2026 ASEE Annual Conference & Exposition

Motivation: Engineering students entering the biomedical field face the dual challenge of designing innovative devices while navigating the complex legal and regulatory landscape that governs patient safety. To address this challenge, this SHARE activity adapts instructional strategies originally developed in a semester-long risk management course taught to a combined upper-level undergraduate and graduate level biomedical engineering class. The exercise suggested here draws upon the instructor’s extensive medical-device experience to blend theory, regulatory frameworks, and analysis of real-world failures in a focused, transferable learning activity. Students often struggle to translate theory into practice when confronted with ambiguity, organizational pressure, and incomplete information. This activity responds to these challenges through structured, guided case-based instruction that emphasizes experiential learning for complex, multidisciplinary decision-making. The activity blends high-level conceptual frameworks with analysis of real-world failures and culminates in students teaching core concepts to others through original case development.
Learning Objectives: Upon completion of this activity, students will be able to:
1. Understand how risk management integrates into the real-world medical device design and commercialization process, including regulatory and ethical considerations.
2. Apply high-level frameworks for risk, regulation, and ethics to ambiguous, real-world case scenarios.
3. Demonstrate communication and professional judgment skills by teaching selected concepts through original case development.
Implementation: The core SHARE activity uses structured case analysis and student-driven inquiry to engage students in applying theory to practice. Two instructor-curated exemplar cases serve as scaffolding. Information on these cases and related materials (including an introductory video) are given in the Appendices. Educators may, in the interest of available time, choose to truncate the activity to a single week by introducing the Challenger and Theranos material only. Student presentation of either case may then be evaluated using the Student Presentation Grading Rubric found in Appendix 7.
Case 1 - Challenger Disaster – involves ethical decision-making under uncertainty, communication breakdowns, and suppressed risk signals. Case 2 - Theranos – involves regulatory misalignment, misuse of regulatory pathways, and organizational ethics. These cases function as reference standards, modeling how conceptual frameworks apply imperfectly in practice. Students explicitly connect case features to assessment rubrics before completing their own deliverables.
Class Outline: Two-Week (Four-Class) Application and Teaching Module
Purpose: Exposure to the application of risk management, regulation, and ethics using exemplar cases, followed by exposure to deeper engagement by positioning students as teachers of risk, regulatory, and ethical concepts. Class periods should be a minimum of one hour to allow time for lecture, discussion and student presentations (in Class 3 & 4).
Week 1 – Modeling and Deconstruction
Class 1: Frameworks and Challenger discussion. Short lecture introducing high-level concepts in risk management and ethics, emphasizing risk and uncertainty rather than tools. Instructor-led discussion of Challenger focusing on ethical tension, organizational decision-making, and communication failures. Explicit mapping of discussion elements to the case presentation rubric. Appendix 2 provides a short introductory video that consolidates the risk and ethical topics, as well as providing an overview of the two cases. Appendix 3 is a summation of the key risk-related lecture topics, while Appendix 4 provides an overview of the Challenger case topics and suggested discussion questions.
Class 2: Theranos discussion with explicit attention to how cases are used in teaching, including preservation of ambiguity and the role of instructor notes. Appendix 5 provides an overview of the Theranos case topics and suggested discussion questions. For week 2, students will select a case topic drawn from historical or contemporary biomedical or engineering failures (list of potential topics given in the Appendix 6) and present these in Class 3 and (optionally) Class 4.
Week 2 – Student-as-Teacher
Class 3: Student presentations of developed cases emphasizing principles of risk and crisis management. Class 4: Meta-discussion on teaching effectiveness and submission of written case studies. If additional time is needed for student presentations, these may continue in the final class.
Assessment: Oral presentations lasting 10 minutes are evaluated using a case presentation rubric (Appendix 7). Written case studies are evaluated using a rubric assessing background research, key points relevant to risk and crisis management, discussion questions, instructor notes, and supporting materials, reinforcing peer-to-peer learning and curricular sustainability (Appendix 8). In a full semester class the student-created case is viewed as a "capstone" activity and represents 25 percent of total grade (6.25% presentation grade, 18.75% written case and materials). A lower percentage would be expected for this short exercise.
Situational Factors Affecting Implementation - This SHARE activity can be implemented in upper-level undergraduate or graduate engineering, business, or bioethics courses where understanding the intersection of design, regulation, and ethics is essential. Key situational factors include instructional time, class size, and student background. Required resources are minimal and include publicly available case materials, short lecture slides introducing high-level frameworks, and provided grading rubrics. Learning-management systems may be used to support preparation and engagement but are not required.