Knowledge Base Repository
In addition to research papers, the Design Society is developing several valuable resources for those interested in the study of design. These include a repository of PhD theses, a library of case studies and transcripts of design activities, and an archive of our newsletters. Please note that these resources are accessible exclusively to Design Society members.
Holistic Model-Based Perspective on MedTech-Pharma Interfaces for New Combination Product Development
Yaroslav Menshenin (1), Jude Cancellieri (2), Guillaume Bonnefond (3), Romain Pinquié (1), Pierre Chevrier (1)
Type:
Year:
2025
Editor:
Ali A. Yassine, Christopher Langner, Matthias Kreimeyer, Tyson R. Browning, Steven D. Eppinger
Author:
Series:
DSM
Institution:
1: Univ. Grenoble Alpes, CNRS, Grenoble INP, G-SCOP, France; 2: BD Medical - Pharmaceutical Systems, Becton Dickinson and Company, Franklin Lakes, NJ, USA; 3: BD Medical - Pharmaceutical Systems, Becton Dickinson and Company, Le Pont-de-Claix, France
Page(s):
1-10
DOI number:
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.
Keywords:
