Download or read book New Medical Devices written by Institute of Medicine and published by National Academies Press. This book was released on 1988-02-01 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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:
Download or read book Innovation and Invention in Medical Devices written by Institute of Medicine and published by National Academies Press. This book was released on 2001-12-01 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book New Medical Devices written by K. B. Ekelman and published by . This book was released on 1988 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: As in other areas of technological advance, the benefits of new medical devices are not without cost and raise many issues for study. We know that certain medical devices, such as the computed tomographic scanner, have reduced the net cost of treating som diseases. But how are other new technologies related to the rising cost of health care, and how can we ensure the most cost-effective use of new equipment? How can we promote innovation in medical technologies when the trends in the judical application of tort law have made industries hesitant to develop products for which profits may be modest and liabilities severe? The symposium considered topics in three general areas, which make up the three major devisions of this volume. These topics are 1) innovation and use of new medical devices; 2) current trends in federal and private support of technological innovation, medical device regulation, product liability, and health care reimbursement; and 3) several perspectives on how these trends interact to influence the availability and appropriate use of new medical devices.
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.
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
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.
Download or read book Sources of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1995-01-01 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: Evidence suggests that medical innovation is becoming increasingly dependent on interdisciplinary research and on the crossing of institutional boundaries. This volume focuses on the conditions governing the supply of new medical technologies and suggest that the boundaries between disciplines, institutions, and the private and public sectors have been redrawn and reshaped. Individual essays explore the nature, organization, and management of interdisciplinary R&D in medicine; the introduction into clinical practice of the laser, endoscopic innovations, cochlear implantation, cardiovascular imaging technologies, and synthetic insulin; the division of innovating labor in biotechnology; the government- industry-university interface; perspectives on industrial R&D management; and the growing intertwining of the public and proprietary in medical technology.
Download or read book New Medical Devices written by Karen B. Ekelman and published by . This book was released on 1988 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biodesign written by Stefanos Zenios and published by Cambridge University Press. This book was released on 2010 with total page 779 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. Outlining a systematic, proven approach for innovation - identify, invent, implement - and integrating medical, engineering, and business challenges with real-world case studies, this book provides a practical guide for students and professionals.
Download or read book Promoting Access to Medical Technologies and Innovation Intersections between Public Health Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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.
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
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Download or read book Innovation and Invention in Medical Devices written by Institute of Medicine and published by National Academies Press. This book was released on 2001-10-31 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book New Medical Devices Invention Development and Use written by Karen B. Ekelman and published by Theclassics.Us. This book was released on 2013-09 with total page 76 pages. Available in PDF, EPUB and Kindle. Book excerpt: This historic book may have numerous typos and missing text. Purchasers can usually download a free scanned copy of the original book (without typos) from the publisher. Not indexed. Not illustrated. 1988-01-01 edition. Excerpt: ...of Health Politics, Policy and Law 11:501-523. Galen, M. 1986. Birth control options limited by litigation. National Law Journal 9(October): l, 26. General Accounting Office. 1986. Medical Devices: Early Warning of Problems Is Hampered by Severe Underreporting. Washington, D.C.: General Accounting Office. Health Industry Manufacturers Association. 1985. Memorandum from Legal Task Force of Product Liability (on file with author). Kionka, E. J. 1977. Torts: Injuries to Persons and Property. St. Paul, Minn.: West Publishing Co. Lowrance, W. W. 1976. Of Acceptable Risk. Los Altos, Calif.: William Kaufmann, Inc. Mallor, J., and B. Roberts. 1980. Punitive damages: Toward a principled approach. Hastings Law Journal 31:641. Metzger, M. B. 1984. Corporate criminal liability for defective products: Policies, problems, and prospects. The Georgetown Law Journal 73:1-88. New York Times. Editorial. December 27, 1986. O'Connell, J. 1984. Alternatives to the tort system for personal injury. San Diego Law Review 23:17-35. Page, J. A. 1983. Generic product risks: The case against comment k and for strict tort liability. New York University Law Review 58:853-891. Peterson, M. A. 1987. Civil Juries in the 1980's. Santa Monica, Calif.: Rand Institute for Civil Justice. Pharmaceutical Manufacturers Association. 1986. Tort Reform File (documents on file with author). Prosser, W., and P. Keeton. 1984. Prosser and Keeton on Torts, 5th ed. St. Paul, Minn.: West Publishing Co. Raney, M. B. 1986. Medical-device defects. Trial (May):39-42. Rordamor, W. 1984. Doctor, lawyer, bionics chief. California Lawyer (December):45,101. Schwadel.F. 1985. Robins and plaintiffs face uncertain future: Chapter 11 filing postpones 5,100 Dalkon Shield cases. Wall Street Journal..
Download or read book Commercializing Successful Biomedical Technologies written by Shreefal S. Mehta and published by Cambridge University Press. This book was released on 2008-04-24 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: Successful product design and development requires the ability to take a concept and translate the technology into useful, patentable, commercial products. This book guides the reader through the practical aspects of the commercialization process of drug, diagnostic and device biomedical technology including market analysis, product development, intellectual property and regulatory constraints. Key issues are highlighted at each stage in the process, and case studies are used to provide practical examples. The book will provide a sound road map for those involved in the biotechnology industry to effectively plan the commercialization of profitable regulated medical products. It will also be suitable for a capstone design course in engineering and biotechnology, providing the student with the business acumen skills involved in product development.
