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MedTech Product Development Framework for Post-Pandemic Era

Published online by Cambridge University Press:  26 May 2022

N. Glazkova
Affiliation:
Skolkovo Institute of Science and Technology, Russia
Y. Menshenin*
Affiliation:
Skolkovo Institute of Science and Technology, Russia
D. Vasilev
Affiliation:
Karfidov Lab, Russia
C. Fortin
Affiliation:
Skolkovo Institute of Science and Technology, Russia

Abstract

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A case study during pandemic revealed the major drawbacks of the traditional product development process for MedTech industry. Disruption of conventional manufacturing, urgent need for accelerated design and production, faster regulatory approval have challenged the industry. In this paper the conventional medical product development process is explored based on the intramuscular injector case study. The study revealed core areas for improvement of the medical devices development process. The paper proposes the Lean-Agile methodology with the incorporated elements of Concurrent Engineering.

Type
Article
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), 2022.

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