Work-in-Progress: Development of a Domain-Agnostic Standards Curriculum in Partnership with a Medical Device Manufacturer

Michael Gordon Browne; Anthony E. Felder; Adrian P. Defante

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Conference: 2024 ASEE Annual Conference & Exposition
Location: Portland, Oregon
Publication Date: June 23, 2024
Start Date: June 23, 2024
End Date: July 12, 2024
Conference Session: Biomedical Engineering Division (BED) Postcard Session (Best of WIPs)
Tagged Division: Biomedical Engineering Division (BED)
Permanent URL: https://peer.asee.org/48534

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Paper Authors

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Michael Gordon Browne The University of Illinois Chicago orcid.org/0000-0002-5091-0817

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Clinical Assistant Professor teaching engineering design, medical device quality and regulatory processes, innovation, and entrepreneurship to University of Illinois at Chicago Biomedical Engineering Students and Medical Students the University of Illinois College of Medicine Innovation Medicine Program. Research interests focus on the emulation of realistic medical device design in education and the quality assessment of educational design projects.

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Anthony E. Felder The University of Illinois Chicago orcid.org/0000-0002-4533-8369

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Dr. Felder earned a Ph.D. in Bioengineering from the University of Illinois at Chicago. His current focus is on engineering education and its restructuring to better meet the diverse needs of students and industries. Dr. Felder is also active in ophthalmology research for the multimodal imaging of retinal oxygenation and novel medical device design.

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Adrian P. Defante

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Abstract

The medical device industry is one of the most highly regulated industries and, as a result, medical device manufacturers rely heavily on technical performance standards when developing and clearing medical devices with the FDA. Standards organizations like the International Standards Organization (ISO) and the American Society for Testing and Materials (ASTM) create and curate both these standards guiding the safe and effective design of near countless technologies and processes, including medical devices. ABET requirements advise the incorporation of standards into engineering curriculum but that focus frequently corresponds to ISO 13485:2016 Quality Management Systems. While ISO 13485 is critical for our students entering the medical device industry where quality assurance is key, it is ineffective at teaching students how to incorporate consensus specifications into the engineering design or assessment of a new technology. Capstone design courses may require the incorporation of performance standards during the design process but approach and rigor can be widely varied. As a result, our protocol involves collaborating with a local medical device manufacturer to development and pilot curriculum modules for the effective incorporation of standards in engineering education. These modules incorporate learning objectives that span Bloom’s Taxonomy from recognition and application of standards to reflection/revision and creation of new standards. Our aim is to build domain-agnostic modules at different levels of learning, acting as a centralized curriculum for standards education. The modules and their implementation will enhance students’ understanding of standards, including 1) searching and identifying appropriate standards, 2) writing appropriate protocols for the verification of standards, 3) proposing revisions to standards, and 4) developing new standards. Thus far we have piloted modules 1, 3, and 4 in our “FDA and ISO Requirements for the Development and Manufacturing of Medical Devices” course. Module 1, searching and identifying appropriate standards, was done in partnership with our university engineering librarian and extensive university licensing of consensus standards catalogs (including ISO and ASTM). For module 3, we designed a class activity to revise a standard for blood glucose monitoring systems (ISO 15197) with student groups representing different medical device manufacturers, standards organizations, and relevant parties. Each group leveraged their own base of proprietary information to negotiate and propose revisions to the standard. Finally, we have piloted module 4, developing new standards, by having students collectively outline then draft substantive portions of a standard governing “the use of generative AI in the completion of biomedical engineering coursework”. Engagement in each activity has been high though future efforts aim to assess both student satisfaction and learning outcomes associated with standard modules. The final submission will contain qualitative outcomes from two iterations of modules. While working alongside a medical device manufacturer, these modules have been piloted specifically related to medical devices and biomedical engineering students. Nevertheless, our final efforts will include ensuring that module content and materials are domain-agnostic such that we may share our methodology not only across engineering disciplines, but across learning levels. This will ultimately enable the sharing of standards modules with other departments, universities, and even with our industry partners.

Citation
Format

Browne, M. G., & Felder, A. E., & Defante, A. P. (2024, June), Work-in-Progress: Development of a Domain-Agnostic Standards Curriculum in Partnership with a Medical Device Manufacturer Paper presented at 2024 ASEE Annual Conference & Exposition, Portland, Oregon. https://peer.asee.org/48534

TY - CPAPER
AB - The medical device industry is one of the most highly regulated industries and, as a result, medical device manufacturers rely heavily on technical performance standards when developing and clearing medical devices with the FDA. Standards organizations like the International Standards Organization (ISO) and the American Society for Testing and Materials (ASTM) create and curate both these standards guiding the safe and effective design of near countless technologies and processes, including medical devices. ABET requirements advise the incorporation of standards into engineering curriculum but that focus frequently corresponds to ISO 13485:2016 Quality Management Systems. While ISO 13485 is critical for our students entering the medical device industry where quality assurance is key, it is ineffective at teaching students how to incorporate consensus specifications into the engineering design or assessment of a new technology. Capstone design courses may require the incorporation of performance standards during the design process but approach and rigor can be widely varied. As a result, our protocol involves collaborating with a local medical device manufacturer to development and pilot curriculum modules for the effective incorporation of standards in engineering education. These modules incorporate learning objectives that span Bloom’s Taxonomy from recognition and application of standards to reflection/revision and creation of new standards. Our aim is to build domain-agnostic modules at different levels of learning, acting as a centralized curriculum for standards education. The modules and their implementation will enhance students’ understanding of standards, including 1) searching and identifying appropriate standards, 2) writing appropriate protocols for the verification of standards, 3) proposing revisions to standards, and 4) developing new standards. Thus far we have piloted modules 1, 3, and 4 in our “FDA and ISO Requirements for the Development and Manufacturing of Medical Devices” course. Module 1, searching and identifying appropriate standards, was done in partnership with our university engineering librarian and extensive university licensing of consensus standards catalogs (including ISO and ASTM). For module 3, we designed a class activity to revise a standard for blood glucose monitoring systems (ISO 15197) with student groups representing different medical device manufacturers, standards organizations, and relevant parties. Each group leveraged their own base of proprietary information to negotiate and propose revisions to the standard. Finally, we have piloted module 4, developing new standards, by having students collectively outline then draft substantive portions of a standard governing “the use of generative AI in the completion of biomedical engineering coursework”. Engagement in each activity has been high though future efforts aim to assess both student satisfaction and learning outcomes associated with standard modules. The final submission will contain qualitative outcomes from two iterations of modules. While working alongside a medical device manufacturer, these modules have been piloted specifically related to medical devices and biomedical engineering students. Nevertheless, our final efforts will include ensuring that module content and materials are domain-agnostic such that we may share our methodology not only across engineering disciplines, but across learning levels. This will ultimately enable the sharing of standards modules with other departments, universities, and even with our industry partners.
AU - Michael Gordon Browne
AU - Anthony E. Felder
AU - Adrian P. Defante
CY - Portland, Oregon
DA - 2024/06/23
PB - ASEE Conferences
TI - Work-in-Progress: Development of a Domain-Agnostic Standards Curriculum in Partnership with a Medical Device Manufacturer
UR - https://peer.asee.org/48534
ER -