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INVESTIGATION ON METHODS AND CHARACTERISTICS IN MEDICAL DEVICE DEVELOPMENT

Part of: Socio-technical Issues in Design

Published online by Cambridge University Press:  11 June 2020

J. Kuhl ,
O. Sankowski  and
D. Krause
J. Kuhl*
Affiliation:
Hamburg University of Technology, Germany
O. Sankowski
Affiliation:
Hamburg University of Technology, Germany
D. Krause
Affiliation:
Hamburg University of Technology, Germany
*
*juliane.kuhl@tuhh.de

Abstract

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A targeted development of safe medical products can be supported by design methods. This paper analyses which design methods are applied in the development of medical devices and whether they are adapted for considering medical devices’ special features (legal, human and technical issues). In particular, variety management, risk assessment and user-centered design for medical devices are examined. Typically, interdisciplinary risk assessment is methodically supported. Additionally, user-centered design methods for requirements assessment, design verification and design validation are applied.

Keywords

biomedical designdesign methodsrisk managementuser-centred designmedical device development
Type
Article
Information
Proceedings of the Design Society: DESIGN Conference , Volume 1 , May 2020 , pp. 1969 - 1978
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), 2020. Published by Cambridge University Press

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