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Practical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approach
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The Medical Device Industry : Science, Technology, and Regulation in a Competitive Environment
author
:
Estrin, Norman F.
publisher
:
CRC Press
isbn10 | asin
:
0824782682
print isbn13
:
9780824782689
ebook isbn13
:
9780585331881
language
:
English
subject
Medical instruments and apparatus industry--United States, Pharmaceutical industry--United States.
publication date
:
1990
lcc
:
HD9994.U52M42 1990eb
ddc
:
338.4/7681761/0973
subject
:
Medical instruments and apparatus industry--United States, Pharmaceutical industry--United States.
Page i
The Medical Device Industry
Science, Technology, and Regulation in a Competitive Environment
edited by Norman F. Estrin
Health Industry Manufacturers Association Washington, D.C.
Page ii
ISBN 0-8247-8268-2
This book is printed on acid-free paper.
Copyright 1990 by MARCEL DEKKER, INC. All Rights Reserved
Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming, and recording, or by any information storage and retrieval system, without permission in writing from the publisher.
MARCEL DEKKER, INC. 270 Madison Avenue, New York, New York 10016
Current printing (last digit):
10 9 8 7 6 5 4 3 2 1
PRINTED IN THE UNITED STATES OF AMERICA
Page iii
To my parents, my family (Mitzi, Laura, Melissa, Yale, and Lea), for their love
Page v
FOREWORD
The challenge of competing in today's fast-paced scientific, technical, regulatory, and economic environment is truly formidable. Medical device manufacturers and others involved in ensuring the availability of quality healthcare products must become experts in understanding the regulatory process. They must deliver products that are safe and effective and have instructions designed to help prevent product misuse. They must assure safety in the work place and minimize adverse effects on the environment. Today's manufacturers must address these issues not only on a domestic basis, but internationally as well.
The issues are multifaceted and complex and raise a number of questions: How will changing coverage and payment policies affect our marketing strategies? What will be the impact of regulatory harmonization in the European community? How will the dramatic changes in Eastern Europe and the Soviet Union affect our marketing strategies? Are we accessing the latest in technological advances by utilizing technology transfer mechanisms already in use by foregin competitors? Are we ready to make the most of changes in the domestic and international standards processes? Is our educational system adequate to keep us competitive?
This book, which brings together contributors from a wide variety of organizations and disciplines, attempts to answer these and other important questions and provides valuable insights on both the domestic and global aspects of medical device manufacture, regulation, and marketing.
ALAN H. MAGAZINE, PRESIDENT HEALTH INDUSTRY MANUFACTURERS ASSOCIATION WASHINGTON, D.C.
Page vii
PREFACE
We live in a world of rapid technological innovation. As the new decade unfolds, manufacturers of health-care products will be surrounded by a constellation of challenges and opportunities. Complex and fluctuating regulatory approaches by the Food and Drug Administration, evolving requirements for occupational safety and health, growing concern over pollution of the environment, changing health-coverage policies, and the advent of the global market will profoundly affect the competitiveness of the U.S. medical device industry.
This volume is designed to give manufacturers of medical devices and diagnostic products, government officials, attorneys, academicians, consultants, and students practical knowledge about biomedical technology, regulation, and their relationship to quality health care.
Organized for simplicity, the text examines four areas of major interest and influence. Parts two through five cover the regulatory environment, describing device regulation by the Food and Drug Administration. Parts six and seven cover occupational and environmental safety and health, introducing issues related to regulation by the Environmental Protection Agency and the Occupational, Safety and Health Administration. The reader will understand the legal and marketing implications of initiatives promulgated by the Health Care Financing Administration through reading the sections on coverage, payment, and marketing: staying competitive, parts eight through ten. International issues are discussed in parts eleven through fourteen and provide the tools needed for operating successfully in a global market.
For each of the four areas covered, we begin with a historical overview and legal framework to provide the reader with the perspective necessary to comprehend and evaluate subsequent information. The chapters that follow delineate the role of organizations that have impact on the regulatory environment and offer pragmatic advice from experienced professionals on industry practices. This "how to" approach to responding to regulatory initiatives
Page viii
will be especially helpful to companies developing their own programs and procedures.
Current and Emerging Issues concludes each of the four areas. Here, the reader gets a sense of the dynamic forces shaping the medical device industry. Issues will change. Some of those cited in this section will turn out to be minor perturbations, while others may have major regulatory and economic repercussions. A review of these issues will help the reader to identify and evaluate the significance of future issues.
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