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Apr 18, 2024
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BE 3405 - Biomedical Device Evaluation3 lecture hours 0 lab hours 3 credits
Course Description
This course addresses the unique patient safety and efficacy concerns associated with medical devices and specifically how such devices are rigorously tested and evaluated. Classic experimental design and statistical techniques are used to compare device performance measures, assess accuracy, and test experimental hypotheses. The use and interpretation of statistical software is also covered in this course. (prereq: MA 3611 , senior standing)
Course Learning Outcomes
Upon successful completion of this course, the student will be able to:
- Describe the general FDA process by which medical devices are able to enter the U.S. market
- Identify and define the different FDA classifications for medical devices
- Demonstrate familiarity with those standards that address medical device safety and efficacy: IEC, AAMI/ANSI, NFPA, UL
- Design basic experiments to assess medical device efficacy, determine substantial equivalency, and how to properly analyze the statistical results from such experiments
Prerequisites by Topic
- Fundamentals of hypothesis testing: Understanding Type I and Type II errors, relationship between sample sizes, power
- Foundation and application of common inferential statistics: t-tests, ANOVA, regression
Course Topics
- FDA requirements and the medical device regulatory process: pre-market approval, substantial equivalence, 510(k)
- Use of standards in evaluation of medical device safety and efficacy (AAMI, ANSI, NFPA, UL)
- Design of experiments to assess medical device efficacy
- Applications and use of inferential statistics: t-test, ANOVA, regression, chi-square.
- Case study data analysis
- Design and execution of clinical trials for medical devices, biologics and drugs.
Coordinator
Dr. Olga Imas
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