|
|
|
|
|
|
|
This last function can be the responsibility of the pharmaceutical company, the manufacturing partner, or a specialist product development organization. Each approach has its own advantages and disadvantages, and the choice depends on individual circumstances. Tables 1, 2, and 3 show some of the advantages and disadvantages of each approach. |
|
|
|
|
|
|
|
|
IV.
Management of Diverse Project Resources |
|
|
|
|
|
|
|
|
The first step has been taken, and a competent team is in place. What does the project manager have to do to manage the resource? |
|
|
|
|
|
|
|
|
The very diversity of skills needed to carry out a device development causes the first headache for the project manager, to coordinate this wide range of input, to ensure that the entire team is working to the same schedules, that all to be done is being done, and that activities are not being duplicated. |
|
|
|
|
|
|
|
|
Very importantly, the project manager must understand enough about each of the many disciplines to coordinate them and to act as a facilitator for their often conflicting requirements. This does not mean that the project manager must be a competent practitioner in all (or indeed in any) of them, but he must speak many technical languages and act as a conduit and interpreter of information between different disciplines. Avoiding the Tower of Babel effect is a prime responsibility. |
|
|
|
|
|
|
|
|
For example, if there is a need to facilitate a debate between the formulation chemist, the materials scientist and the toolmaker on alternative solutions to, say, a dose uniformity problem, the project manager must understand the meaning of such concepts as excipients and micronization, the triboelectric series and plastic deformation, and hot runners and ejector pins. Real problems arise on projects at the interfaces, particularly where one discipline underestimates or ignores the need for another. The project manager must ensure that the needs and constraints of each party are understood by the others to the extent needed to make the best decision for the project. |
|
|
|
|
|
|
|
|
This facility to understand and debate with all disciplines is the most important skill the device development project manager can have and one of the most difficult to acquire. It comes only through experience and an insatiable desire to learn applied across all the disciplines. It is destroyed by the fatal assumption that any one or two skills are much more important to the development than others. |
|
|
|
|
|
|
|
|
V.
The Makeup of the Project Team |
|
|
|
|
|
|
|
|
Project teams are not and should not be static institutions, established on day one and set in stone for the duration of the project. |
|
|
|
|
|