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TOWARDS A VERIFICATION AND VALIDATING TESTING FRAMEWORK TO DEVELOP BESPOKE MEDICAL PRODUCTS IN RESEARCH-FUNDED PROJECTS

Published online by Cambridge University Press:  27 July 2021

Emanuel Balzan*
Affiliation:
University of Malta
Pierre Vella
Affiliation:
University of Malta
Philip Farrugia
Affiliation:
University of Malta
Edward Abela
Affiliation:
University of Malta
Glenn Cassar
Affiliation:
University of Malta
Maria Victoria Gauci
Affiliation:
University of Malta
*
Balzan, Emanuel, University of Malta Dept. of Indus. and Manuf. Engineering Malta, emanuel.balzan@um.edu.mt

Abstract

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Research funded projects are often concerned with the development of proof-of-concept products. Consequently, activities related to verification and validation testing (VVT) are often not considered in depth, even though various design iterations are carried out to refine an idea. Furthermore, the introduction of additive manufacturing (AM) has facilitated, in particular, the development of bespoke medical products. End bespoke products, which will be used by relevant stakeholders (e.g. patients and clinicians) are fabricated with the same manufacturing technologies used during prototyping. As a result, the detailed design stage of products fabricated by AM is much shorter. Therefore, to improve the market-readiness of bespoke medical devices, testing must be integrated within the development from an early stage, allowing better planning of resources. To address these issues, in this paper, a comprehensive VVT framework is proposed for research projects, which lack a VVT infrastructure. The framework builds up on previous studies and methods utilised in industry to enable project key experts to capture risks as early as the concept design stage.

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), 2021. Published by Cambridge University Press

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TOWARDS A VERIFICATION AND VALIDATING TESTING FRAMEWORK TO DEVELOP BESPOKE MEDICAL PRODUCTS IN RESEARCH-FUNDED PROJECTS
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