| 1 |
Basic principles observed |
Basic principles observed |
Basic principles observed |
Basic principles observed |
Proof-of-Concept |
| 2 |
Technology concept formulated |
Technology concept formulated |
Technology concept formulated |
Technology concept formulated |
Proof-of-Concept |
| 3 |
Experimental proof of concept |
Experimental proof of concept in vitro and in vivo research model |
Experimental proof of concept in vitro and in vivo research models |
Experimental proof of concept in vitro |
Proof-of-Concept |
| 4 |
Technology validated in lab |
Proof of concept in vitro and in vivo research models |
Proof of concept in vitro and in vivo research models |
Proof of concept in vitro and in vivo research models |
Prototype in Lab |
| 5 |
Technology validated in relevant environment |
Non-clinical and pre-clinical research studies, & initial demonstration of feasibility and efficacy |
Product Development Plan |
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| 6 |
Technology demonstrated in relevant environment |
Phase I clinical trials |
Phase I clinical trials |
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| 7 |
System prototype demonstration in operational environment |
Phase 2 clinical trials |
Clinical safety and effectiveness trials in operational environment |
Clinical validation in 1 site |
Prototype in Live Environment |
| 8 |
System complete and qualified |
Phase 3 clinical trials |
Overall risk-benefit Trials |
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| 9 |
Actual system proven in operational environment |
Pharmaceutical can be distributed or marketed |
Medical device can be distributed or marketed |
Clinical validation in multi-site |
Ready-to-Market |