The assessors will score your answers to questions 2 to 11, question 1 is not scored. You will receive feedback for each scored question.
You must answer all questions. Your answer to each question can be up to 400 words long. Do not include any website addresses (URLs) in your answers.
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. Need or challenge
What is the healthcare challenge that this project addresses and what impacts will your solution have?
If your project addresses a specific healthcare need, what is the current 'gold standard'?
Give evidence that the healthcare challenge is real and sizeable. Explain how your project will address it. Define the market, both nationally and internationally, that will generate demand for your proposed solution.
How will the project outputs or the solution lead to a commercial opportunity for your organisation?
How will the outputs of the project meet the healthcare challenge?
Give any input you have from healthcare professionals, patients, potential partners or representatives of the onward supply chain.
Measure the potential positive impact on socio-economic factors and healthcare at a patient and community level. Detail the number of anticipated users and the benefits your solution will provide, with estimated timescales.
Question 3. Scientific Evidence
What is the underpinning scientific evidence to support your solution?
Detail all relevant prior experimental or technical evidence and explain how the previous results link to the proposed study.
Outline any preclinical or clinical work conducted to date and the outcomes.
You can submit one appendix to support your answer. It can include diagrams and charts. It must be a PDF and can be up to 4 A4 pages long. The font must be legible at 100% zoom.
Question 4. Innovation
What is innovative about your idea?
Identify the extent to which the project is innovative, from a commercial, scientific and technical perspective. Refer to existing products, current gold standards and practices that are currently in use and those known to be under development both in the UK and internationally. Comment on how this innovation will fit into the current standard of care.
If relevant outline the target product profile for your innovation in terms of safety & performance characteristics.
Describe both the technical and commercial benefits and shortcomings of your approach. This could include the results of competitor analyses and literature surveys.
Highlight the timeliness and novelty of your innovation and explain it in an industrial context.
Question 5. Technical approach
What technical approach will be adopted and how will the project be managed?
Provide an overview of the technical approach including the main objectives of the work.
Describe where you are now and where you want to be at the end of the project in terms of the deliverables. Describe the stages of the project (the work packages) and link the main areas of work together with their resource and management requirements.
Identify milestones and go or no-go points.
- describe how the method and technical approach is appropriate to the needs of the project
- ensure there is enough detail in your project plan for the assessors to understand tasks involved and resources required
- ensure any study design is robust, and the key milestone timings are realistic
- have committed enough resource and have the capability to undertake the project
- ensure clear management reporting lines have been identified
If relevant, compare and contrast alternative research and development (R&D) strategies and describe why your proposed approach will offer the best outcome.
Provide justification for the use of animal or human subjects and the numbers of animals and samples to be tested.
You must submit a project plan or Gantt chart as an appendix to support your answer. You can also include a study design, protocol or approach. It must be a single PDF and can be up to 4 A4 pages long. The font must be legible at 100% zoom.
Question 6. Freedom to Operate
Do you have the freedom to operate?
Detail any existing intellectual property (IP) which may affect or which is relevant to project delivery and exploitation?
State the ownership of IP and, where necessary, how rights have been assigned.
Provide evidence that you have freedom to operate (FTO), who conducted the FTO, and that you can work without infringing other patents, for example by summarising the results of patent searches.
Detail any IP that you expect to be generated as a result of your project, and who will own it.
Describe your strategy for protecting the knowledge resulting from the project. If it is a collaborative project, how will you assign IP rights to project partners?
Question 7. Exploit the opportunity
How do you intend to exploit the opportunity?
How will the outputs of this project take you nearer to your objectives, and what will the steps be in this journey?
Describe how these outputs will be exploited including, where applicable:
- the route to market, channel, geographies
- reconfiguration of the value system, such as who will benefit or pay
- changes to business models and business processes for the payor, provider or patient
Provide evidence that the proposed solution would be commercially viable for the target market. For example; cost of manufacturing at launch and at scale, and pricing.
Describe the size of the market opportunities that this project would create, including details of:
- the current nature of the specific markets at which the project is targeted
- the dynamics of this market including measuring its current size then actual and predicted growth rates, providing references to sources
- the projected or target market share gains over time for the project outcome taking account of possible restrictions on market access and penetration, including any potential competitors
- the longer term potential economic benefits to the UK in terms of increasing revenue, profitability, job creation
Outline the regulatory pathway for the innovation you are developing and how this project fits into your regulatory strategy.
- define what regulatory requirements apply to your innovation
- outline the evidence requirements & strategy to demonstrate conformity
You can submit an appendix to support your answer. It must be a single PDF and can be up to 4 A4 pages long. The font must be legible at 100% zoom.
Question 8. Technical, commercial, and environmental risks
What are the technical, commercial and environmental risks to project success? What is the project’s risk management strategy?
Innovate UK recognises that projects of this type are risky, and organisations that succeed focus on key risks, but we ask that the project has adequate arrangements for managing these risks.
- the main risks and uncertainties of the project and provide a detailed risk analysis for the project content and approach
- including the technical, regulatory, commercial, managerial and environmental risks as well as other uncertainties, such as ethical issues associated with the project
- creating the risk register defining the severity and likelihood of specific risks along with measures taken to reduce risk, using an international standard such as ISO 14971 where possible
- the potential impact of these scenarios, stating how the project would mitigate all significant and relevant risks
Identify project management tools and mechanisms that will be used to minimise operational risk. This should include the arrangements for managing the consortium where applicable. Identify ownership of each of the risks.
You must submit a risk register as an appendix to support your answer. It must be a PDF and can be up to 2 A4 pages long. The font must be legible at 100% zoom.
Question 9. Skills and experience
Does your team have the right skills and experience and access to facilities to deliver the project and exploit it?
Detail the expertise and track record of the project team, including collaborators and subcontractors. Explain if you have worked with them before and on what basis. Show your capability to deliver the project and exploit the output.
You must consider:
- how the project builds the UK supply chain and addresses end-user needs
- if collaborative, are the consortium’s formation objectives clear
- if collaborative, is extra benefit gained from the collaboration
- if subcontractors are being used, is there adequate justification
- whether the project has access to the appropriate facilities, resources, tools, equipment and human capability
If you are planning to use subcontractors from outside the UK then you must provide evidence that no UK alternative exists or strong justification to support your choice of non-UK contractor.
Question 10. Resources Required
What are the resources required to deliver the project and how much will they cost?
You must indicate the anticipated eligible project costs, making clear the level of contribution from any project partners and the level of funding required.
This information must complement the financial summary table in the application form.
Detail the resources required to carry out the project for example; materials, capital equipment and people. Fully break down the costs and justify them for example; quotations to prove value for money. This must include all internal and external costs.
Costs must be consistent with the category of R&D being undertaken.
You must consider:
- the robustness and justification of budget breakdown for the scale and complexity of the project
- clarity of cost allocation
- whether financial support required is within the limits set by the competition
- value for public money
- financial commitments to the project from non-grant claiming partners
- whether funding will be available to cover cash flow pending quarterly reimbursement of costs from Innovate UK
Question 11. Financial Support and Added Value
How does financial support from Innovate UK add value?
What difference would public funding make? For example; a faster route to market, more partners or reduced risk?
Describe the likely impact of the project on the wider businesses of the partners involved.
Tell us why you are not able to wholly fund the project from your own resources or other forms of private-sector funding.
Tell us what avenues of alternate funding you have explored and the responses.
Tell us your alternate plan should public funding not meet any or all of your request.