Holistic Model-Based Perspective on MedTech-Pharma Interfaces for New Combination Product Development

In today's product development landscape, MedTech combination products are becoming increasingly complex, integrating both software and hardware components. Combination products such as on-body injectors and autoinjectors are designed to assist end-users in administering drugs into the patient's body, enabling controlled drug delivery with a time delay. These products typically consist of two regulated components: the drug, developed by pharmaceutical industry, and the drug delivery system, developed by the MedTech industry. From the MedTech developer's perspective, the innovation process begins under uncertainty due to a lack of, or very limited, information about the drug's parameters. As a result, the MedTech industry must carry out early-stage design activities based on design assumptions. This paper aims to develop a holistic framework for defining MedTech-Pharma interfaces. Such a framework would accelerate innovation across engineering design teams and support faster time-to-market for MedTech product development in collaboration with the pharmaceutical industry.