Development Pathway

The APDC provides support for commercialization of devices for pediatric healthcare from initial concept to the completed marketed product. The Consortium brings together existing centers of excellence in the Atlanta region to provide a seamless, cost efficient development pathway.

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Stages of Development

1. Concept: This will include devices that are still ideas or that are being designed and sketched.

2. Prototype: This will apply once a physical model of the device exists. The terms early and advanced prototype may be applied.

3. Preclinical: Use this terminology once the device is being bench tested, tested in models, or undergoing laboratory testing

4. Clinical: Use this terminology once the final designed device is being tested in humans

5. Manufacturing: To describe issues surrounding mass production of a device that will be sold commercially

6. Marketing: To describe when a device is under formal regulatory review by the FDA

7. Commercial Use: Once a device has received FDA clearance or approval and is being used in practice academia or the private sector. APDC has a distinct pathway to move projects to commercialization.