BME 3320

Engineered Medical Devices

Course Description

Course information provided by the 2026-2027 Catalog.

This course is an introduction to the engineering, clinical, legal and regulatory aspects of medical device performance and failure. Topics covered include a broad survey of the thousands of successful medical devices in clinical use, as well as historical case studies of devices that were withdrawn from the market. In-depth study of specific medical devices will include: cardiovascular medicine, orthopedics, and general medicine (defibrillators, blood pressure cuffs, stethoscopes…) We will study the principles of operation (with hands-on examples), design evolution, modes of failure, and their ethical implications. Guest lectures will be provided by practicing engineers from medical device companies to provide real-world perspective of the development process. In addition to a mid-term and final exam covering topics presented in class, students will prepare a written report that critically investigates a particular medical device that has been recalled by the FDA, of the student’s choosing. The report will include the design history, engineering analysis, and recommendations for future improvements (re-design). The ultimate objectives of this course are to (1) provide students with a broad understanding of the spectrum of devices in healthcare, (2) stimulate critical analysis of medical device design, and (3) convey practical knowledge and skills that are valuable for a future career in the medical device industry.

Last 4 Terms Offered (None)

Learning Outcomes

• Be familiar with a wide range of medical devices currently available, their principles of operation, development history, and risks of failure. |Possess a broad understanding of the medical device industry, including trade organizations, government and academic societies.
• Understand the best practices for development of a medical device, gaining an appreciation for the complexity of the various technical and human-factors issues required to design a successful, safe, effective device.
• Possess the ability to critically analyze the design of a medical device.
• Acquire skills and techniques to foster innovation of medical devices.

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