Health Care Reform Regulation And Innovation In The Medical Device Industry
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Health Care Reform Regulation And Innovation In The Medical Device Industry
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Author : Thomas James Duesterberg
language : en
Publisher: Hudson Inst
Release Date : 1994-01
Health Care Reform Regulation And Innovation In The Medical Device Industry written by Thomas James Duesterberg and has been published by Hudson Inst this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994-01 with Competition categories.
Left on the sidelines as stepchild of the health care debate has been America's enormous success in inventing and producing innovative medical technology that has saved lives and improved the quality of care for millions of people in the United States and around the world. By overemphasizing what's wrong with the current health care system, the White House and Congress threaten to harm what's right with it--our world-leading talent for inventing and constantly improving medical techniques and treatments.The results of this comprehensive report undertaken by the Competitiveness Center of Hudson Institute illustrate the threat posed to this industry's heath--and to our health--by unwise reforms that would increase government control of the U.S. health care system. This book details the successes of, and challenges facing, innovative and effective American industry, underscoring the predicament it would face under various reform scenarios, particularly those featuring a uniform benefits package, price controls, and new burdens on the acquisitions of equipment.
A Comparative Analysis Of Medical Device Regulations In The Eu And The Usa
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Author : Ann-Marie Jahn
language : en
Publisher: GRIN Verlag
Release Date : 2016-01-12
A Comparative Analysis Of Medical Device Regulations In The Eu And The Usa written by Ann-Marie Jahn and has been published by GRIN Verlag this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-01-12 with Business & Economics categories.
Bachelor Thesis from the year 2012 in the subject Economy - Health Economics, grade: First, Berlin School of Economics and Law, language: English, abstract: Innovations in the medical device industry have improved the health of the world population with the ability to better diagnose, prevent, predict and cure illnesses. The number of medical devices on the market is increasing exponentially, together with the complexity, diversity and technical variation of such products. In light of its impact on patient health, regulation of medical devices is necessary to ensure that safe and effective products enter the marketplace, and that the product’s benefit to the patient population outweighs its potential risks. Although there has been increasing public scrutiny of health care reform, medical devices and their global regulation has been a minor field of health economic studies. This study examines the medical device regulatory systems and its impact on health care economics, exemplarily on the legislative programs of two major markets - the United States (U.S.) and European Union (EU). Modern medical device technology dates its origin to the early 19th century, but has grown most significantly in the last 50 years (Banta, p. 15). Today, 10,000 different families of medical device types exist with more than 400,000 different individual products on the market (Eucomed 2011). Outstanding developments have included heart-lung machines, artificial joints, as well as radiographic imaging and the means to perform advanced brain surgery. The medical device technology sector is extremely innovative, with seven out of ten major medical innovations in the last 40 years coming from this field (Fuchs, Sox, JR. 2001). Despite these technological advances, medical devices sometimes fail during use and can actually result in patient harm. The purpose of regulating medical equipment is to minimize the risk of harm to the end user and to prevent potentially unsafe products from entering the marketplace. The main obstacle in developing and implementing effective regulation is the term safety itself, as it can hardly be measured and there is no formula that can be consistently applied. Guidelines have been established that measure product risk, mitigate risks where possible, and then evaluate the residual risks to determine which are acceptable. This means by implication that acceptance of risk is part of the regulation process in order to bring life-saving technologies with unknown long-term effects to the market.
The Changing Economics Of Medical Technology
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 1991-02-01
The Changing Economics Of Medical Technology written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1991-02-01 with Medical categories.
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.
Buying Medical Technology In The Dark
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Author : United States. Congress. House. Committee on Small Business. Subcommittee on Regulation, Business Opportunities, and Technology
language : en
Publisher:
Release Date : 1994
Buying Medical Technology In The Dark written by United States. Congress. House. Committee on Small Business. Subcommittee on Regulation, Business Opportunities, and Technology and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994 with Medical categories.
New Medical Devices
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 1988-02-01
New Medical Devices written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1988-02-01 with Medical categories.
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.
Innovation And Protection
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Author : I. Glenn Cohen
language : en
Publisher: Cambridge University Press
Release Date : 2022-04-07
Innovation And Protection written by I. Glenn Cohen and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-04-07 with Law categories.
A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Medical Technology In Japan
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Author : Christa Altenstetter
language : en
Publisher: Routledge
Release Date : 2017-09-08
Medical Technology In Japan written by Christa Altenstetter and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-08 with Medical categories.
Japan is suffering from a "device gap." Compared to its American and European counterparts, Japan lags in adopting innovative medical devices and making new treatments and procedures available to its patients. Many blame its government and bureaucracy for Japan's delayed access to modern medicine and new medical devices. Christa Altenstetter examines the contextual social, historical, and political conditions of Japan's medical field to make sense of the state of the country's medical profession and its regulatory framework. She explores the development of regulatory frameworks and considers possibilities for eventual reform and modernization. More specifically, Altenstetter looks into how physicians and device companies connect to the government and bureaucracy, the relationships connecting Japanese patients to their medical system and governmental bureaucracy, and how the relationships between policymakers and the medical profession are changing. The issues addressed here are becoming increasingly relevant as numerous countries in Asia, Latin America, and Central and Eastern Europe are only now beginning to regulate medical technology, following the lead of the US and the European Union. Those interested in global medicine and Asian studies will find this book both informative and compelling.
Managing Medical Devices Within A Regulatory Framework
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Author : Beth Ann Fiedler
language : en
Publisher: Elsevier
Release Date : 2016-09-10
Managing Medical Devices Within A Regulatory Framework written by Beth Ann Fiedler and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-09-10 with Law categories.
Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle. This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements. Covers compliance with FDA and CE regulations, plus EU directives for service and maintenance of medical devices Provides operational and clinical practice recommendations in regard to regulatory changes for risk management Discusses best practices for equipment procurement and maintenance Provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices
Regulating Health Care Markets
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Author : Parker Rogers
language : en
Publisher:
Release Date : 2023
Regulating Health Care Markets written by Parker Rogers and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023 with categories.
Chapter One examines how FDA regulation affects innovation and market concentration. I examine this question by exploiting FDA deregulation events that affected certain medical device types but not others. I collect comprehensive data on medical device innovation, device safety, firm entry, prices, and regulatory changes and enhance these data using text analysis methods. My analysis of these data reveals three key findings. First, deregulation events significantly increased the quantity and quality of new technologies in affected medical device types relative to controls. These increases are particularly strong among small and inexperienced firms. Second, these events increased firm entry and reduced prices for medical procedures that utilize affected medical device types. Finally, rates of serious injuries and deaths attributable to defective devices did not significantly increase following these events. Interestingly, deregulating certain device types was associated with reduced adverse event rates, possibly due to firms increasing their emphasis on product safety in response to increased litigation risk. In Chapter Two, we analyze wartime prosthetic device patents to investigate how demand shocks and procurement environments can shape medical innovation. We use machine learning tools to develop new data describing the aspects of medical and mechanical innovations that are emphasized in patent documents. Our analysis of historical patents yields three primary facts. First, we find that the U.S. Civil War and World War I led to substantial increases in the quantity of prosthetic device patenting relative to patenting in other medical and mechanical technology classes. Second, we find that the Civil War led inventors to increase their focus on reducing cost, while World War I did not. The Civil War era emphasis on cost is consistent with a role for that period's cost-conscious procurement model. Third, we find that inventors emphasized dimensions of product quality (e.g., a prosthetic limb's comfort or facilitation of employment) that aligned with differences in buyers' preferences across wars. We conclude that procurement environments can significantly shape the dimensions of the technical frontier with which inventors engage. In Chapter Three, we study how government price reforms affect innovation, market structure, and product quality within the health care sector. We exploit a Medicare payment reform that reduced expenditures on certain types of durable medical equipment (DME) by 66% while leaving other types unaffected. We find that manufacturers filed 29% fewer patents and introduced 22% fewer new models in DME types affected by the price reform relative to those that were unaffected. Additionally, patents filed after the price reform increasingly focused on "process" rather than "product" innovation, consistent with increased market demand for lower-cost products. The market structure was also affected, with 25% fewer manufacturers entering affected product markets and a 65% increase in outsourcing to foreign companies. The shift towards cost-cutting, both in patenting and supply chain restructuring, was associated with increased device repair rates among Medicare beneficiaries and reported adverse events. Firms that outsourced to foreign manufacturers experienced the highest increase in adverse events. While the Medicare price reform generated substantial savings, these gains were dampened by the adverse effects on innovation, market structure, and product quality in the long run. Our findings highlight the importance of considering long-run impacts when designing policy reforms.
Handbook Of Medical Device Regulatory Affairs In Asia
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Author : Jack Wong
language : en
Publisher: CRC Press
Release Date : 2013-03-27
Handbook Of Medical Device Regulatory Affairs In Asia written by Jack Wong and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-03-27 with Medical categories.
Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.