The research plan should be between 24 and 36 months in length, must involve at least two eligible types of organisation (small-to-medium-sized enterprises (SME), NHS providers or higher education institutions (HEI)) and lead organisation must be registered in England.
Funded activities covered are research and development of:
- Medical devices
- In vitro diagnostic devices
- Digital health technologies that fall under Tier C of the NICE Evidence Framework for Digital Health Technologies
- Artificial Intelligence (AI) technologies including Augmented or Ambient Intelligence (these will be classed as medical devices)
The research plan should cover the following:
- What is the problem being addressed
- A clear explanation of the problem to be addressed
- The impact on patients, the public and health and care services
- The current unmet need both within the NHS and globally
- How your proposed solution would meet these needs
- Why is this research important in terms of improving the health and/or wellbeing of the public and/or to patients and health care services
- Clearly identify the health and care need your research meets or contributes to
- What will be the anticipated value or contribution the intervention will provide
- Have a clear health economic case
- Have outcomes/impact on patient benefit short and long term (see IMPACT Section)
- Why is the approach superior to existing NHS practice
- Review of existing evidence – How does the existing literature support this proposal
- Why this research is needed now, in terms of time, relevance, and competing solutions
- What is the level of innovation of the proposed technology
- What is the level of innovation including technical and clinical validation (proof of concept)
- What challenges still need to be addressed and overcome
- What is the research question/aims and objectives? (see Research Planning - Research question/aims and objectives Section)
- Project plan (see Project Planning Section)
Before starting your project:
- Consider your research question
- Ensure your application meets NIHR assessment criteria
- Involve patients, carers and the public
- Get methodology advice
- Seek advice on how to run your study
- Develop your research team
- Consider whether your research might generate intellectual property
- Seek regulatory approval
- Plan for impact
- Present your application clearly
- Plan costs
Other information:
Health Technology Pathway Navigation Tool:
This tool has been specifically designed to cater to innovators, developers, and stakeholders who are interested in exploring and gaining a comprehensive understanding of England's Med-Tech landscape. It serves as a guide, outlining the essential steps and activities involved in the entire process of developing Health Technology in England, starting from research all the way to patient treatment.
Developed by the Accelerated Access Collaborative (AAC), this tool offers a thorough mapping of the crucial stages that innovators should navigate, beginning with concept development and extending to the widespread implementation of their innovations within the NHS. It also provides information about the support services available at each stage of this journey.
Each step in the tool includes a schematic flowchart that highlights important milestones, key organisations, timelines, policies, guidelines, a checklist of tasks, and other pertinent considerations that innovators should keep in mind. While the flowchart primarily focuses on medical devices and diagnostics, it can also be applied to a wide range of digital health technologies.
NHS Innovation Service:
The primary goal of the NHS Innovation Service is to enhance and expedite the adoption of meaningful innovations within the NHS and social care sector. They offer valuable resources and coordinated assistance to innovators, equipping them with the necessary information and guidance to effectively navigate the complex health and care system. By leveraging this support, innovators can accelerate the delivery of their innovations to healthcare professionals and patients.
The NHS Innovation Service operates as a centralised online support service that caters to health and care innovators nationwide. They also facilitate collaboration among various organisations, fostering an environment where stakeholders can come together to address the specific needs of innovators.
If you require further guidance and advice, it is highly recommended to reach out to the NHS Innovation Service. You can log your product even as an early innovation via NHS Improvement’s Innovation Team
Your Idea
Research Planning
Project Planning
Impact