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Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher : Unknown
Page : 124 pages
File Size : 40,8 Mb
Release : 2012
Category : Business & Economics
ISBN : MINN:31951D03556747Q
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 141 pages
File Size : 47,7 Mb
Release : 2010-10-04
Category : Medical
ISBN : 9780309162906
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.
Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Page : 225 pages
File Size : 55,6 Mb
Release : 1991-02-01
Category : Medical
ISBN : 9780309044912
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.
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher : Unknown
Page : 216 pages
File Size : 46,8 Mb
Release : 2011
Category : Medical
ISBN : MINN:31951D03457388U
Author : United States. Congress. House. Committee on Energy and Commerce
Publisher : Unknown
Page : 168 pages
File Size : 45,9 Mb
Release : 2011
Category : Energy policy
ISBN : STANFORD:36105050598072
Author : Institute of Medicine,Board on Health Sciences Policy,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
Publisher : National Academies Press
Page : 112 pages
File Size : 51,9 Mb
Release : 2001-10-31
Category : Medical
ISBN : 9780309183208
The objective of the workshop that is the subject of this summary report was to present the challenges and opportunities for medical devices as perceived by the key stakeholders in the field. The agenda, and hence the summaries of the presentations that were made in the workshop and which are presented in this summary report, was organized to first examine the nature of innovation in the field and the social and economic infrastructure that supports such innovation. The next objective was to identify and discuss the greatest unmet clinical needs, with a futuristic view of technologies that might meet those needs. And finally, consideration was given to the barriers to the application of new technologies to meet clinical needs.
Author : I. Glenn Cohen,Timo Minssen,W. Nicholson Price II,Christopher Robertson,Carmel Shachar
Publisher : Cambridge University Press
Page : 295 pages
File Size : 41,5 Mb
Release : 2022-04-07
Category : Law
ISBN : 9781108838634
A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Page : 241 pages
File Size : 52,7 Mb
Release : 1990-02-01
Category : Medical
ISBN : 9780309042864
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.
Author : Annetine C. Gelijns
Publisher : National Academies
Page : 78 pages
File Size : 50,7 Mb
Release : 1989
Category : Clinical medicine
ISBN : NAP:13516
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 318 pages
File Size : 45,9 Mb
Release : 2011-10-25
Category : Medical
ISBN : 9780309212458
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.
Author : World Intellectual Property Organization
Publisher : WIPO
Page : 259 pages
File Size : 45,7 Mb
Release : 2013
Category : Law
ISBN : 9789280523089
This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Author : Institute of Medicine,National Academy of Engineering
Publisher : National Academies Press
Page : 203 pages
File Size : 49,9 Mb
Release : 1988-01-01
Category : Medical
ISBN : 9780309038478
In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.
Author : H. Tristram Engelhardt
Publisher : M & M Scrivener Press
Page : 253 pages
File Size : 42,5 Mb
Release : 2014-05-14
Category : Business & Economics
ISBN : 9780980209471
Innovation and the Pharmaceutical Industry: Critical Reflections on the Virtues of Profit examines the central role of profit in the development of pharmaceuticals, medical devices, and health care generally. Recent efforts to understand this role have often underestimated and even dismissed its importance, arguing for its replacement by other means and mechanisms. However, as the essays in this volume attest, it would be impossible to account adequately for the range of pharmaceuticals and medical devices that have become part of everyday medicine without recognizing that the depth and scope of innovations are tied not simply to altruism, a concern for the common good, or the pursuit of knowledge for its own sake, but crucially to the pursuit of private good and of individual profit. Balancing a concern for theory and practice, the analyses and evaluations provided in these essays touch directly on many of the most heated and important debates in pharmaceutical ethics, such as profit margins, corporate social responsibility, drug advertising, litigation, patents, and parallel trade. Reflecting critically on the problems and prospects of medical innovation, they invite a rethinking of the foundations of the bioethics and business ethics of the pharmaceutical and medical device industries by focusing on the long-term impact of policy decisions for human health and well-being.
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 140 pages
File Size : 40,8 Mb
Release : 2010-11-04
Category : Medical
ISBN : 9780309158497
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.
Author : National Research Council,Institute of Medicine,Board on Health Care Services,Policy and Global Affairs,Board on Science, Technology, and Economic Policy
Publisher : National Academies Press
Page : 92 pages
File Size : 48,8 Mb
Release : 2002-05-06
Category : Medical
ISBN : 9780309183017
A wave of new health care innovation and growing demand for health care, coupled with uncertain productivity improvements, could severely challenge efforts to control future health care costs. A committee of the National Research Council and the Institute of Medicine organized a conference to examine key health care trends and their impact on medical innovation. The conference addressed the following question: In an environment of renewed concern about rising health care costs, where can public policy stimulate or remove disincentives to the development, adoption and diffusion of high-value innovation in diagnostics, therapeutics, and devices?