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Learn about key considerations during the Design & Development stage of the medical device translational pathway, and explore the support available to help move your idea closer to the clinic.
| TRL Level | Technology Stage | RRL Focus | Regulatory Readiness Level Summary |
|---|---|---|---|
TRL 1-3 | Basic research & concept | RRL 1-2 | Identify regulations, assess ethical and safety issues, early clinical planning |
Jump to read: Idea | Unmet Clinical Need | Intellectual Property (IP) | Documentation
- Checklist: Questions to be considered for TRL 0-1
Please work through the questions below and complete the template word document of Medical Device Project Checklist which can be used to initiate dialogue with the UCL Traslational Research Office and the Joint Research Office.
Understanding Your Idea
1. What is your idea, and could it be classed as a medical device?
(If unsure, please visit RegMetrics or UCL's JRO website.)2. Where and how was your idea developed?
(For example, during clinical work, research, or patient feedback.)3. What clinical problem does your idea aim to solve?
(Define the unmet need you’re addressing.)4. What is the intended use of your idea?
(Consider linking this to your Target Product Profile – TPP.)5. Could your idea be considered a combination product involving a drug or biological component?
(Combination products may require different regulatory pathways.)Research, Evidence & Vision
6. Do you have any early data or evidence to support your idea?
(This could include observations, feasibility testing, or user feedback.)7. Have you started a literature review to support your concept, and how are you documenting your findings?
(This helps build the scientific and clinical case for your device.)8. Do you have a prototype (even a basic or non-GMP version)?
(Early prototypes help with concept validation and feedback.)9. What’s your long-term vision for this idea?
(For example: spin-out, NHS adoption, licensing, or academic outputs.)10. Are you currently working with any collaborators?
(Inside or outside UCL, including clinicians, engineers, or industry partners.)11. Have you spoken to anyone at UCL about your idea yet?
(We can help connect you with the right support team or platform.)Your Network & Affiliation
12. What is your current affiliation with UCL and its partner NHS Trust?
(Include your department, research group, or clinical role.)13. Have you discussed your idea with a commercial partner or UCL Business (UCLB)?
(Including funders, suppliers, or potential licensees.)Development, Standards & Support Needs
14. Does your team include both clinical and engineering expertise?
(If not, we can help identify and connect you to the right people or please visit the IHE website UCL Institute of Healthcare Engineering | Faculty of Engineering)15. Are you working to any recognised technical or clinical standards?
(For example, ISO 13485, IEC 60601, or other NHS-linked quality systems.)16. Have you considered a Quality Management System (QMS) for your device?
(Early planning for a QMS will help with compliance and regulatory readiness.)17. Have you involved patients, the public, or healthcare professionals to inform your development?
(This is often called PPIE – Patient and Public Involvement and Engagement.)18. Have you sought expert advice on regulatory requirements?
(This might include advice on classification, CE/UKCA marking, or clinical evaluation planning.
- What should be in place by the end of TRL 3?
By the time your medical device reaches Technology Readiness Level (TRL) 3, you’ve moved beyond the basic concept stage. You now have early proof-of-concept data showing your idea could work. But to succeed in future stages, you also need to start laying a solid regulatory foundation.
By TRL 3, You Should Aim to Have:
A Clear Problem–Solution Fit
A defined unmet clinical need supported by clinical context. A clear description of how your device addresses that need. Early engagement with end users (clinicians, patients, carers).Why This Matters:
Many promising devices stall after early development — not because the science fails, but because regulatory and practical planning started too late. Thinking about regulatory readiness now sets you up for smoother progress through clinical evaluation and approval.
Support & Next Steps
Established and engaged with UCL’s internal experts in medical device development. Outlined a development plan for reaching TRL 4–6, including funding needs. Begun identifying your target patient group, clinical setting, and market fit.- Considered early ethical issues, data use, and IP position.
- Begun documenting development steps and design decisions (early Design History File).
- Awareness of what will be needed later for clinical evidence and risk management.
Regulatory Awareness (RRL 1–2)
Identified whether your product is likely to be regulated as a medical device. Started mapping out relevant regulations (e.g., UK MDR, EU MDR).Initial Technical Feasibility
A working concept or lab-based demonstration of a key function. Some evidence that the underlying science or engineering is sound.
- Potential funding for TRL1-3
Visit the UCL Translational Office Sharepoint site.(UCL log-in required)
IDEA:
Target Product Profile (TPP) – captures the ‘benefit’ of the proposed medical device and key considerations in the strategic development of the product (incl. technical, scientific and medical information required to satisfy regulators and industry partners).
Key considerations for adoption include:
- Intended use - ‘Unidentified’ opportunities for clinical benefit/use (e.g.arising from creative discussion with expanded audience)?
- Device description - Ergonomics / ease of use
- Contraindications - Destined for stand alone use or routine employment alongside/in combination (e.g. consider comorbidities)?
- Testing - Usability testing assumes device is used as ‘imagined’; Replicate/engineer testing in ‘work as done’ context; Design in ‘Resilience’ (i.e. minimum service adaption to enable adoption and diffusion, regardless of context)
UCL Support:
The Translational Research Office (TRO) have extensive knowledge of the medical devices landscape, and can provide advice on early considerations such as intended use and device descriptions etc, to guide development, as well as longer-term considerations for adoption i.e. help you produce and develop your TPP.
UNMET CLINICAL NEED:
As part of the TPP, comprehensively research and define the potential for benefit of the proposed medical device over current ‘standard of care’.
Understand the patient and clinician ‘pull’ – are they clearly aligned or conflicted?
UCL Support:
The Translational Research Group (TRG) within the Translational Research Office, will help define the project plan to how your project successfully meets the unmet clinical, ensures costs are accurately calculated to cover the project sufficiently, identifies suitable funding streams and helps with the application. Importantly these funding streams require active project management which the TRG can provide throughout the entire project.
INTELLECTUAL PROPERTY (IP):
Engage with Business experts to ascertain if you have a novel invention, ensure freedom to operate and to protect foreground/arising intellectual property.
UCL Support
If you believe you have an innovative, patentable technology, it’s important you contact UCLB before any form of public domain disclosure.
UCLB are experts that provide confidential support for researchers at UCL, to understand the value of your invention and the best approach to protecting your intellectual property (IP), advising on strategies to commercialise your research such as through forming a spin out company or licensing to a third party.
All researchers with potentially commercialisable research results should fill out a confidential Invention Disclosure Form (IDF) and submit it to their UCLB Business Manager: http://www.uclb.com/for-researchers/do-you-believe-you-have-a-novel-invention/
DOCUMENTATION:
Regulators require appropriate documentation detailing medical device design, manufacturing, specifications, quality measures, usages, safety and impact.
It is necessary to keep and update records throughout the entire lifetime of the device, It is not something that can be done at a later date, when ready for regulatory submission
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system to standardize the documentation process (e.g. approval and review, version control, availability).
Hospital in-house development is now covered by MDR (May 17-21), therefore requiring appropriate QMS, although it remains unclear where in-house academic devices fall since these technically do not constitute institutes treating patients.
RegMetrics has developed an excellent digital tool aimed at people working in the area of medical devices, helping researchers to navigate device and IVD regulations: https://www.reg-metrics.com
UCL Support:
The Devices & Diagnostics Therapeutic Innovation Network (TIN) is implementing a lean QMS to meet the basic regulatory requirements at the early stage of medical device development (i.e. ISO 13485-aligned). The QMS does not provide the documentation required, only the processes needed to be followed to deliver the required documentation (incl. review, approval, version control, access, design & decision traceability).
Join the Devices & Diagnostics TIN
Additionally, the UCL Translational Research Office have been involved in a number of discussions involving the new Medical Device Regulations (MDR) for 2021, to help provide clarity on the applicability of the MDR to academic and partner health institutes.