Abstract
The steady growth of life expectancy calls for a new view on the importance of MedTech combination product development. One can envision that to keep a higher quality of life, more people would require some form of therapy depending on their individual state of health. This would require more medical devices of different types and complexity to be designed for specific drugs. However, from a holistic perspective, several challenges emerge in the development of drug-device combination products. An additional layer of complexity appears due to the increasing complexity of the MedTech devices, as they interact with the other systems and products in the design environment. This paper discusses those potential challenges and proposes ways to mitigate them. The primary focus of this work is on the drug delivery systems, such as autoinjectors.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Similar content being viewed by others
References
Our World in Data Homepage. https://ourworldindata.org/life-expectancy. Accessed 23 Jan 2023
NASA: System Engineering Handbook, SP-2016-61 (2016)
Fortescue, P., Swinerd, G., Stark, J.: Spacecraft Systems Engineering. Wiley, Hoboken (2011)
Dahmann, J.S., Baldwin, K.J.: Understanding the current state of US defense systems of systems and the implications for systems engineering. In: 2nd Annual IEEE Systems Conference, pp. 1–7 (2008). https://doi.org/10.1109/SYSTEMS.2008.4518994
Piaszczyk, C.: Model based systems engineering with department of defense architectural framework. Syst. Eng. 14(3), 305–326 (2011)
D’Ambrosio, J., Soremekun, G.: Systems engineering challenges and MBSE opportunities for automotive system design. In: 2017 IEEE International Conference on Systems, Man, and Cybernetics (SMC), pp. 2075–2080 (2017)
Loureiro, G., Leaney, P.G., Hodgson, M.: A systems engineering framework for integrated automotive development. Syst. Eng. 7(2), 153–166 (2004)
Golkar, A.A., Keller, R., Robinson, B., de Weck, O., Crawley, E.F.: A methodology for system architecting of offshore oil production systems. In: DSM 2009: Proceedings of the 11th International DSM Conference, pp. 343–356 (2009)
Griffin, P.M., Nembhard, H.B., DeFlitch, C.J., Bastian, N.D., Kang, H., Muñoz, D.A.: Healthcare Systems Engineering. Wiley, New Jersey (2016)
Alexander, K., Clarkson, P.J., Bishop, D., Fox, S.: Good Design Practice for Medical Devices and Equipment: A Framework. University of Cambridge, Institute for Manufacturing (2001)
Glazkova, N., Menshenin, Y., Vasilev, D., Fortin, C.: MedTech product development framework for post-pandemic era. Proc. Des. Soc. 2, 1273–1282 (2022)
Corns, S., Gibson, C.: A model-based reference architecture for medical device development. In: INCOSE International Symposium, vol. 22, no. 1, pp. 2066–2075 (2012)
Malins, R.J., Stein, J., Thukral, A., Waterplas, C.: SysML activity models for applying ISO 14971 medical device risk and safety management across the system lifecycle. In: INCOSE International Symposium, vol. 25, no. 1, pp. 489–507 (2015)
Hoadley, D.: Using model-based design in an IEC 62304-compliant software development process. In: MBEES, pp. 129–131 (2010)
Ward, J., Shefelbine, S., Clarkson, P.J.: Requirements capture for medical device design. In: Proceedings of ICED 2003, the 14th International Conference on Engineering Design, pp. 65–66 (2003)
Wang, H.: Multi-level requirement model and its implementation for medical device. Master’s thesis. Purdue University (2018)
INCOSE: The Medical Device Digital Engineering Thread. https://www.incose.org/docs/default-source/working-groups/healthcare/public-library/2018-se-in-healthcare-conference/the-medical-device-digital-engineering-thread.pdf?sfvrsn=e90897c6_2. Accessed 13 Feb 2023
Zwemer, D., Intercax, L.L.C.: Technote: Applications of MBE for healthcare. Intercax LLC, pp.1–15 (2016)
Messaadia, M., Farouk, B., Eynard, B.: Systems Engineering and PLM as an integrated approach for industry collaboration management. IFAC Proc. Vol. 45(6), 1135–1140 (2012)
Sharon, A., de Weck, O.L., Dori, D.: Improving project-product lifecycle management with model-based design structure matrix: a joint project management and systems engineering approach. Syst. Eng. 16(4), 413–426 (2013)
Gerhard, D., et al.: MBSE-PLM integration: initiatives and future outlook. In: Noël, F., Nyffenegger, F., Rivest, L., Bouras, A. (eds.) PLM 2022. IFIP, vol. 667, pp. 1–7. Springer, Cham (2022). https://doi.org/10.1007/978-3-031-25182-5_17
Pinquié, R., Rivest, L., Segonds, F., Véron, P.: An illustrated glossary of ambiguous PLM terms used in discrete manufacturing. Int. J. Prod. Lifecycle Manag. 8(2), 142–171 (2015)
FDA Homepage: Combination Product Definition Combination Product Types (2018). https://www.fda.gov/combination-products/about-combination-products/combination-product-definition-combination-product-types. Accessed 09 Jan 2023
Couto, D.S., Perez-Breva, L., Saraiva, P., Cooney, C.L.: Lessons from innovation in drug-device combination products. Adv. Drug Deliv. Rev. 64(1), 69–77 (2012). https://doi.org/10.1016/j.addr.2011.10.008
Rocco, P., Musazzi, U.M., Minghetti, P.: Medicinal products meet medical devices: classification and nomenclature issues arising from their combined use. Drug Discov. Today (2022). https://doi.org/10.1016/j.drudis.2022.07.009
Kühler, T.C., et al.: Development and regulation of connected combined products: reflections from the Medtech & Pharma Platform Association. Clin. Therapeut., 768–782 (2022). https://doi.org/10.1016/j.clinthera.2022.03.009
US Food and Drug Administration, Guidance for industry and FDA staff: early development considerations for innovative combination products (2006). https://www.fda.gov/media/75273/download. Accessed 01 Feb 2023
Code of Federal Regulations Title 21 Chapter 1 Part 4, Regulation of Combination Products (2023). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-4?toc=1. Accessed 08 Feb 2023
Dori, D., et al.: OPCloud: an OPM integrated conceptual‐executable modeling environment for industry 4.0. In: Systems Engineering in the Fourth Industrial Revolution, pp. 243–271 (2019)
Dori, Dov: Object-Process Methodology: A Holistic System Paradigm. Springer, Heidelberg (2002). https://doi.org/10.1007/978-3-642-56209-9
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2024 IFIP International Federation for Information Processing
About this paper
Cite this paper
Menshenin, Y., Pinquié, R., Chevrier, P. (2024). Holistic Perspective to the Drug-Device Combination Product Development Challenges. In: Danjou, C., Harik, R., Nyffenegger, F., Rivest, L., Bouras, A. (eds) Product Lifecycle Management. Leveraging Digital Twins, Circular Economy, and Knowledge Management for Sustainable Innovation. PLM 2023. IFIP Advances in Information and Communication Technology, vol 701. Springer, Cham. https://doi.org/10.1007/978-3-031-62578-7_22
Download citation
DOI: https://doi.org/10.1007/978-3-031-62578-7_22
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-031-62577-0
Online ISBN: 978-3-031-62578-7
eBook Packages: Computer ScienceComputer Science (R0)
