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find result X, then, we carry out test B on five more devices, whereas, if we get result Y, then, we modify five devices and repeat test A etc.) and the team will not get the necessary commitment from a service function. |
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Clinical testing is usually the greatest and the least of the project manager's headaches. It is the greatest in the sense that getting there on time with a good device doing what it is meant to do is, perhaps, the major challenge for the project manager and the objective at which much of his effort is aimed. It is least in the sense that once there with a good device, an efficacious molecule, and a well designed trial, the rest should fall into place. |
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A wide range of tools is available for managing all types of projects. Many general tools are relevant to drug device development and ought to be used by the project manager. We shall concentrate on commenting on some key tools for device development. |
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The project plan is the primary tool of project control and an important means of communication with the team. The huge range of skills and functions needed to develop a successful device make planning even more important than in other projects. The availability of planning tools for personal computers, such as MS Project and MacProject, has made the professional planner redundant in many situations. In one respect, direct control of the plan by the team members is a good thing because it promotes ownership, commitment, and the ability to change the plan quickly and easily as circumstances demand. On the other hand, the use of this tool is a skill that must be acquired, not just in respect to the technical aspects of using the tool but also in the ability to draw together diverse and interdependent activities in a logical and consistent manner (in other words, to think like a planner). Bad planning can be worse than no planning at all. |
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There should be a top level plan which shows, in outline, all the activities for the complete development. There should be more detailed plans for each project phase, and within those, yet more detailed plans for individual functions. The detailed plans should reflect the requirements of the higher level plan but should feed back into it so that the questions What do we have to do? and What have we got time to do? receive the right balance of emphasis depending on the relative priorities of functionality and timescales. The plans together should form a self consistent set. |
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