Course Description
Introduction of the application of human factors and ergonomics in the design of biomedical devices as well as the regulatory framework for device pre-market approval.
Additional Requirements for Graduate Students:
Graduate students will be required to develop and present to the
rest of the class advanced case studies of biomedical device
failures, predominantly due to inattention to human factors
and/or ergonomics. The case study report and presentation will
be graded for graduate credit.
Athena Title
Biomedical Device Design
Equivalent Courses
Not open to students with credit in BIOE 4720E or BIOE 6720E
Prerequisite
BCHE 3520
Semester Course Offered
Offered every year.
Grading System
A - F (Traditional)
Course Objectives
Students will be exposed to a broad range of current topics in human factors and ergonomics and biomedical device regulation in the U.S. and other countries. Upon completion of this course, students will be prepared to apply human factors and ergonomics knowledge in healthcare industry, especially toward biomedical device design, or continue to higher levels of study in the field. Graduate students will be required to develop and present to the rest of the class advanced case studies of biomedical device failures, predominantly due to inattention to human factors and/or ergonomics. The case study report and presentation will be graded for graduate credit.
Topical Outline
TOPICAL OUTLINE Topics will include: Federal food, drug, and cosmetic act Profiles of FDA biomedical device recalls General principles of human abilities Environment of use Anthropometry and biomechanics Cross-national and cross-cultural design Documentation Testing and evaluation Controls Visual displays Connections and connectors Alarm design Workstations Signals, symbols, and markings Packing Device lifecycle Hand tool design Mobile medical devices Smart-phone-based devices Home healthcare