Author: James Love
Publisher:
ISBN: 9781641052696
Category : Law
Languages : en
Pages : 268
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Book Description
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.
Author: Gerald B. Halt
Publisher: Springer
ISBN: 3030044629
Category : Technology & Engineering
Languages : en
Pages : 339
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Book Description
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.
Author: World Intellectual Property Organization
Publisher: WIPO
ISBN: 9280523082
Category : Law
Languages : en
Pages : 259
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Book Description
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.
Author: Gerald B. Halt (Jr.)
Publisher:
ISBN: 9783030044633
Category : Medical instruments and apparatus
Languages : en
Pages : 333
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Book Description
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.
Author: Suzan Onel
Publisher:
ISBN: 9781402441622
Category : Medical instruments and apparatus
Languages : en
Pages : 0
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309082552
Category : Medical
Languages : en
Pages : 112
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Book Description
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: World Intellectual Property Organization
Publisher: WIPO
ISBN: 9280530070
Category : Law
Languages : en
Pages : 156
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Book Description
The first report in a new flagship series, WIPO Technology Trends, aims to shed light on the trends in innovation in artificial intelligence since the field first developed in the 1950s.
Author:
Publisher: Academic Press
ISBN: 0128154349
Category : Science
Languages : en
Pages : 502
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Book Description
Clinical and Medical Innovation in Anesthesiology: Technology, Development, and Commercialization reflects recent trends of industry globalization and value-conscious healthcare. Written by a team of medical, engineering and business experts, this book provides a clear process for the identification, invention and implementation of new solutions in anesthesiology. Readers will gain practical advice, as well as examples of both successful and failed case studies. This is the ideal resource for anesthesiology clinicians, students and researchers who not only want to bring patient use and application to their inventions but also understand all steps needed to bring an idea for technical innovation to market. - Helps readers understand everything involved in bringing clinical and medical innovation in anesthesiology from concept to market - Features case studies on innovative products from around the world - Includes end-of-chapter 'Getting Started' sections to encourage readers to learn from real projects and apply important lessons to their own work
Author: Stefanos Zenios
Publisher: Cambridge University Press
ISBN: 0521517427
Category : Medical
Languages : en
Pages : 779
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Book Description
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.
Author: Theodore R. Kucklick
Publisher: CRC Press
ISBN: 1439811954
Category : Medical
Languages : en
Pages : 497
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Book Description
Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designer
