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
| ACTIVITIES | PERCENTAGES |
|---|---|
| Quiz | 30% |
| FDA Report | 10% |
| Final Oral Presentation | 30% |
| Term Paper | 30% |
Calendar
| LEC # | TOPICS | INSTRUCTORS | KEY DATES |
|---|---|---|---|
| I. Principles Of Implant Design (Working Paradigms) | |||
| 1 | Clinical Problems Requiring Implants for Solution | I. V. Yannas / M. Spector | |
| 2 | Principles of Implant Design / Design Parameters: Permanent versus Absorbable Devices | I. V. Yannas / M. Spector | |
| 3 | The Missing Organ and its Replacement | I. V. Yannas | |
| 4 |
Criteria for Materials Selection |
I. V. Yannas | |
| 5 | Tissue Engineering I: Scaffolds | M. Spector | |
| 6 | Tissue Engineering II: Cells and Regulators | M. Spector | |
| 7 | Case Study of Organ Regeneration | I. V. Yannas | |
| II. Design Parameters | |||
| 8 | Design Specifications: Biomaterials Survey | M. Spector | |
| Quiz | |||
| 9 | Biocompatibility: Local and Systemic Effects | M. Spector | Final composition of design team/final choice of topic |
| 10 | Design Specifications: Tissue Bonding and Modulus Matching | M. Spector | |
| 11 | Degradation of Devices: Natural and Synthetic Polymers | I. V. Yannas | |
| 12 | Biocompatibility: Scar Formation and Contraction | I. V. Yannas | |
| 13 | Degradation of Devices: Corrosion and Wear | M. Spector | |
| 14 | Federal Regulation of Devices I | M. Spector | |
| 15 | Oral Presentations of Proposals for Design II | I. V. Yannas / M. Spector | |
| 16 | Federal Regulation of Devices II | M. Spector | |
| III. Design Solution In-use | |||
| 17 | Scaffolds for Cartilage Repair | S. Vickers | |
| 18 | Implants for Bone | M. Spector | |
| 19 |
Implants for Plastic Surgery |
Dr. D. P. Orgill | FDA report due |
| 20 | Cardiovascular Prostheses: Heart Valves and Blood Vessels | Dr. F. Schoe | |
| 21 | Devices for Nerve Regeneration | I. V. Yannas | |
| 22 | Musculoskeletal Soft Tissues: Meniscus, Intervertebral Disk | M. Spector | |
| 23 | Dental and Otologic Implants | M. Spector | Design report due |
| 24 | Other Devices: Spinal Cord, Heart Lung | M. Spector | |
| 25 | Final Oral Presentation of Designs (Mock FDA Panel) | ||
