The experience I have comes from working within a device development group in a big pharma company organized in a project based environment. The organization structure is based on teams with specific goals. Main business goals for big pharm companies is to develop drugs so most of the medical devices I was involved in working on were part of single entity combination products [where the PMOA (primary mode of action) is attributed to the drug) rather than “pure” medical devices. Some teams were tasked to develop the drug product and other the medical device. There were synergies between these teams, of course, as they have to interact to ensure compatibility between the drug and device. Both teams were comprised of functional area experts including project managers. There is hierarchy that these teams report to other higher governing teams that oversee the early and late development of the program. Early development team oversees the early clinical studies of the drug product development (e.g. phase 1-2b) while late development governing team oversees late stages of clinical studies and commercialization of the product. This project based organization works well for my department as we are able to understand the complexities of the drug product in which we have to develop a suitable medical device for and deliver the results on time as most of time development of drugs take longer than medical devices.
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