Table 5 Number of technologies at each step of the qualification process
Steps 1 and 2 | Step 3 | Step 4 | Step 5 | Step 6 | Step 7 | Step 8 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Product category | Identified candidate technologies | Desk research met TPP | Technical testing | Environmental testing | Usability testing | Qualified devices | ||||||||||
Heat | Humidity | Dusta | Powerb | |||||||||||||
# For review | # Met TPP | # Test | # Pass | # Test | # Pass | # Test | # Pass | # Test | # Pass | # Test | # Pass | # Test | # Pass | Total | ||
Syringe Pump | 21 | 21 | 6 | 3 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 6 | 1 | 1 |
Bilirubinometer | 12 | 12 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | N/A | 3 | 3 | 3 | 2 | 2 | |
Phototherapy | 17 | 17 | 4 | 3d | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 |
Glucometer | 13 | 13 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | N/A | 2f | 2 | 3 | 2 | 2 | |
Haemoglobinometer | 20 | 20 | 7 | 7 | 5 | 5 | 5 | 5 | 5 | N/A | 3f | 3 | 5 | 2 | 2 | |
CPAP | 18 | 18 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 2 | 2 |
Flow Splitter | 4 | 4 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | N/A | 3 | 3 | 3 | |
Oxygen Concentrator | 24 | 24 | 4 | 3e | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 |
Pulse Oximeter (Continuous) | 25 | 25 | 6 | 6 | 5 | 5 | 5 | 5 | 5 | N/A | 5 | 5 | 5 | 2 | 2 | |
Suction Pump | 7 | 7 | 3 | 3 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 1 |
Radiant Warmer | 13 | 13 | 3 | 2e | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
Temperature Monitor (Continuous)c | 30 | 30 | 0 | — | — | — | — | — | — | — | — | — | — | — | — | 0 |
Conductive Warmerc | 31 | 31 | 0 | — | — | — | — | — | — | — | — | — | — | — | — | 0 |
Respiratory Rate/Apnoea Monitorc | 36 | 36 | 0 | — | — | — | — | — | — | — | — | — | — | — | — | 0 |
Total | 271 | 271 | 45 | 39 | 34 | 34 | 34 | 34 | 34 | 18 | 18 | 28 | 27 | 37 | 23 | 23 |