Design of Medical Devices and Implants >> Content Detail

Study Materials


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This page presents various outlines, notes, textbook selections, and journal articles assigned for some class sessions.

TORA = Amazon logo Yannas, I. V. Tissue and Organ Regeneration in Adults. New York, NY: Springer-Verlag, 2001. ISBN: 9780387952147.

I. Principles Of Implant Design (Working Paradigms)
1Clinical Problems Requiring Implants for Solution

Chapter 1 Outline (PDF)

TORA. Chapter 1.

2Principles of Implant Design / Design Parameters: Permanent versus Absorbable DevicesChapter 2 Outline (PDF)
3The Missing Organ and its ReplacementTORA. Chapter 1.
4Criteria for Materials SelectionTORA. Chapter 1.
5Tissue Engineering I: ScaffoldsLanger, Robert, and Joseph P. Vacanti. "Tissue Engineering." Science, New Series 260, no. 5110 (May 14, 1993): 920-926.
6Tissue Engineering II: Cells and Regulators
7Case Study of Organ Regeneration

TORA. Chapters 6, 7, and 10.

Yannas, I. V., et al. "Wound Tissue Can Utilize a Polymeric Template to Synthesize a Functional Extension of Skin." Science, New Series 215, no. 4529 (January 8, 1982): 174-176.

II. Design Parameters
8Design Specifications: Biomaterials Survey
9Biocompatibility: Local and Systemic Effects
10Design Specifications: Tissue Bonding and Modulus Matching
11Degradation of Devices: Natural and Synthetic PolymersAmazon logo Spector, Myron. "Biomaterials." Chapter 19 in Plastic Surgery. Vol. 1. Edited by B. M. Achauer, et al. Mosby: St. Louis, 2000. ISBN: 9780815110194.
12Biocompatibility: Scar Formation and ContractionTORA. Chapters 1, 2, and 4.
13Degradation of Devices: Corrosion and Wear
14Federal Regulation of Devices I

FDA Guidance for Industry documents:

E6 Good Clinical Practice: Consolidated Guidance (PDF)

E10 Choice of Control Group and Related Issues in Clinical Trials (PDF)

Tripartite Biocompatibility for Medical Devices

15Oral Presentations of Proposals for Design II
16Federal Regulation of Devices IIWhat is CE Marking?
III. Design Solution In-use
17Scaffolds for Cartilage Repair
18Implants for Bone
19Implants for Plastic Surgery
20Cardiovascular Prostheses: Heart Valves and Blood Vessels

Mitchell, L. Shannon, and Laura E. Niklason. "Requirements for Growing Tissue-Engineered Vascular Grafts." Cardiovascular Pathology 12 (2003): 59-64.

Niklason, L. E., J. Gao, W. M. Abbot, K. K. Hirschi, S. Houser, R. Marini, and R. Langer. "Functional Arteries Grown in Vitro." Science 284 (April 16, 1999): 489-493.

Schoen, Frederick J., and Robert J. Levy. "Tissue Heart Valves: Current Challenges and Future Research Perspectives." Founder's Award, 25th Annual Meeting of the Society for Biomaterials, Providence, RI, April 28-May 2, 1999.

Rabkin, Elena, and Frederick J. Schoen. "Cardiovascular Tissue Engineering." Cardiovascular Pathology II (2002): 305-317.

21Devices for Nerve RegenerationTORA. Chapter 6.
22Musculoskeletal Soft Tissues: Meniscus, Intervertebral Disk
23Dental and Otologic Implants
24Other Devices: Spinal Cord, Heart Lung
25Final Oral Presentation of Designs (Mock FDA Panel)


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