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development; drug formulation and development pharmacy; pharmacology; clinical research; regulatory affairs; packaging; production line design; assembly and filling equipment design; production validation; market research and marketing. This long (but not exhaustive) list can result in two challenges. First, there is often difficulty in assembling all the skills at the right time. Second, the project manager faces a real challenge in pulling all of these disparate strands together. |
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It is unusual that any single organization has every skill in-house. The challenge lies not just in creating an internal structure with representatives of all the disciplines, but in maintaining those skills at the leading edge of practice and in providing a career structure for people with minority skills. The answer is to form a collaborative team from a number of different organizations, each of which is expert and competent in one or several of the key disciplines. In other words, outsourcing of some elements is usually necessary. |
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Choosing the members of the team is the first important step in the development process and, critically important, because the success of the project depends on it. Each organization contributing to the collaboration should possess one or a number of core skills and have sufficient knowledge of the others' contributions to interact effectively. It is no good engaging the very best design house if it has no people with experience or knowledge of the vagaries and subtleties of the drug/device interaction. |
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If going it alone is often inadvisable, having too many different organizations contributing to the development can also be a mistake. The challenge of communicating and coordinating across the project team requires a limited number of primary collaborators. Experience shows that it is easy to lose control with more than three. Of course, there is no reason why any of the primary contributors should not engage and manage specialist subcontract services. |
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There are three broad categories of skill required to develop a device: |
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analytical chemistry, drug formulation, clinical research, regulatory affairs and marketing which are usually best undertaken by a pharmaceutical company (although outsourcing of some of these elements is possible and increasingly likely) |
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assembly and filling line development; molding and tool making are usually undertaken by a specialist GMP manufacturing company. Some elements (particularly filling and final assembly) frequently remain the responsibility of the pharmaceutical partner |
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the design, consisting of industrial design and ergonomics, mechanical engineering and design, electronics, software, and so forth. |
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