FDA and Intellectual Property Strategies for Medical Device Technologies

Written By Gerald B. Halt
FDA and Intellectual Property Strategies for Medical Device Technologies
  • Publsiher : Springer
  • Release : 24 January 2019
  • ISBN : 3030044629
  • Pages : 333 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled FDA and Intellectual Property Strategies for Medical Device Technologies written by Gerald B. Halt which was release on 24 January 2019, this book published by Springer. Available in PDF, EPUB and Kindle Format. Book excerpt: 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.

FDA and Intellectual Property Strategies for Medical Device Technologies

FDA and Intellectual Property Strategies for Medical Device Technologies
  • Author : Gerald B. Halt,John C. Donch,Amber R. Stiles,Lisa Jenkins VanLuvanee,Brandon R. Theiss,Dana L. Blue
  • Publisher : Springer
  • Release Date : 2019-01-24
  • Total pages : 333
  • ISBN : 3030044629
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Summary : 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 ...

Medical Device Technologies

Medical Device Technologies
  • Author : Gail Baura
  • Publisher : Academic Press
  • Release Date : 2011-09-28
  • Total pages : 528
  • ISBN : 3030044629
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Summary : 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 ...

BIOMEDICAL DEVICE TECHNOLOGY

BIOMEDICAL DEVICE TECHNOLOGY
  • Author : Anthony Y. K. Chan
  • Publisher : Charles C Thomas Publisher
  • Release Date : 2016-03-28
  • Total pages : 788
  • ISBN : 3030044629
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Summary : This book provides a comprehensive approach to studying the principles and design of biomedical devices as well as their applications in medicine. It is written for engineers and technologists who are interested in understanding the principles, design and applications of medical device technology. The book is also intended to be ...

Health Technology Assessment of Medical Devices

Health Technology Assessment of Medical Devices
  • Author : World Health Organization
  • Publisher : Who Medical Device Technical
  • Release Date : 2012-10-25
  • Total pages : 39
  • ISBN : 3030044629
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Summary : WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy ...

Medical Technology into Healthcare and Society

Medical Technology into Healthcare and Society
  • Author : A. Faulkner
  • Publisher : Springer
  • Release Date : 2008-11-28
  • Total pages : 238
  • ISBN : 3030044629
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Summary : From bandage to the bioreactor, this book looks at five different device technologies from inception to healthcare practice, drawing on medical sociology, science and technology studies and political science. It examines 'evidence', regulation and governance processes, and diverse stakeholders in innovating the technologies that shape health care....

New Frontiers in Medical Device Technology

New Frontiers in Medical Device Technology
  • Author : Arye Rosen,Harel D. Rosen
  • Publisher : Unknown
  • Release Date : 1995
  • Total pages : 364
  • ISBN : 3030044629
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Summary : 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 ...

Medical Devices for Pharmacy and Other Healthcare Professions

Medical Devices for Pharmacy and Other Healthcare Professions
  • Author : Ahmed Ibrahim Fathelrahman,Mohamed Izham Mohamed Ibrahim,Albert I. Wertheimer
  • Publisher : CRC Press
  • Release Date : 2021-12-30
  • Total pages : 420
  • ISBN : 3030044629
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Summary : Today, more than ever, the pharmacist is a full-member of the health team and many of the pharmacist’s patients are using a host of other devices from various specialty areas of medicine and surgery. Medical Devices for Pharmacy and Other Healthcare Professions presents a comprehensive review of most devices ...

Handbook of Human Factors in Medical Device Design

Handbook of Human Factors in Medical Device Design
  • Author : Matthew Bret Weinger,Michael E. Wiklund,Daryle Jean Gardner-Bonneau
  • Publisher : CRC Press
  • Release Date : 2010-12-13
  • Total pages : 844
  • ISBN : 3030044629
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Summary : Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance...

New Frontiers in Medical Device Technology

New Frontiers in Medical Device Technology
  • Author : Arye Rosen,Harel D. Rosen
  • Publisher : For Dummies
  • Release Date : 1995-07-14
  • Total pages : 364
  • ISBN : 3030044629
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Summary : 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 ...

Strategic Pricing for Medical Technologies

Strategic Pricing for Medical Technologies
  • Author : Christopher D. Provines
  • Publisher : Unknown
  • Release Date : 2012-09-01
  • Total pages : 232
  • ISBN : 3030044629
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Summary : In Strategic Pricing for Medical Technologies, industry veteran and pricing expert, Christopher D. Provines, provides a comprehensive and practical guide to pricing medical technologies. Medical technologies include medical devices, in-vitro diagnostics, in-vivo diagnostics, combination products, and medical supplies & equipment. The book will help you better quantify, communicate, and capture value ...

Medical Device Design

Medical Device Design
  • Author : Peter J. Ogrodnik
  • Publisher : Academic Press
  • Release Date : 2019-10-30
  • Total pages : 538
  • ISBN : 3030044629
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Summary : Medical Device Design: Innovation from Concept to Market, Second Edition 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; this book fills that need. ...

Innovation and Invention in Medical Devices

Innovation and Invention in Medical Devices
  • Author : Institute of Medicine,Board on Health Sciences Policy,Based on a Workshop of the Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
  • Publisher : National Academies Press
  • Release Date : 2001-12-01
  • Total pages : 112
  • ISBN : 3030044629
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Summary : 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 ...

MEDICAL DEVICES

MEDICAL DEVICES
  • Author : Carlo Boccato,Sergio Cerutti,Joerg Vienken
  • Publisher : Springer Nature
  • Release Date : 2022
  • Total pages : 275
  • ISBN : 3030044629
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Summary : This book provides caregivers and administrators with high-quality support for strategic decision making in the selection and use of medical devices so as to ensure value optimization. Medical treatment is increasingly complex, with wide application of medical devices and corresponding involvement of physics and engineering. A multidisciplinary methodology that brings ...

Clinical Evaluation of Medical Devices

Clinical Evaluation of Medical Devices
  • Author : Karen M. Becker,John J. Whyte
  • Publisher : Springer Science & Business Media
  • Release Date : 2007-11-05
  • Total pages : 360
  • ISBN : 3030044629
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Summary : The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and ...

Medical Devices Bulletin

Medical Devices Bulletin
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1989
  • Total pages : 518
  • ISBN : 3030044629
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Summary : Download or read online Medical Devices Bulletin written by , published by which was released on 1989. Get Medical Devices Bulletin Books now! Available in PDF, ePub and Kindle....