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Combination Products are medical products comprising two or more regulated components, such as a drug and a device. The drug/device development processes are strictly regulated and are not fully aligned in time. This creates uncertainty for the MedTech companies which have to develop the devices possessing limited knowledge about the final drug formulation to be released by the Pharmaceutical company later in the drug development process. This challenge calls for a holistic systems approach to the Combination Product development process. The paper advocates that systems engineering methods and tools provide appropriate means to support the MedTech product development process. This is achieved through the definition of the role of a system architect and the allocation of his/her responsibilities to the activities using the DSM-based approach. As a case study, the method is applied to the definition of system architect's role in the product strategy stage of drug delivery system development.

Keywords:

MedTech, systems engineering, DSM, product development, combination product