Clinical Evaluation of Medical Devices: Principles and Case Studies

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Karen M. Becker, John J. Whyte
Springer Science & Business Media, Nov 5, 2007 - Technology & Engineering - 360 pages
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.

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Contents

Regulatory Requirements for Clinical Studies
21
Requirements for Medicare Coverage
59
Postmarket Requirements for Significant Risk Devices 81 Suzan Onel
99
Intellectual Property Protection for Medical Devices
117
HIPAA Compliance in Clinical Research 141 Peter M Kazon and Sharon D Brooks
153
Developing DrugDevice Combination Products
161
Wall Streets Perspective on Medical Device
187
Left Ventricular Assist Device
199
A Randomized ShamProcedure
217
Use of Multiple Imputation Models
251
Case Studies on the Local Coverage Process 253 Mitchell I Burken
269
Role of Device Retrieval and Analysis
305
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