i4i Translational Research Pathway

i4i

Clinical Need

This checklist has been developed to help with your project planning and assist with the writing and submission of your grant application(s).

  • Is there a clear case for improved clinical practice if the device/technology is introduced?
  • Does the technology address a clear unmet, existing, or emerging clinical/healthcare need that will be future-proof?

 

Requirement

Summary

Additional questions

Patient Benefit

Is there evidence that the technology or intervention is novel and will lead to delivering a clear benefit to patients in the short to medium term?

 

Innovation

Does the proposed device/technology present a significant level of innovation over current commercially available products and will lead to new ways of working and/or new treatments?

  • Does it meet an unmet need?

Proof of Concept

Is the project ready to move from the prototype (proof of concept) stage through commercial development to adoption and diffusion within the NHS and beyond?

  • What is the status of development?
  • What is the case for further development based on work to date and evidence from the literature?
  • What is the current state of technical and clinical validation and what needs to be addressed and overcome?

Project Team

Does the project team have all of the relevant expertise and skills to develop the proposed device/technology toward commercialisation?

  • What are the roles of co-applicants, collaborators, and sub-contractors?
  • Is there a PPI representative supporting the team?
  • Have you got/ need a project manager?

Project Plan

Does the project plan have clear aims, deliverables/objectives, and milestones? Does the project have specific, realistic, and achievable goals with defined outputs that are achievable in the set time? Is the final output an advanced or clinically validated device, technology, or intervention ready for follow on funding?

  • What is your research question?
  • What are the individual work packages in the project plan?
  • What are the main hurdles technically, clinically, and commercially?
  • What are the key risks to the project?
  • What is the project exit point?
  • Will the project have a high impact on patients, the public, healthcare staff, and the healthcare system?

Public involvement

Have the team ensured that there is public and patient involvement in all aspects of product and clinical development, including evaluation, validation, and dissemination of results, throughout the project?

  • What evidence is there for involvement of patient and public in all aspects of the development of technology?
  • What evidence is there for other relevant stakeholders being involved in the development of the technology?
  • Will training be offered to public members?
  • Has there been public involvement input into patient documentation and other research materials?
  • Is there a public involvement representative in the Team (co-applicant)?
  • Will the public involvement lead be part of the steering group?
  • Was there public involvement pre-award to identify research priorities?
  • Will public involvement input involve carrying out research?
  • Will PPI involve engagement with dissemination to research participants, colleagues, or members of the public on the findings of a study?

Equality, Diversity and Inclusion

Has the team considered EDI criteria of the research team, public involvement group, and future study participants? 

  • What steps will you take to ensure the inclusion of minority groups?
  • How will your public involvement strategy enable the recruitment and retention of diverse public contributors?
  • How will you support a diverse public involvement group?
  • Have you integrated EDI into your Team?
  • Have you integrated EDI into your clinical study, geographical need to establish sites, population?
  • Is your team culturally competent and what training may be required?
  • How will results be disseminated to ensure accessible and inclusive formats for all?
  • Are you excluding anyone, if so why?

IP and Commercial

Does the device/technology have intellectual property protection with the freedom to operate? Is the project supported by a sound business/ commercialisation case that includes awareness and understanding of the market opportunities, competitive products, and potential barriers to entering the market?

  • Who owns the IP (including any third-party IP)?
  • Who manages the IP (background and arising)?
  • What competitive technologies exist?
  • When will the technology be patient-ready?
  • What regulatory hurdles are anticipated
  • Who will be responsible for overcoming these hurdles?
  • Proposals must set out a commercial strategy that takes into account the regulatory pathway, IP management, commercial barriers, health economics, and route to market.

NHS Adoption Plan

Will the product or service be in a position to be adopted into and used by the NHS? Does the team understand the importance of stakeholders into achieving adoption and dissemination in the NHS/healthcare system?

  • What is the strategy for adoption into healthcare service?
  • What is the route to market for the technology?

Value for Money

Is there a clear justification for all research costs? Does the project cost represent good science and potential impact? Does the project have a strong health economic case that show potential economic benefits/savings in the future?

 

 

Author: Roy Harris      Created: March 2018    Last Updated: November 2024