Clinical Evaluation of Medical Devices (eBook, PDF)

Principles and Case Studies
Redaktion: Becker, Karen M.; Whyte, John J.

• Format: PDF

Produktbeschreibung

Highly praised in its first edition, Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition has been expanded and updated to include the many innovations and clinical research methods that have developed since the first edition, as well as current information on the regulatory, legal, and reimbursement environment for medical devices. The book's deeply experienced authors summarize the key principles and approaches employed in medical device clinical trials and illustrate their uses in a revealing series of detailed, real-world case studies. Highlights include new information on the requirements and process for gaining reimbursement from Medicare and private insurers on new products-including case studies of research specifically designed for this purpose-and new statistical methods applied to medical device trials. Additional case studies provide examples of combination products, three-phase development models (i.e., feasibility, FDA approval, and Medicare reimbursement), and novel study designs. The cases demonstrate a wide range of designs that have been successfully applied to many different research problems, as well as to a variety of therapeutic or diagnostic products. Authoritative and highly practical, Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition, provides a gold-standard resource for clinical professionals and regulatory specialists working at the forefront of new therapeutics, diagnostics, and medical device development and marketing today.

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Produktdetails

• Verlag: Humana Press
• Seitenzahl: 360
• Erscheinungstermin: 5. November 2007
• Englisch
• ISBN-13: 9781597450041
• Artikelnr.: 37339344

Inhaltsangabe

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.

Rezensionen

"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