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SBRI HEALTHCARE

Frequently Asked Questions (FAQs)

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FAQs

How does an SBRI competition work?

SBRI enables government departments to connect with technology organisations, finding innovative solutions to specific public sector challenges and needs. It aims to use the power of government procurement to accelerate technology development and/or implementation. SBRI offers an excellent opportunity for businesses, especially early-stage companies, to develop and demonstrate technology. SBRI is a simple structured process and offers different funding options depending on the maturity of the proposed innovation.

Phase 1 proposals concentrate on research and development which will significantly contribute to proving the scientific, technical and commercial feasibility of the proposed project. Phase 1 projects are eligible to apply for Phase 2, however the number of proposals funded depends on merit and is subject to budget availability. The principal research and development effort takes place in Phase 2, which aims to produce a well-defined prototype. At the end of Phase 2 it is intended that what has been developed will be manufactured and marketed as a way of fulfilling requirements.

SBRI Healthcare Phase 3 is independent from Phases 1 and 2, and a previous SBRI award is not a prerequisite to apply. Phase 3 focuses on the implementation of mature innovations to facilitate adoption by the relevant health or social care providers.

FAQ (All Phases) Eligibility

Am I eligible to submit an application to an SBRI Healthcare competition?

Any organisation can submit an application, although it is expected that opportunities presented by SBRI will be particularly attractive for SMEs. Organisations other than industry are expected to present a strong and robust plan for commercialisation.

SBRI is aimed at organisations working on the development of an innovative process, material, device, product or service. Successful applications will be those whose innovation best addresses the specific needs identified, with the potential to make a measurable improvement to currently available products, processes, materials, devices or services.

Development contracts will be awarded only to individual organisations. However, organisations may wish to demonstrate how collaboration with the relevant partners will enhance their overall development. Work may be subcontracted but this is the responsibility of the main contractor.

I am a pre-startup company, can I apply?

Yes, but contracts must be awarded to legal entities.

I am based at a university, can I apply?

Universities may apply; however, they must demonstrate a route to market, i.e., the application must include a plan to commercialise the results. It is unlikely that a university on its own will be able to demonstrate the appropriate level of commercialisation to be successful beyond Phase 1; therefore, the application should explain how the product will be developed by a commercial organisation or lead to sustained adoption in the relevant setting(s).

What innovations are considered eligible for SBRI Healthcare?

Competitions are open to any innovation, including medical devices, in vitro diagnostics, digital health solutions and AI solutions, behavioural interventions, and service improvements. All innovations must meet the entry criteria and challenges described in the Challenge Brief on the individual competition page.

Can I apply for a SBRI Healthcare award if I have other sources of funding?

Applicants with other sources of funding are eligible to apply to SBRI Healthcare, provided the project that would be funded by SBRI Healthcare is not already supported by another funding stream. Applicants must articulate how the SBRI Healthcare award would be distinct from existing studies and what additional evidence would be collected to support the development, implementation and/or adoption of the proposed innovation.

My company is a registered charity, can I apply?

Yes, registered charities are eligible to enter SBRI competitions via their trading company limited by guarantee. All organisations must demonstrate a route to market.

I am based outside of England, can I apply?

Applications are accepted from the UK and any country in the European Union, including associated countries for EU Research and Innovation. However, please be aware that projects must show a clear health benefit to the UK.

Legal entities from all other countries may be project partners, but cannot be the lead organisation.

Can I sub-contract work outside of England or the UK?

In principle this is possible, as long as the applicant can demonstrate that the subcontractors have the appropriate expertise, value for money and how this will benefit UK healthcare and the economy.

Are there preferences in the type of organisations selected to lead a project?

All applications are assessed based on the quality of the proposal by relevant experts based on the published criteria. Irrespective of the host organisation, all applications are expected to demonstrate that the right expertise is available for the support of the project (e.g., if a trial is included, the involvement of a healthcare provider would be expected) and route to commercialisation.

Project Partners

Do I need to have a clinical partner and do they need to be identified prior to submission?

For Phases 1 and 2, it is strongly advised that clinical partners are identified prior to submission. The most successful applicants demonstrate an existing relationship with a named clinician or similar expert at the time of application. Ideally this will be a named NHS member of staff with whom you have had at least initial discussions about the feasibility of your project.

For Phase 3, it is mandatory to have a clinical partner identified and their commitment secured.

I am in touch with NHS Trusts and sites, would these count as clinical partners?

Yes, NHS sites can be clinical partners. Please list all clinical partners in the application by providing the name, details and role description in the appropriate section of the application – up to 10 clinical partners can be added. If there are multiple clinical sites involved, please provide the main contacts/people responsible for this project at each of the NHS sites. We do not expect a supporting letter from the organisation.

Do I need to partner with one of the health innovation networks to be eligible to apply?

It is not an eligibility criteria to partner with a health innovation network; however, it is strongly encouraged that you do. The health innovation networks are uniquely positioned to support the development of health innovation and, by partnering with them, you can tap into their knowledge, expertise and networks to support the spread and adoption of your technology. Any organisation based in the UK (including Scotland, Northern Ireland and Wales) can access the Health Innovation Network.

Can I work in collaboration with other companies?

Contracts will only be awarded to individual organisations. However, applicants may identify components of the work which they wish to subcontract and may also employ specialist consultants or advisers if they believe this will increase the chances of the project being successful.

What is the best way to find project partners (commercial partners or clinical partners)?

We strongly advise that you get in touch with your local health innovation network to develop partnerships and get advice. You can also contact your local university. Alternatively the signposting service can help you find the right partners. The NIHR Office for Clinical Research Infrastructure (NOCRI) can also help connect you to experts in the NIHR research facilities and facilitate collaboration between your company and clinicians.

To find out more information on the Health Innovation Network and their contact details, you can visit their website here

Applicants must demonstrate a route to market, i.e., the application must include a plan to commercialise the results. Applicants must will be able to demonstrate the appropriate level of commercialisation to be successful beyond Phase 1; therefore the application should explain how the product will be developed by a commercial organisation or lead to sustained adoption in the relevant setting(s). Some examples could include contacting health innovation networks, health economics consultancy agencies, desktop research and competitive analysis, clinical champions, patient representation groups, charities, potential customers etc.

Can you submit an application with a University partner?

Yes. Competitions are open to single organisations (contracts are executed with individual legal entities) based in the UK or EU from the private, public, and third sectors, including companies (large corporates and small and medium enterprises), charities, universities and NHS providers,
as long as a strong commercial strategy is provided. Organisations based outside the UK or EU with innovations in remit can apply as subcontractors of a lead UK/EU based organisation or via a UK or EU subsidiary.

How much do health innovation networks charge for their service?

Different health innovation networks have different processes. Initial contact is generally free and often with the health innovation network commercial team for signposting and advice & guidance. This is often a scoping exercise to understand the innovation and which gaps may need addressing. If an innovator decides to engage further with a health innovation network such as using a health innovation network for clinical work, health economics, or other reasons, the charges are usually agreed on a case-by-case basis. These would be acceptable project costs.

The health innovation networks can also often assist in addressing health inequalities and the NHS Net Zero agenda, procurement implications and carbon calculators.

Evidence

Do clinical trial studies need to take place in the UK?

Although this is not an eligibility criterion, it is strongly advised that clinical evaluations are conducted in the UK as the SBRI Healthcare programme acts as a pre-procurement programme and the main objective is to address NHS needs. As such, it is expected that any evidence generated can be translated to demonstrate the innovation’s applicability to be adopted into the NHS.

Would clinical evidence gathered in other parts of the world be considered appropriate for this application?

Clinical evidence can be derived from anywhere in the world and could be considered as appropriate, provided there is clear evidence that this is applicable to the chosen NHS care pathway in the UK. Irrespective of where the evidence was derived, applicants should ensure the innovations are suitable for or could be adapted for the NHS or the relevant care provider in the UK.

Our technology is agnostic and can be applied to different clinical questions, do we need to show experimental data specific to the competition clinical area/s to be eligible to apply?

Innovations that are being repurposed from other clinical areas are eligible to apply if there is sufficient evidence to demonstrate its applicability to the clinical areas of the competition. This is dependent on the evidence generated for your innovation. Please note, the different Phases have different requirements.

My innovation was developed with the NHS clinical teams without public and patient involvement and engagement (PPIE), am I eligible to apply?

While the programme appreciates that innovations may require different levels of PPIE during development, it is expected that the organisation has involved patients/members of the public during the research and development phase. PPIE is one of the assessment criteria and will be reviewed by a Panel of experts, including PPIE members.

There should be continued PPIE as part of the project, to ensure that patients and members of the public are involved and can provide feedback that will support the refinement of the innovation during the implementation stage, and this should be clearly described in the application.

Are innovations developed for social care and adopted by the local authority eligible?

Yes. We recognise the importance of innovations designed for the community, education, or home environment in addressing health challenges, and would welcome applications for these innovations provided they address the challenges described in the respective brief and meet the entry criteria.

The SBRI Healthcare development agreement is with a NHS Trust, does this suggest that public engagement should take place in or that solutions should be directed towards the Trust’s geographical region?

No, solutions can be directed towards any region in the UK. Nottingham University Hospitals only acts as a legal entity for administrative purposes on behalf of the funder and their involvement does not affect the national ambition and benefits that the SBRI Healthcare programme aims to achieve.

Funding

Who owns the Intellectual Property generated by the project?

Intellectual property rights are retained by the applicant although certain rights of usage may be applied by the funding authority including royalty-free, non-exclusive licence rights and the right to require licences to third parties, at a fair market price. Applicants are encouraged to review the standard SBRI Agreement before applying.

As a university should I use Full Economic Cost (FEC)?

No. Costs should be calculated to reflect fair market value.

Can an SME be the lead applicant for the application or does it have to be an NHS trust/organisation? Will the funds be directly allocated to the SME or to the NHS body?

SMEs can be the lead applicant on the application, and collaborate with an NHS provider for the delivery of the study. Funds will be paid to the lead organisation who will be responsible for paying collaborators and subcontractors where applicable.

Is there any flexibility on the project start date?

Successful projects are expected to start by the start date indicated in the outcome letter. To reduce the gap between Phase 1 and 2 awards, we require that all Phase 1 projects start and end at the same time. If the project team is unable to start by the required start date, the alternate start date of Phase 2 and 3 projects must be discussed and agreed with the SBRI Healthcare Programme Management Office.

Should project costs include VAT?

The application’s maximum budget and itemised project costs should exclude VAT. Please note that SBRI Healthcare awards are subject to VAT. If applicable, the host organisation may invoice SBRI Healthcare with 20% VAT in addition to the NET cost. It is the host organisation’s responsibility to determine if VAT is applicable.

Please note, the maximum allowable project cost differs between the different SBRI Healthcare Phases.

Can overheads be included in project costs?

An element of overheads may be included in project costs. However, such an element must be realistic. Assessors will consider financial costs in terms of ‘value for money’ at the assessment stage. Projects showing costs that are considered unreasonable may be rejected on these grounds.

Do SBRI Healthcare awards constitute State Aid?

No, SBRI Healthcare is not a research grant and follows pre-procurement rules and does not constitute state aid.

Is any match funding required?

No match funding is required.

How many awards will be made in each competition?

We cannot give a specific number as the amount of awards will be subject to budget availability.

Competitions - Phase 1 and 2

If a product is already on the market but in need of further R&D, would that be excluded?

Although there is no specific entry point for a Phase 1 award, it is important to note that Phase 1 awards should focus on the establishment of the technical merit, feasibility and commercial potential of a proposed technology.

Examples of exit points include:

• Feasibility technical study
• Market validation
• Business plan developed
• Clinical partners identified
• Evidence generation plan for adoption
• Development of PPIE strategy
• Health inequalities impact assessment

What is the minimum entry point for a Phase 1 award and what activities are fundable under a Phase 1 award?

Phase 1 awards enable the establishment of the technical merit, feasibility and commercial potential of a proposed technology. While demonstration of proof of concept is not required, the most competitive proposals are those with some data to support the case for further development and illustrate technical feasibility. Project costs can include:
• Labour
• Materials
• Capital equipment
• Subcontractors
• Travel & subsistence
• Indirect costs

At the end of Phase 1, projects are expected to have established the technical merit, feasibility, and commercial potential of the proposed technology. Examples of exit points include:

• Feasibility technical study
• Market validation
• Business plan developed
• Clinical partners identified
• Evidence generation plan for adoption
• Development of PPIE strategy
• Health inequalities impact assessment

Do I need to have a Phase 1 award to be eligible for Phase 2 or can I apply directly to Phase 2?

Companies must first apply and be successful in securing Phase 1 funding in order to have access to Phase 2.

Applicants cannot apply to Phase 2 directly. The aim is to de-risk projects and allow organisations to deliver feasibility work to make a stronger bid for Phase 2. Subject to NHS England budget and priorities, Phase 1 awardees may be invited to apply for Phase 2 during the course of their Phase 1 project.

Can sites involved in Phase 1 be different in Phase 2?

Yes, it is possible. We suggest clarifying this point in the application by providing justification for the addition/exclusion of sites.

Can we apply for a Phase 1 project that is longer than 6 months in duration?

No, the maximum project duration is not negotiable and cannot be extended for funded projects.

What are the requirements for the supporting video pitch to be submitted for the Panel meeting?

If your application has been shortlisted, you will be required to submit a video pitch to support your application assessment at the Panel meeting. The video should be no longer than 3 minutes and in MP4 format. Please upload the video on the file sharing platform of your choice and send the video link to SBRI@lgcgroup.com.

Would any development of prototypes be expected during a Phase 1 project?

At the end of Phase 1, projects are expected to have established the technical merit, feasibility, and commercial potential of the proposed technology. Examples of exit points include:
• Feasibility technical study
• Market validation
• Business plan developed
• Clinical partners identified
• Evidence generation plan for adoption
• Development of PPIE strategy
• Health inequalities impact assessment

Following successful completion of Phase 1, projects can apply for further funding at Phase 2 to continue development, subject to budget availability. It is expected that at the end of Phase 2, some of the following will be achieved:
• Minimum viable product developed
• Early clinical evidence gathered to demonstrate safety and accuracy
• Developed commercialisation strategy
• Health economics
• Evidence gathered towards regulatory approval
• Implementation plan for adoption
• Strong involvement and engagement with patients and the public
• Next stream of funding identified / investment readiness

If an innovation has already been developed and deployed into the NHS, would Phase 1 still be suitable?

Yes, it could be eligible. Details on technologies excluded from competitions are available in the competition challenge briefs

Is it permissible to submit a proposal that has been part of a previous SBRI Healthcare phase one project?

It is possible to submit a proposal from a technology that has been part of a previous SBRI Healthcare Phase 1, provided there is no overlap between the projects

Is there analytics support?

HecoAnalytics are contracted by SBRI Healthcare to provide a Health Economics (HE) analysis package for SBRI Healthcare Phase 1 projects. The package of work is completed throughout the Phase 1 project to allow companies to assimilate the HE output and to integrate it into their development plans for Phase 2 accordingly. The package consists of a NICE META Tool analysis and HecoAnalytics’ Evidence Map.

Competitions - Phase 3

Do I need to have obtained SBRI Healthcare Phase 1 and 2 awards to be eligible for Phase 3?

Phase 3 is a standalone and independent competition; thus, previous SBRI awards are not a pre-requisite for Phase 3.

What activities are funded under Phase 3?

Phase 3 projects should concentrate on implementation of the innovation in the relevant setting and collect the evidence that will facilitate subsequent adoption, procurement, or recommendations in official guidance. Activities that would be supported include, but are not limited to:
• Implementation studies
• Human factors
• Technology refinement
• Developing a partnership with the relevant NHS, health or social care setting, or other providers.
• Health economics and cost benefit analyses
• Activities in relation to Intellectual Property, freedom to operate and market analysis
• Activities associated with the dissemination of outputs SBRI Healthcare

Phase 3 does not support proposals to procure products or services without the intention to generate evidence to support implementation and subsequent adoption.

What is the minimum entry criteria to enter a Phase 3 competition?

Phase 3 competitions are open to innovations that are in the advanced stage of development and demonstrate that they have the following evidence:

• UKCA marked or CE-marked with a clear timeline to achieve UKCA. If UKCA, CE-mark or equivalent regulatory approval is not yet obtained, there must be evidence to demonstrate that the innovation is close to obtaining approval and/or a product/solution in use in at least one Trust.
• A clear partnership established with the relevant service(s)/site(s) and clinical team(s).
• Clinical efficacy and safety demonstrated through clinical trial(s).
• For digital solutions, evidence that the technology has passed or close to passing the necessary information governance and cyber security requirements where relevant. Evidence that the NHSX Digital Technology Assessment Criteria (DTAC) has been considered should be demonstrated in your proposal. In addition to fulfilling the entry criteria, it is expected that the innovation addresses the challenges described in the competition challenge brief.

Application

How do I submit my application?

All bids should be made using the SBRI Healthcare Programme Management Office Research Management System (RMS) Application Portal.

You must create a login using your email address and a password.

Please note that all project partners should be invited to the application through the system via email to participate as co-applicants after which they must confirm and approve their participation; the application cannot be submitted without doing so.

Details of the challenge and expected outcomes of the projects can be found in the project documents. You are strongly advised to read all published competition documents before completing the application form.

If my application fits more than one sub-category theme, can I apply to more than one?

Applications may fit multiple sub-categories; however, you may only select 1 category on the application portal so please select the most appropriate. The funding envelope is for the entire competition and funding is based on quality. There is no specific budget allocated to different challenges and categories. Thus, there is no advantage or disadvantage to selecting a specific sub-category theme.

Please note, given the duration of SBRI Healthcare awards, applicants are encouraged to consider what evidence could be feasibly collected within the project duration.

Can each organisation submit more than one application?

Organisations are welcome to submit more than one application if they have multiple innovations that address the challenge brief and meet the entry criteria. However, there must be significant differences between the innovations submitted and consideration given towards the resources needed to deliver the projects.

How are applications selected for funding?

Proposals will be reviewed and shortlisted based on the input of a group of selected assessors with the relevant expertise.

For Phase 1, shortlisted applicants are invited to submit a video pitch to support their application which is reviewed by a Panel of experts and patient/public representatives.

For Phase 3, shortlisted applicants are invited to attend an interview with a Panel of experts and patient/public representatives.

For more information on the application and assessment process, please refer to the Invitation to Tender and launch webinar recording.

Who should I contact if I have any further questions?

Questions about SBRI Healthcare competitions should be sent to sbri@lgcgroup.com.

Questions about SBRI as a government programme should be addressed to support@innovateuk.gov.uk.

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