Clinical Evaluation of Medical Devices
Principles and Case Studies
(Sprache: Englisch)
Review of the Key Principles and Approaches to Medical Device Trials
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Produktinformationen zu „Clinical Evaluation of Medical Devices “
Review of the Key Principles and Approaches to Medical Device Trials
Klappentext zu „Clinical Evaluation of Medical Devices “
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.
Inhaltsverzeichnis zu „Clinical Evaluation of Medical Devices “
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.
Bibliographische Angaben
- 2010, 2nd Edition., 360 Seiten, Masse: 15,3 x 23 cm, Kartoniert (TB), Englisch
- Herausgegeben: Karen M. Becker, John J. Whyte
- Verlag: Springer, Berlin
- ISBN-10: 1617375586
- ISBN-13: 9781617375583
Sprache:
Englisch
Pressezitat
"Those preparing for or working on the development or clinical evaluation of a device will certainly find this book of value." -Respiratory Care From Reviews of the First Edition...
"...provide[s] a wealth of useful information for those that are interested in conducting and evaluating clinical trials...highly recommended to the profession." -Biomaterials Forum
"...interesting and important reading for anybody who works in or with the medical device industry...to orthopedic surgeons in research or those who participate...in developing new devices. Several sections are of great value as an introduction and a supplement." -Acta Orthopaedica Scandinavica
"...useful as a supplement to courses on design of medical instrumentation, advanced design, biostatistics, and introductory physiology...will likely prove useful also as a reference text for practitioners in the field." -IEEE Engineering in Medicine and Biology
"...definitely fills a need for a description of principles and approaches to the clinical trials of medical devices... the book is valuable and highly recommended." -IFMBE News
"...useful as a reference book for those involved in the development of clinical trials..." - Annals of the Royal College of Surgeons of England
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