Moot Court Cases: Bringing Standards to Life

Area of Science:

• Biomedical Engineering Education
• Medical Device Regulation
• Product Liability Law

Background:

• Biomedical engineering curricula often lack comprehensive coverage of product liability and the role of regulatory standards in medical device design.
• Students possess a limited understanding of how design choices impact legal outcomes and public safety.
• Existing FDA regulations (21 CFR 820) emphasize compliance but may not fully convey the practical implications for designers.

Purpose of the Study:

• To develop innovative moot court case studies for biomedical engineering students.
• To enhance student comprehension of the relationship between medical device design, product liability, and regulatory compliance.
• To promote the integration of standards (ISO 13485, ISO/IEEE 11073) into engineering education.

Main Methods:

• Creation of case study narratives simulating real-world legal scenarios.
• Development of educational materials including lesson plans, videos, tutorials, and online modules.
• Facilitation of student engagement through stakeholder perspective analysis and argumentation.

Main Results:

• Preliminary development of case studies shows promise for educational application.
• The initiative aims to reduce barriers to standards adoption in engineering programs.
• A call for collaboration with educators to refine and expand the educational materials.

Conclusions:

• Moot court case studies offer a practical approach to teaching medical device design, liability, and standards.
• Comprehensive educational materials are needed to support educators in integrating these critical topics.
• Collaborative efforts are essential for the successful development and dissemination of these resources.