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Clinical Evaluation of Medical Devices

Principles and Case Studies

  • Book
  • © 2006
  • Latest edition

Overview

Editors:
  1. Karen M. Becker

    1. Becker & Associates Consulting Inc., Washington, DC

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

  2. John J. Whyte

    1. Discovery Health Channel, Silver Spring

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

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Table of contents (19 chapters)

  1. Front Matter

    Pages i-x
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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 M. Becker
      Pages 3-19

    3. Regulatory Requirements for Clinical Studies of Medical Devices and Diagnostics

      • Daniel A. Kracov, Lisa M. Dwyer
      Pages 21-58

    4. Requirements for Medicare Coverage and Reimbursement for Medical Devices

      • Esther R. Scherb, Stuart S. Kurlander
      Pages 59-80

    5. Postmarket Requirements for Significant Risk Devices

      • Suzan Onel
      Pages 81-97

    6. Applications of Bayesian Methods to Medical Device Trials

      • Telba Z. Irony, Richard Simon
      Pages 99-116

    7. Intellectual Property Protection for Medical Devices

      • Fariborz Moazzam, Michael D. Bednarek
      Pages 117-139

    8. HIPAA Compliance in Clinical Research

      • Peter M. Kazon, Sharon D. Brooks
      Pages 141-152

    9. Overview of Medicare Coverage of Clinical Trials

      • Julie K. Taitsman
      Pages 153-159

    10. Developing Drug-Device Combination Products With Unapproved Components

      • Guy Chamberland
      Pages 161-185

    11. Wall Street’s Perspective on Medical Device Evaluation

      • Adam K. Galeon
      Pages 187-196

  3. Case Studies

    1. Front Matter

      Pages 197-197
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    2. Challenges in Conducting Implantable Device Trials

      • Ursula Maria Schmidt-Ott, Alan J. Moskowitz, Annetine C. Gelijns, Julie C. Choe, Michael Parides, Deborah V. Davis Ascheim
      Pages 199-215

    3. BELIEF

      • Jan Erik Nordrehaug, Janet M. Fauls
      Pages 217-232

    4. Clinical Trials of an Anti-Adhesion Adjuvant

      • Michael P. Diamond
      Pages 233-240

    5. Use of Multiple Imputation Models in Medical Device Trials

      • Donald B. Rubin, Samantha R. Cook
      Pages 241-251

    6. Case Studies on the Local Coverage Process

      • Mitchell I. Burken
      Pages 253-267

    7. Reimbursement Analysis

      • Robin Bostic
      Pages 269-283

    8. Polyurethane Pacemaker Leads

      • Ken Stokes
      Pages 285-304
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Keywords

About this book

The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs.

Reviews

"Those preparing for or working on the development or clinical evaluation of a device will certainly find this book of value." -Respiratory Care

 

From Reviews of the First Edition...

"...provide[s] a wealth of useful information for those that are interested in conducting and evaluating clinical trials...highly recommended to the profession." -Biomaterials Forum

"...interesting and important reading for anybody who works in or with the medical device industry...to orthopedic surgeons in research or those who participate...in developing new devices. Several sections are of great value as an introduction and a supplement." -Acta Orthopaedica Scandinavica

"...useful as a supplement to courses on design of medical instrumentation, advanced design, biostatistics, and introductory physiology...will likely prove useful also as a reference text for practitioners in the field." -IEEE Engineering in Medicine and Biology

"...definitely fills a need for a description of principles and approaches to the clinical trials of medical devices... the book is valuable and highly recommended." -IFMBE News

"...useful as a reference book for those involved in the development of clinical trials..." - Annals of the Royal College of Surgeons of England

Editors and Affiliations

  • Becker & Associates Consulting Inc., Washington, DC

    Karen M. Becker

  • Discovery Health Channel, Silver Spring

    John J. Whyte

Bibliographic Information

  • Book Title: Clinical Evaluation of Medical Devices

  • Book Subtitle: Principles and Case Studies

  • Editors: Karen M. Becker, John J. Whyte

  • DOI: https://doi.org/10.1007/978-1-59745-004-1

  • Publisher: Humana Totowa, NJ

  • eBook Packages: Chemistry and Materials Science, Chemistry and Material Science (R0)

  • Copyright Information: Humana Press 2006

  • Hardcover ISBN: 978-1-58829-422-7Published: 15 December 2005

  • Softcover ISBN: 978-1-61737-558-3Published: 05 November 2010

  • eBook ISBN: 978-1-59745-004-1Published: 05 November 2007

  • Edition Number: 2

  • Number of Pages: 360

  • Number of Illustrations: 53 b/w illustrations

  • Topics: Biomaterials

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