Teaching Design Standards and Regulations on Medical Devices Through a Collaborative Project-Based Learning Approach

The final goal a course of Medical Device Design is to convey the importance of multidisciplinary approach in Biomedical Engineering (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 methods have been suggested among the more effective strategies for bridging technical competences with the development of transversal skills and consequently in the professional formation of engineering students. 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 paper describes the teaching/learning experience in a new course on Laboratory of Biomedical Technologies at the first year of the Master’s Degree programme in BME at University of Pisa (Italy), where standards and regulations were introduced as design constraints for the project-based final examination. The collaborative design and prototyping of a walking frame are discussed in detail, to demonstrate the feasibility and the challenges of the proposed approach.