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IP Strategies for Medical Device Technologies by James Love,David Postolski Pdf
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.
Gerald B. Halt (Jr.),John C. Donch (Jr.),Amber R. Stiles,Lisa Jenkins VanLuvanee,Brandon R. Theiss,Dana L. Blue
Author : Gerald B. Halt (Jr.),John C. Donch (Jr.),Amber R. Stiles,Lisa Jenkins VanLuvanee,Brandon R. Theiss,Dana L. Blue Publisher : Unknown Page : 333 pages File Size : 53,7 Mb Release : 2019 Category : Medical instruments and apparatus ISBN : 3030044637
FDA and Intellectual Property Strategies for Medical Device Technologies by Gerald B. Halt (Jr.),John C. Donch (Jr.),Amber R. Stiles,Lisa Jenkins VanLuvanee,Brandon R. Theiss,Dana L. Blue Pdf
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.
FDA and Intellectual Property Strategies for Medical Device Technologies by Gerald B. Halt,John C. Donch,Amber R. Stiles,Lisa Jenkins VanLuvanee,Brandon R. Theiss,Dana L. Blue Pdf
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 by World Intellectual Property Organization Pdf
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.
FDA and Intellectual Property Strategies for Medical Device Technologies by Gerald B. Halt,John C. Donch,Amber R. Stiles,Lisa Jenkins VanLuvanee,Brandon R. Theiss,Dana L. Blue Pdf
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. by World Intellectual Property Organization,World Health Organisation (WHO),World Trade Organisation (WTO) Pdf
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.
WIPO Re:Search - Collaborating to Mobilize the Power of Intellectual Property for Global Health by World Intellectual Property Organization,BIO Ventures for Global Health Pdf
WIPO Re:Search aims to catalyze the development of medical products for neglected tropical diseases, malaria and tuberculosis through innovative research partnerships and knowledge sharing.
The Medical Device R&D Handbook by Theodore R. Kucklick Pdf
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
WIPO Technology Trends 2021- Assistive Technology by World Intellectual Property Organization Pdf
This groundbreaking report looks at patenting and technology trends in innovation in assistive technology. It identifies the prominent technologies, top players and markets for patent protection across seven domains – mobility, cognition, communication, hearing, the built environment, self-care and vision. Using a scale of technology readiness, it reveals which of the identified assistive products filed for patent protection are closest to commercialization.
Author : World Health Organization Publisher : World Health Organization Page : 147 pages File Size : 41,8 Mb Release : 2010 Category : Medical ISBN : 9789241564045
Institute of Medicine,Board on Health Sciences Policy,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
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 : 42,7 Mb Release : 2001-10-31 Category : Medical ISBN : 9780309183208
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.
Benjamin M. Legum,Amber R. Stiles,Jennifer L. Vondran
Author : Benjamin M. Legum,Amber R. Stiles,Jennifer L. Vondran Publisher : Walter de Gruyter GmbH & Co KG Page : 410 pages File Size : 51,8 Mb Release : 2019-07-08 Category : Science ISBN : 9783110521900
Engineering Innovation by Benjamin M. Legum,Amber R. Stiles,Jennifer L. Vondran Pdf
Engineering Innovation is an overview of the interconnected business and product development techniques needed to nurture the development of raw, emerging technologies into commercially viable products. This book relates Funding Strategies, Business Development, and Product Development to one another as an idea is refined to a validated concept, iteratively developed into a product, then produced for commercialization. Engineering Innovation also provides an introduction to business strategies and manufacturing techniques on a technical level designed to encourage passionate clinicians, academics, engineers and savvy entrepreneurs. Offers a comprehensive overview of the process of bringing new technology to market. Identifies a variety of technology management skill sets and management tools. Explores concept generation in conjunction with intellectual property development for early-stage companies. Explores Quality and Transfer-to-Manufacturing.
3D Printing, Intellectual Property and Innovation by Rosa Maria Ballardini,Marcus Norrgård,Jouni Partanen Pdf
3D printing (or, more correctly, additive manufacturing) is the general term for those software-driven technologies that create physical objects by successive layering of materials. Due to recent advances in the quality of objects produced and to lower processing costs, the increasing dispersion and availability of these technologies have major implications not only for manufacturers and distributors but also for users and consumers, raising unprecedented challenges for intellectual property protection and enforcement. This is the first and only book to discuss 3D printing technology from a multidisciplinary perspective that encompasses law, economics, engineering, technology, and policy. Originating in a collaborative study spearheaded by the Hanken School of Economics, the Aalto University and the University of Helsinki in Finland and engaging an international consortium of legal, design and production engineering experts, with substantial contributions from industrial partners, the book fully exposes and examines the fundamental questions related to the nexus of intellectual property law, emerging technologies, 3D printing, business innovation, and policy issues. Twenty-five legal, technical, and business experts contribute sixteen peer-reviewed chapters, each focusing on a specific area, that collectively evaluate the tensions created by 3D printing technology in the context of the global economy. The topics covered include: • current and future business models for 3D printing applications; • intellectual property rights in 3D printing; • essential patents and technical standards in additive manufacturing; • patent and bioprinting; • private use and 3D printing; • copyright licences on the user-generated content (UGC) in 3D printing; • copyright implications of 3D scanning; and • non-traditional trademark infringement in the 3D printing context. Specific industrial applications – including aeronautics, automotive industries, construction equipment, toy and jewellery making, medical devices, tissue engineering, and regenerative medicine – are all touched upon in the course of analyses. In a legal context, the central focus is on the technology’s implications for US and European intellectual property law, anchored in a comparison of relevant laws and cases in several legal systems. This work is a matchless resource for patent, copyright, and trademark attorneys and other corporate counsel, innovation economists, industrial designers and engineers, and academics and policymakers concerned with this complex topic.