Syllabus

Myron Spector, and Ioannis V. Yannas

Two sessions / week; 1.5 hours / session

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
• Issues Related to Anatomy, Histology, Physiology, and Pathology
• US Food and Drug Administration Regulations

Grading

One quiz, 1 FDA report for design project, 2 oral presentations of design projects, term paper for design project.

• 30% Quiz
• 10% FDA Report (Total length is 8 pages, 11/2 line spacing, minimum font: 12. This includes text, all images and all references)
• Oral Presentation of Proposal
• 30% Final Oral Presentation
• 30% Term Paper (Total length is 20 pages, 11/2 line spacing, minimum font: 12. This includes text, all images and all references)

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.

Chapters

I. Principles of Implant Design (Working Paradigms)

  1. Clinical Problems Requiring Implants for Solution: Defining the Problem
  2. Principles of Implant Design (The Paradigm): Design Specifications
  3. Implants to Facilitate Tissue/Organ Regeneration
  4. Implant for Skin Regeneration: Case Study
  5. Replacing Organs with Permanent Prostheses
  6. Hip Repacement Prosthesis Design: Case Study
  7. Tissue Engineering


II. Design Parameters and Implant Design Protocols

  8. Design Parameters
  9. Effects of the Implant on the Body: Biocompatibility
10. Degradation of Devices
11. Clinical Trial Design and Outcome Studies; Federal Regulation of Medical Devices


III. Implants for Specific Applications

12. Dental Implants
13. Joint Replacement Prostheses
14. Implants for Musculoskeletal Tissues
15. Implants for Plastic Surgery
16. Cardiovascular Prostheses
17. Other Organ Regeneration and Replacement: Cell-Seeded Devices