×

Uh-oh, it looks like your Internet Explorer is out of date.

For a better shopping experience, please upgrade now.

Clinical Evaluation of Medical Devices: Principles and Case Studies / Edition 2
     

Clinical Evaluation of Medical Devices: Principles and Case Studies / Edition 2

by Karen M. Becker, John J. Whyte
 

See All Formats & Editions

ISBN-10: 1617375586

ISBN-13: 9781617375583

Pub. Date: 11/05/2010

Publisher: Springer-Verlag New York, LLC

This expanded and updated edition includes the many innovations and clinical research methods that have developed since the first edition, as well as current information on the regulatory, legal, and reimbursement environment for medical devices. The authors summarize the key principles and approaches employed in medical device clinical trials and illustrate their

Overview

This expanded and updated edition includes the many innovations and clinical research methods that have developed since the first edition, as well as current information on the regulatory, legal, and reimbursement environment for medical devices. The authors summarize the key principles and approaches employed in medical device clinical trials and illustrate their uses in a revealing series of detailed, real-world case studies. Highlights include new information on the requirements and process for gaining reimbursement from Medicare and private insurers on new products -including new case studies of research specifically designed for this purpose-and new statistical methods applied to medical device trials. Additional case studies provide examples of combination products, three-phase development models (i.e., feasibility, FDA approval, and Medicare reimbursement), and novel study designs. The cases demonstrate a wide range of designs that have been successfully applied to many different research problems, as well as to a variety of therapeutic or diagnostic products.

Product Details

ISBN-13:
9781617375583
Publisher:
Springer-Verlag New York, LLC
Publication date:
11/05/2010
Edition description:
Softcover reprint of hardcover 2nd ed. 2006
Pages:
360
Product dimensions:
5.90(w) x 9.00(h) x 1.00(d)

Table of Contents

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

Index

Customer Reviews

Average Review:

Post to your social network

     

Most Helpful Customer Reviews

See all customer reviews