Medical Devices Development Roadmap

Step 1: Design & Development

Successful translation of an idea into an NHS-adopted medical device is reliant upon the early and continued consultation & effective decision-making of a diverse group of individuals. This earliest phase of medical device translation should encompass the first iteration of a Target Product Profile (TPP), which defines the Unmet Clinical Need and Intended Use of the device, Device Classification and initiates Risk Identification & Management. Processes should be put in place to start the regulatory-complaint documentation for the medical device and management of Intellectual Property, whether for key enabling technologies or emerging foreground IP. 

Step 2: Laboratory/Pre-clinical Evaluation

In this early research & development phase of medical device translation, it is important to address the question: Does your research prototype match the TPP and meet all the essential safety & performance requirements? What data will be required to satisfy the Regulator as to the appropriate systematic development and testing of the device according to Medical device Regulations (MDR)?

Step 3: Manufacturing a Clinical Trial Product

This section includes important considerations when transitioning to the manufacture of a ‘clinical prototype’. How ‘scalable’ is your device manufacturing process? Is it best aligned to support future commercialisation of an effective clinical trial product? 

Step 4: The Clinical Investigation and Finalised Medical Device

Medical device manufacturers are required to conduct clinical evaluation to compare a new device to standard of care practice, or established similar devices. Considerations at this stage include finance, manufacturing and regulatory & ethical compliance.

Step 5: Commercial Adoption

Having completed the primary clinical and performance evaluation, further progression of the new Medical Device requires commercial adoption beyond UCL in order for NHS uptake. Before a product can be granted European market approval, it needs to be CE-marked as testament to regulatory conformity with health, safety, and environmental protection standards. The University does not hold CE-marks itself and so it is at this stage in the Medical Device life cycle that the product ‘exits’ from being an ‘in-house’ development project.