Moot Court Cases: Bringing Standards to Life.

Biomedical engineering instructors teach the medical devices design theory and practice following the recommendations derived from the FDA regulations included in 21CFR820 and portraying it as less of a choice but the designer's obligation to uphold laws intended to reduce medical device design risk and protect the general public from defective goods. Although product liability cases are frequently adjudicated in a court of law, many students have only a vague notion of the link between design and product liability issues, and furthermore the important role that standards play in everyday design practice. To give real-life context for the connection between product liability and the benefits of using standards in design, we are aiming to develop moot court case studies that will offer engineering students the opportunity to investigate the viewpoint of various stakeholders and to bring arguments in support of their position. Our work-in-progress is part of a larger effort to reduce the barriers to standards adoption by engineering programs by creating a complete set of educational materials for educators based on specific case studies that foster consideration and use of standards in quality systems (ISO 13485:2016), and cyber-security in medical device design (ISO/IEEE 11073). Materials include lesson plans, content, and homework assignments that will be delivered as videos, tutorials, case study narratives, and Canvas modules. Our preliminary efforts have encouraged continuation of the development of content, though our efforts will benefit from other educator participation - this paper is a "Call to Action" for collaborators.