Clinical evaluation of medical devices

Front Matter....Pages i-x
Front Matter....Pages 1-1
Clinical Trials in Development and Marketing of Medical Devices....Pages 3-19
Regulatory Requirements for Clinical Studies of Medical Devices and Diagnostics....Pages 21-58
Requirements for Medicare Coverage and Reimbursement for Medical Devices....Pages 59-80
Postmarket Requirements for Significant Risk Devices....Pages 81-97
Applications of Bayesian Methods to Medical Device Trials....Pages 99-116
Intellectual Property Protection for Medical Devices....Pages 117-139
HIPAA Compliance in Clinical Research....Pages 141-152
Overview of Medicare Coverage of Clinical Trials....Pages 153-159
Developing Drug-Device Combination Products With Unapproved Components....Pages 161-185
Wall Street’s Perspective on Medical Device Evaluation....Pages 187-196
Front Matter....Pages 197-197
Challenges in Conducting Implantable Device Trials....Pages 199-215
BELIEF....Pages 217-232
Clinical Trials of an Anti-Adhesion Adjuvant....Pages 233-240
Use of Multiple Imputation Models in Medical Device Trials....Pages 241-251
Case Studies on the Local Coverage Process....Pages 253-267
Reimbursement Analysis....Pages 269-283
Polyurethane Pacemaker Leads....Pages 285-304
Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves....Pages 305-329
The Use of Surrogate Outcome Measures....Pages 331-335
Back Matter....Pages 337-346