Basic principles and research data observed and reported. Research findings reviewed and assessed. Preliminary evaluation of potential targets and mechanisms.

Technology concept and/or application formulated. Research ideas, hypothesis, experimental designs, potential targets, technologies, solutions (also digital), protocols identified and developed, peer reviewed and approved.

Active R&D, data collection and analysis initiated. First hypothesis testing, target identification, characterisation of potential candidates’, data collection. 

Technological components (also digital) evaluation, exploration of alternative concepts carried out. 

Early proof of concept (PoC)/system application tested in laboratory environment and where applicable in a limited number of in vitro & in vivo models.

Preclinical R&D. PoC, safety of potential candidates, device or system demonstrated in a relevant laboratory or animal model. Formulation and manufacturing process development initiated (non-GMP). Identification of relevant data required for technological assessment.  

System components integrated and tested regarding preliminary efficiency and reliability. Software architecture and other system components development to address reliability, scalability, operability, security etc. Other system components development.

Technology validated in relevant environment. Pre-clinical studies, including GLP animal safety & toxicity, ADME data sufficient to support submission of the selected candidate to phase 1. 

GMP manufacturing process and quality controls identified. Validation of system components/architectures and processes in relevant laboratory/operational environment. 

Classification of device/digital system by appropriate regulatory body established. Verification, validation and accreditation when appropriate initiated. 

Technology demonstrated in relevant environment. Clinical development: phase 1 clinical trials evaluation proceeding to phase 2. 

Medical device/digital system prototype demonstrated in operational environment. Clinical testing and safety demonstrated and in line with predictions. 

Digital system components releases are “beta” versions and configuration controlled. Required accreditation in progress

System prototype demonstration in operational environment. Phase 2 clinical trial completed. Phase 3 clinical trial plan defined and approved. 

Medical device/digital system final product design is validated and final prototypes intended for commercial use produced and tested. When appropriate, verification and validation for accreditation completed. 

System complete and qualified. Manufacturing processes validated. Phase 3 clinical trial completed and licensing/authorisation given. 

Pre-market application submitted and approved for medical device. 

Digital system development completed and demonstrated in real life conditions, support structure in place to resolve technical issues. 

Product launched/ready for launch. Post-marketing studies and surveillance in place