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.

InhaltsangabePart 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 and Biodegradation 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

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