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OverviewThis 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. Full Product DetailsAuthor: Gerald B. Halt , John C. Donch , Amber R. Stiles , Lisa Jenkins VanLuvaneePublisher: Springer Nature Switzerland AG Imprint: Springer Nature Switzerland AG Edition: 1st ed. 2019 Weight: 0.705kg ISBN: 9783030044619ISBN 10: 3030044610 Pages: 333 Publication Date: 05 February 2019 Audience: Professional and scholarly , Professional & Vocational Format: Hardback Publisher's Status: Active Availability: Manufactured on demand  We will order this item for you from a manufactured on demand supplier. Table of ContentsIntroduction.- Development of A New Medical Device.- Determining If A Medical Device Technology Is FDA Regulated.- Basic FDA Regulatory Requirements For Medical Devices.- Other Regulatory Consideration For Medical Devices.- Benefits of Having FDA Approval.- Patents.- Trademarks and Trade Dress.- Trade Secrets.- Copyrights In Medical Device Technology.- Design Protection For Medical Devices.- Intellectual Property Issues in Medical Device Labeling and Marketing.- Enforcement, Infringement and Monetization of Intellectual Property Rights.- Successful Implementation of a Medical Device Company’s IP Strategy.- Tips for Avoiding and Preventing Intellectual Property Problems.- Successful Implementation of a Medical Device Company’s Regulatory Strategy.- Tips for Avoiding and Preventing Regulatory Problems.- Potential Combined IP and Regulatory Pitfalls.ReviewsIt is a well-written integrated patent and FDA strategy guide that addresses challenges unique to medical devices and ensures success in this fast-changing market. The authors are to be praised for writing a practical and useful guide for readers seeking a quick, deep dive into this challenging area that intersects engineering, science, law and regulation. (John A. Tessensohn, European Intellectual Property Review, Vol. 41 (12), 2019) Author InformationGerald B. Halt, Jr. is a Patent Attorney, shareholder and President at Volpe & Koenig, P.C. Jay focuses his practice on securing, licensing and enforcing the value of intellectual property rights. His practice includes litigation, inter partes matters, administrative proceedings, licensing of trademarks and technology, validity opinions and due diligence reviews. Jay also serves as President of the firm. While his experience with technology is varied, Jay’s particular area of focus is on electrical, electronic and computer software technologies, including optical and wireless communication systems, computers, communication system protocols, microwave systems and components, optical barcode scanners, fiber optic systems and semiconductor devices. Tab Content 6Author Website:Countries AvailableAll regions |
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