ABSTRACT
Development project managers are increasingly becoming involved in managing combination drug–device projects. This chapter describes the types of drug–device products recognized by regulatory authorities, as well as the regulatory pathways to market approval. It also describes how the choice of primary mode of action determines the development plan for the product. Finally, the chapter ends with a comparison of drug development and device development, including quality and risk management systems, use of Agile methodologies, and typical team structures.
