your application and winners of contracts will be selected. All applicants will be provided feedback.

What we will ask you

The application is split into 3 sections:

1. Project details.

2. Application questions.

3. Finances.

1. Project details

These sections are not scored.

Application details

The lead applicant must complete this section. Give your project’s title, start date and duration.

Who made you aware of the competition?

Select a category to state who made you aware of the competition. You cannot choose more than one.

How long has your organisation been established for?

Select a category to state how long has your organisation been established for. You cannot choose more than one.

What is your organisation’s primary area focus?

Select a category to state your organisation’s primary focus area. You cannot choose more than one.

Equality Diversity and Inclusion

We collect and report on equality, diversity and inclusion (EDI) data to address under-representation in business innovation and ensure equality, diversity and inclusion across all our activities.

All participants must complete this EDI survey and the lead must then select yes in the application question. The survey will ask you questions on your gender, age, ethnicity and disability status. You will always have the option to ‘prefer not to say’ if you do not feel comfortable sharing this information.

Project summary

Please provide a short summary of your project and describe how it meets the scope of the competition.

Describe your project briefly. Be clear about what makes it innovative and how it relates to the scope of the competition. How does it tackle different aspects of the challenge and how will it provide an integrated solution?

Give details of the lead organisation. Before you submit we expect you to have discussed your application within your own organisation and any other relevant organisations.

List any organisations you have named as subcontractors.

Your answer for this section can be up to 800 words long.

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

Public description

Please provide a brief description of your project. This question is mandatory, but we will not assess this content as part of your application.

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. We have the right to amend the description before publication if necessary, but will consult you about any changes.

Your answer can be up to 400 words long.

2. Application questions

The assessors will score your answers for questions 2 to 8. Question 1 is not scored. You will receive feedback for each scored 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.

Question 1. Applicant location (not scored)

You must state the name of your organisation along with your full registered address.

If you are working in collaboration you must also state the name and full registered address of all your partners.

We are collecting this information to understand the geographical location of all participants of a project.

Question 2. Proposed approach

Provide a description and justification for your proposal and its intended use.

Explain how it has the potential to address the aims of the competition scope.

Describe the current state of development, validation or readiness of the solution.

You can submit a single appendix as a PDF containing images and diagrams to support your answer. It can be no larger than 10MB and up to 2 A4 pages long. The font must be legible at 100% zoom.

This question will be scored against this assessment criterion: ‘How well does the proposal meet the challenge?’

Question 3. Technical project summary

Give a short background to the main technical challenges you are looking to address.

Describe or explain:

  • how you will address the challenge
  • what the innovation is
  • the main technical deliverables
  • the research and development that will prove the scientific, environmental and commercial merit of the project
  • what might be achieved by deploying the innovation to address the selected challenge

This question will be scored against this assessment criterion: ‘How valid is the technical approach?’

Question 4. Current state of the art and intellectual property

Detail other products currently available on the market and how the innovation of your proposed project differentiates itself from them.

Include details of:

  • any existing intellectual property (IP)
  • its significance to your freedom to operate

This question will be scored against these assessment criteria: ‘How innovative is this project? How much does the project develop or employ novel concepts, approaches, methodologies, tools or technologies for this area?’

Question 5. Project plan and methodology

Describe your project plan and identify the main milestones.

The emphasis throughout should be on practicality. We are seeking evidence that the technology works, can be made into a viable product and can achieve the proposed benefits.

Describe or explain:

  • what resources will be needed to deliver the project
  • what the main success criteria would be
  • the identified project management processes that will ensure you achieve the milestones
  • the main technical, commercial and environmental risks and what you will do to mitigate them
  • how you would handle any IP issues which might arise during the project

Please ensure that if you are working with subcontractors you explain how you will maintain freedom to operate and fulfil the IP requirements detailed in the contract. Allow for the preparation of an outline development plan for a potential phase 2, towards the end of phase 1.

You must upload a project plan or Gantt chart as an appendix in PDF format no larger than 10MB and up to 2 A4 pages. The font must be legible at 100% zoom.

Your milestones must be:

  • clear
  • defined using SMART (specific, measurable, achievable, realistic and time-bound) criteria
  • associated with the appropriate deliverables and payments

You must indicate your required payment schedule by month.

This question will be assessed against these assessment criteria:

‘Does the proposal show a clear plan for establishing technical and commercial feasibility and the development of a working prototype? Is there a clear management plan? What are the main technical, commercial and environmental risks to project success? Will these be effectively managed? Are the milestones and evaluation procedures appropriate?’

Please note information from the finances section will be used to support the assessment of this question. Proposed milestones and associated payments stated in this section must match those entered in the finance summary on your application.

Question 6. Technical team and expertise

Provide a brief description of your technical team. Include the expertise of each team member or subcontractor that is relevant to your application, outlining why they are critical to the project’s success and how much of their time will be spent on the project.

This question will be scored against this assessment criterion: ‘Does the applicant have the skills, capabilities and experience to deliver the intended benefits?’

Question 7. Costs and value for money

How much will the project cost for phase 1? How does it represent value for money for the team and the taxpayer?

Describe or explain:

  • the total eligible project costs, inclusive of VAT, you are requesting in terms of the project goals
  • how this project represents value for money for you and the taxpayer

Indicate your potential costs for a phase 2 development plan.

Progression to the potential phase 2 depends on your success in phase 1.

You can submit a single appendix as a spreadsheet no larger than 10MB and up to 2 A4 pages long to support your answer. The font must be legible at 100% zoom.

Costs quoted must reflect actual costs at a “fair market value” and not include profit.

SBRI is a procurement of R&D services. If successful you will receive a contract to deliver the proposed activity. You will submit an invoice for the work undertaken. If you are VAT registered, your total costs are expected to include VAT that you would charge as a service provider. VAT is the responsibility of the invoicing business, and applications are expected to list total costs inclusive of VAT.

If you are not VAT registered, then you must give your costs without VAT. You will not be able to increase invoice values to cover VAT after you have submitted an application.

We cannot provide VAT advice and advise you to seek independent advice for example from HMRC.

Full Economic Cost (FEC) calculations are not relevant for SBRI competitions. SBRI is a competitive process and applications will come from a variety of organisations. Whatever calculation you use to arrive at your total eligible project costs your application will be assessed against applications from other organisations. Bear this in mind when calculating your total eligible project costs. You can include overheads but remember that this is a competitive process.

The assessors are required to judge the application finances in terms of value for money. In other words, does the proposed cost for effort and deliverables reflect a fair market price? They will score your finances against this assessment criterion: ‘Are the budget and costs realistic, justified and appropriate for the aims and methods?’

Please note information from the finances section will be used to support the assessment of this question. Proposed costs stated in this section must match those entered in the finance summary on your application.

Question 8. Commercial potential

Describe how you would realise the commercial potential of your proposal and to what timescales, including a clear plan to deliver that and a route to market. Focus on your proposed customer’s needs but you may also mention the future commercial potential across the public or private sector and the international market.

How far is the challenge you are addressing shared across the public and private sector in the UK and further afield? Describe the competitive advantage that your proposal has over existing or alternative technologies that meet market needs.

This question will be scored against these assessment criteria: ‘Is there a clear commercial potential for a marketable product, process or service and a clear plan to deliver that and a clear route to market? How significant is the competitive advantage of this technology over existing technologies that meet the market’s needs?’

3. Finances

Enter your phase 1 project costs, organisation details, milestones and funding details. For full information on what costs you can claim, see our project costs guidance.

You must select whether you are VAT registered before entering your project costs.

If you are VAT registered then you must enter your project costs exclusive of VAT. As part of the application process VAT will be automatically calculated and added to your project cost total.

If you are not VAT registered, then you must enter your project costs exclusive of VAT. You will not be able to increase invoice values to cover VAT later should you become VAT registered.

VAT is the responsibility of the invoicing business. We will not provide any further advice and advise you to seek independent advice from HMRC.

Background and further information

About Small Business Research Initiative competitions

SBRI provides innovative solutions to challenges faced by the public sector. This can lead to better public services and improved efficiency and effectiveness.

The SBRI programme:

  • supports economic growth and enables the development of innovative products and services through the public procurement of R&D
  • generates new business opportunities for companies
  • provides a route to market for their ideas
  • bridges the seed funding gap experienced by many early-stage companies

SBRI competitions are open to all organisations that can demonstrate a route to market for their solution. The SBRI scheme is particularly suited to small and medium-sized businesses, as the contracts are of relatively small value and operate on short timescales. Developments are 100% funded and focused on specific identified needs, increasing the chance of exploitation.

Suppliers for each project will be selected by an open competition process and retain the intellectual property generated from the project, with certain rights of use retained by the contracting authority. This is an excellent opportunity to establish an early customer for a new technology and to fund its development.

Data sharing

Your submitted application and any other information you provide at the application stage can be submitted to each agency on an individual basis for its storage, processing and use. Any relevant information produced during the application process concerning your application can be shared by one agency with the other, for its individual storage, processing and use.

This means that any information given to or generated by Innovate UK in respect of your application may be passed on to the Knowledge Transfer Network (KTN) and vice versa.

Innovate UK is directly accountable to you for its holding and processing of your information, including any personal data and confidential information. It is held in accordance with its Information Management Policy.

Innovate UK and KTN are directly accountable to you for their holding and processing of your information, including any personal data and confidential information. Data is held in accordance with their own policies. Accordingly, Innovate UK, and KTN will be data controllers for personal data submitted during the application.

Innovate UK complies with the requirements of GDPR, and is committed to upholding the data protection principles, and protecting your information. The Information Commissioner’s Office also has a useful guide for organisations, which outlines the data protection principles.

Further help and information

If you want help to find an organisation to work with, contact the KTN.

If you have any questions about the scope requirements of this competition, email support@innovateuk.ukri.org

If you need more information about how to apply or you want to submit your application in Welsh, email support@innovateuk.ukri.org or call 0300 321 4357.

Our phone lines are open from 9am to 11:30am and 2pm to 4:30pm, Monday to Friday (excluding bank holidays).

Innovate UK is committed to making support for applicants accessible to everyone.

We can provide help for applicants who face barriers when making an application. This might be as a result of a disability, neurodiversity or anything else that makes it difficult to use our services. We can also give help and make other reasonable adjustments for you if your application is successful.

If you think you need more support, it is important that you contact our Customer Support Service as early as possible during your application process. You should aim to contact us no later than 10 working days before the competition closing date.

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