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The process of determining customers' needs begins with good market research. All too often, good is interpreted to mean extensive. The market for drug delivery cannot be researched in the same way as the market for washing powder. Better to concentrate on fewer influential respondents, particularly when seeking the views of health care professionals, and to ensure that the interviews thoroughly explore their views. The project manager has the difficult task of leading the Marketing Department and the technical experts on the team in translating the findings of market research into the first draft of the Product Requirement Specification. |
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Tools, such as Customer Preference Modeling, which allow more objective trade-offs between features and cost and between different features, should be used at this stage. |
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Research later in the project, in the form of acceptance trials with professionals and with patients, should always use tangible stimulus material. This should take the form of more or less realistic models of different concepts for meeting the Requirements Specification, which respondents can comment on and which can be used to explore how well users cope with operating the device. For a device for self-administration, patients should receive about the same level of training and explanation as they would in a real clinical setting, and their subsequent attempts to use the device models can be recorded on video for later analysis. |
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The project manager should be the conscience of the team. He has to ensure that the optimal concept is chosen, based on the findings of the trial, rather than on the prejudices of the team, which do not always coincide. The project manager also has to encourage the team to solve real issues which arise from the research and to avoid the temptation of sweeping these problems under the carpet. For example, a majority of patient respondents might criticize the procedure for reloading the device, and this might well be supported by the practical evidence based on their attempts to do so with the models during the interview. To ignore these findings and to rationalize the issue away by asserting that patients will learn in time to cope would be a big mistake and would result in a substantially poorer device than if the difficult task of solving the ergonomic difficulty was faced. |
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VIII.
The Product Requirement Specification |
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Good devices have been launched without ever having a formal Product Requirement Specification but that is just good luck. |
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Professionally managed device development should have a Requirement Specification in place before the start of the Engineering Model phase. |
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