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A Novel User-Centred Framework for the Holistic Design of Therapeutic Medical Devices

Published online by Cambridge University Press:  26 May 2022

E. Abela*
Affiliation:
University of Malta, Malta
P. Farrugia
Affiliation:
University of Malta, Malta
M. V. Gauci
Affiliation:
University of Malta, Malta
P. Vella
Affiliation:
University of Malta, Malta
G. Cassar
Affiliation:
University of Malta, Malta
E. Balzan
Affiliation:
University of Malta, Malta

Abstract

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Numerous and complex sequence of activities in medical device development often result in time consuming and expensive engineering processes. In this study, patient and designer requirements were identified and integrated within a novel framework which supports medical device design through a consolidated understanding of user-experience whilst directly coalescing the applicable regulatory requirements in terms of product compliance and certification. This assists in the development of safe and reliable products which reflect the need for increased usability considerations during design.

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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