Poster Q19 - Promoting student engagement with standards: A product liability case study

Introduction: This study reports on an initiative to engage biomedical engineering students with technical standards through a product liability in-class activity similar to a moot court. Working in teams, students are provided with an ambiguous case study that they investigate and engage in a debate as part of the prosecution or the defense team to convince the rest of the class whether standards compliance had a role in the product liability case or not. Of specific interest in this work are (a) the positioning of the case study in terms of how standards can be taught in an engaging way, and (b) knowledge of standards as measured by pre- and post-student surveys. This work reports on the first-time run of a moot court class activity using a fictional medical device cybersecurity breach case study and discusses the challenges encountered, the opportunities to improve the class activity, and the benefits to students we observed.

Materials and

Methods: Creating a case study on standards used in a moot court case requires a systematic approach to gather relevant information and present it in a clear and concise manner to all the stakeholders involved in the process. Our method involved 8 major steps.

1. Identify the moot court learning objectives and measurable learning outcomes.
2. Formulate a relevant moot court product liability position.
3. Analyze the premise of the case: Analyze the moot court case to understand how the standards were applied and how use plays a role in product liability.
4. Develop a case study outline
5. Write the case study: With the outline as a guide, write a 2-4 page case summary. Be sure to include as many details as possible, but it is helpful to leave room in the outline for the student actor team to have input and explore for themselves how standards were (or might be) applied in the case.
6. Review and revise: With the revised case study in hand, review it for accuracy, clarity, and assurance that the use of standards will follow from trial arguments.
7. Identify case roles and share the case study.
8. Survey for impact: Conduct pre- and post-survey of the impact the case study on the understanding of standards in design.

The first seven steps build out the case study that will set the stage for the student team members to take the next step and prepare for the moor court session itself.

Results, Conclusions, and Discussions: IRB-approved pre- and post-surveys were conducted to measure the impact of the moot court experience. Overall, students found the exercise engaging and a good vehicle for delivering content that can often be perceived as “dry” and with little context available to put into perspective its importance to engineers. A related result is that students were able to better appreciate the role of standards, as a concept, separate from the specific details of the standards included in the exercise. Of the 20 survey questions, several results suggested students gained knowledge or had a better understanding of the role of standards in design. Sample results are as follows:
1. If given a biomedical engineering issue or case, I am confident in my ability to identify the relationship between Standards and the issue presented: “Strongly Agree” increase of 14%
2. I have a strong foundational knowledge of the regulatory aspects of biomedical engineering. “Strongly Agree” increase of 27%
3. My current knowledge of Standards is very important as I complete my biomedical engineering education: Pre- and post-survey results were similar.
4. My current knowledge of Standards will be integral to my next professional or educational steps: Pre- and post-survey results were similar.
These results are only a small sample of the data collected to assess the impact of the impact of the moot court experience on standards knowledge.

At our university the teaching of standards is an integral part of the Senior Design Experience. The moot court experience appears to suggest that use and application of standards (Q1 and Q2) had more impact on students then knowing the importance of standards (Q3) and the understanding that standards are important in professional practice (Q4). In essence, the moot court activity may have been more influential on the “why” of the importance of standards versus the “what” of our conventional didactic class lectures. By presenting the role of the standards at issue in the moot court exercise as well as the details, students gain a better appreciation for the former, even if they were unclear of the latter.

Acknowledgements (Optional): Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health under Award Number R25-EB014774-07
National Institute of Standards and Technology under Award Number 70NANB21H176