Karen M. Becker & John J. Whyte 
Clinical Evaluation of Medical Devices 
Principles and Case Studies

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.

Table of Content

Fundamentals of Clinical Study Design and Evaluation.- Clinical Trials in Development and Marketing of Medical Devices.- Regulatory Requirements for Clinical Studies of Medical Devices and Diagnostics.- Requirements for Medicare Coverage and Reimbursement for Medical Devices.- Postmarket Requirements for Significant Risk Devices.- Applications of Bayesian Methods to Medical Device Trials.- Intellectual Property Protection for Medical Devices.- HIPAA Compliance in Clinical Research.- Overview of Medicare Coverage of Clinical Trials.- Developing Drug-Device Combination Products With Unapproved Components.- Wall Street’s Perspective on Medical Device Evaluation.- Case Studies.- Challenges in Conducting Implantable Device Trials.- BELIEF.- Clinical Trials of an Anti-Adhesion Adjuvant.- Use of Multiple Imputation Models in Medical Device Trials.- Case Studies on the Local Coverage Process.- Reimbursement Analysis.- Polyurethane Pacemaker Leads.- Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves.- The Use of Surrogate Outcome Measures.