Open-Source Medical Devices as Tools for Teaching Design, Standards and Regulations of Medical Technologies

A multidisciplinary approach is necessary to design medical devices. Scientific and technical knowledge has to address the clinical needs of patients and healthcare providers, and biomedical engineering (BME) education has to promote problem-solving abilities and teamwork. In the BME field, standards and regulations on medical technologies have a paramount role, as they ensure safety and efficacy of the devices but, despite their importance, it is difficult to engage students’ attention when teaching norms and legislations. This chapter (The authors would like to thank Dr. Giulia Carbognani, Dr. Marco Ferrari and the ITS Maker Institute of Fornovo di Taro (PR) for the help in the fabrication of the prototype of the walking frame. Dr. Stefano Moroni, Dr. Riccardo Granati and Dr. Matilde Tomasi for helping in the design and fabrication of walking frame, and Dr. Francesco Niccolini, Dr. Carlotta Bonfiglioli and Dr. Eleonora Del Pia for helping in the design and fabrication of AMBU+. The content of this chapter is partially described in the paper: “Teaching Design Standards and Regulations on Medical Devices Through a Collaborative Project-Based Learning Approach” published in 2019 (Prepregs) and on the EU report of the UBORA project “Compendium of innovation created through UBORA (King & Fries, Int J Eng Educ 19(2):346–353, 2003).) describes some case studies, which demonstrate how the development of open-source medical devices could engage the participation of students, and their fruitful understanding on the fundamental role of legislation and standardization. The devices here presented were developed by students, working in team, during a course on medical device design at the University of Pisa, which was based on the conceived-design-implement-operate methodology empowered by the use of the UBORA platform (see Chap. 2). Standards and regulations were introduced as design constraints for the project-based final examination. The collaborative design and prototyping of a walking frame and an “smart” manual breathing unit are discussed in detail, and their blueprints are available on the UBORA e-platform as open-source tools to be used in university courses for a new generation of biomedical engineers.