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:

Buy at Amazon 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

ACTIVITIESPERCENTAGES
Quiz30%
FDA Report10%
Final Oral Presentation30%
Term Paper30%


Calendar

LEC #TOPICSINSTRUCTORSKEY DATES
I. Principles Of Implant Design (Working Paradigms)
1Clinical Problems Requiring Implants for SolutionI. V. Yannas / M. Spector 
2Principles of Implant Design / Design Parameters: Permanent versus Absorbable DevicesI. V. Yannas / M. Spector 
3The Missing Organ and its ReplacementI. V. Yannas 
4

Criteria for Materials Selection

I. V. Yannas 
5Tissue Engineering I: ScaffoldsM. Spector 
6Tissue Engineering II: Cells and RegulatorsM. Spector

 

 
7Case Study of Organ RegenerationI. V. Yannas 
II. Design Parameters
8Design Specifications: Biomaterials SurveyM. Spector 
 Quiz  
9Biocompatibility: Local and Systemic EffectsM. SpectorFinal composition of design team/final choice of topic
10Design Specifications: Tissue Bonding and Modulus MatchingM. Spector 
11Degradation of Devices: Natural and Synthetic PolymersI. V. Yannas 
12Biocompatibility: Scar Formation and ContractionI. V. Yannas 
13Degradation of Devices: Corrosion and WearM. Spector 
14Federal Regulation of Devices IM. Spector 
15Oral Presentations of Proposals for Design III. V. Yannas / M. Spector 
16Federal Regulation of Devices IIM. Spector 
III. Design Solution In-use
17Scaffolds for Cartilage RepairS. Vickers 
18Implants for BoneM. Spector 
19

Implants for Plastic Surgery

Dr. D. P. OrgillFDA report due
20Cardiovascular Prostheses: Heart Valves and Blood VesselsDr. F. Schoe 
21Devices for Nerve RegenerationI. V. Yannas 
22Musculoskeletal Soft Tissues: Meniscus, Intervertebral DiskM. Spector 
23Dental and Otologic ImplantsM. SpectorDesign report due
24Other Devices: Spinal Cord, Heart LungM. Spector 
25Final Oral Presentation of Designs (Mock FDA Panel)