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Credit: 1
course unit
Elective course
Catalog Description:
This course introduces students to bioengineering research and
development as related to meeting clinical needs. The course is broadly
organized about the question of "what makes medical technology
work". It introduces students to the assessment of medical
technology including studies to evaluate safety and effectiveness of new
devices. Introduction to regulatory, ethical, legal, and economic issues
as they relate to the success of new medical technologies. The course
will be taught through examination of case studies, which may vary from
year to year. Recent case studies have included mammography, heart assist
devices and the artificial heart, hyperthermia, safety of radiofrequency
energy. The course is taught partly as a seminar, with lectures by
departmental and invited outside experts and student presentations in
addition to lectures by the instructor.
Prerequisites:
Graduate standing. Undergraduates can enroll with approval of
advisor and instructor. BE seniors are encouraged to take the course.
Textbook(s) and/or Other Required Materials:
Journal articles and handouts from instructor
Course Objectives:
This course is presently a graduate course, is being renumbered as
BE 515 to encourage more undergraduates to take it. The goal of the
course is to introduce students to the wider cluster of issues related to
“what makes medical technology work” focusing on the
interplay of medical, technical engineering, and social (regulatory,legal,ethical,economic)
constraints.
Topics Covered:
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Introduction:
what makes medical technology work? Constraints on medical technology
(regulatory, economic, medical, technical)
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Regulatory
constraints: FDA premarket approval requirements
for medical devices; 510(k) and PMA, postmarket
surveillance
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Medical
constraints: defining the medical need for a new technology
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Economic
constraints: Third party reimbursement as it impacts the success of new
medical technologies
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Introduction
to clinical trials: Phase 1,2,3; elements of study design; sample size
and power considerations
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Sample
case studies: Mammography; The artificial heart and assist devices; RF
fields
Class Schedule:
Lecture: 3 hrs/week
Contribution
towards Professional Component:
100% Engineering science
Contribution
towards Program Outcomes:
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Multidisciplinary
Ability
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Med.
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Problem Solving
Approach
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High
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Problem Solving
Methods
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Low
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Experimentation
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Low
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Design
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Low
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Professional
Orientation
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High
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Person(s) Preparing
Description and Date:
K. R. Foster
July 2007
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