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


2.79J or permission of instructor.


  • 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.


Quiz 30%
FDA Report 10%
Final Oral Presentation 30%
Term Paper 30%


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  

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  
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  

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)