Leadership personnel from PMDI will facilitate a self-assessment by each consortium member as the first step in building relationships. It is during this initial interaction with the children’s hospital and its surrounding community that the PMDI product development approach utilizing the FDA Center for Devices and Radiological Health Vision (CDRH) – Total Product Life Cycle will be introduced as shown in Figure 1.
Figure 1 presents two approaches to product development. The path shown along the left edge and bottom of the figure presents the sequential approach to product development where the process proceeds in a clear step wise fashion. The second approach as shown in thethe CDRH graphic presents many of the same steps but also demonstrates the interconnectivity of these processes.
CDRH has provided a comprehensive pathway for product development. The traditional approach has been to move along the circumference of the circle, developing a device in a well structured sequence. PMDI recognizes, and has shown, that by utilizing the multiple links parsing the CDRH development approach, teams can be formed that develop products in a more parallel process. For example, including the commercial interests during the initial inventor/engineering meetings reduces the number of prototypes because the production concerns are incorporated during the concept/design phase of the project. It has also proven to be worthwhile to include the marketing and sales and trial design expertise early in the development process to reduce the time to market, thus reducing the cost. These examples are comparable to linking Concept/Prototype with Manufacturing/Marketing/Commercial Use from the CDRH pathway. This also allows early participation in the development effort by small business.