SYSTEM ARCHITECTURE
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Authors
Yaroslav Menshenin, Romain Pinquié, Pierre Chevrier
Abstract
The steady growth of life expectancy calls for a new view on the importance of MedTech combination product development. One can envision that to keep a higher quality of life, more people would require some form of therapy depending on their individual state of health. This would require more medical devices of different types and complexity to be designed for specific drugs. However, from a holistic perspective, several challenges emerge in the development of drug-device combination products. An additional layer of complexity appears due to the increasing complexity of the MedTech devices, as they interact with the other systems and products in the design environment. This paper discusses those potential challenges and proposes ways to mitigate them. The primary focus of this work is on the drug delivery systems, such as autoinjectors.
Cite this Publication
Menshenin, Y., Pinquié, R., Chevrier, P. (2024) Holistic Perspective to the Drug-Device Combination Product Development Challenges. In: Danjou, C., Harik, R., Nyffenegger, F., Rivest, L., Bouras, A. (eds) Product Lifecycle Management. Leveraging Digital Twins, Circular Economy, and Knowledge Management for Sustainable Innovation. PLM 2023. IFIP Advances in Information and Communication Technology, vol 701, pp.235-242. Springer, Cham. https://doi.org/10.1007/978-3-031-62578-7_22
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    • 2025 - SIMILARITY ASSESSMENT OF THE ENGINEERING CONCEPTS: DECISION-MAKING SUPPORT AND METRICS
    • 2024 - The Influence of Human-Systems Integration on “Fuzzy Front End” of Innovation: A MedTech Case Study
    • 2024 - Holistic Perspective to the Drug-Device Combination Product Development Challenges
    • 2023 - New Product Development Process for MedTech Combination Products
    • 2023 - Defining a New Role of System Architect at the Product Strategy Stage of a MedTech Product Development Through the DSM-Based Method
    • 2022 - Model-Based System Architecting and Decision-Making
    • 2022 - MBSE-PLM INTEGRATION: INITIATIVES AND FUTURE OUTLOOK
    • 2021 - Integration of MBSE and PLM: complexity and uncertainty
    • 2021 - Study of system interfaces through the notion of complementarity
    • 2020 - ​A System Concept Representation Framework and its Testing on Patents, Urban Architectural Patterns, and Software Patterns
    • 2018 - A Framework for Concept and its Testing on Patents
  • Posts
  • Bio
  • Book
  • Research
  • Publications
  • Scientific Posters
  • Selected presentations
  • Teaching
    • MBSE Class (2023-)
    • Systems Engineering Class (2018-2022)
    • Space Sector Course (2015-2021)
  • Certificates
  • Interviews and articles
    • Article about Space Sector Course
    • Pursuing the innovation in systems engineering
    • Interview for Science and Life Magazine
    • Radio Culture
  • Scientific Community
    • DESIGN Society
    • DSM Community
    • INCOSE
    • IAF
    • IFIP WG 5.1
    • Health Systems Design SIG
  • Library
    • 2025 - SIMILARITY ASSESSMENT OF THE ENGINEERING CONCEPTS: DECISION-MAKING SUPPORT AND METRICS
    • 2024 - The Influence of Human-Systems Integration on “Fuzzy Front End” of Innovation: A MedTech Case Study
    • 2024 - Holistic Perspective to the Drug-Device Combination Product Development Challenges
    • 2023 - New Product Development Process for MedTech Combination Products
    • 2023 - Defining a New Role of System Architect at the Product Strategy Stage of a MedTech Product Development Through the DSM-Based Method
    • 2022 - Model-Based System Architecting and Decision-Making
    • 2022 - MBSE-PLM INTEGRATION: INITIATIVES AND FUTURE OUTLOOK
    • 2021 - Integration of MBSE and PLM: complexity and uncertainty
    • 2021 - Study of system interfaces through the notion of complementarity
    • 2020 - ​A System Concept Representation Framework and its Testing on Patents, Urban Architectural Patterns, and Software Patterns
    • 2018 - A Framework for Concept and its Testing on Patents