Fda And Intellectual Property Strategies For Medical Device Technologies
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Fda And Intellectual Property Strategies For Medical Device Technologies
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Author : Gerald B. Halt (Jr.)
language : en
Publisher:
Release Date : 2019
Fda And Intellectual Property Strategies For Medical Device Technologies written by Gerald B. Halt (Jr.) and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019 with Medical instruments and apparatus categories.
This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection. This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators. Investigates the FDA approval process as it pertains to medical device technology Address some of the major FDA hurdles that medical device innovators often face while seeking approval Discusses the interplay between FDA regulatory review of medical device technology and intellectual property strategy Explores the benefits of protecting, managing and enforcing intellectual property obtained for medical device technology so that innovators can obtain the best possible commercial results from their IP ownership Uses real case studies to illustrate concepts covered.
Ip Strategies For Medical Device Technologies
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Author : James Love
language : en
Publisher:
Release Date : 2020-04-07
Ip Strategies For Medical Device Technologies written by James Love and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-07 with Law categories.
Medical device professionals encounter numerous challenges from successfully developing a medical device company to understanding and navigating the various intellectual property issues that arise as they seek to protect and commercialize their inventions. This is an essential resource for understanding the nuances of protecting and launching a medical device in the United States and abroad. Written by IP and patent attorneys with experience representing the unique business needs of startups, entrepreneurs, and early-stage companies, this guide covers creating and leveraging patent portfolios; freedom to operate; limiting risk of infringement; trademarks in the context of medical devices; strategies for licensing and monetizing patents; and more.
Fda And Intellectual Property Strategies For Medical Device Technologies
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Author : Gerald B. Halt
language : en
Publisher: Springer
Release Date : 2019-01-24
Fda And Intellectual Property Strategies For Medical Device Technologies written by Gerald B. Halt and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-01-24 with Technology & Engineering categories.
This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection. This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators.
Promoting Access To Medical Technologies And Innovation Intersections Between Public Health Intellectual Property And Trade
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Author : World Intellectual Property Organization
language : en
Publisher: WIPO
Release Date : 2013
Promoting Access To Medical Technologies And Innovation Intersections Between Public Health Intellectual Property And Trade written by World Intellectual Property Organization and has been published by WIPO this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with Law categories.
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.
Intellectual Property And Health Technologies
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Author : Joanna T. Brougher
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-11-08
Intellectual Property And Health Technologies written by Joanna T. Brougher and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-11-08 with Medical categories.
Intellectual Property and Health Technologies Balancing Innovation and the Public's Health Joanna T. Brougher, Esq., MPH At first glance, ownership of intellectual property seems straightforward: the control over an invention or idea. But with the recent explosion of new scientific discoveries poised to transform public health and healthcare systems, costly and lengthy patent disputes threaten both to undermine the attempts to develop new medical technologies and to keep potentially life-saving treatments from patients who need them. Intellectual Property and Health Technologies grounds readers in patent law and explores how scientific research and enterprise are evolving in response. Geared specifically to the medical disciplines, it differentiates among forms of legal protection for inventors such as copyrights and patents, explains their limits, and argues for balance between competing forces of exclusivity and availability. Chapters delve into the major legal controversies concerning medical and biotechnologies in terms of pricing, markets, and especially the tension between innovation and access, including: The patent-eligibility of genes The patent-eligibility of medical process patents The rights and roles of universities and inventors The balancing of access, innovation, and profit in drug development The tension between biologics, small-molecule drugs, and their generic counterparts International patent law and access to medicine in the developing world As these issues continue to shape and define the debate, Intellectual Property and Health Technologies enables professionals and graduate students in public health, health policy, healthcare administration, and medicine to understand patent law and how it affects the development of medical technology and the delivery of medicine.
Promoting Access To Medical Technologies And Innovation Intersections Between Public Health Intellectual Property And Trade
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Author : World Intellectual Property Organization
language : en
Publisher: WIPO
Release Date : 2020-07-28
Promoting Access To Medical Technologies And Innovation Intersections Between Public Health Intellectual Property And Trade written by World Intellectual Property Organization and has been published by WIPO this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-07-28 with Law categories.
This study seeks to reinforce the understanding of the interplay between the distinct policy domains of health, trade and intellectual property, and of how they affect medical innovation and access to medical technologies. The second edition comprehensively reviews new developments in key areas since the initial launch of the study in 2013.
Medical Device Innovation Handbook
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Author : William Durfee
language : en
Publisher: Lulu.com
Release Date : 2014-03-23
Medical Device Innovation Handbook written by William Durfee and has been published by Lulu.com this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-03-23 with Business & Economics categories.
A short handbook for the medical device innovator who wishes to understand the innovation process for new medical devices.
Fda And Intellectual Property Strategies For Medical Device Technologies
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Author : Gerald B. Halt
language : en
Publisher: Springer
Release Date : 2019-02-05
Fda And Intellectual Property Strategies For Medical Device Technologies written by Gerald B. Halt and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-02-05 with Technology & Engineering categories.
This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection. This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators.
Regulating Innovation
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Author : United States. Congress. House. Committee on Science, Space, and Technology. Subcommittee on Investigations and Oversight
language : en
Publisher:
Release Date : 1994
Regulating Innovation written by United States. Congress. House. Committee on Science, Space, and Technology. Subcommittee on Investigations and Oversight and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994 with Business & Economics categories.
Reliable Design Of Medical Devices
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Author : Richard C. Fries
language : en
Publisher: CRC Press
Release Date : 2005-11-21
Reliable Design Of Medical Devices written by Richard C. Fries and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-11-21 with Medical categories.
As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.