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ther advanced than it is, are major stumbling blocks. Time and time again, we come across attempts to initiate the manufacturing of designs which are no more refined than proof-of-principle models. |
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As the development progresses, the emphasis and the immediate objectives change. The planning and management of the project are enhanced immeasurably by dividing the development into phases and being clear about the objectives and the levels of hardware sophistication in each phase. |
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Figure 1 shows a project structure which, experience has shown, is suitable for developing drug delivery devices. All device developments, whether they are clean sheet projects taking five years from concept to launch or fast track developments of simple devices taking less than a year, go through these or very similar stages. Sometimes it is possible or desirable to take a short cut or eliminate a stage, but, then, it is dangerous to pretend that no short cut has been taken and it is as well to acknowledge that the technical risk is increased. |
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Massive short cutting, generally, is a false economy. So is the monolithic concept of design, where there are no planned design iterations. In this case, the initial project schedule often seems seductively short. The reality is that this approach results in unplanned and seemingly endless design modifications, a configuration out of control, unmanageable risk, and often, failure. |
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There are other models that can be used to structure the project. One does not have to use the model of Figure 1, but some structure should be used. |
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VII.
Meeting Customers' Needs |
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It is necessary, but not sufficient, that devices be safe and efficacious. They must be well designed, easy to use and, in the case of devices for patient self-administration, they should promote patient compliance. The cleverest and most advanced delivery concept can be let down by poor attention to the real clinical needs of health professionals and patients. |
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The project manager has the responsibility to ensure that industrial design is not an after thought. It is no good predicting what responses patients will have to different designs of device. Good quality research must be done to determine patients' and health professionals' views and to observe objectively how they cope with operating the proposed design of a device. The project manager has to curb the natural desire of the team to forge ahead without this information, and he must ensure that the lessons learned from patient and doctor acceptance trials are applied to the design. |
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