As undergraduate engineering students develop technical skills and an inclination to base design decisions on technical constraints, the application of engineering standards is often seen as a mandate of design instructors, rather than a beneficial practice. When students carry this view into industry, medical device development and regulatory approval can be hindered, so industry is placing a greater value on students who appreciate and can effectively apply medical device standards. Engineering curricula often introduce standards in the junior and senior years, likely because they tend to require some technical background. However, many engineering standards are based on logic and can be understood at a lower level.
We hypothesized that, by introducing a design project that requires incorporation of a medical device standard in a first-term introductory course, and by illustrating its importance using a device failure case study, students can gain an appreciation for the importance of standards that can extend to upper-level courses. Specifically, after presenting students case study reports in which poor design of electrode lead connectors contributed to the deaths of patients, specific standards from IEC 60601-2-25 related to the standard color code and required recess of conductive material in ECG lead cables were discussed. Students were then given a set of commercial lead wires (with reference to another standard that specifies the connector dimensions), along with compatible mating pins. Using these, the students were instructed to design, fabricate and test a standard-compliant connector block to accept the lead wires. Other modules in the course provided the students with skills in applying computer-aided design, 3-D printing and basic electrical testing.
Future assessment of the effectiveness of this approach will involve assessing student attitudes and tendencies to apply medical device standards in capstone design projects in the junior and senior years. Comparisons will be made between students who applied standards in their freshman course and students who took a previous course that concentrated on introducing technical skills only.
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