Moot Court Cases: Bringing Standards to Life

ABET criteria for accreditation include the use of standards in capstone projects. However, integrating engineering standards into the curriculum is hindered by several reasons that include the intensity of the academic programs, faculty with little or no knowledge of standards, lack of textbooks or educational materials, and high costs for providing access to standards. 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 open access moot court case studies where engineering students acting as different stakeholders will have to present oral arguments and rebuttals to a panel of appellate judges, which in our case would be law students or professors. 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 quality systems (ISO 13485), biocompatibility (ISO 10993), and software development (IEEE 829) standards in medical device design. 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 continuing the development of content, though our efforts will benefit from other educator participation - this paper is a "Call to Action" for collaborators.