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NEW PRODUCT DEVELOPMENT PROCESS FOR MEDTECH COMBINATION PRODUCTS

Published online by Cambridge University Press:  19 June 2023

Yaroslav Menshenin ,
Romain Pinquié  and
Pierre Chevrier
Yaroslav Menshenin*
Affiliation:
Univ. Grenoble Alpes, CNRS, Grenoble INP, G-SCOP
Romain Pinquié
Affiliation:
Univ. Grenoble Alpes, CNRS, Grenoble INP, G-SCOP
Pierre Chevrier
Affiliation:
Univ. Grenoble Alpes, CNRS, Grenoble INP, G-SCOP
*
Menshenin, Yaroslav, Grenoble INP, France, yaroslav.menshenin@grenoble-inp.fr

Abstract

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The MedTech product development is experiencing a growing complexity of the design process. The design challenge is to keep the medical device simple and user-friendly while maintaining its interconnectivity with the other systems and products. The additional layer of complexity comes from the need to satisfy both - direct customers (pharma companies), and indirect ones (patients, health care practitioners, and pharmacists). Solving those design challenges must not compromise the safety of the end-user and must follow the regulatory requirements.

This research proposes the systematic design process for MedTech combination product development with the emphasis on product strategy and concept development operationalized by design thinking participative toolkit. The proposed approach serves the purpose of increasing the traceability between the early made business decisions on a product strategy level of MedTech company, and the engineering decisions made on product concept level. The ultimate goal of the research is to support the decision-makers with methods and tools which would allow them to make informed decisions on investment in a new MedTech combination product by Pharma and MedTech companies.

Keywords

MedTechSystems Engineering (SE)Design ThinkingNew product developmentDesign process
Type
Article
Information
Proceedings of the Design Society , Volume 3: ICED23 , July 2023 , pp. 2795 - 2804
Creative Commons
Creative Common License - CCCreative Common License - BYCreative Common License - NCCreative Common License - ND
This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.
Copyright
The Author(s), 2023. Published by Cambridge University Press

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