1
|
Basic principle observed |
The idea has been formulated, proof of concept only |
0 |
2
|
Technology concept formulated |
A software prototype has been made and tested virtually |
0 |
3
|
Experimental proof of concept |
Analytical studies and feasibility studies. The device must be built |
17 |
4
|
Technology validated in the lab |
The device has been tested on non-human or one healthy case study for validation. |
26 |
5
|
Technology validated in the relevant environment validation. |
The device has been tested on healthy participants |
21 |
6
|
Technology demonstrated in the relevant environment |
The device has been tested on a target population in a clinical setting (ISO Standard not complete) |
29 |
7
|
System prototype demonstration in an operational environment |
The device has been tested for its intended purpose in an operational environment (outside of the clinic and lab) ISO Standards should be complete |
14 |
8
|
System complete and qualified |
The device is ready to be commercialized and has been validated |
1 |
9
|
Actual system is proven in an operational environment |
The device is available in the market |
27 |