Clinical Evaluation of Medical Devices
Principles and Case Studies
Samenvatting
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.
Specificaties
Inhoudsopgave
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