Clinical Evaluation of Medical Devices: Principles and Case Studies

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Dezember 2005



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.


Part I. Fundamentals of Clinical Study Design and Evaluation

Clinical Trials in Development and Marketing of Medical Devices
Karen M. Becker

Regulatory Requirements for Clinical Studies of Medical Devices and Diagnostics
Daniel A. Kracov and Lisa M. Dwyer

Requirements for Medicare Coverage and Reimbursement for Medical Devices
Esther R. Scherb and Stuart S. Kurlander

Postmarket Requirements for Significant Risk Devices
Suzan Onel

Applications of Bayesian Methods to Medical Device Trials
Telba Z. Irony and Richard Simon

Intellectual Property Protection for Medical Devices
Fariborz Moazzam and Michael D. Bednarek

HIPAA Compliance in Clinical Research
Peter M. Kazon and Sharon D. Brooks

Overview of Medicare Coverage of Clinical Trials
Julie K. Taitsman

Developing Drug-Device Combination Products With Unapproved Components
Guy Chamberland

Wall Street's Perspective on Medical Device Evaluation: Innovation Investing
Adam K. Galeon

Part II. Case Studies

Challenges in Conducting Implantable Device Trials: Left Ventricular Assist Device in Destination Therapy
Ursula Maria Schmidt-Ott, Alan J. Moskowitz, Annetine C. Gelijns, Julie C. Choe, Michael Parides, and Deborah V. Davis Ascheim

BELIEF: A Randomized, Sham-Procedure- Controlled Trial of Percutaneous Myocardial Laser Therapy
Jan Erik Nordrehaug and Janet M. Fauls

Clinical Trials of an Anti-Adhesion Adjuvant
Michael P. Diamond

Use of Multiple Imputation Models in Medical Device Trials
Donald B. Rubin and Samantha R. Cook

Case Studies on the Local Coverage Process
Mitchell I. Burken

Reimbursement Analysis: From Concept to Coverage
Robin Bostic

Polyurethane Pacemaker Leads: The Contribution of Clinical Expertise to the Elucidation of Failure Modes andBiodegradation Mechanisms
Ken Stokes

Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves
Frederick J. Schoen

The Use of Surrogate Outcome Measures: A Case Study: Home Prothrombin Monitors
John J. Whyte



"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 orthopedic surgeons in research or those who 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
EAN: 9781588294227
ISBN: 1588294226
Untertitel: Principles and Case Studies. 2006. Auflage. Sprache: Englisch.
Erscheinungsdatum: Dezember 2005
Seitenanzahl: 360 Seiten
Format: gebunden
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