New Medical Devices

Author : Institute of Medicine,National Academy of Engineering
Publisher : National Academies Press
Page : 203 pages
File Size : 55,8 Mb
Release : 1988-01-01
Category : Medical
ISBN : 9780309038478

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New Medical Devices by Institute of Medicine,National Academy of Engineering Pdf

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 : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Page : 225 pages
File Size : 50,9 Mb
Release : 1991-02-01
Category : Medical
ISBN : 9780309044912

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The Changing Economics of Medical Technology by Institute of Medicine,Committee on Technological Innovation in Medicine Pdf

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 : Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publisher : Academic Press
Page : 218 pages
File Size : 54,6 Mb
Release : 2020-01-25
Category : Technology & Engineering
ISBN : 9780128209615

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Trends in Development of Medical Devices by Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam Pdf

Trends in Development of Medical Devices covers the basics of medical devices and their development, regulations and toxicological effects, risk assessment and mitigation. It also discusses the maintenance of a medical device portfolio during product lifecycle. This book provides up-to-date information and knowledge on how to understand the position and benefits of new introduced medical devices for improving healthcare. Researchers and industry professionals from the fields of medical devices, surgery, medical toxicology, pharmacy and medical devices manufacture will find this book useful. The book's editors and contributors form a global, interdisciplinary base of knowledge which they bring to this book. Provides a roadmap to medical devices development and the integration of manufacturing steps to improve workflows Helps engineers in medical devices industries to anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, government regulations Presents new strategies that readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce imperfections in production and develop products that enable completely new treatment possibilities

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 : 50,9 Mb
Release : 2001-10-31
Category : Medical
ISBN : 9780309183208

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Innovation and Invention in Medical Devices by Institute of Medicine,Board on Health Sciences Policy,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices Pdf

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 : Annetine C. Gelijns
Publisher : National Academies
Page : 78 pages
File Size : 47,5 Mb
Release : 1989
Category : Clinical medicine
ISBN : NAP:13516

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Technological Innovation by Annetine C. Gelijns Pdf

Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
Publisher : Woodhead Publishing
Page : 256 pages
File Size : 43,8 Mb
Release : 2015-08-18
Category : Medical
ISBN : 9780081002919

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Medical Devices by Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo Pdf

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulations Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards Includes a useful case study demonstrating the design and approval process

Author : Arye Rosen,Harel D. Rosen
Publisher : For Dummies
Page : 384 pages
File Size : 47,7 Mb
Release : 1995-07-14
Category : Medical
ISBN : STANFORD:36105026618004

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New Frontiers in Medical Device Technology by Arye Rosen,Harel D. Rosen Pdf

New Frontiers in Medical Device Technology offers the engineering, medical, and business communities an up-to-date report on current and emerging medical technologies. This timely and authoritative book brings together a core of experts who provide comprehensive coverage of new medical device technologies and focuses on the link between the engineering and medical aspects. Relevant engineering principles are reviewed before focusing on the state-of-the-art technologies and their applications. For engineers, this book will provide knowledge of the needs, applications, and biological effects of medical devices and thus point the way toward new opportunities for engineering solutions. Members of the medical community will gain an understanding of the engineering concepts applied to medical devices and their most recent applications. Business and legal professionals will acquire a better understanding of medical technology and its enormous market potential.

Author : Jeanne Lenzer
Publisher : Little, Brown
Page : 336 pages
File Size : 54,8 Mb
Release : 2017-12-12
Category : Medical
ISBN : 9780316343787

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The Danger Within Us by Jeanne Lenzer Pdf

Did you know... Medical interventions have become the third leading cause of death in America. An estimated 10 percent of Americans are implanted with medical devices -- like pacemakers, artificial hips, cardiac stents, etc. The overwhelming majority of high-risk implanted devices have never undergone a single clinical trial. In The Danger Within Us, award-winning journalist Jeanne Lenzer brings these horrifying statistics to life through the story of one working class man who, after his "cure" nearly kills him, ends up in a battle for justice against the medical establishment. His crusade leads Lenzer on a journey through the dark underbelly of the medical device industry, a fascinating and disturbing world that hasn't been written about before. What Lenzer exposes will shock readers: rampant corruption, elaborate cover-ups, shameless profiteering, and astonishing lack of oversight, all of which leads to dangerous devices (from artificial hips to pacemakers) going to market and into our bodies. In the vein of America's Bitter Pill and A Civil Action, The Danger Within Us is a stirring call for reform and a must-read for anyone who cares about the future of American healthcare. "Before you get anything implanted in your body, read this book."-Shannon Brownlee, author of Overtreated

Author : World Health Organization
Publisher : World Health Organization
Page : 147 pages
File Size : 54,7 Mb
Release : 2010
Category : Medical
ISBN : 9789241564045

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Medical Devices by World Health Organization Pdf

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

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 : 48,8 Mb
Release : 2010-10-04
Category : Medical
ISBN : 9780309162906

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Public Health Effectiveness of the FDA 510(k) Clearance Process by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf

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,Division of Behavioral and Social Sciences and Education,Committee on Human-Systems Integration,Committee on the Role of Human Factors in Home Health Care
Publisher : National Academies Press
Page : 322 pages
File Size : 44,8 Mb
Release : 2010-11-14
Category : Medical
ISBN : 9780309156295

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The Role of Human Factors in Home Health Care by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on Human-Systems Integration,Committee on the Role of Human Factors in Home Health Care Pdf

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.

Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Page : 254 pages
File Size : 43,8 Mb
Release : 1995-01-01
Category : Medical
ISBN : 9780309176682

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Sources of Medical Technology by Institute of Medicine,Committee on Technological Innovation in Medicine Pdf

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.

Author : I. Glenn Cohen,Timo Minssen,W. Nicholson Price II,Christopher Robertson,Carmel Shachar
Publisher : Cambridge University Press
Page : 295 pages
File Size : 52,7 Mb
Release : 2022-04-07
Category : Law
ISBN : 9781108838634

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Innovation and Protection by I. Glenn Cohen,Timo Minssen,W. Nicholson Price II,Christopher Robertson,Carmel Shachar Pdf

A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.

Author : Peter J Ogrodnik
Publisher : Academic Press
Page : 376 pages
File Size : 40,6 Mb
Release : 2012-12-17
Category : Technology & Engineering
ISBN : 9780123919434

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Medical Device Design by Peter J Ogrodnik Pdf

This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products

Author : Gail D. Baura,Gail Baura
Publisher : Academic Press
Page : 529 pages
File Size : 43,6 Mb
Release : 2011-10-07
Category : Science
ISBN : 9780123749765

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Medical Device Technologies by Gail D. Baura,Gail Baura Pdf

Medical Device Technologies introduces undergraduate engineering students to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining eight chapters focus on medical device laboratory experiments. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. The systems approach lets students quickly identify the relationships between devices. Device key features are based on five applicable consensus standard requirements from organizations such as ISO and the Association for the Advancement of Medical Instrumentation (AAMI). The medical devices discussed are Nobel Prize or Lasker Clinical Prize winners, vital signs devices, and devices in high industry growth areas Three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation are included in appropriate device chapters Exercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literature Eight laboratory experiments are detailed that provide hands-on reinforcement of device concepts