2026 ASEE Annual Conference & Exposition

[Case Study Paper]
The rapid pace of medical device innovation has outstripped the ability of regulatory systems to keep up, creating ethical and safety challenges that future engineers must navigate. This activity introduces students to those realities and encourages them to consider the ethical and regulatory challenges they are likely to face as professionals. To address this gap, a classroom activity was developed around the Netflix documentary film The Bleeding Edge, which exposes the human and systemic consequences of the medical device industry’s drive for innovation and profit. The activity engages students in examining real-world ethical dilemmas related to medical device approval, safety, and commercialization, emphasizing the complex balance between technological progress and public welfare.
The class completes the activity in three parts. Before class, students watch the film Each pair of students is assigned a different theme to focus on so that the class covers a range of topics without repeating ideas. Themes include the FDA’s 510(k) approval process, conflicts of interest, lobbying, innovation versus safety, and women’s health. After watching the film, the class meets for a discussion where each pair leads a short conversation on their assigned theme. Afterward, the student-pair moderators write a summary of the main points raised. Separately, every student posts a short reflection describing three key takeaways from the film and class discussion. The instructor mostly observes and keeps things moving, allowing students to lead the dialogue and take responsibility for the ethical analysis.
Student reflections show that the film and discussions helped them think more critically about the processes behind medical innovation. Many indicated having a better understanding of how regulation, commercialization, profits, and ethics intersect and a stronger sense of empathy for patients affected by device failures. Students also recognized that ethical responsibility goes beyond simply following regulations, in that it involves transparency, advocacy, and moral judgment. The instructor noticed that students were particularly engaged and eager to participate, showing more energy and curiosity than in most typical class sessions, and for that reason alone, this was a productive and meaningful activity.
This case study shows how film, peer-led discussion, and reflection can create an engaging way to teach ethics while building students’ awareness of the real-world issues engineers face. The approach can be easily adapted for other courses that deal with emerging technologies and the ethical questions that come with them.