Developing a Round Robin Module to Integrate Consensus Standards in a BME Course

Purpose: Proficiency with consensus standards is essential for biomedical engineers to develop effective, safe, and compliant medical devices. However, biomedical engineering curricula often omits or limits standards content to select topics. This study aims to bridge this gap by developing and implementing a novel, standards-based module that enhances students’ ability to interpret, apply, and revise consensus standards by identifying sources of error through round-robin testing. Methods: A hands-on learning module was designed and implemented in an upper-level biomedical engineering course. The curriculum incorporated the use of a custom-designed tensile testing device alongside a mock standard to introduce students to protocol development, standard revision, and real-world challenges in testing variability. Eight student teams conducted round-robin testing using devices configured with deliberate adulterations. Assessment included a group report, a post-module survey, and student reflections on identifying and applying standards. Results: Students reported confidence in extracting requirements from standards, applying them to verification testing, and identifying potential limitations in testing protocols. Teams were generally successful in recognizing adulterations. The post-module survey indicated that students found the activity effective for increasing their confidence in preparing them for industry applications, though some suggested extending the module duration and improving instructional clarity for increased effectiveness. Conclusion: This study describes the development and implementation of a standards-based module in biomedical engineering. Ultimately, students engaged in higher-order problem-solving and improved their understanding of standards implementation, testing variability, and collaborative verification processes. The findings suggest that this curriculum model could be expanded across engineering disciplines to enhance workforce preparedness in quality engineering and R&D roles.