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NEW PRODUCT DEVELOPMENT PROCESS FOR MEDTECH COMBINATION PRODUCTS

Published online by Cambridge University Press:  19 June 2023

Yaroslav Menshenin ,
Romain Pinquié  and
Pierre Chevrier
Yaroslav Menshenin*
Affiliation:
Univ. Grenoble Alpes, CNRS, Grenoble INP, G-SCOP
Romain Pinquié
Affiliation:
Univ. Grenoble Alpes, CNRS, Grenoble INP, G-SCOP
Pierre Chevrier
Affiliation:
Univ. Grenoble Alpes, CNRS, Grenoble INP, G-SCOP
*
Menshenin, Yaroslav, Grenoble INP, France, [email protected]

Abstract

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The MedTech product development is experiencing a growing complexity of the design process. The design challenge is to keep the medical device simple and user-friendly while maintaining its interconnectivity with the other systems and products. The additional layer of complexity comes from the need to satisfy both - direct customers (pharma companies), and indirect ones (patients, health care practitioners, and pharmacists). Solving those design challenges must not compromise the safety of the end-user and must follow the regulatory requirements.

This research proposes the systematic design process for MedTech combination product development with the emphasis on product strategy and concept development operationalized by design thinking participative toolkit. The proposed approach serves the purpose of increasing the traceability between the early made business decisions on a product strategy level of MedTech company, and the engineering decisions made on product concept level. The ultimate goal of the research is to support the decision-makers with methods and tools which would allow them to make informed decisions on investment in a new MedTech combination product by Pharma and MedTech companies.

Keywords

MedTechSystems Engineering (SE)Design ThinkingNew product developmentDesign process
Type
Article
Information
Proceedings of the Design Society , Volume 3: ICED23 , July 2023 , pp. 2795 - 2804
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), 2023. Published by Cambridge University Press

References

Batista, J., Hassan, A. and Bonjour, E. (2020), “Design thinking to enhance requirements analysis in systems engineering”, Proceedings of the Design Society, Proceedings of the Design Society: DESIGN Conference 2, Vol. 1, pp. 2255–2264. https://doi.org/10.1017/dsd.2020.257Google Scholar
Bazzano, A.N., Martin, J., Hicks, E., Faughnan, M. and Murphy, L. (2017), “Architecture framework human view: The NATO approach”, PloS One, Vol. 12 No. 11, pp. 1–24. https://doi.org/10.1371/journal.pone.0186744Google Scholar
Food and Drug Administration - FDA (2018), The Drug Development Process. [online] Available at: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process (accessed 25.11.2022).Google Scholar
Food and Drug Administration - FDA (1997), Design Control Guidance For Medical Device Manufacturers. [online] Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-control-guidance-medical-device-manufacturers (accessed 25.11.2022).Google Scholar
Glazkova, N., Menshenin, Y., Vasilev, D. and Fortin, C. (2022), “MedTech Product Development Framework for Post-Pandemic Era”, Proceedings of the Design Society, 2, pp. 1273–1282. https://doi.org/10.1017/pds.2022.129CrossRefGoogle Scholar
Greene, M.T., Gonzalez, R. and Papalambros, P.Y. (2019), “Measuring Systems Engineering and Design Thinking Attitudes”, Proceedings of the Design Society: International Conference on Engineering Design, Vol. 1 No. 1, pp. 3939–3948. https://doi.org/10.1017/dsi.2019.401Google Scholar
Greene, M.T., Gonzalez, R., Papalambros, P.Y. and Mcgowan, A.-M. (2017), “Design Thinking vs. Systems Thinking for Engineering Design: What's the Difference?”, 21st International Conference on Engineering Design, Vancouver, Canada. Available at: https://www.nasa.gov/sites/default/files/atoms/files/61_greene_design_thinking_vs_systems_thinking_for_engineering_desgin_what_s_the_difference_1.pdfGoogle Scholar
Guntveit, M., Kj⊘rstad, M. and Sevaldson, B. (2020), “Early Validation of Stakeholder Needs by Applying Co-creation Sessions”, INCOSE International Symposium, Vol. 30 No. 1, pp. 1398–1415. https://doi.org/10.1002/j.2334-5837.2020.00793.xCrossRefGoogle Scholar
Handley, H.A. and Smillie, R.J. (2008), “Architecture framework human view: The NATO approach”, Systems Engineering, Vol. 11 No. 2, pp. 156–164. https://doi.org/10.1002/sys.20093CrossRefGoogle Scholar
Haruyama, S., Kim, S.K., Beiter, K.A., Dijkema, G.P.J. and de Weck, O. (2013), “A new project-based curriculum of design thinking with systems engineering techniques”, International Journal of System of Systems Engineering, Vol. 4 No. 2, pp. 162–173. https://doi.org/10.1504/IJSSE.2013.056296CrossRefGoogle Scholar
Fisher, M.J. and Johansen, E. (2020), “Human-centered design for medical devices and diagnostics in global health”, Global Health Innovation, Vol. 3 No. 1, pp. 1–15. https://doi.org/10.15641/ghi.v3i1.762CrossRefGoogle Scholar
Katz, T., Orr, K. and Wheatcraft, L. (2022), Guide to Needs and Requirements, INCOSE-TP-2021-003-01.Google Scholar
Lee, S.H., Yang, M.C., Carramolino, B. and Rudnik, J. (2021), “The Inspiration Design Toolkit: A Human-Centered Design Tool for a System Engineering Course”, Volume 4: 18th International Conference on Design Education (DEC). https://doi.org/10.1115/DETC2021-66577CrossRefGoogle Scholar
Lee, S., Rudnik, J. and de Weck, O. (2020), “Experimenting with Design Thinking and Systems Engineering Methodologies - Using a Commercial Cislunar Space Development Project as an Example”, Industrial Designers Society of America.Google Scholar
Lewrick, M., Link, P. and Leifer, L. (2019), The Design Thinking Toolbox: A Guide to Mastering the Most Popular and Valuable Innovation Methods, John Wiley & Sons, Hoboken, NJ, USA.Google Scholar
Micouin, P. (2014), Model-Based Systems Engineering: Fundamentals and Methods, John Wiley & Sons, Hoboken, NJ, USA. https://doi.org/10.1002/9781118579435CrossRefGoogle Scholar
Shafaat, A. and Kenley, C.R. (2015), “Exploring the Role of Design in Systems Engineering”, INCOSE International Symposium, Vol. 25 No. 1, pp. 357–370. https://doi.org/10.1002/j.2334-5837.2015.00068.xCrossRefGoogle Scholar
Sjøkvist, N.M. and Kjørstad, M. (2019), “Eliciting Human Values by Applying Design Thinking Techniques in Systems Engineering”, INCOSE International Symposium, Vol. 29 No. 1, pp. 478–499. https://doi.org/10.1002/j.2334-5837.2019.00615.xCrossRefGoogle Scholar
Tomita, Y., Watanabe, K., Shirasaka, S. and Maeno, T. (2017), “Applying Design Thinking in Systems Engineering Process as an Extended Version of DIKW Model”, INCOSE International Symposium, Vol. 27 No. 1, pp. 858–870. https://doi.org/10.1002/j.2334-5837.2017.00398.xCrossRefGoogle Scholar
Wade, J., Hoffenson, S. and Gerardo, H. (2017), “Systemic Design Engineering”, INCOSE International Symposium, Vol. 27 No. 1, pp. 721–735. https://doi.org/10.1002/j.2334-5837.2017.00389.xCrossRefGoogle Scholar
Watanabe, K., Tomita, Y., Ishibashi, K., Ioki, M. and Shirasaka, S. (2017), “Framework for Problem Definition - A Joint Method of Design Thinking and Systems Thinking”, INCOSE International Symposium, Vol. 27 No. 1, pp. 57–71. https://doi.org/10.1002/j.2334-5837.2017.00345.xCrossRefGoogle Scholar
Wheatcraft, L., Katz, T., Ryan, M. and Wolfang, R.B. (2022), Needs, requirements, verification, validation lifecycle manual, Needs, requirements, verification, validation lifecycle manual, INCOSE Requirements Working Group.Google Scholar
Zhao, Y.-Y. (2015), “Towards innovative system development: A joint method of design thinking and systems thinking”, INCOSE International Symposium, Vol. 25 No. 1, pp. 1427–1437. https://doi.org/10.1002/j.2334-5837.2015.00140.xCrossRefGoogle Scholar