(D-121) Teaching The Role and Application of Biomedical Engineering Standards Through a Moot Court Exercise

Introduction:: Introducing students to the role and application of standards is an important, though often under emphasized part of an engineering education. The material is dry and can be difficult to convey in a compelling and engaging manner. For this purpose, a moot court exercise, where students take on the role of litigants in a case involving the use (or lack thereof) of standards helps to bring the role of these concepts to life. The case developed for this exercise primarily focuses on cybersecurity standards as this a growing, and now mandated area of concern for the FDA, and hence, graduating Biomedical Engineers. This work represents the authors’ “first run” of this exercise as a teaching tool and a quantitative assessment of it’s effectiveness in delivering the content.


Materials and Methods:: A moot court case was developed that saw a number of “real world” BME issues including the actual definition of a medical device, use and misuse of at-home medical devices, cybersecurity and data privacy of connected devices, and the standards that apply to these areas.

The exercise was run as part of a BME Senior Design class comprising about 90 students, with 8 students serving in various court roles (lawyers, plaintiff, defendant, and witnesses). Each student was given a “cheat sheet” with items to consider and was given a week to research and prepare for their role. The case itself was played out over a 50-minute class period. The concept of engineering standards and regulations were covered in class a few weeks before the exercise to introduce the material.

To evaluate the effectiveness of the exercise as a teaching tool, a pre- and post- exercise survey was administered to the students and graded for completion. All appropriate IRB permissions were secured for this work. The pre-exercise survey asked students about their general knowledge of standards and how they differ from regulations. In the post-exercise survey, these questions were repeated and additional questions specific to the exercise were included to measure student learning from the exercise itself as well as engagement with the material. The survey was crafted by, and the data analyzed a third-party survey consultant. Results were considered statistically significant at p< =0.05. Values between 0.05 and 0.1 were considered trends of interest.


Results, Conclusions, and Discussions::
Results
Between the pre- and post-exercise surveys, statistically significant improvements were seen in understanding regulatory language (12%), the applicability of quality systems to labeling requirements (11.3%), the responsibility of end users for cybersecurity (10%), confidence in understanding the role of standards (16%), and confidence in their foundational knowledge of BME regulatory affairs (12%). Other trends (0.05< p< =0.1) corroborate these results. Please see Table 1 for a summary of these results.

Concepts that did not show significant improvement between the pre- and post-exercise surveys were those that have been extensively covered during the course and that students have a high degree of competency before the exercise. These include the need for patient safety, and the role of the FDA separate from the application of engineering standards.

Regarding the exercise itself, students self-reported at a rate of 3:1 that they were favorable of the exercise and found it helpful in preparing them to practice engineering. The majority would recommend that it be included in the normal course curriculum.




Conclusions
The role and application of engineering standard can be difficult to present in a compelling way. Within Biomedical Engineering, standards play a critical role in ensuring user safety, with cybersecurity becoming a more substantial focus area for regulators. To address these issues, a moot court exercise was crafted to help improve the context for understanding standards. The exercise was conducted by, and observed, by students. The results of surveys conducted before and after the exercise show that students exhibited significant improvements in many of the areas covered during the exercise. Overall, students found the exercise a valuable part of their education.




Discussion
In general, student found the exercise to be engaging and a “fun” way yet instructional way to spend class time at the end of the week. Limitations were observed however, and future iterations of the exercise will strive to include more students in the preparation, if not the actual presentation of the content. It is also felt that a discussion after the exercise, but before the post-exercise survey, could help to reinforce particular points and further improve student learning.


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