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Clinical Evaluation of Medical Devices

Principles and Case Studies

  • Book
  • © 1998

Overview

Editors:
  1. Karen Becker Witkin

    1. The Weinberg Group, Inc., USA

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Table of contents (12 chapters)

  1. Front Matter

    Pages i-xi
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  2. Fundamentals of Clinical Study Design and Evaluation

    1. Front Matter

      Pages 1-1
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    2. Clinical Trials in Development and Marketing of Medical Devices

      • Karen Becker Witkin
      Pages 3-21

    3. Observational Research

      • Rosanne B. McTyre, Linda M. Pottern
      Pages 23-40

    4. Choosing and Evaluating Outcome Measures for Clinical Studies of Medical Devices

      • Selma A. Kunitz, Michele Gargano, Rene Kozloff
      Pages 41-58

    5. Regulatory Requirements for Clinical Trials of Medical Devices and Diagnostics

      • Sharon A. Segal
      Pages 59-78

  3. Introduction to Case Studies

    1. Front Matter

      Pages 79-81
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    2. Clinical Studies of Prosthetic Heart Valves Using Historical Controls

      • Gary L. Grunkemeier
      Pages 83-102

    3. Prospective Multicenter Clinical Trials in Orthopedics

      • John D. Van Vleet
      Pages 103-132

    4. Long-Term Evaluation of Total Hip Arthroplasty

      • Frederick J. Dorey
      Pages 133-149

    5. Injectable Collagen and a Rare Adverse Event—True Association or Artifact?

      • Diane E. Mandell, Rosanne B. McTyre, Frank DeLustro, Ross Erickson
      Pages 151-164

    6. In Vitro Diagnostics

      • Wayne R. Patterson
      Pages 165-189

    7. A Controlled Study of Intra-Articular Hyalgan® in the Treatment of Osteoarthritis of the Knee

      • Roberto Fiorentini, Frank C. Dorsey, Sharon A. Segal, Roland Moskowitz
      Pages 191-207

    8. Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves

      • Frederick J. Schoen
      Pages 209-231

    9. Polyurethane Pacemaker Leads

      • Ken Stokes
      Pages 233-255

  4. Back Matter

    Pages 257-271
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Keywords

About this book

The world is changing rapidly, and nowhere is this more apparent than in medicine. The standards are rapidly rising in the field of medical device trials. A few years ago, device developers would look askance if one told them that medical device trials and drug trials should have the same stan­ dards. Today, such a statement does not seem as outrageous, although there is still a large gap in the design of trials and number oftrials conducted for medical device and drug development programs. More than 20 years after the enactment of the US Medical Device Amendments, we can see that they served as an impetus to raise clinical trial standards for devices. Whether the data to establish the safety and efficacy of a device come from one, two, or even more clinical trials is less important in evaluating the device than whether the data are medically and scientifically support­ ive of its safety and efficacy. Having at least two separate studies, and at least two sites confirm results, adds a great deal of scientific credibility and support to a conclusion of safety and efficacy, even though a confirmatory trial is not yet a regulatory requirement in most countries.

Editors and Affiliations

  • The Weinberg Group, Inc., USA

    Karen Becker Witkin

Bibliographic Information

  • Book Title: Clinical Evaluation of Medical Devices

  • Book Subtitle: Principles and Case Studies

  • Editors: Karen Becker Witkin

  • DOI: https://doi.org/10.1007/978-1-4757-2756-2

  • Publisher: Humana Totowa, NJ

  • eBook Packages: Springer Book Archive

  • Copyright Information: Springer Science+Business Media New York 1998

  • Softcover ISBN: 978-1-61737-040-3Published: 05 November 2010

  • eBook ISBN: 978-1-4757-2756-2Published: 09 March 2013

  • Edition Number: 1

  • Number of Pages: XI, 271

  • Number of Illustrations: 33 b/w illustrations

  • Topics: Biomaterials

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