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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 ,
Pierre Vella ,
Philip Farrugia ,
Edward Abela ,
Glenn Cassar  and
Maria Victoria Gauci
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.

Keywords

Service designAdditive ManufacturingProject managementVerification and ValidationTesting
Type
Article
Information
Proceedings of the Design Society , Volume 1: ICED21 , August 2021 , pp. 3199 - 3208
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

References

Abuhav, I. (2018) ISO 13485:2016. 2nd edn. Boca Raton, Florida: CRC Press. doi: 10.1201/9781351000796.Google Scholar
Bensalem, S., Havelund, K. and Orlandini, A. (2014) ‘Verification and validation meet planning and scheduling’, International Journal on Software Tools for Technology Transfer, 16(1), pp. 1–12. doi: 10.1007/s10009-013-0294-x.CrossRefGoogle Scholar
Bjarnason, E. et al. (2014) ‘Challenges and practices in aligning requirements with verification and validation: a case study of six companies’, Empirical Software Engineering, 19(6), pp. 1809–1855. doi: 10.1007/s10664-013-9263-y.CrossRefGoogle Scholar
Engel, A. (2010) Verification, Validation, and Testing of Engineered Systems. Edited by P. Hahn. New Jersey: John Wiley & Sons, Inc., Hoboken.10.1002/9780470618851CrossRefGoogle Scholar
Ford Motor Company (2011) ‘Failure Mode and Effects Analysis, FMEA Handbook (with Robustness Linkages)’, International Journal of Quality & Reliability Management, 13(5), p. 286. Available at: https://fsp.portal.covisint.com/documents/106025/14555722/FMEAHandbookv4.2/4c14da5c-0842-4e60-a88b-75c18e143cf7.Google Scholar
Forsberg, K. and Mooz, H. (1992) ‘The Relationship of Systems Engineering to the Project Cycle’, Engineering Management Journal, 4(3), pp. 36–43. doi: 10.1080/10429247.1992.11414684.CrossRefGoogle Scholar
Garzaniti, N., Fortin, Clément and Golkar, A. (2019) ‘Toward a Hybrid Agile Product Development Process’, in Fortin, Clement et al. (eds) Product Lifecycle Management in the Digtal Twin Era. Moscow: Springer Nature Switzerland, pp. 191–200. doi: https://doi.org/10.1007/978-3-030-42250-9_18.CrossRefGoogle Scholar
Hoppe, M., Engel, A. and Shachar, S. (2007) ‘SysTest: Improving the verification, validation, and testing process— Assessing six industrial pilot projects’, Systems Engineering, 10(4), pp. 323–347. doi: 10.1002/sys.20082.CrossRefGoogle Scholar
Joshi, A., Zhu, B. Z. and Xu, L. (2019) Trends in Medical Device Recalls. Available at: https://www.medtechintelligence.com/feature_article/trends-in-medical-device-recalls/#comments (Accessed: 6 December 2012).Google Scholar
Lévárdy, V., Hoppe, M. and Honour, E. (2004) ‘8.2.3 Verification, Validation & Testing Strategy and Planning Procedure’, INCOSE International Symposium. doi: 10.1002/j.2334-5837.2004.tb00603.x.CrossRefGoogle Scholar
Mankins, J. C. (2009) ‘Technology readiness assessments: A retrospective’, Acta Astronautica. doi: 10.1016/j.actaastro.2009.03.058.Google Scholar
Mao, J. Y. et al. (2005) ‘The state of user-centered design practice’, Communications of the ACM, 48(3), pp. 105–109. doi: 10.1145/1047671.1047677.CrossRefGoogle Scholar
Morrison, R. J. et al. (2015) ‘Regulatory Considerations in the Design and Manufacturing of Implantable 3D-Printed Medical Devices’, Clinical and Translational Science. doi: 10.1111/cts.12315.CrossRefGoogle ScholarPubMed
Murphy, B., Wakefield, A. and Friedman, J. (2008) ‘Best practices for verification, validation, and test in model-based design’, SAE Technical Papers. doi: 10.4271/2008-01-1469.CrossRefGoogle Scholar
Pahl, G. et al. (2007) Engineering design: A systematic approach, Engineering Design: A Systematic Approach. doi: 10.1007/978-1-84628-319-2.CrossRefGoogle Scholar
Shabi, J., Reich, Y. and Diamant, R. (2017) ‘Planning the verification, validation, and testing process: a case study demonstrating a decision support model’, Journal of Engineering Design. doi: 10.1080/09544828.2016.1274964.CrossRefGoogle Scholar
Tahera, K., Earl, C. and Eckert, C. (2014) ‘Integrating virtual and physical testing to accelerate the engineering product development process’, International Journal of Information Technology and Management, 13(2-3), pp. 154–175. doi: 10.1504/IJITM.2014.060307.CrossRefGoogle Scholar
Uusitalo, E. J. et al. (2008) ‘Linking requirements and testing in practice’, Proceedings of the 16th IEEE International Requirements Engineering Conference, RE'08, pp. 265–270. doi: 10.1109/RE.2008.30.CrossRefGoogle Scholar
Ward, J. and Clarkson, J. (2002) Good Design Practice for Medical Devices and Equipment – Design Verification, Institute for Manufacturing University of Cambridge. Cambridge.Google Scholar