Level 1 |
Basic observations and new hypothesis reported |
Basic observations and new hypothesis reported |
Level 2 |
Novel paradigm/composition of matter/method formulated; corroborating preliminary results obtained |
Technology concept and/or application formulated; no experimental proof or detailed analysis yet supports the conjecture |
Level 3 |
Analytical or experimental proof-of-concept (POC) established; In-vitro demonstration of consistent results to validate hypothesis |
R&D is initiated: analytical studies set the technology into an appropriate context and “proof-of-concept” laboratory-based studies physically validate that the analytical predictions are correct |
Level 4 |
Proof-of-concept established in complex in-vitro settings along with demonstrated competitive added value |
Basic technological elements integrated to establish that the “pieces” will work together to achieve concept-enabling levels of performance for a component and/or breadboard |
Level 5 |
Invention validated in a relevant environment; In-vivo POC established in small animals. |
Component and/or breadboard validated in a relevant environment |
Level 6 |
Invention validated in a relevant environment; In-vivo POC established in other species (canine, feline, etc.) |
System/subsystem model or prototype near the desired configuration in terms of performance, weight, and volume tested in a relevant environment |
Level 7 |
Invention demonstrated in an operational environment; In-vivo POC established in non-human primates |
System prototype demonstrated in an operational environment |
Level 8 |
Invention completed and qualified through test and demonstration; POC established in humans / Phase I clinical trials |
Actual system completed and qualified through test and demonstration |
Level 9 |
Invention proven successful in Phase II and III clinical trials and in commercial settings |
Actual system proven through successful mission operations |