Work In Progress: Improving Student Views of Medical Device Standards through Implementation in a First-term Biomedical Engineering Course

Jeffrey A. LaMack; Larry Fennigkoh; Paul Licato

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Conference: 2019 ASEE Annual Conference & Exposition
Location: Tampa, Florida
Publication Date: June 15, 2019
Start Date: June 15, 2019
End Date: June 19, 2019
Conference Session: Biomedical Division Postcard Session
Tagged Division: Biomedical Engineering
Page Count: 5
DOI: 10.18260/1-2--33627
Permanent URL: https://peer.asee.org/33627
Download Count: 426

Paper Authors

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Jeffrey A. LaMack Milwaukee School of Engineering

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Dr. LaMack serves as undergraduate program director and course instructor in the Biomedical Engineering program in the Electrical Engineering and Computer Science Department at the MIlwaukee School of Engineering (MSOE). His areas of specialty include biophysical transport phenomena, biocomputing, physiology, and engineering design. Dr. LaMack holds a Ph.D. in Biomedical Engineering from Duke University, and he is an alumnus of the Biology Scholars Program of the American Society of Microbiology. Prior to becoming focused on engineering education, his research interests included hemodynamics and the study of how vascular cells respond to fluid forces and its implications in vascular pathologies.

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Larry Fennigkoh P.E. Milwaukee School of Engineering

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Dr. Larry Fennigkoh is a professor of biomedical engineering at the Milwaukee School of Engineering teaching graduate and undergraduate courses in medical instrumentation, biomedical engineering design, biomechanics, biostatistics, and human physiology. He is a Registered Professional Engineer and board certified in clinical engineering. He is also a member of the Institute of Electrical & Electronic Engineers, Association for the Advancement of Medical Instrumentation, American College of Clinical Engineering, American Society for Engineering Education, and an inducted Fellow within both the American Institute for Medical and Biological Engineering, and the American College of Clinical Engineering.

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Paul Licato Milwaukee School of Engineering

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Abstract

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.

Citation
Format

LaMack, J. A., & Fennigkoh, L., & Licato, P. (2019, June), Work In Progress: Improving Student Views of Medical Device Standards through Implementation in a First-term Biomedical Engineering Course Paper presented at 2019 ASEE Annual Conference & Exposition , Tampa, Florida. 10.18260/1-2--33627

TY - CPAPER
AB - 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.

AU - Jeffrey A. LaMack
AU - Larry Fennigkoh P.E.
AU - Paul Licato
CY - Tampa, Florida
DA - 2019/06/15
PB - ASEE Conferences
TI - Work In Progress: Improving Student Views of Medical Device Standards through Implementation in a First-term Biomedical Engineering Course
UR - https://peer.asee.org/33627
DO - 10.18260/1-2--33627
ER -