When a project progresses from the initial research and development work performed in support of product development to the test and evaluation and approval and acquisition of the material, management shifts from JSTO-CBD, under DTRA, to JPEO-CBD. Though both offices are overseen by the CBDP, there is no one office or individual who oversees the entire process for any given product. The discussion below highlights some of the challenges that this structure can pose for efficient development and presents some possible alternative options for consideration by DASD(CBD). These changes could help to improve the current processes, should a requirements-driven process be maintained, or support a revised, capabilities-driven process, as discussed in Chapter 4.
The development of a final product is often iterative in nature, with failures in T&E identifying weaknesses that can only be resolved with additional R&D. At such times, the project management shifts from JPEO-CBD, which manages the T&E process, back to JSTO-CBD for additional R&D before returning to JPEO-CBD for the next round of testing and, potentially, approval. Successful transition between these offices requires a shared understanding of appropriate transition points. If an agreement is not in place, there is a risk that a gap between the perceived roles could result in the development of a project management “valley of death” and reduced program efficiency. While such issues can potentially be resolved through good working relationships between the offices, reliance on that relationship for success is not recommended as it can be strongly influenced by personality rather than policy. To address this concern, the committee recommends that DASD(CBD) consider alternative program management methods, including incorporation of an end-to-end project management authority to be maintained by an individual with scientific and technical expertise, as opposed to an acquisition specialist. In addition, liaisons such as those used between the management offices and the COCOMs, or secondments between offices and laboratories could support the development of both formal and informal relationships between program personnel and facilitate the development of trust and understanding between the various parties and offices.
One particularly stark example of the importance of an end-to-end project management authority, or at least consensus on the appropriate transition point, is in the development of medical countermeasures (see Box 5.1 highlighting some failures of medical products where poor transition between development stages was a contributing factor). The root of the difficulty is that development and acquisition of these items must contend with regulatory requirements—e.g., good laboratory and manufacturing processes, clinical trials, and acquisition of safety and efficacy data—and these requirements must be met in order to obtain FDA