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Many developments begin with an invention or some other piece of creative thinking. The management of the transition from invention to full product development must take account of the fact that inventors of device concepts are often not good at developing detailed and robust engineering solutions. This issue can arise both with in-house and with licensed-in concepts and, if not managed well, can be troublesome or fatal later. |
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The makeup of the team should change according to the development stage. Inventors, naturally, feel strong ownership for their creation and sometimes fail to recognize their deficiencies. In this case, the goal of the project manager must be to retain the creativity, commitment, and experience of the inventor while moving the design responsibility to a results-focused professional development team. One good approach is to retain the inventor as advisor or guru, but not in such a rôle where he can single handedly override the design authority that the project manager has vested in the development team. This needs a degree of tact usually to be found only in career diplomats. |
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Similarly with the rest of the development, the project manager must engage and disengage different skills at the appropriate time during the development. In many cases, getting the right people when they are most needed requires careful planning and persistence. |
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For many skills, the appropriate time to be engaged is earlier than has conventionally been the case. Input from component manufacturers and from those responsible for assembly, filling, testing, packaging, and marketing the product should not be left to the end. The best devices are easy to mold, easy to assemble, easy to fill, work well with the drug, and meet the market needs, and this cannot be achieved by ignoring these aspects to the last minute. The project management challenge is to engage downstream skills early enough and to ensure that they are seen as full team members and that their input is heeded. It is more difficult to coordinate bigger teams with sometimes conflicting demands, so the temptation is strong to keep the team small and easily managed. Nevertheless, experience across industry shows that overall quality and timescales are enhanced by getting parallel input early, compared with the conventional serial approach. |
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Parallel working does not mean that everyone does everything at once and that the project lacks structure. |
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Inexperienced device development managers often see the development as a single monolithic task. This, and thinking that the project is fur- |
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