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MULTIDISCIPLINARY DESIGN ANALYSIS AND OPTIMIZATION FRAMEWORK FOR REGULATORY DRIVEN MEDICAL DEVICE DEVELOPMENT

Published online by Cambridge University Press:  19 June 2023

Soumya Ranjan Mishra and
Kamran Behdinan
Soumya Ranjan Mishra*
Affiliation:
University of Toronto
Kamran Behdinan
Affiliation:
University of Toronto
*
Mishra, Soumya Ranjan, University of Toronto, Canada, sr.mishra@mail.utoronto.ca

Abstract

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Multidisciplinary design optimization (MDO) is a technique used in the design of systems involving the integration of many disciplines. The architecture and formulation of MDO has an impact on the solution time and optimality of final designs. The process of developing medical devices requires the combination of medical and technical knowledge and abilities. Developing a medical device is done by a complicated collection of Product Development Processes that entail tremendous oversight to ensure conformity to regulatory requirements. Regulatory standards often provide stern “Go / No-Go” policies which may discretize the design variables further increasing the complexity of the optimization problem. This work proposes a novel design approach which utilizes systems engineering practices to undertake complex multidisciplinary design optimization while implementing regulatory guidelines for medical devices. The formulated model is then applied and examined in a case study towards the development of a piezoelectric respiratory sensor. It is observed that the novel framework would extensively improve the design space definition and process driven product development practices.

Keywords

Multi- / Cross- / Trans-disciplinary processesOptimisationBiomedical design

Information

Type
Article
Information
Proceedings of the Design Society , Volume 3: ICED23 , July 2023, pp. 2735 - 2744
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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