Resumen de Teaching design standards and regulations on medical devices through a collaborative project-based learning approach
Licia di Pietro, Ermes Botte, Riccardo Granati, Stefano Moroni, Matilde Tomasi, Giovanni Vozzi, Carmelo de Maria
The final goal a course of Medical Device Design is to convey the importance of multidisciplinary approach in BiomedicalEngineering (BME), where scientific and technical knowledge has to address the clinical needs of patients and healthcare providers,and has to promote problem-solving abilities and teamwork. In such context, project/problem-based teaching-learning methodshave been suggested among the more effective strategies for bridging technical competences with the development of transversalskills and consequently in the professional formation of engineering students. In the BME field, standards and regulations onmedical technologies have a paramount role, as they ensure safety and efficacy of the devices but, despite their importance, it isdifficult to engage students’ attention when teaching norms and legislations. This paper describes the teaching/learning experiencein a new course on Laboratory of Biomedical Technologies at the first year of the Master’s Degree programme in BME atUniversity of Pisa (Italy), where standards and regulations were introduced as design constraints for the project-based finalexamination. The collaborative design and prototyping of a walking frame are discussed in detail, to demonstrate the feasibilityand the challenges of the proposed approach.
