The assessors will score all your answers apart from question 1 and 2. You will receive feedback for each scored question.
You must answer all questions. Your answer to each question can be up to 600 words long. Do not include any website addresses (URLs) in your answers.
Question 1. Applicant location (not scored)
You must state the name and full registered address of your organisation and any partners working on the project. We are collecting this information to understand the geographical location of all applicants.
Question 2. Project category (not scored)
Digital Health Technology Catalyst has been integrated into the Biomedical Catalyst. Is your project a digital health project?
Question 3. Health or Healthcare Need or Challenge
What is the health or healthcare challenge that this project addresses and what impacts will your solution have?
- describe the health or healthcare challenge this project addresses and the impacts your solution will have
- provide evidence that the health or healthcare challenge is real and define the market that will generate demand for your proposed solution
- outline any socio-economic benefits of your solution
- provide any input you have received from healthcare professionals, patients, potential partners or representatives of the onward supply chain
If your project addresses a specific health or healthcare need, how does your solution compare to the current gold standard?
Question 4. Scientific evidence
What is the underpinning scientific evidence to support your solution?
Detail all relevant prior experimental or technical evidence and explain how this links to the proposed study. Include any preclinical or clinical work conducted to date and the outcomes.
You must 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 and no larger than 10mb in size. The font must be legible at 100% zoom.
Question 5. Innovation
What is innovative about your idea from a commercial, scientific and technical perspective?
You can for example:
- refer to existing products, current gold standards and practices that are currently in use, and how your innovation compares
- comment on how this innovation will fit into the current standard of care
- explain both the technical and commercial benefits and shortcomings of your approach
- outline the target product profile for your innovation in terms of safety and performance characteristics
This could include the results of competitor analyses and literature surveys. This list is not exhaustive.
Question 6. Technical approach
What technical approach will be adopted and how will the project be managed?
Please provide an overview of the technical approach including the main objectives of the work with enough detail for the assessors to understand tasks involved and resources required.
You must describe:
- the current status of your innovation and where you expect to be at the end of the project
- the stages of the project (the work packages) and link the main areas of work together with their resource and management requirements
- key milestones and any stage gates
- how the method and technical approach is appropriate to the needs of the project and the timescale
- how any study design is robust and that key milestone timings are realistic
- your resources and capability to undertake the project
- clear management reporting lines
If relevant, compare and contrast alternative R&D strategies and describe why your proposed approach will offer the best outcome.
You must 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 and no larger than 10mb in size. The font must be legible at 100% zoom.
Question 7. Freedom to operate
Do you have freedom to operate?
- any existing intellectual property (IP) which may affect, or which is relevant to, project delivery and exploitation
- the current state of IP ownership and, where necessary, how rights have been assigned
- if completed, who conducted any FTO analysis
- 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
- any IP that you expect to be generated as a result of your project, and who will own it
You must provide evidence that you have freedom to operate and that you can work without infringing other patents, for example by summarising the results of patent searches.
Question 8. Exploit the opportunity
Describe the size of the market you have identified and how you intend to exploit it.
- the dynamics of this market including its current size, actual and predicted growth rates and provide 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 long-term potential economic benefits to the UK in terms of increasing revenue, profitability, job creation
- the regulatory requirements for the innovation you are developing and the strategies to demonstrate conformity
- how the outputs of your project take you nearer to your organisation’s objectives, and what will the steps be to achieve this
Describe where applicable:
- your route to market, channel, geographies
- who will benefit and how
- any 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. Consider cost of manufacturing at launch and at scale.
These examples are not exhaustive.
You must submit an exploitation plan to support your answer. It must be a single PDF and can be up to 4 A4 pages long and no larger than 10mb in size. The font must be legible at 100% zoom.
Question 9. Technical, commercial and environmental risks
Innovate UK recognises that projects of this type are risky, we expect that your project has adequate arrangements for managing these risks. What are the technical, commercial and environmental risks to project success?
- your project’s risk management strategy
- the main risks and uncertainties of the project and provide a detailed risk analysis for the project content and approach
- the technical (including regulatory), commercial, managerial and environmental risks as well as other uncertainties, such as ethical issues associated with the project
- the potential impact of these risks, stating how the project would mitigate them
- the project management tools and mechanisms that will be used to minimise operational risk
You must submit a risk register as an appendix using an international standard such as ISO 14971 where possible to support your answer. It must be a PDF and can be up to 2 A4 pages long and up to 10mb in size. The font must be legible at 100% zoom.
Question 10. Skills and experience
Does the team have the right skills, experience and access to facilities to deliver the project and exploit it?
Detail the expertise and track record of the project participants, including collaborators and subcontractors, to demonstrate your capability to deliver the project and exploit the output. Explain whether you have worked with them before and on what basis.
- how the project supports or builds on the existing UK supply chain and addresses end user needs
- how the work is being conducted internally where possible and, if subcontractors are being used, there is adequate justification for the choice made
- how the project has access to the appropriate facilities, resources, tools, equipment and human capability
All subcontractor costs must be justified and appropriate to the total project costs. Extenuating circumstances where overseas work may be allowable include, but are not limited to; clinical trials in a specific patient population.
You must provide justification by email to email@example.com at least 10 working days before the competition closes. Innovate UK will decide whether to approve your request via email. The application assessors will also be asked to judge whether you have sufficiently made a case for the use of overseas subcontractors.
If you are planning to use subcontractors outside the UK then you must provide evidence that no UK alternative exists and strong justification to support your choice of non-UK contractor.
Question 11. Resources required
What are the resources required to deliver your project and how much will they cost?
- provide justification of the breakdown of your costs, for example any quotations you have received
- include all internal and external costs for your project. Costs must be consistent with the category of R&D being undertaken
- describe how funding will be available to cover cash flow pending quarterly reimbursement of costs from Innovate UK
- explain your eligible project costs, from each of the project partners and the level of funding required
- explain the resources required to carry out your project including materials, capital equipment and people
This information should complement the financial summary table in the application form.
Question 12. Financial support and added value
How does financial support from Innovate UK and its funding collaborators add value to your project?
- what advantages would public funding offer your project, for example; appeal to investors, more partners, reduced risk or a faster route to market (this list is not exhaustive)
- the likely impact of the project outcomes on the organisations involved
- what your project would look like without public funding
- why you are not able to wholly fund the project from your own resources or other forms of private-sector funding
- the avenues of alternate funding you have explored and the responses
- how failure to secure public funding for your project would affect the R&D activity undertaken by the project partners (and related spend profile)
- your plan should public funding not meet any or all of your request