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Moot Court Cases: Bringing Standards to Life

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Conference

2022 ASEE - North Central Section Conference

Location

Pittsburgh, Pennsylvania

Publication Date

March 18, 2022

Start Date

March 18, 2022

End Date

April 4, 2022

Page Count

9

DOI

10.18260/1-2--39254

Permanent URL

https://peer.asee.org/39254

Download Count

397

Paper Authors

biography

Matthew R. Williams Case Western Reserve University

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Matt Williams is an Assistant Professor of Biomedical Engineering with an emphasis on experiential learning including engineering design, programming, data acquisition/processing, and fabrication. His research interests include the control of prosthetics and assistive technology for stroke and spinal cord injury.

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biography

Daniela Solomon Case Western Reserve University Orcid 16x16 orcid.org/0000-0002-6200-5216

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Daniela Solomon is the Research Services Librarian liaison to Case School of Engineering at Case Western Reserve University. She received her BS in Electrical Engineering from Romania and holds an MLSI from the University of Arizona. Her research interests include bibliometrics, scholarly communications, instruction, information needs of engineering students and faculty, technical standards, and outreach.

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biography

Colin K Drummond Case Western Reserve University Orcid 16x16 orcid.org/0000-0002-9053-3649

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In January 2015, Colin re-joined the Department of Biomedical Engineering as Professor and Assistant Chair, having previously spent a year in the School of Nursing. From 2008-2013, Colin was the Director of the Coulter-Case Translational Research Partnership (CCTRP) in the Department of Biomedical Engineering. Colin’s research interests are on educational pedagogy, the practical application of simulation and healthcare information technology to support clinical decision-making, including advances in understanding wearable analytics for human performance assessment. He is active in developing experiential and co-curricular activities for students, the development of standards modules for design classes, and collaborative projects that address patient need.

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Abstract

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.

Williams, M. R., & Solomon, D., & Drummond, C. K. (2022, March), Moot Court Cases: Bringing Standards to Life Paper presented at 2022 ASEE - North Central Section Conference, Pittsburgh, Pennsylvania. 10.18260/1-2--39254

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