Author: Mark C. West
Publisher: CRC Press
ISBN: 1000848000
Category : Business & Economics
Languages : en
Pages : 120
Book Description
The United States spends more than 17% of its GDP on healthcare, while other developed countries average 8.7% of GDP on healthcare expenditures. All this spending doesn’t equate to value, quality, or performance, however. Among 11 high-income countries, the United States healthcare industry ranked last during the past seven years in four key performance categories: administrative efficiency, access to care, equity, and healthcare outcomes. This book presents the implantable medical device (IMD) supply chain ecosystem as a microcosm of how these challenges of affordability and healthcare outcomes are created and are allowed to fester. The IMD Spiderweb, as the authors call it, is exposed as an example of how a wide range of participants—including physicians, health system CEOs, group purchasing organizations, health insurance companies, and supply chain executives—become ensnared in a web designed to benefit only one player. Health systems in the United States pay as much as six times more for some IMDs than their counterparts do in Europe, and prices for the same IMD model vary even among different U.S. hospitals. While there is a fascination with the latest and greatest device, there is also a shroud around visibility into how these products have performed and are likely to perform in patients. The costs continue to rise not only in healthcare expenditures, but also in death and disability. The IMD Spiderweb is presented as a prime lesson in the challenges in healthcare affordability and outcomes that occur throughout the entire healthcare industry. It is also put forward as an opportunity. The story behind how these challenges arose and continue to be deepened by the current healthcare ecosystem also provides a foundation for solutions.
Implantable Medical Devices and Healthcare Affordability
Author: Mark C. West
Publisher: CRC Press
ISBN: 1000848000
Category : Business & Economics
Languages : en
Pages : 120
Book Description
The United States spends more than 17% of its GDP on healthcare, while other developed countries average 8.7% of GDP on healthcare expenditures. All this spending doesn’t equate to value, quality, or performance, however. Among 11 high-income countries, the United States healthcare industry ranked last during the past seven years in four key performance categories: administrative efficiency, access to care, equity, and healthcare outcomes. This book presents the implantable medical device (IMD) supply chain ecosystem as a microcosm of how these challenges of affordability and healthcare outcomes are created and are allowed to fester. The IMD Spiderweb, as the authors call it, is exposed as an example of how a wide range of participants—including physicians, health system CEOs, group purchasing organizations, health insurance companies, and supply chain executives—become ensnared in a web designed to benefit only one player. Health systems in the United States pay as much as six times more for some IMDs than their counterparts do in Europe, and prices for the same IMD model vary even among different U.S. hospitals. While there is a fascination with the latest and greatest device, there is also a shroud around visibility into how these products have performed and are likely to perform in patients. The costs continue to rise not only in healthcare expenditures, but also in death and disability. The IMD Spiderweb is presented as a prime lesson in the challenges in healthcare affordability and outcomes that occur throughout the entire healthcare industry. It is also put forward as an opportunity. The story behind how these challenges arose and continue to be deepened by the current healthcare ecosystem also provides a foundation for solutions.
Publisher: CRC Press
ISBN: 1000848000
Category : Business & Economics
Languages : en
Pages : 120
Book Description
The United States spends more than 17% of its GDP on healthcare, while other developed countries average 8.7% of GDP on healthcare expenditures. All this spending doesn’t equate to value, quality, or performance, however. Among 11 high-income countries, the United States healthcare industry ranked last during the past seven years in four key performance categories: administrative efficiency, access to care, equity, and healthcare outcomes. This book presents the implantable medical device (IMD) supply chain ecosystem as a microcosm of how these challenges of affordability and healthcare outcomes are created and are allowed to fester. The IMD Spiderweb, as the authors call it, is exposed as an example of how a wide range of participants—including physicians, health system CEOs, group purchasing organizations, health insurance companies, and supply chain executives—become ensnared in a web designed to benefit only one player. Health systems in the United States pay as much as six times more for some IMDs than their counterparts do in Europe, and prices for the same IMD model vary even among different U.S. hospitals. While there is a fascination with the latest and greatest device, there is also a shroud around visibility into how these products have performed and are likely to perform in patients. The costs continue to rise not only in healthcare expenditures, but also in death and disability. The IMD Spiderweb is presented as a prime lesson in the challenges in healthcare affordability and outcomes that occur throughout the entire healthcare industry. It is also put forward as an opportunity. The story behind how these challenges arose and continue to be deepened by the current healthcare ecosystem also provides a foundation for solutions.
Medical Devices
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241564040
Category : Medical
Languages : en
Pages : 147
Book Description
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
Publisher: World Health Organization
ISBN: 9241564040
Category : Medical
Languages : en
Pages : 147
Book Description
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
Hearing Health Care for Adults
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309439264
Category : Medical
Languages : en
Pages : 325
Book Description
The loss of hearing - be it gradual or acute, mild or severe, present since birth or acquired in older age - can have significant effects on one's communication abilities, quality of life, social participation, and health. Despite this, many people with hearing loss do not seek or receive hearing health care. The reasons are numerous, complex, and often interconnected. For some, hearing health care is not affordable. For others, the appropriate services are difficult to access, or individuals do not know how or where to access them. Others may not want to deal with the stigma that they and society may associate with needing hearing health care and obtaining that care. Still others do not recognize they need hearing health care, as hearing loss is an invisible health condition that often worsens gradually over time. In the United States, an estimated 30 million individuals (12.7 percent of Americans ages 12 years or older) have hearing loss. Globally, hearing loss has been identified as the fifth leading cause of years lived with disability. Successful hearing health care enables individuals with hearing loss to have the freedom to communicate in their environments in ways that are culturally appropriate and that preserve their dignity and function. Hearing Health Care for Adults focuses on improving the accessibility and affordability of hearing health care for adults of all ages. This study examines the hearing health care system, with a focus on non-surgical technologies and services, and offers recommendations for improving access to, the affordability of, and the quality of hearing health care for adults of all ages.
Publisher: National Academies Press
ISBN: 0309439264
Category : Medical
Languages : en
Pages : 325
Book Description
The loss of hearing - be it gradual or acute, mild or severe, present since birth or acquired in older age - can have significant effects on one's communication abilities, quality of life, social participation, and health. Despite this, many people with hearing loss do not seek or receive hearing health care. The reasons are numerous, complex, and often interconnected. For some, hearing health care is not affordable. For others, the appropriate services are difficult to access, or individuals do not know how or where to access them. Others may not want to deal with the stigma that they and society may associate with needing hearing health care and obtaining that care. Still others do not recognize they need hearing health care, as hearing loss is an invisible health condition that often worsens gradually over time. In the United States, an estimated 30 million individuals (12.7 percent of Americans ages 12 years or older) have hearing loss. Globally, hearing loss has been identified as the fifth leading cause of years lived with disability. Successful hearing health care enables individuals with hearing loss to have the freedom to communicate in their environments in ways that are culturally appropriate and that preserve their dignity and function. Hearing Health Care for Adults focuses on improving the accessibility and affordability of hearing health care for adults of all ages. This study examines the hearing health care system, with a focus on non-surgical technologies and services, and offers recommendations for improving access to, the affordability of, and the quality of hearing health care for adults of all ages.
Rare Diseases and Orphan Products
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
Book Description
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.
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
Book Description
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.
Medical Device Regulations
Author: Michael Cheng
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54
Book Description
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54
Book Description
The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
The Healthcare Imperative
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309144337
Category : Medical
Languages : en
Pages : 852
Book Description
The United States has the highest per capita spending on health care of any industrialized nation but continually lags behind other nations in health care outcomes including life expectancy and infant mortality. National health expenditures are projected to exceed $2.5 trillion in 2009. Given healthcare's direct impact on the economy, there is a critical need to control health care spending. According to The Health Imperative: Lowering Costs and Improving Outcomes, the costs of health care have strained the federal budget, and negatively affected state governments, the private sector and individuals. Healthcare expenditures have restricted the ability of state and local governments to fund other priorities and have contributed to slowing growth in wages and jobs in the private sector. Moreover, the number of uninsured has risen from 45.7 million in 2007 to 46.3 million in 2008. The Health Imperative: Lowering Costs and Improving Outcomes identifies a number of factors driving expenditure growth including scientific uncertainty, perverse economic and practice incentives, system fragmentation, lack of patient involvement, and under-investment in population health. Experts discussed key levers for catalyzing transformation of the delivery system. A few included streamlined health insurance regulation, administrative simplification and clarification and quality and consistency in treatment. The book is an excellent guide for policymakers at all levels of government, as well as private sector healthcare workers.
Publisher: National Academies Press
ISBN: 0309144337
Category : Medical
Languages : en
Pages : 852
Book Description
The United States has the highest per capita spending on health care of any industrialized nation but continually lags behind other nations in health care outcomes including life expectancy and infant mortality. National health expenditures are projected to exceed $2.5 trillion in 2009. Given healthcare's direct impact on the economy, there is a critical need to control health care spending. According to The Health Imperative: Lowering Costs and Improving Outcomes, the costs of health care have strained the federal budget, and negatively affected state governments, the private sector and individuals. Healthcare expenditures have restricted the ability of state and local governments to fund other priorities and have contributed to slowing growth in wages and jobs in the private sector. Moreover, the number of uninsured has risen from 45.7 million in 2007 to 46.3 million in 2008. The Health Imperative: Lowering Costs and Improving Outcomes identifies a number of factors driving expenditure growth including scientific uncertainty, perverse economic and practice incentives, system fragmentation, lack of patient involvement, and under-investment in population health. Experts discussed key levers for catalyzing transformation of the delivery system. A few included streamlined health insurance regulation, administrative simplification and clarification and quality and consistency in treatment. The book is an excellent guide for policymakers at all levels of government, as well as private sector healthcare workers.
Medical Devices and the Public's Health
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
Book Description
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.
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
Book Description
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.
New Medical Devices
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309038472
Category : Medical
Languages : en
Pages : 203
Book Description
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.
Publisher: National Academies Press
ISBN: 0309038472
Category : Medical
Languages : en
Pages : 203
Book Description
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.
The Future of Disability in America
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309104726
Category : Medical
Languages : en
Pages : 619
Book Description
The future of disability in America will depend on how well the U.S. prepares for and manages the demographic, fiscal, and technological developments that will unfold during the next two to three decades. Building upon two prior studies from the Institute of Medicine (the 1991 Institute of Medicine's report Disability in America and the 1997 report Enabling America), The Future of Disability in America examines both progress and concerns about continuing barriers that limit the independence, productivity, and participation in community life of people with disabilities. This book offers a comprehensive look at a wide range of issues, including the prevalence of disability across the lifespan; disability trends the role of assistive technology; barriers posed by health care and other facilities with inaccessible buildings, equipment, and information formats; the needs of young people moving from pediatric to adult health care and of adults experiencing premature aging and secondary health problems; selected issues in health care financing (e.g., risk adjusting payments to health plans, coverage of assistive technology); and the organizing and financing of disability-related research. The Future of Disability in America is an assessment of both principles and scientific evidence for disability policies and services. This book's recommendations propose steps to eliminate barriers and strengthen the evidence base for future public and private actions to reduce the impact of disability on individuals, families, and society.
Publisher: National Academies Press
ISBN: 0309104726
Category : Medical
Languages : en
Pages : 619
Book Description
The future of disability in America will depend on how well the U.S. prepares for and manages the demographic, fiscal, and technological developments that will unfold during the next two to three decades. Building upon two prior studies from the Institute of Medicine (the 1991 Institute of Medicine's report Disability in America and the 1997 report Enabling America), The Future of Disability in America examines both progress and concerns about continuing barriers that limit the independence, productivity, and participation in community life of people with disabilities. This book offers a comprehensive look at a wide range of issues, including the prevalence of disability across the lifespan; disability trends the role of assistive technology; barriers posed by health care and other facilities with inaccessible buildings, equipment, and information formats; the needs of young people moving from pediatric to adult health care and of adults experiencing premature aging and secondary health problems; selected issues in health care financing (e.g., risk adjusting payments to health plans, coverage of assistive technology); and the organizing and financing of disability-related research. The Future of Disability in America is an assessment of both principles and scientific evidence for disability policies and services. This book's recommendations propose steps to eliminate barriers and strengthen the evidence base for future public and private actions to reduce the impact of disability on individuals, families, and society.
Bringing Medical Devices to Market
Author: Charlene Cho
Publisher:
ISBN: 9781641059718
Category : Medical instruments and apparatus
Languages : en
Pages : 389
Book Description
"Each chapter in this book describes the general concepts that frame a given subject area and addresses some of the basic administrative, regulatory, and compliance concerns that arise in the context of bringing a medical device to market"--
Publisher:
ISBN: 9781641059718
Category : Medical instruments and apparatus
Languages : en
Pages : 389
Book Description
"Each chapter in this book describes the general concepts that frame a given subject area and addresses some of the basic administrative, regulatory, and compliance concerns that arise in the context of bringing a medical device to market"--