Design of Medical Devices and Implants >> Content Detail



Amazon logo When you click the Amazon logo to the left of any citation and purchase the book (or other media) from, MIT OpenCourseWare will receive up to 10% of this purchase and any other purchases you make during that visit. This will not increase the cost of your purchase. Links provided are to the US Amazon site, but you can also support OCW through Amazon sites in other regions. Learn more.

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.


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:

Amazon logo 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.


FDA Report10%
Final Oral Presentation30%
Term Paper30%


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

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
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

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)


© 2009-2020, All Rights Reserved.
Higher Ed Space ® is a registered trademark of AmeriCareers LLC.