Presentation
Becoming Human Factors Practitioners: Student Perspectives on Learning Human Factors in Undergraduate Medical Device Design
DescriptionTopic and Background
Human factors engineering is increasingly essential for ensuring that medical technologies are safe, usable, and effective. However, undergraduate programs often focus on technical problem-solving and device prototyping, offering limited opportunities for students to gain hands-on experience with usability methods or to understand the professional practice of human factors. As a result, many students graduate with strong technical training but little preparation for how usability, regulatory guidance, and user-centered evaluation shape medical device development. This presentation examines an educational model where students not only learn human factors concepts but also practice as human factors professionals, supported by mentorship from experts and collaboration with industry. In a redesigned senior capstone experience, students served in the role of human factors consultants rather than traditional product developers.
This project is structured as a self-reflective action research study, with the student co-authors serving as both learners and evaluators of the model. As biomedical engineering students, each student completed five prior co-ops in the medical device industry intentionally selected the human factors consulting track to broaden their training and better understand how usability influences clinical adoption, patient safety, and workflow efficiency.
Guided by faculty and industry mentors with expertise in healthcare usability, students conducted formative and summative studies to evaluate medical devices, packaging, and clinical workflows. They applied methods including contextual inquiry in clinical simulation labs, PCA task analysis, persona and user profile development, use-related risk analysis (URRA), and SEIPS-based systems modeling. Acting as consultants to peer design teams (whose projects included Histology Preparation Devices, Hand-held breath analyzers) and working with an industry-based combination product, they practiced influencing design decisions, communicating findings to non-specialists, and navigating trade-offs across innovation, usability, and compliance.
Overview of Student Learning
Student motivation to engage in human factors was critical to first evaluate.
“My industry experience conducting anthropometric studies with the U.S. Air Force revealed that human factors is a small discipline with massive impact. I enjoy talking with users, analyzing behavior, and translating feedback into improved designs. This role allows me to be both an engineer and a researcher working directly with people—understanding what matters most to diverse users in healthcare environments.” — Student Co-Author 2
“Growing up around the medical field and observing family members rely on devices like splints, braces, and surgical tools sparked my interest in usability and user experience. Through co-ops conducting contextual inquiry and task analysis, I learned how deeply human factors influences clinical adoption, ease of use, and ultimately patient outcomes. This capstone strengthens my ability to incorporate use considerations into future medical device design work.” — Student Co-Author 3
“Biomedical engineering education becomes highly technical, and through previous design courses we learned that even brilliantly engineered devices fail if real users cannot operate them safely and effectively. Human factors allows us to fully understand how people interact with medical devices—helping us shift from asking ‘Can we build it?’ to ‘Will people be able to use it successfully?’ This experience helped us see engineering through a human lens rather than defaulting to purely technical thinking.” — Student Co-Author 4
Students’ learning occurred across two dimensions. First, they learned human factors methods: how to conduct formative and summative studies, identify safety and usability risks, analyze user interactions, and translate findings into design recommendations. Mentorship was critical here, as faculty and industry experts offered feedback on study design, data interpretation, and alignment with FDA usability engineering expectations.
Second, students learned to be human factors practitioners. Serving as consultants to peer design teams, they practiced framing usability issues in ways that influenced design decisions, communicating findings to non-specialists, and navigating stakeholder priorities. Working with industry collaborators further exposed students to the organizational realities of timelines, resource constraints, and compliance requirements, making their roles more authentic. Through this dual process, students developed both conceptual proficiency and a sense of professional identity in human factors.
Importance of the Approach
This model demonstrates that undergraduate education can move beyond classroom exercises to provide meaningful, practice-based training in human factors. Mentorship by experts grounded student work in professional standards, while industry engagement ensured that projects were realistic and clinically relevant. Students reported that this combination deepened their appreciation of usability as integral to innovation, patient safety, and clinical workflow efficiency not as an optional add-on. Importantly, students came to view themselves not only as engineers but as contributors to the broader mission of safe and effective healthcare.
Takeaway Points
Human factors education is strengthened when taught as both a body of methods and as a practice-based discipline.
Mentorship from human factors experts provides essential scaffolding for students to develop methodological rigor and regulatory awareness.
Collaborating with industry grounds learning in real-world challenges, reinforcing the relevance of usability in medical device development.
Acting as consultants, students gain experience in professional communication, stakeholder engagement, and identity formation as human factors practitioners.
By combining mentorship, industry engagement, and experiential consulting roles, undergraduate programs can prepare future engineers who are both methodologically competent and professionally prepared to ensure medical devices are safe, usable, and effective. This presentation will share the educational framework, examples of student projects, and lessons learned for integrating human factors into undergraduate design curricula.
Human factors engineering is increasingly essential for ensuring that medical technologies are safe, usable, and effective. However, undergraduate programs often focus on technical problem-solving and device prototyping, offering limited opportunities for students to gain hands-on experience with usability methods or to understand the professional practice of human factors. As a result, many students graduate with strong technical training but little preparation for how usability, regulatory guidance, and user-centered evaluation shape medical device development. This presentation examines an educational model where students not only learn human factors concepts but also practice as human factors professionals, supported by mentorship from experts and collaboration with industry. In a redesigned senior capstone experience, students served in the role of human factors consultants rather than traditional product developers.
This project is structured as a self-reflective action research study, with the student co-authors serving as both learners and evaluators of the model. As biomedical engineering students, each student completed five prior co-ops in the medical device industry intentionally selected the human factors consulting track to broaden their training and better understand how usability influences clinical adoption, patient safety, and workflow efficiency.
Guided by faculty and industry mentors with expertise in healthcare usability, students conducted formative and summative studies to evaluate medical devices, packaging, and clinical workflows. They applied methods including contextual inquiry in clinical simulation labs, PCA task analysis, persona and user profile development, use-related risk analysis (URRA), and SEIPS-based systems modeling. Acting as consultants to peer design teams (whose projects included Histology Preparation Devices, Hand-held breath analyzers) and working with an industry-based combination product, they practiced influencing design decisions, communicating findings to non-specialists, and navigating trade-offs across innovation, usability, and compliance.
Overview of Student Learning
Student motivation to engage in human factors was critical to first evaluate.
“My industry experience conducting anthropometric studies with the U.S. Air Force revealed that human factors is a small discipline with massive impact. I enjoy talking with users, analyzing behavior, and translating feedback into improved designs. This role allows me to be both an engineer and a researcher working directly with people—understanding what matters most to diverse users in healthcare environments.” — Student Co-Author 2
“Growing up around the medical field and observing family members rely on devices like splints, braces, and surgical tools sparked my interest in usability and user experience. Through co-ops conducting contextual inquiry and task analysis, I learned how deeply human factors influences clinical adoption, ease of use, and ultimately patient outcomes. This capstone strengthens my ability to incorporate use considerations into future medical device design work.” — Student Co-Author 3
“Biomedical engineering education becomes highly technical, and through previous design courses we learned that even brilliantly engineered devices fail if real users cannot operate them safely and effectively. Human factors allows us to fully understand how people interact with medical devices—helping us shift from asking ‘Can we build it?’ to ‘Will people be able to use it successfully?’ This experience helped us see engineering through a human lens rather than defaulting to purely technical thinking.” — Student Co-Author 4
Students’ learning occurred across two dimensions. First, they learned human factors methods: how to conduct formative and summative studies, identify safety and usability risks, analyze user interactions, and translate findings into design recommendations. Mentorship was critical here, as faculty and industry experts offered feedback on study design, data interpretation, and alignment with FDA usability engineering expectations.
Second, students learned to be human factors practitioners. Serving as consultants to peer design teams, they practiced framing usability issues in ways that influenced design decisions, communicating findings to non-specialists, and navigating stakeholder priorities. Working with industry collaborators further exposed students to the organizational realities of timelines, resource constraints, and compliance requirements, making their roles more authentic. Through this dual process, students developed both conceptual proficiency and a sense of professional identity in human factors.
Importance of the Approach
This model demonstrates that undergraduate education can move beyond classroom exercises to provide meaningful, practice-based training in human factors. Mentorship by experts grounded student work in professional standards, while industry engagement ensured that projects were realistic and clinically relevant. Students reported that this combination deepened their appreciation of usability as integral to innovation, patient safety, and clinical workflow efficiency not as an optional add-on. Importantly, students came to view themselves not only as engineers but as contributors to the broader mission of safe and effective healthcare.
Takeaway Points
Human factors education is strengthened when taught as both a body of methods and as a practice-based discipline.
Mentorship from human factors experts provides essential scaffolding for students to develop methodological rigor and regulatory awareness.
Collaborating with industry grounds learning in real-world challenges, reinforcing the relevance of usability in medical device development.
Acting as consultants, students gain experience in professional communication, stakeholder engagement, and identity formation as human factors practitioners.
By combining mentorship, industry engagement, and experiential consulting roles, undergraduate programs can prepare future engineers who are both methodologically competent and professionally prepared to ensure medical devices are safe, usable, and effective. This presentation will share the educational framework, examples of student projects, and lessons learned for integrating human factors into undergraduate design curricula.
Event Type
Oral Presentations
TimeTuesday, March 249:15am - 9:37am EDT
LocationMorgan
Simulation and Education