Syllabus

This design subject teaches rational approaches to the development of implantable medical devices. Students work in groups to develop the design for a medical device.

Course Meeting Times

Lectures: 2 sessions / week, 1.5 hours /session

Prerequisites

2.79J or permission of instructor.

Topics

• Paradigm for design of medical devices/implants:
  • Functional Requirements
  • Effects of the Device on the Body
  • Effects of the Body on the Device
  • Benefit/Risk Ratio
• Principles related to the permanent replacement and regeneration (tissue engineering) of tissues and organs; selected issues addressed through case studies
• Considerations of anatomy, histology, physiology, and pathology
• U.S. Food and Drug Administration regulations

Design Projects

Students will work in groups of 3 or 4 people. All individuals in the group will receive the same grade for the Oral Presentation and Term Paper. All students will be required to participate in the Oral Presentations.

The designs need be realistic, but the devices will not be fabricated. Professors Yannas and Spector will allocate a fixed amount of "consulting" time to each group.

Reading Materials

Assigned articles from the literature are listed on the readings page.

A textbook for the course, known as TORA, is:

Yannas, I. V. Tissue and Organ Regeneration in Adults. New York, NY: Springer, 2001. ISBN: 9780387952147.

Students may also wish to consult other reference works on anatomy, histology, physiology and pathology.

Grading

Calendar