CDRH Vision-Total Product Life Cycle
Five pediatric medical device projects that PMDI plans to manage or provide mentorship for over the next two years are shown in Figure 4 as they relate to the CDRH Total Product Life Cycle. One of the simple outcomes metrics for the next two years is how far along the TPLC a project moves. In Table 5 we predict advancement for each of the five projects.
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Figure 4. PMDI 2 Year Projects and Relationships to CDRH-TPLC |
| Project Title | TPLC Entry Point | TPLC Position 2 Y | Function |
|---|---|---|---|
| 1. Tracheostomy Air Flow | Concept | Preclinical | Detection of obstruction in artificial airways of infants and children |
| 2. Attention Point | Prototype | Clinical | Objective diagnosis of attention deficit hyperactivity disorder |
| 3. PED-ER | Preclinical | Commercial Use | Infant and pediatric resuscitation aid |
| 4. Sonic Window | Clinical | Manufacturing | Hand held ultrasonic imaging device |
| 5. Rhinoguard | Marketing | Commercial Use | Facilitation of atraumatic nasotracheal intubation |
Table 5. PMDI Two Year Projects and Predicted End Points |
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