Hostname: page-component-848d4c4894-nr4z6 Total loading time: 0 Render date: 2024-06-02T22:19:46.825Z Has data issue: false hasContentIssue false
  • English
  • Français

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

Core share and HTML view are not available for this content. However, as you have access to this content, a full PDF is available via the ‘Save PDF’ action button.

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

References

Alexander, K. and Clarkson, P.J. (2000), “Good design practice for medical devices and equipment, Part I: a review of current literature”, Journal of Medical Engineering & Technology, Vol. 24 No. 1, pp. 5–13. https://doi.org/10.1080/030919000293987Google ScholarPubMed
Azman, N. et al. (2017), “Review on Design for Medical Device”, MATEC Web Conference, Vol. 135 No. 5, pp. 20. https://doi.org/10.1051/matecconf/201713500020CrossRefGoogle Scholar
Bundesverband Medizintechnologie (BVMed) (2016), “Der lange Weg eines Medizinprodukts von der Idee bis zur Anwendung am Patienten”, Article, 20.01.2016Google Scholar
Catelani, M., Ciani, L. and Risaliti, , C. (2014), Risk assessment in the use of medical devices: A proposal to evaluate the impact of the human factor, 2014 IEEE International Symposium on Medical Measurements and Applications (MeMeA), Lisboa, pp. 1–6. https://doi.org/10.1109/MeMeA.2014.6860088Google Scholar
da Silveira, G.J.C., Borenstein, D. and Fogliatto, F.S. (2001), “Mass customization: Literature review and research directions”, Internatioanl Journal of Production Economics, Vol. 72 No. 1, pp. 1–13. https://doi.org/10.1016/S0925-5273(00)00079-7CrossRefGoogle Scholar
European Parliament (2017), Regulation (EU) 2017/745, Council of 5 April 2017Google Scholar
Gräßler, I. (2004), Kundenindividuelle Massenproduktion. Entwicklung, Vorbereitung der Herstellung, Veränderungs-management, Springer, Heidelberg. https://doi.org/10.1007/978-3-642-18681-3CrossRefGoogle Scholar
Kuhl, J. and Krause, D. (2018), “Strategies for Customer Satisfaction and Customer Requirement Fulfillment within the Trend of Individualization”, 29th CIRP Design Conference, 8. - 10. Mai 2019, Procedia CIRP, Póvoa de Varzim, https://doi.org/10.1016/j.procir.2019.04.278CrossRefGoogle Scholar
Koren, Y. et al. (2013), “Open-architecture products”, In: CIRP Annals Vol. 62 No. 2, pp. 719–729. https://doi.org/10.1016/j.cirp.2013.06.001CrossRefGoogle Scholar
Lantada, A.D. and Morgado, P.L. (2013), General Considerations for the Development of Biomedical Devices, In: Lantada, A.L. (Eds.): Handbook on Advanced Design and Manufacturing Technologies for Biomedical Devices, Springer, Boston, pp. 19–47. https://doi.org/10.1007/978-1-4614-6789-2CrossRefGoogle Scholar
Lindemann, U., Reichwald, R. and Zäh, M.F. (2006), Individualisierte Produkte - Komplexität beherrschen in Entwicklung und Produktion, Springer, Berlin. https://doi.org/10.1007/3-540-34274-5CrossRefGoogle Scholar
Liu, L. et al. (2012), Use-related risk analysis for medical devices based on improved FMEA, WORK: A Journal of Prevention, Assessment & Rehabilitation, https://doi.org/10.3233/WOR-2012-0976-5860CrossRefGoogle Scholar
Luna, D. et al. (2016), “Impact of participatory design for drug-drug interaction alerts. A comparison study between two interfaces”, MIE, pp. 68–72.Google ScholarPubMed
Lettl, C. (2007), “User involvement competence for radical innovation”, Journal of engineering and technology management, Vol. 24 No. 1-2, pp. 53–75. https://doi.org/10.1016/j.jengtecman.2007.01.004CrossRefGoogle Scholar
Maier, A. et al. (2017), “Sensing behaviour in healthcare design”, In: Proceedings of the 21st International Conference on Engineering Design (ICED 17), Vancouver, Canada, 21-25.08.2017.Google Scholar
Pahl, G. et al. (Eds.) (2007), Engineering Design. A Systematic Approach, Vol. 3, Springer, Berlin. https://doi.org/10.1007/978-1-84628-319-2Google Scholar
Sanders, E.B.N. (2006), Design research in 2006. Design research quarterly, Vol. 1, No.1, pp.1–8.Google Scholar
Sankowski, O. and Krause, D. (2018), “Using Multi-Channel Human-System Interaction for User-Centered Product Design”. Proceedings of ASME 2018 International Mechanical Engineering Congress and Exposition, November 9-15, Pittsburgh, Pennsylvania, USA. https://doi.org/10.1115/IMECE2018-88091CrossRefGoogle Scholar
Santos, I.C.T (2013), Product development methodologies: the case of medical devices, Thesis, Faculdade de Engenharia da Universidade do Porto, PortugalGoogle Scholar
Simpson, T.W. et al. (2014), “Advances in Product Family and Product Platform Design”, Methods & Applications, Springer, New York. https://doi.org/10.1007/978-1-4614-7937-6Google Scholar
Spallek, J. and Krause, D. (2016), “Process Types of Customisation and Personalisation in Design for Additive Manufacturing Applied to Vascular Models”, Procedia CIRP, Vol. 50, pp. 281–286. https://doi.org/10.1016/j.procir.2016.05.022CrossRefGoogle Scholar
US Food and Drug Administration (FDA) (1997), Design control guidance for medical device manufacturers, Food and Drug Administration, Rockville.Google Scholar
Wang, L. et al. (2019), A linguistic risk prioritization approach for failure mode and effects analysis: A case study of medical product development. Quality and Reliability Engineering International, pp. 1735–1752. https://doi.org/10.1002/qre.2472Google Scholar