Laboratory/Pre-clinical Evaluation (Devices)

Highlighting requirements of the "Laboratory/Pre-clinical Evaluation" stage in order for successful medical devices translation.

TRL 4–6: Developing and Validating Your Prototype - from early prototype to ready-for-clinical-trial design

At this stage, you're turning your idea into a tangible, testable prototype. It's where the groundwork laid in TRL 1–3 begins to evolve into something real — and regulatory planning becomes more formal. 

Jump to read: Prototype | Evaluation

Checklist: Questions to be considered for TRL 4-6

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. Where is your intended market for the device? 
(Is it aimed at NHS adoption, international markets, or specific healthcare settings?) 

Research, Evidence & Vision 

2. Do you have robust proof-of-concept data in place? 
(This should support both the technical and clinical potential of your idea.) 

3. Have you defined your diagnostic targets or performance endpoints? 
(These may include sensitivity, specificity, safety, or clinical effectiveness.) 

4. Have you outlined your pre-clinical testing requirements and aligned them with relevant standards? 
(This may be essential to support your regulatory strategy and clinical planning.) 

5. If your device includes AI, how are you sourcing and curating the training data? 
(Consider dataset quality, bias mitigation, and clinical relevance.)  

Your Network & Affiliation 

7. Have you finalised any discussions with UCL Business (UCLB) about intellectual property and patents? 
(This is important for protecting your innovation and enabling commercialisation.) 

Development, Standards & Support Needs 

8. Do you have a detailed project plan and development timeline? 
(This can include R&D phases, regulatory milestones, and funding timelines.) 

9. Is your product design finalised or still evolving? 
(Design freeze is often needed before verification and validation steps.) 

10. Where are you planning to test your design (lab, simulation, or clinical setting)? 
(This may include bench testing, usability assessments, or clinical sites.) 

What should be in place between TRL 4–6? 

Technical Progress 

• A working prototype has been built and refined. 
• You've tested it in a relevant or simulated environment (e.g., lab bench, mock clinical setting). 
• Design iteration based on technical feedback is ongoing. 

Regulatory Readiness (RRL 3–4) 

• You've completed initial risk assessments (e.g., usability, safety). 
• You've identified your device's classification under medical device regulations. 
• Early work on your Design History File (DHF) and Technical Documentation has started. 
• You've mapped out clinical investigation needs, if applicable. 
• Planning is underway for clinical evaluation, with discussions around trial protocol design. 
• You’re establishing a Quality Management System (QMS) or planning to access one through collaboration. 

Strategic Planning 

• You've refined your Target Product Profile (TPP) — clearly describing the intended use, users, and setting. 
• You have a roadmap toward regulatory submission and commercial or NHS adoption. 
• You’ve identified funding needs and possible sources for TRL 6–7 and beyond.

Engagement and Collaboration 

• You’ve connected with regulatory, translational, or clinical trial experts (e.g., at UCL). 
• You may be working with engineers, designers, or industry partners to improve your prototype. 
• You're starting to engage with potential end-users for usability and design feedback. 

By the end of TRL 6, you should be ready to: 

• Begin preparing for clinical testing or regulatory submission. 
• Finalise a prototype that is ready for trials in real clinical settings. 
• Have a strong understanding of the regulatory pathway, expected evidence, and risks. 
• Secure appropriate ethical and institutional approvals for next-stage testing. 

Potential funding for TRL 4-6

Visit the UCL Translational Office Sharepoint site.(UCL log-in required)