A Consumer's Perspective on Medical Devices

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Publisher :
ISBN 13 :
Total Pages : 96 pages
Book Rating : 4.0/5 (18 download)

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Book Synopsis A Consumer's Perspective on Medical Devices by : United States. Congress. House. Committee on Commerce. Subcommittee on Oversight and Investigations

Download or read book A Consumer's Perspective on Medical Devices written by United States. Congress. House. Committee on Commerce. Subcommittee on Oversight and Investigations and published by . This book was released on 1995 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Medical Device Regulatory Practices

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Publisher : CRC Press
ISBN 13 : 9814669113
Total Pages : 578 pages
Book Rating : 4.8/5 (146 download)

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Book Synopsis Medical Device Regulatory Practices by : Val Theisz

Download or read book Medical Device Regulatory Practices written by Val Theisz and published by CRC Press. This book was released on 2015-08-03 with total page 578 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv

The Role of Human Factors in Home Health Care

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Publisher : National Academies Press
ISBN 13 : 0309156297
Total Pages : 322 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Role of Human Factors in Home Health Care by : National Research Council

Download or read book The Role of Human Factors in Home Health Care written by National Research Council and published by National Academies Press. This book was released on 2010-11-14 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rapid growth of home health care has raised many unsolved issues and will have consequences that are far too broad for any one group to analyze in their entirety. Yet a major influence on the safety, quality, and effectiveness of home health care will be the set of issues encompassed by the field of human factors research-the discipline of applying what is known about human capabilities and limitations to the design of products, processes, systems, and work environments. To address these challenges, the National Research Council began a multidisciplinary study to examine a diverse range of behavioral and human factors issues resulting from the increasing migration of medical devices, technologies, and care practices into the home. Its goal is to lay the groundwork for a thorough integration of human factors research with the design and implementation of home health care devices, technologies, and practices. On October 1 and 2, 2009, a group of human factors and other experts met to consider a diverse range of behavioral and human factors issues associated with the increasing migration of medical devices, technologies, and care practices into the home. This book is a summary of that workshop, representing the culmination of the first phase of the study.

A Consumer's Perspective on Medical Devices

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Publisher :
ISBN 13 :
Total Pages : 88 pages
Book Rating : 4.0/5 ( download)

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Book Synopsis A Consumer's Perspective on Medical Devices by : United States. Congress. House. Committee on Commerce. Subcommittee on Oversight and Investigations

Download or read book A Consumer's Perspective on Medical Devices written by United States. Congress. House. Committee on Commerce. Subcommittee on Oversight and Investigations and published by . This book was released on 1995 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Technological Innovation

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Publisher : National Academies
ISBN 13 :
Total Pages : 78 pages
Book Rating : 4.1/5 (351 download)

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Book Synopsis Technological Innovation by : Annetine C. Gelijns

Download or read book Technological Innovation written by Annetine C. Gelijns and published by National Academies. This book was released on 1989 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Innovation and Protection

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Publisher : Cambridge University Press
ISBN 13 : 1108838634
Total Pages : 295 pages
Book Rating : 4.1/5 (88 download)

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Book Synopsis Innovation and Protection by : I. Glenn Cohen

Download or read book Innovation and Protection written by I. Glenn Cohen and published by Cambridge University Press. This book was released on 2022-04-07 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.

Medical Devices and the Public's Health

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Publisher : National Academies Press
ISBN 13 : 0309212456
Total Pages : 318 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine

Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

The Medical Device Industry

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Publisher : CRC Press
ISBN 13 : 9780824782689
Total Pages : 1020 pages
Book Rating : 4.7/5 (826 download)

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Book Synopsis The Medical Device Industry by : Norman F. Estrin

Download or read book The Medical Device Industry written by Norman F. Estrin and published by CRC Press. This book was released on 1990-08-31 with total page 1020 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

The Great American Rip-Off

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Publisher : Dog Ear Publishing
ISBN 13 : 1598585746
Total Pages : 170 pages
Book Rating : 4.5/5 (985 download)

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Book Synopsis The Great American Rip-Off by : Susan M. Finley

Download or read book The Great American Rip-Off written by Susan M. Finley and published by Dog Ear Publishing. This book was released on 2008 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book gives the reader a look at the complicated U.S. health care system through the eyes of a consumer. It explores two key questions: Why, with all of the resources that have been devoted to solving the health care crisis, does the situation continue to deteriorate? And, what, exactly, could be done differently this time to turn the situation around? The author examines obstacles that have stood in the way of health care reform in the past - including politics, government red tape, profit-driven providers, moneyed lobbyists and special interest groups and even, our own consumer "entitlement mentality" - and challenges the reader to envision a scenario in which innovation in health care might be possible. The author argues that consumers are the key to forward progress on health care: we'll only see consumer-driven solutions when enough people demand them. This book is a challenge to consumers to speak up and hold our leaders in the medical community, the government and corporate America accountable for developing solutions that work for us. Susan M. Finley is a small business owner and marketing strategist. She began her career as a bank product manager, and in 1994 co-founded Michaelson Kelbick Partners Inc. (MKP), a firm specializing in marketing and communications for the financial services industry. Over the course of a decade, the agency managed marketing communications for some of the largest bank mergers in recent history. In 2003, she left MKP (now renamed mkp communications, inc.). Her knowledge and understanding of the complicated U.S. health care financing system comes from a three-year research and consulting project, started in the hopes of serving as a catalyst for consumer-driven changes in health care. She lives in North Carolina, where she and her husband have recently founded Finley and Finley, LLC, to continue their research on potential avenues for innovation in the health care and financial services industries.

Bringing a Medical Device to the Market

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Publisher : CRC Press
ISBN 13 : 1000632180
Total Pages : 274 pages
Book Rating : 4.0/5 (6 download)

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Book Synopsis Bringing a Medical Device to the Market by : Gennadi Saiko

Download or read book Bringing a Medical Device to the Market written by Gennadi Saiko and published by CRC Press. This book was released on 2022-09-29 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many of us in science have this "Aha!" moment when the mental puzzle is put together and you get a clear picture of a product, which will change the world. Moreover, you have a clear understanding of how it can be a commercial success. So, you decide to start a new company, a startup, and have a clear path to success. However, soon you come face to face with reality, where things are much more complicated. Only a minute fraction of startups survives and becomes successful. This is particularly true in the complex world of medical devices. There are many good books on startups but this book is specifically about startups specializing in medical devices, which are very different from other ones. It is written by a MedDev entrepreneur for first-time MedTech entrepreneurs.

Public Health Effectiveness of the FDA 510(k) Clearance Process

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Publisher : National Academies Press
ISBN 13 : 0309162904
Total Pages : 141 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine

Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

The Changing Economics of Medical Technology

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Publisher : National Academies Press
ISBN 13 : 030904491X
Total Pages : 225 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis The Changing Economics of Medical Technology by : Institute of Medicine

Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Modern Methods of Clinical Investigation

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Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Modern Methods of Clinical Investigation by : Institute of Medicine

Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

E-health and Consumer Empowerment

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Publisher :
ISBN 13 :
Total Pages : 102 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis E-health and Consumer Empowerment by : United States. Congress. Senate. Committee on Commerce, Science, and Transportation. Subcommittee on Science, Technology, and Space

Download or read book E-health and Consumer Empowerment written by United States. Congress. Senate. Committee on Commerce, Science, and Transportation. Subcommittee on Science, Technology, and Space and published by . This book was released on 2004 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Medical Devices

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Publisher : World Health Organization
ISBN 13 : 9241564040
Total Pages : 147 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Medical Devices by : World Health Organization

Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9

Medical Devices

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Publisher : DIANE Publishing
ISBN 13 : 0788180991
Total Pages : 89 pages
Book Rating : 4.7/5 (881 download)

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Book Synopsis Medical Devices by : Michael Bilirakis

Download or read book Medical Devices written by Michael Bilirakis and published by DIANE Publishing. This book was released on 1999-07 with total page 89 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hearing on technological advances in the field of medical devices from the perspective of the Food & Drug Admin. (FDA), as well as from patients & providers. Witnesses: Michael Friedman, Bruce Burlington, & Susan Alpert, FDA; John F. Hansbrough, Dir. of the Regional Burn Center, UCSD Medical Center; C. Warren Olanow, Chairman, Dept. of Neurology, Mount Sinai Medical Center; Robert A. Schmidt, Dir. of Mammography, Univ. of Chicago Hospitals; Joseph M. Smith, Asst. Prof. of Medicine, Washington University School of Medicine; & Joy Vaas. Also includes prepared statement submitted by Nonprescription Drug Manufacturers Assoc .

Reauthorization of the Medical Device User Fee and Modernization Act

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Publisher :
ISBN 13 :
Total Pages : 160 pages
Book Rating : 4.0/5 ( download)

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Book Synopsis Reauthorization of the Medical Device User Fee and Modernization Act by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health

Download or read book Reauthorization of the Medical Device User Fee and Modernization Act written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2008 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: