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Design of Medical Devices and Implants

3-0-9 units · Graduate

Solution of clinical problems by use of implants and other medical devices. Systematic use of cell-matrix control volumes. The role of stress analysis in the design process. Anatomic fit: shape and size of implants. Selection of biomaterials. Instrumentation for surgical implantation procedures. Preclinical testing for safety and efficacy: risk/benefit ratio assessment. Evaluation of clinical performance: design of clinical trials. Project materials drawn from orthopedic devices, soft tissue implants, artificial organs, and dental implants.

Spring 2025

This design course teaches a systematic approach for development of an implantable or injectable medical device to treat a specific and well-defined clinical problem, criteria for preparing applications to the US Food and Drug Administration for approval to conduct clinical trials, and the steps to start a company to make it available to the patient. Students work in teams to develop the design for an FDA Class III medical device or combination product (incorporating drugs and/or biologics). The emphasis is on the science and engineering underlying the design of novel treatments for problems in any one of the 78 organs of the body.

Spring 2006

This design course targets the solution of clinical problems by use of implants and other medical devices. Topics include the systematic use of cell-matrix control volumes; the role of stress analysis in the design process; anatomic fit, shape and size of implants; selection of biomaterials; instrumentation for surgical implantation procedures; preclinical testing for safety and efficacy, including risk/benefit ratio assessment evaluation of clinical performance and design of clinical trials. Student project materials are drawn from orthopedic devices, soft tissue implants, artificial organs, and dental implants.

Readings

  • A textbook for the course, known as TORA, is:
    Listed reading
  • Yannas, I. V. Tissue and Organ Regeneration in Adults . New York, NY: Springer, 2001. ISBN: 9780387952147.
    Listed reading
  • This page presents various outlines, notes, textbook selections, and journal articles assigned for some class sessions.
    Listed reading
  • TORA = Yannas, I. V. Tissue and Organ Regeneration in Adults . New York, NY: Springer-Verlag, 2001. ISBN: 9780387952147.
    Listed reading
  • Chapter 1 Outline ( PDF ) ↗
    Listed reading
  • TORA. Chapter 1.
    Listed reading
  • LEC #: 2 · TOPICS: Principles of Implant Design / Design Parameters: Permanent versus Absorbable Devices · READINGS: Chapter 2 Outline ( PDF ) ↗
    Reading assignment
  • LEC #: 3 · TOPICS: The Missing Organ and its Replacement · READINGS: TORA. Chapter 1.
    Reading assignment
  • LEC #: 4 · TOPICS: Criteria for Materials Selection · READINGS: TORA. Chapter 1.
    Reading assignment
  • LEC #: 5 · TOPICS: Tissue Engineering I: Scaffolds · READINGS: Langer, Robert, and Joseph P. Vacanti. “Tissue Engineering.” Science, New Series 260, no. 5110 (May 14, 1993): 920-926.
    Reading assignment
  • TORA. Chapters 6, 7, and 10.
    Listed reading
  • 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.
    Listed reading
  • LEC #: 11 · TOPICS: Degradation of Devices: Natural and Synthetic Polymers · READINGS: Spector, Myron. “Biomaterials.” Chapter 19 in Plastic Surgery . Vol. 1. Edited by B. M. Achauer, et al. Mosby: St. Louis, 2000. ISBN: 9780815110194.
    Reading assignment
  • LEC #: 12 · TOPICS: Biocompatibility: Scar Formation and Contraction · READINGS: TORA. Chapters 1, 2, and 4.
    Reading assignment
  • LEC #: 16 · TOPICS: Federal Regulation of Devices II · READINGS: What is CE Marking? ↗
    Reading assignment
  • Mitchell, L. Shannon, and Laura E. Niklason. “Requirements for Growing Tissue-Engineered Vascular Grafts.” Cardiovascular Pathology 12 (2003): 59-64.
    Listed reading
  • 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.
    Listed reading
  • 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.
    Listed reading
  • Rabkin, Elena, and Frederick J. Schoen. “Cardiovascular Tissue Engineering.” Cardiovascular Pathology II (2002): 305-317.
    Listed reading
  • LEC #: 21 · TOPICS: Devices for Nerve Regeneration · READINGS: TORA. Chapter 6.
    Reading assignment

Prerequisites & course information

Same subject as HST.524[J] Prereq: ( Biology (GIR) , Chemistry (GIR) , and Physics I (GIR) ) or permission of instructor G (Spring) 3-0-9 units

Sources