Clinical Evaluation of Medical Devices

1. Front Matter

   Pages i-x

   PDF

2. Fundamentals of Clinical Study Design and Evaluation

   1. Front Matter

      Pages 1-1

      PDF

   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

      PDF

   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

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.

• Monitor
• Polyurethan
• biodegradation
• diagnostics
• medical devices
• technology assessment

"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

• Becker & Associates Consulting Inc., Washington, DC

  Karen M. Becker

• Discovery Health Channel, Silver Spring

  John J. Whyte

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