Abstract
Engineering products benefit from the application of systematic design methodologies during their development processes, as these methodologies help to achieve time- and cost-effective solutions with enhanced functionalities, increased safety and improved reliability. Recent trends, including open innovation, collaborative engineering and the “makers” movement, are reshaping traditional engineering design and opening new horizons in many industrial fields that benefit from user-oriented designs and from creativity promotion through collaboration. The medical field, with the birth of the open-source medical device concept, can greatly benefit from the mentioned trends, although special considerations need to be taken into account. Medical devices are very special products, due to their intimate interaction with the human body and their potential risks. In consequence, even if open innovation and open-source approaches may transform biomedical engineering towards equitable access medical technologies, the transition from classical medical device development towards open-source medical devices should be managed with a focus on safety and regulation compliance. In this chapter, modern methodologies for product development are presented, and key aspects for open-source medical devices are highlighted, with the intention of providing a harmonized methodology for user-centred, safe and regulation-compliant open-source medical technologies.
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Notes
- 1.
Thingiverse: Digital design for physical objects, https://www.thingiverse.com [last access: January 2020].
- 2.
GrabCAD: Design Community, CAD Library, 3D Printing Software, https://grabcad.com [last access: January 2020].
References
Abu-Faraj, Z. O. (2008). Bioengineering/biomedical engineering education and career development: Literature review, definitions and constructive recommendations. International Journal of Engineering Education, 24(5), 990–1011.
Ahluwalia, A., De Maria, C., & Díaz Lantada, A. (2018a). The Kahawa Declaration: A manifesto for the democratization of medical technology. Global Health Innovation, 1(1), 1–4.
Ahluwalia, A., De Maria, C., Madete, J., Díaz Lantada, A., Makobore, P. N., Ravizza, A., Di Pietro, L., Mridha, M., Muñoz-Guijosa, J. M., ChacónTanarro, E., & Torop, J. (2018b). Biomedical engineering project based learning: Euro-African design school focused on medical devices. International Journal of Engineering Education, 34(5), 1709–1722.
Arcarisi, L., Pietro, L. D., Carbonaro, N., Tognetti, A., Ahluwalia, A., & De Maria, C. (2019). Palpreast – A new wearable device for breast self-examination. Applied Sciences, 9(3), 381.
Bonaccorsi, A., & Rossi, C. (2003). Why open source software can succeed. Research policy, 32(7), 1243–1258.
Crawley, E. F., Malmqvist, J., Östlund, S., & Brodeur, D. R. (2007). Rethinking engineering education: The CDIO approach (pp. 1–286). Springer.
De Graaf, E., & Kolmos, A. (2003). Characteristics of problem-based learning. International Journal of Engineering Education, 19(5), 657–662.
De Maria, C., Di Pietro, L., Díaz Lantada, A., Madete, J., Makobore, P. N., Mridha, M., … Ahluwalia, A. (2018). Safe innovation: On medical device legislation in Europe and Africa. Health Policy and Technology, 7(2), 156–165.
Díaz Lantada, A., & De Maria, C. (2019, April). Towards open-source and collaborative project based learning in engineering education: Situation, resources and challenges. International Journal of Engineering Education, accepted for publication.
Di Pietro, L., Botte, E., Granati, R., Moroni, S., Tomasi, M., Vozzi, G., & De Maria, C. (2019, July). Teaching design standards and regulations on medical devices through a collaborative project-based learning approach. International Journal of Engineering Education, accepted for publication.
Droste, M. (2019). Bauhaus. Aktualisierte Ausgabe. Taschen.
Fasterholdt, I., Lee, A., Kidholm, K., Yderstraede, K. B., & Pedersen, K. M. (2018). A qualitative exploration of early assessment of innovative medical technologies. BMC Health Services Research, 18, 837.
Ferretti, J., Di Pietro, L., & De Maria, C. (2017). Open-source automated external defibrillator. HardwareX, 2, 61–70.
Fogliatto, F., & Da Silveira, G. (Eds.). (2011). Mass customization (Springer Series in Advanced Manufacturing). Springer.
Gao, J., & Bernard, A. (2017). An overview of knowledge sharing in new product development. International Journal of Advanced Manufacturing Technology, 94(5-8), 1545–1550.
Gausemeier, J., & Moehringer, S. (2002). VDI 2206: A new guideline for the design of mechatronic systems. IFAC Proceedings, 35(2), 785–790.
Gershenfeld, N. (2005). Fab: the coming revolution on your desktop-from personal computers to personal fabrication. Basic Books.
Graessler, E. (2017). A new V-model for interdisciplinary product engineering. 59th Ilmenau Scientific Colloquium, TU Ilmenau.
Graham, R. (2018). The global state of the art in engineering education. MIT Press.
Hansen, F. (1956). Konstruktionssystematik. VEB-Verlag Technik.
International Organization for Standardization. (2016). ISO 13485:2016: Medical devices – Quality management systems – Requirements for regulatory purposes. ISO.
International Organization for Standardization. (2017). ISO 14971:2017: Medical devices – Application of risk management to medical devices. ISO.
Jacoby, B. (1996). Service-learning in higher education: Concepts and practices. Jossey-Bass.
Kaiser, W., & König, W. (2006). Geschichte des Ingenieurs. Ein Beruf in sechs Jahrtausenden. Carl Hanser Verlag.
Kesselring, F. (1951). Bewertung von Konstruktionen. VDI Verlag.
Kesselring, F. (1954). Technische Kompositionslehre. Springer.
Kuhlenkamp, A. (1971). Konstruktionslehre der Feinwerktechnik. Hanser.
Larmer, J. (2014). Project-based learning vs. Problem-based learning vs. X-BL. Edutopia.
Lessig, L., Cusumano, M., & Shirky, C. (2005). Perspectives on free and open source software. MIT Press.
Malkin, R. A. (2007). Design of health care technologies for the developing world. Annual Review of Biomedical Engineering, 9, 567–587.
Matousek, R. (1957). Konstruktionslehren des allgemeinen Maschinenbaus. Springer.
Mushtaq, U., & Pearce, J. M. (2018). Open source appropriate nanotechnology. In Nanotechnology and global sustainability (pp. 220–245). CRC Press.
Ng, P. K., & Jee, K. S. (2014). Concurrent knowledge sharing and its importance in product development. Journal of Applied Sciences, 14, 2978–2985.
Niemann, G. (1975). Maschinenelemente. Springer.
Niezen, G.; Eslambolchilar, P.; Thimbleby, H..- “Open-source hardware for medical devices”. BMJ innovations, 2(2), 78-83, 2016.
Oberloier, S., & Pearce, J. (2018). General design procedure for free and open-source hardware for scientific equipment. Designs, 2(1), 2.
Pahl, G., & Beitz, W. (transl. & ed. Wallace, K.). (1988). Engineering design: A systematic approach. The Design Council/Springer.
Perilli, A.. From creative AI to open source sculpture: how tech is changing art. It’s Nice That, 23rd May, 2017. Online, as of May 2019: https://www.itsnicethat.com/
Rautenstrauch, C., Seelmann-Eggebert, R., & Turowski, K. (Eds.). (2002). Moving into mass customization. Springer.
Roozenburg, N., & Eeckels, J. (1995). Product design: Fundamentals and methods. Wiley.
Rosenfeld Halverson, E., & Sheridan, K. M. (2014). The maker movement in education. Harvard Educational Review, 84(4).
Sarmah, B., & Rahman, Z. (2017). Transforming jewellery designing: Empowering customers through crowdsourcing in India. Global Business Review, 18(5), 1325–1344.
Shuman, L. J., Besterfield-Sacre, M., & McGourty, J. (2005). The ABET professional skills, can they be taught? Can they be assessed? Journal of Engineering Education, 94, 41–55.
Sienko, K. H., Sarvestani, A. S., & Grafman, L. (2013). Medical device compendium for the developing world: A new approach in project and service-based learning for engineering graduate students. Global Journal of Engineering Education, 15(1), 13–20.
Sivarasu, S. (2019). Frugal Biodesign: An approach for developing appropriate medical devices in low-resource settings. Biomedical Engineering for Africa, 47.
The European Parliament and the Council of the European Union. (2017a). Regulation (EU) 2017/745 on medical devices. https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32017R0745. Last access Jan 2020.
The European Parliament and the Council of the European Union. (2017b). Regulation (EU) 2017/746 on in vitro diagnostic medical devices. https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1565171051278&uri=CELEX:32017R0746. Last access Jan 2020.
Trimi, S., & Berbegal-Mirabent, J. (2012). Business model innovation in entrepreneurship. International Entrepreneurship and Management Journal, 8(4), 449–465.
Tschochner, H. (1954). Konstruieren und Gestalten. Abrißeiner Konstruktions- und Gestaltungslehre unter besonderer Berücksichtigung von Maschinenbau und Feinmechanik. Girardet, Essen.
Ulrich, K., & Eppinger, S. (2007). Product design and development (4th ed.). Mc-Graw Hill/Irwin.
UNESCO. World declaration on higher education for the twenty-first century: Vision and action, adopted by UNESCO’s World Conference on Higher Education on 9 October 1998.
United Nations General Assembly. Transforming our World: The 2030 Agenda for Sustainable Development, on 21 October 2015, A/RES/70/1.
Verein DeutscherIngenieure. (1993). VDI 2221: Systematic approach to the development and design of technical systems and products. VDI (rev. 2017).
Verein DeutscherIngenieure. (2004). VDI 2206: Design methodology for mechatronic systems. VDI.
Wang, F. Y., Carley, K. M., Zeng, D., & Mao, W. (2007). Social computing: From social informatics to social intelligence. IEEE Intelligent Systems, 22(2), 79–83.
Wächtler, R. (1967). Beitrag zur Theorie des Entwickelns (Konstruierens). Feinwerktechnik, 71, 353–358.
Wilkinson, M. D., et al. (2016). Comment: The FAIR Guiding Principles for scientific data management and stewardship. Scientific Data, 3, 160018., 1–9.
Wu, D., Rosen, D. W., Wang, L., & Schaefer, D. (2015). Cloud-based design and manufacturing: A new paradigm in digital manufacturing and design innovation. Computer-Aided Design, 59, 1–14.
Yazdi, Y., & Acharya, S. (2013). A new model for graduate education and innovation in medical technology. Annals of Biomedical Engineering, 41(9), 1822–1833.
Yock, P. G., et al. (2015). Biodesign: The process of innovating medical technology (2nd ed., pp. 1–952). Cambridge University Press.
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De Maria, C., Díaz Lantada, A., Di Pietro, L., Ravizza, A., Ahluwalia, A. (2022). Towards a Harmonized Methodology for the Development of Safe and Regulation Compliant Open-Source Medical Devices. In: Ahluwalia, A., De Maria, C., Díaz Lantada, A. (eds) Engineering Open-Source Medical Devices. Springer, Cham. https://doi.org/10.1007/978-3-030-79363-0_2
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