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This specification should be based on prior experience and good market research, because this is the only way to ensure that everyone on the team has the same concept of what the device must be, that the concept supports the market requirements, and that the temptation of creeping elegance is avoided. The Requirements Specification is a living document and can be changed. However, the change should be made consciously and with full understanding of the implications for project duration and risk. A certain degree of inertia is a good thing, so that change requires some effort. The inertia should increase as the assignment progresses, so that changes to the Requirement Specification become almost impossible as the preparation of clinical trial material approaches. All affected by changes should agree to them and sign them off. |
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The project manager is the keeper of the Requirement Specification. This means that the project manager has to negotiate and interpret conflicting needs and document their resolution in the Specification. The project manager must also ensure that the design meets the Specification and is shown to do so by arranging different types of testing. If the device fails to meet the Requirement Specification, the project manager must make the team face this and resolve it explicitly by improving the performance of the device or by accepting the deficiency formally by changing the Specification. |
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There are three broad categories of device testing; mechanical and life testing, analytical testing, and clinical testing. |
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Because it is outside normal pharmaceutical practice, mechanical testing is often ignored. The project manager should ensure that the device is tested properly for robustness and that the tests represent the most severe environments that the device will encounter in the glove compartments of motor cars, in handbags and pockets, and across the globe from Scandinavia in winter to a tropical paradise. |
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The need for analytical testing to support the in vitro investigation of the device's functionality is well understood. The critical tasks for the project manager are to ensure an adequate test plan, provide sufficient resources, and establish protocols which are followed. Analytical testing is often on the critical path, particularly when technical problem solving is underway. A big mistake, frequently made, is to treat the analytical test resource as an external service rather than as an integral part of the development team. In the midst of a major technical problem, the test plan can change on a daily basis (Let's carry out test A on five devices and, if we |
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