2025 - ​Holistic Model-Based Perspective on MedTech-Pharma Interfaces for New
Combination Product Development

Authors
Yaroslav Menshenin, Jude Cancellieri, Guillaume Bonnefond, Romain Pinquié, Pierre Chevrier
Abstract
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.
Cite this Publication
Menshenin, Y., Cancellieri, J., Bonnefond, G., Pinquié, R., Chevrier, P. (2025) Holistic Model-Based Perspective on MedTech-Pharma Interfaces for New Combination Product Development. In Proceedings of the 27th International DSM Conference (DSM 2025), Hoboken, NJ, USA, pp. 1-10. http://doi.org/10.35199/dsm2025.01