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

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

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

Chapter 1 Outline (PDF)

TORA. Chapter 1.

2 Principles of Implant Design / Design Parameters: Permanent versus Absorbable Devices Chapter 2 Outline (PDF)
3 The Missing Organ and its Replacement TORA. Chapter 1.
4 Criteria for Materials Selection TORA. Chapter 1.
5 Tissue Engineering I: Scaffolds Langer, Robert, and Joseph P. Vacanti. "Tissue Engineering." Science, New Series 260, no. 5110 (May 14, 1993): 920-926.
6 Tissue Engineering II: Cells and Regulators  
7 Case 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
8 Design Specifications: Biomaterials Survey  
9 Biocompatibility: Local and Systemic Effects  
10 Design Specifications: Tissue Bonding and Modulus Matching  
11 Degradation of Devices: Natural and Synthetic Polymers Buy at Amazon Spector, Myron. "Biomaterials." Chapter 19 in Plastic Surgery. Vol. 1. Edited by B. M. Achauer, et al. Mosby: St. Louis, 2000. ISBN: 9780815110194.
12 Biocompatibility: Scar Formation and Contraction TORA. Chapters 1, 2, and 4.
13 Degradation of Devices: Corrosion and Wear  
14 Federal 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

15 Oral Presentations of Proposals for Design II  
16 Federal Regulation of Devices II What is CE Marking?
III. Design Solution In-use
17 Scaffolds for Cartilage Repair  
18 Implants for Bone  
19 Implants for Plastic Surgery  
20 Cardiovascular 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.

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