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2024 - The Influence of Human-Systems Integration on “Fuzzy Front End” of Innovation: A MedTech Case Study

Authors
Yaroslav Menshenin, Romain Pinquié
Abstract
Human-Systems Integration (HSI) can be considered as the combination of Systems Engineering and Human-Centered Design approaches. To support HSI, the system of interest (SoI) and its broader context should be developed with a specific engineering design objective and consider humans part of the system. Using a MedTech industry case study, this paper explores the influence of including MedTech end-users, such as Healthcare Professionals, within the SoI definition. The MBSE approach models the “fuzzy front end” of innovation for the MedTech Combination Product and places the end-users within the SoI boundaries. The paper advocates that such an approach shifts the paradigm of enabling the human factors considerations to the early innovation phases rather than waiting for the first physical prototype.
Cite this Publication
Menshenin, Y., Pinquié, R. (2024) The Influence of Human-Systems Integration on “Fuzzy Front End” of Innovation: A MedTech Case Study. In Proceedings of the INCOSE Human-Systems Integration Conference, Jeju, South Korea. https://hal.science/hal-04871699/​
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    • 2025 - Holistic Model-Based Perspective on MedTech-Pharma Interfaces for New Combination Product Development
    • 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 & Awards
  • 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 - Holistic Model-Based Perspective on MedTech-Pharma Interfaces for New Combination Product Development
    • 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