Guidance for Applicants - Phase 3

Information entered into this section provides a summary of your application.

Application title
Please provide the title for the project. This should be descriptive, concise and contain keywords relevant to the project. Any abbreviations should be spelled out in full.

Sub-challenge selection
Please select the appropriate sub-challenge addressed by your innovation.

Host organisation
Please name the organisation that will be responsible if the project is funded. Including management of the funding, project deliverables and arising intellectual properties.

Contract duration
Projects can be up to a maximum of 12 months for Phase 3.

Total contract cost (NET)
This will be auto-populated based on the information provided in Section 6.

• The upper funding limit of SBRI Healthcare Phase 3 competitions is £500,000 excluding VAT.

Name of innovation
Please provide the name of the proposed innovation.

Type of innovation
Please choose the most appropriate description of the innovation using the dropdown list provided. If “Other” is selected, please provide a short description of the innovation.

Technology readiness level (TRL)
Please choose the most appropriate TRL of the innovation using the dropdown list provided.

Health category
Please choose the most appropriate health category related to your application using the dropdown list provided.

Health Innovation Network involved in the project
Please select all that apply from the list provided.

Health Innovation Network role
Please describe the role of the Health Innovation Network in the project (max 50 words).

Complete details relevant to your organisation. Please choose from the dropdown list where provided.

• Host organisation website

• Company registration number (for those in the UK)

• Region (where the host organisation is registered, using the dropdown list provided)

• Type of organisation

• Host organisation size

• Host organisation status

• Annual turnover (max 10 words)

A plain English summary is a clear explanation of your project. The plain English summary may be used to inform reviewers, including experts who might not have specialist knowledge of your field as well as public members/patients who might review your funding application. If your application for funding is successful, the summary may be used on the SBRI Healthcare website.

Please make sure your summary is free of technical jargon, easy to read, and provides an overview of your proposal.

It is helpful to involve patients / carers / members of the public in developing a plain English summary.

When writing your summary consider including the following information where appropriate:

• aim(s) of the project

• background to the project

• design and methods used

• patient and public involvement

• dissemination

The plain English summary is not the same as a scientific abstract, please do not cut and paste this or other sections of your application form to create the plain English summary.

Please provide a narrative description for what the innovation is and how it addresses the theme AND sub-challenge selected.

• The following should be provided:

• A brief description of the proposed solution

• What is the problem that the solution aims to address and how does this meet the published challenge brief?

• What are the expected outcomes of the project?

• How will the solution benefit patients, the NHS and/or Social Care sector and the wider market?

The applicants should address the following questions in detail:

What stage of development is your innovation?

Please state whether the proposed technology is in use in the NHS or elsewhere, specifying if it is in research settings, piloted roll out or routine use.

The following evidence should be provided:

• UKCA certification for the innovation in the proposed pathway. Please provide proof of certification using “Regulatory approval document and evidence” attachment in Section 7.

• If not yet CE marked/UKCA certified, evidence must be provided that this is in progress and whether approval will be obtained within the duration of the project.

• If CE marked but not yet UKCA certified, please provide a clear roadmap to achieve UKCA mark by June 2028 for general medical devices or June 2030 for in vitro diagnostic medical devices.

• If CE mark or UKCA are not relevant, please specify if other regulatory approval is needed and whether this has been obtained.

• Please state whether the innovation has been through the NICE Early Value Assessment and whether it was recommended for early use in the NHS subject to fulfilment of NICE Evidence Generation Plan.

• Digital interventions must consult the NICE Digital Health Technology Framework and the application should evidence plans to meet the appropriate evidence guidelines. This comprises both clinical effectiveness and economic evaluation. Please consult the NHS England guidelines for “Designing and building products and services” for the latest links to relevant standards, guidelines and consultations.

• Evidence that NHS Digital Technology Assessment Criteria (DTAC has been considered, if relevant.

What is the evidence?

• Please provide demonstration and evidence of clinical safety and efficacy through the appropriate studies, e.g., clinical trials.

• This may include a description of the size of sample evidence, which may include the number of patients/participants and sites involved in the generation of evidence.

• Whether Patient and Public Involvement and Engagement (PPIE) played a role in the development of the innovation and how PPIE contributed to the studies to gather evidence.

Please provide a list of references cited throughout the application including the list of evidence on safety and efficacy (e.g., sensitivity, specificity, positive and negative predictive values (PPV and NPV respectively)) of the proposed solution (i.e., peer reviewed publications, conference proceedings, poster, reports, etc.) in Section 7 “Supporting Information”.

Where does your innovation fit within the care pathway?

• Please provide (as an attachment in Section 7) a schematic illustrating how your innovation will disrupt the clinical pathway and compare with standard practices. Please aim to include all steps in the pathway (triage/analysis etc.).

• Describe how your innovation would improve the proposed care pathway (e.g. better patient outcomes, reduced hospital admissions, length of hospital stay, workforce required, etc.) providing statistics/percentage of the improvement where available.

What is the impact on the system?

• This may include a description on how the innovation would impact health services, how the system will need to adapt (including people, process, and culture) in order to deliver system-wide benefits.

The applicants are expected to provide the following information:

• The proposed work packages, including PPIE, equity of access and net zero elements of the proposal.

• Detail of what will be conducted within each of the work packages, the rationale behind these work packages, key measurable deliverables, and how these will be delivered.

• Make sure you provide an appropriate level of detail for the proposed study design. This may include both quantitative and qualitative methodologies, power calculation, study cohort, the patient/service users affected and if relevant, implementation research plan in the context of where the innovation will be delivered.

• Include steps needed to obtain relevant approvals, if applicable.

• A project Gantt chart to support the project breakdown must be provided as an attachment in Section 7.

• Key risks to the project and state how these will be mitigated against.

• If you are not planning to engage with patients, you MUST explain why.

All projects are strongly recommended to conduct an independent (service) evaluation as part of the project (within the duration of the project). Projects without an independent evaluation partner must provide an evaluation strategy and detail the outcomes to be measured. It is important that your evaluation is robust and can undergo independent scrutiny. The aim of the evaluation is to understand how your innovation is implemented, what effects it has, for whom, how, and why.

Please consider the following elements when designing a real-world evaluation study: 

• The unmet need assessed by relative priority nationally or regionally, including assessment of potential health gain.

• The outcomes are strong enough to support scale and spread as expected.

• The proposed method of implementation is easy, credible and adaptable for spread, including technical and operational elements.

• Resources (finance/staff) are quantified and available across sufficient proportion of market.

• There is appropriate economic assessment (e.g., return on investment).

Please include the following detail in your real-world evaluation strategy:

• Your overarching evaluation aims (e.g., health economics, health outcomes, enablers and barriers to implementation and delivery) 

• The evaluation methods you propose to carry out (e.g., process, impact, economic) 

• A logic model. Applicants must attach a schematic to illustrate this in Section 7 “Supporting information”.

• Potential evaluation outcomes may include (this is not an exhaustive list):

  • Clinical outcomes

  • Time to and accuracy of diagnosis

  • Outpatient appointments, including follow-up appointments

  • Inpatient admissions, including bed-days, length of stay, and readmissions

  • Ambulance calls

  • Primary care appointments

  • Medicines use

  • Workforce capacity

  • Releasing beds

  • Quality of life

  • Patient Experience

  • Efficiencies

  • Acceptability by patient and clinicians

  • Costs, including procurement cost, associated costs, downstream cost, cost-saving, cost-releasing

  • Sustainability and environmental impact

• Your proposed evaluation partner, or if not known, an outline of the plan and a realistic cost estimation should be provided. Furthermore, please describe your approach for appointing an independent evaluation partner. 

Please list up to 10 key milestones for Phase 3 projects along with timings for completion. The number of milestones should be appropriate for the project, you do not need to use the maximum number.

The milestones should be comprehensive (including but not limited to technical, clinical, commercial activities, net zero, PPIE and equity of care, health economics/evaluation and impact and ethical/regulatory approvals) and the success criteria able to be assessed objectively (e.g. ‘all tests delivered to 99% accuracy’ or ‘for statistical significance, 2000 samples must be processed’) with an emphasis throughout on practicality as this initiative is seeking evidence that the technology is viable in the proposed setting and can be effectively deployed to, and adopted by, NHS trusts. Appropriate record keeping and reporting are essential, but reports are not in themselves the main goal of the project. Please indicate the roles that would contribute to the milestone under ‘Resource’.

Please provide details of any direct competitor or market alternatives, which should include the following:

• The advantages of the proposed solution compared to the current standard of care.

• How your proposed solution is innovative.

• Details of any competing innovations or alternatives in the wider market (either on the market or in development) and description of the advantages and innovativeness of your proposed solution over these (i.e., what is your unique selling point).

• If there are no competing innovations, please describe how your proposed solution compares to current standard of care.

• Companies may wish to consider working with other companies to bring forward solutions that can make a real difference.

The definition of Intellectual Property (IP) includes patents, trademarks, designs, copyright (such as new software, checklists, scales, protocols, questionnaires, toolkits, guidelines or similar), research tools (such as data analysis techniques, assays, cell lines, biomarkers, materials or equipment and devices) and (clinical) data.

Please provide details on the following:

• Any relevant existing background IP that will be utilised during the project and the current ownership arrangements, including patents or patent applications.

• Any foreground IP which will be produced or improved during the project and how this IP will be captured and managed. Also provide details regarding expected ownership of foreground IP.

• Any Freedom to Operate (FTO) search that has been conducted to date. If no search has been conducted, please explain your rationale.

Please give an overview of your commercialisation and implementation strategies, and business plan for the product or service you are developing, including market launch and long-term adoption. Please include:

• A review of the market size and expected penetration rate (Total Available Market, Serviceable Available Market, Serviceable Obtainable Market) for proposed innovation in the UK, NHS and beyond (EU, US, etc) including growth rate of the market.

• Barriers to market entry.

• An overview of your commercialisation and business plans, with consideration of who will use the solution, the likely cost of the solution and/or price strategy, and who will be the payer.

• Your business model for local/regional/national NHS adoption, including implementation costs/implications, workforce requirements, etc.

• If additional funding/investment is required to adopt the solution and if so, what are your plans to raise the required capital.

• If applicable, what are the plans for manufacturing the product and its current scale of production. How easy it is to scale up and if there are any issues that need to be resolved in order to institute a reliable manufacturing process.

• Stakeholder engagement plan to support end user/operational/clinical uptake/buy-in/roll out of the innovation.

• The expected timescales for regional/national spread and the steps needed for adoption after the project.

• Plans for long term sustainability of the technology.

• How you will ensure that the innovation is affordable to the end users, NHS, and the wider system such as Integrated Care Systems (ICSs) both immediately and throughout the life of the product.

• The evidence, both health economics and delivery of true impact, the NHS and wider system will require before the technology can be adopted.

• What steps will be taken to ensure adoption of the innovation following the completion of the project.

NHS England are committed to giving patients and the public a voice. The SBRI Healthcare Programme has embraced this vision and has incorporated patient and public involvement and engagement (PPIE) in the scheme to ensure proposed innovations address the needs of patients and carers, as well as clinicians and health system leaders and users.  

Patient and Public Involvement and Engagement (PPIE) is an accepted and recommended working practice within healthcare research ensuring that solutions are co-produced with patients, meet patient needs, and to ensure there is an acceptability among end-users. Applicants are expected to develop a thorough PPIE strategy as part of their project. Please consider including the following information in this section:

What are your plans for PPIE? Please provide specific details such as the way you will be involving and engaging with the patients and the public, the frequency at which you will plan activities and the specific outputs.

How will the relevant patient groups be involved in the development of innovation roll out and NHS adoption strategy?

How will you ensure that the innovation will be acceptable to patients, their families, carers, the wider support network, and healthcare professionals?

For further information regarding PPIE, we strongly recommend applicants refer to the NIHR Guidance including guidance on reward and payment for involvement, as well as an evidence-based guide on how to involve and engage patients in digital health tech innovation.

The SBRI Healthcare Programme is committed to promoting equality, diversity and inclusion, and reducing health inequalities through the development of technologies and solutions it is funding.

Please provide the following detail in this section:

• Whether the innovation might exacerbate health inequalities, which group(s) of the public/patients might be affected and how might you minimise this.

• How the proposed innovation will ensure equity of access (e.g., underserved ethnicities, under-represented groups, economic groups, vulnerable groups, geography, digital exclusion, etc) along with the steps to understand and alleviate potential negative impacts. More information on what constitutes a health inequality can be found on The King’s Fund website.

• Given the rural nature of many places, an over-reliance on home and community interventions needing to be permanently online should be considered (Wi-Fi and phone signals in rural locations may be weak or unreliable).

• The cost of data use, which would negatively impact on accessibility by some low income or marginalised communities.

• Please explain your assessment of local healthcare inequalities relative to the selected theme and the challenges facing your population, including which data sources have been used for inform this assessment and articulate the plans and objectives that are in place to deliver improvement against these challenges.

Health Innovation Kent Surrey Sussex (KSS) has developed a Health Equity Framework – 10 core principles to think about when designing or implementing an innovation. Applicants are invited to consult the document and ensure they consider health equity in all their decision making. The questions below should be used to anticipate, assess and prevent potential adverse inequities of proposed solutions to different population groups.

Applicants are required to ensure that proposed technologies/solutions are considering steps towards the carbon neutral strategy and objectives for the NHS.
Impact of the innovation on NHS care delivery

• Please provide, in simple terms, the environmental impact that your innovation may have in the care pathway / care setting it is intending to operate in, including how it may contribute to reducing the NHS carbon emissions (as explained in the Delivering a net zero NHS report, pages 11 and 12). Please use the low carbon care STEPS guidance to help with your assessment of the impact of the innovation on the care pathway.

• Have you quantified or estimated the carbon emissions associated with the implementation of your innovation? If yes, please provide some details about the net carbon impact and, if used, the methodology used to get these results. The low carbon care STEPS guidance can also be used to demonstrate impact and use proxies for carbon emissions.

• Organisation commmitment

Please provide an outline on how you are planning to align with the NHS Sustainable Supplier Roadmap and carbon reduction targets: 

Are you aware of the NHS Sustainable Supplier Roadmap, the Evergreen Framework for suppliers and the carbon reduction targets? Y/N, please specify. 

What are you currently doing and planning to do regarding your product(s) and at an organisation level, to fulfil the requirements set by the NHS supplier roadmap? How will you ensure you align with the supplier roadmap and how long do you think it will take for readiness to fulfil the requirements set by the NHS Supplier’s roadmap? 

 As you plan to implement at scale in the NHS and grow, what measure will you take to control your emissions (considering manufacturing plan, supply chain, organisation growth, etc). 

Please add details of all team members and their role in the project. A maximum of 10 team members can be added. Do not include sub-contractors in this section.

Team members are those that belong to the host organisation with responsibility for the day-to-day management and delivery of the project. Those outside of the host organisation should be listed as sub-contractors or advisors.

Members of the project team will need to be registered and approved on the RMS portal before they can be added to an application. After being added to the application, they will first be ‘invited’ by the RMS to participate as a team member; if they accept, they will receive a further email to confirm their participation. The same process applies with the clinical partners and sub-contractor.

Please note that the application will not submit unless all team members added have confirmed their participation.

Please provide a job title, detailed description of the role performed in the project, time allocated to the project and relevant experience and skills. Time allocated to the project should ideally be expressed as an FTE percentage (the time allocated during the period of the project indicated as a proportion of the working hours for a Full Time Equivalent position).

Relevant commercial and management expertise of team members should be included.

Sub-contractors and advisors are individuals that do not belong to the host organisation and will provide a fee for service (or in-kind contribution); clinical partners should be listed in clinical/HCP partners' section.

Please provide the details of any sub-contractors or advisors involved in your application. A maximum of 10 sub-contractors/advisors can be added. Please provide a job title, detailed description of the role performed in the project, time allocated to the project and relevant experience and skills of the sub-contractor(s) or advisor(s).

The use of sub-contractors is optional; however, where your proposal involves sub-contracted individuals or companies, or benefits from the input of named expert advisors, details should be provided.

While quotes for activities can be in the form of forecasts in this application, you will be asked to provide formal quotes as part of the due diligence process if you are successful. If an advisor provides services at no cost or at a level of expenses incurred only, this detail should be indicated.

Clinical/HCP partners are individuals that do not belong to the host organisation and will provide a fee for service (or in-kind contribution) in relation to the clinical elements of the project.

Please provide the organisation name, clinician/HCP’s job title, a detailed description of the role performed in the project, time allocated to the project and relevant experience and skills of the clinical/HCP partner(s).

The use of a clinical/HCP partner is not mandatory, but it is strongly recommended. A maximum of 10 clinical/HCP partners can be added.

Please provide a detailed description of any other posts that are yet to be confirmed or appointed for the project. Please also provide the job title, a detailed description of the role performed in the project, time allocated to the project and relevant experience and skills that are required for the role. Those named in “Other Posts” will not be able to join the Interview Panel.

Please note that SBRI Healthcare is not a grant and not VAT exempt. If you are successful, you will be awarded a Development Agreement which is subject to VAT. All project costs should be indicated as NET cost incurred and a VAT charge at 20% may be applied. Please note the maximum cost a proposed project can request is detailed in the Competition Brief and the associated Invitation to Tender.

Full economic cost calculations are not relevant in this context. SBRI is a competitive procurement mechanism, and tenders are submitted by a variety of organisations. Whatever calculation you use to arrive at your tender price, your application is assessed against bids from other organisations. The assessors will also judge whether it reflects a fair market value. You are entitled to include overheads but remember that this is a competitive tender. You should bear this in mind when calculating your tender price.

Please provide a line-by-line summary of the costs of the project in the table supplemented. The costs quoted must reflect actual costs at a “fair market value” and profit should not be included.

All costs are eligible except for pure marketing costs (such as LinkedIn Premium, website development, marketing brochures), costs to support basic research, development of research hypotheses, and experimental designs that have no practical commercial application.

Please note that when indicating costs, the NET costs should be provided in the respective rows of the table supplemented. Please see some general guidance here.

• Labour costs (for all those contributing to the project)

• Material costs (including consumables specific to the project)

• Capital equipment costs

• Sub-contract costs

• Travel and subsistence costs

• Indirect costs

• Other costs specifically attributed to the project

• Total NET costs (auto populated)

Please confirm if you will be claiming VAT at 20% (please tick yes if you will apply VAT to the total costs). Please note VAT is the responsibility of the invoicing organisation.

Please provide a justification of the costs, or staff involved, and quotes from sub-contractors where applicable. If there is significant use of sub-contractors, please explain how these will be used and the costs of each. Please note the Assessors are required to judge the application finances in terms of value for money, evaluating whether the proposed cost for effort and deliverables in a proposal reflect a fair market price. Applicants are strongly encouraged to consider the guidance provided in the Cost breakdown section below and summarise the elements in the application justification section.

Itemisation of costs and methods of calculation may be requested at a later date to support the application.

Cost breakdown

Please download, complete and finally attach the Finance spreadsheet with the details of all your costs following the different costs categories:

• START – AWARD DETAILS

• Labour costs

• Material costs

• Capital equipment costs

• Sub-contract costs

• Travel and subsistence costs

• Indirect costs

• Other costs

Please note that for the application to be considered, a complete breakdown of the requested budget using the template provided is required. Budget provided in other formats will not be accepted. The funding requested in the spreadsheet must be aligned with the application form.

Please consider the following when completing the spreadsheet:

Labour costs

• In the Labour costs section, please provide details of posts and salaries of team members. This includes name, role, grade (put N/A if not relevant), annual salary and on-costs (cost incurred by the organisation to employ someone), %FTE dedicated to the project and the total number of months on the project (1-12). Please also include details about staff that are to be recruited and justify staff positions in the ‘Justification of Costs’ section at the bottom of the sheet and ensure the posts/figures entered are in line with those entered in the application form.

• Full economic cost (FEC) calculations are not relevant in this context. SBRI is a competitive procurement mechanism, and tenders are submitted by a variety of organisations. Whatever calculations are used to arrive at the tender price, each application is assessed against bids from other organisations. Applicants should bear this in mind when calculating their tender price. Costs should reflect fair market value.  

• Review salary costs and challenge salaries that seem too high in comparison to what is “market fair rate”.

• Excessive time commitment for specific salaried staff.

• High number of salaried staff for size of project.

• Too few staff contracted for size of project or no salaried staff at host organisation. 

Materials

• Please provide details of the consumables required for the project and justify the costs wherever possible, particularly for larger consumables items.

• Please ensure that granularity is provided on material and consumables.

• If a license for an app/service is listed, it is expected that it is at cost and no profit is charged.

Capital equipment

• Capital expenditure should be clearly justified in relation to the project and the cost should be taken into account for the duration of the project.

• Leasing equipment from a provider or borrowing from existing facilities is an option to consider.

• Any equipment over the value of £250 should be itemised. Anything under can be grouped.

• All equipment should be clearly justified at the bottom of the spreadsheet.

Sub-contract

• Outline the hourly/daily rate for each provider including consultancy, sub-contractors, IP and legal. Here we also expect to see costs associated with net zero activities.

• If successful, quotes from individual sub-contractors will be requested prior to contracting.

Travel and subsistence

• Please include project-related travel costs using the most economic means possible. Please note that meals & accommodation are acceptable.

• Remember to add details to justify the costs (number of visits, travel required, subsistence associated to a specific meeting, etc.) and provide details of conferences and the number of people attending (If applicable).

Indirect costs

• Indirect costs may include estate costs (e.g., building and premises costs), services/utilities, rent or lease, insurance, etc.

• Other indirect costs may include other departmental costs (for example Finance & HR).

• Overhead costs should be charged in proportion to the amount of effort deployed on the project and should be calculated using own cost rates. Costs that are considered unreasonable could be rejected.

Other costs

• This may include all other cost items which do not fit elsewhere, such as any dissemination costs related to publication or dissemination of findings. Please note that services outside England are acceptable but should be clearly justified in the justification section.

• Here we expect to see payment for PPIE time (rates should be provided to justify the costs), PPIE travel fees, accommodation and subsistence where applicable, support costs if required and training.

Please submit the following supporting documents with your application form.

• Finance spreadsheet (mandatory)

• Gantt chart (1 single side A4, mandatory)

• Care pathway (1 single side A4, mandatory)

• Regulatory approval document/clinical evidence to support innovation (up to 5 pages A4 – mandatory)

• Logic model (up to 2 single sides A4, mandatory)

• Additional supporting information (2 single sides A4, optional)

Additional support documents may include a flow diagram illustrating the study design and the flow of participants, diagrams, pictures etc. If submitting a flow diagram, applicants should also describe complex interventions and controls as accurately and fully as possible within their diagram.

NOTE: Uploads MUST be provided as a Word or PDF document or you may not be able to submit your application or it may be difficult for the Panel to view the required information in order to assess your application.

Excessive attachments may lead to your application being excluded from the assessment process.

Please follow the steps on the screen in order to validate and submit your application.

All mandatory fields should be completed, within the word limit, and team members invited must validate and approve their participation.

Please check your application's formatting by printing to view the PDF format before submitting. Pay special attention to images and tables, making adjustments to the online form as needed to ensure clarity and correct alignment.

Once submitted, the completed application can be viewed or downloaded from the RMS Portal. However, you will no longer have the ability to edit the application.

Please visit the SBRI Healthcare competition pages for details on the application deadlines. Only those applications received before the competition deadline will be accepted. PLEASE DO NOT SEND COMPLETED APPLICATIONS BY POST OR BY ANY OTHER MEANS OTHER THAN THROUGH THE RMS PORTAL.

For more information please see www.sbrihealthcare.co.uk. Questions on the challenges and scope of this SBRI Healthcare competition should be addressed to the Programme Management Office via email to sbri@lgcgroup.com.