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Medical Device Technologies

Medical Device Technologies Book
Author : Gail D. Baura
Publisher : Academic Press
Release : 2012
ISBN : 012374976X
Language : En, Es, Fr & De

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Book Description :

The goal of this textbook is to provide undergraduate engineering students with an introduction 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 8 chapters are medical device laboratory experiment chapters. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. The systems approach enables students to quickly identify the relationships between devices. Device key features are based on five applicable consensus standard requirements from organizations such as ISO and the Association for the Advancement of Medical Instrumentation (AAMI). Key Features: The medical devices discussed are Nobel Prize or Lasker Clinical Prize winners, vital signs devices, and devices in high industry growth areas Three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation are included in appropriate device chapters Exercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literature Eight laboratory experiments are detailed that provide hands-on reinforcement of device concepts

FDA and Intellectual Property Strategies for Medical Device Technologies

FDA and Intellectual Property Strategies for Medical Device Technologies Book
Author : Gerald B. Halt,John C. Donch,Amber R. Stiles,Lisa Jenkins VanLuvanee,Brandon R. Theiss,Dana L. Blue
Publisher : Springer
Release : 2019-02-03
ISBN : 9783030044619
Language : En, Es, Fr & De

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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.

Medical Device Technologies

Medical Device Technologies Book
Author : Gail Baura
Publisher : Academic Press
Release : 2020-06
ISBN : 9780128119846
Language : En, Es, Fr & De

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Book Description :

Medical Device Technologies: A Systems Based Overview Using Engineering Standards, Second Edition is a comprehensive overview of medical device technology, with a unified approach to each device area covering technical operation, clinical need, regulatory issues and standards and historical devices. It takes a systems-based view, balancing breadth with depth to give an accessible introduction to this field. Close ties are drawn between the design, the product and the patient. Exercises at the end of each chapter include traditional homework problems, analysis exercises and four questions from assigned primary literature. Eight laboratory experiments in both electrical and mechanical medical devices are explored. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. This systems approach enables the reader to quickly identify the relationships between devices. An accompanying instructor site containing answers to end of chapter exercises, image collections, datasets and solutions for the lab experiments is also included. Covers current research, design issues and engineering standards Includes three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation Presents exercises at the end of each chapter, including problems, analysis exercises and four questions from assigned primary literature Provides eight laboratory experiments that are detailed to provide hands-on reinforcement of device concepts

BIOMEDICAL DEVICE TECHNOLOGY

BIOMEDICAL DEVICE TECHNOLOGY Book
Author : Anthony Y. K. Chan
Publisher : Charles C Thomas Publisher
Release : 2016-03-28
ISBN : 0398090831
Language : En, Es, Fr & De

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Book Description :

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 used as a textbook or reference for biomedical device technology courses in universities and colleges. It focuses on the functions and principles of medical devices (which are the invariant components) and uses specific designs and constructions to illustrate the concepts where appropriate. This book selectively covers diagnostic and therapeutic devices that are either commonly used or that their principles and design represent typical applications of the technology. In this second edition, almost every chapter has been revised—some with minor updates and some with significant changes and additions. For those who would like to know more, a collection of relevant published papers and book references is added at the end of each chapter. Based on feedback, a section on “Common Problems and Hazards” has been included for each medical device. In addition, more information is provided on the indications of use and clinical applications. Two new areas of medical device technology have been added in the two new chapters on “Cardiopulmonary Bypass Units” and “Audiology Equipment.”

FDA and Intellectual Property Strategies for Medical Device Technologies

FDA and Intellectual Property Strategies for Medical Device Technologies Book
Author : Gerald B. Halt,John C. Donch,Amber R. Stiles,Lisa Jenkins VanLuvanee,Brandon R. Theiss,Dana L. Blue
Publisher : Springer
Release : 2019-02-03
ISBN : 3030044629
Language : En, Es, Fr & De

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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.

New Medical Devices

New Medical Devices Book
Author : Institute of Medicine,National Academy of Engineering
Publisher : National Academies Press
Release : 1988-02-01
ISBN : 0309038464
Language : En, Es, Fr & De

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Book Description :

In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.

FDA and Intellectual Property Strategies for Medical Device Technologies

FDA and Intellectual Property Strategies for Medical Device Technologies Book
Author : Gerald B. Halt (Jr.),John C. Donch (Jr.),Amber R. Stiles,Lisa Jenkins VanLuvanee,Brandon R. Theiss,Dana L. Blue
Publisher : Unknown
Release : 2019
ISBN : 9783030044633
Language : En, Es, Fr & De

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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.

New Frontiers in Medical Device Technology

New Frontiers in Medical Device Technology Book
Author : Arye Rosen,Harel D. Rosen
Publisher : Unknown
Release : 1995
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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 and medical aspects. Relevant engineering principles are reviewed before focusing on the state-of-the-art technologies and their applications. For engineers, this book will provide knowledge of the needs, applications, and biological effects of medical devices and thus point the way toward new opportunities for engineering solutions. Members of the medical community will gain an understanding of the engineering concepts applied to medical devices and their most recent applications. Business and legal professionals will acquire a better understanding of medical technology and its enormous market potential.

Medical Devices

Medical Devices Book
Author : Martin Culjat,Rahul Singh,Hua Lee
Publisher : John Wiley & Sons
Release : 2012-11-07
ISBN : 1118453530
Language : En, Es, Fr & De

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Book Description :

Addressing the exploding interest in bioengineering for healthcare applications, this book provides readers with detailed yet easy-to-understand guidance on biomedical device engineering. Written by prominent physicians and engineers, Medical Devices: Surgical and Image-Guided Technologies is organized into stand-alone chapters covering devices and systems in diagnostic, surgical, and implant procedures. Assuming only basic background in math and science, the authors clearly explain the fundamentals for different systems along with such topics as engineering considerations, therapeutic techniques and applications, future trends, and more. After describing how to manage a design project for medical devices, the book examines the following: Instruments for laparoscopic and ophthalmic surgery, plus surgical robotics Catheters in vascular therapy and energy-based hemostatic surgical devices Tissue ablation systems and the varied uses of lasers in medicine Vascular and cardiovascular devices, plus circulatory support devices Ultrasound transducers, X-ray imaging, and neuronavigation An absolute must for biomedical engineers, Medical Devices: Surgical and Image-Guided Technologies is also an invaluable guide for students in all engineering majors and pre-med programs interested in exploring this fascinating field.

New Frontiers in Medical Device Technology

New Frontiers in Medical Device Technology Book
Author : Arye Rosen,Harel D. Rosen
Publisher : For Dummies
Release : 1995-07-14
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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 and medical aspects. Relevant engineering principles are reviewed before focusing on the state-of-the-art technologies and their applications. For engineers, this book will provide knowledge of the needs, applications, and biological effects of medical devices and thus point the way toward new opportunities for engineering solutions. Members of the medical community will gain an understanding of the engineering concepts applied to medical devices and their most recent applications. Business and legal professionals will acquire a better understanding of medical technology and its enormous market potential.

IP Strategies for Medical Device Technologies

IP Strategies for Medical Device Technologies Book
Author : James Love,David Postolski
Publisher : Unknown
Release : 2020-04-07
ISBN : 9781641052696
Language : En, Es, Fr & De

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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.

Connected Medical Device Technologies

Connected Medical Device Technologies Book
Author : BCC Research
Publisher : Unknown
Release : 2017-06
ISBN : 9781622965083
Language : En, Es, Fr & De

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Book Description :

Download Connected Medical Device Technologies book written by BCC Research, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Medical Device Design

Medical Device Design Book
Author : Peter J. Ogrodnik
Publisher : Academic Press
Release : 2019-10-30
ISBN : 0128149639
Language : En, Es, Fr & De

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Book Description :

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. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace. This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design. Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more Presents additional content around software and biocompatibility concerns

Class 1 Devices

Class 1 Devices Book
Author : Peter J Ogrodnik
Publisher : Academic Press
Release : 2014-11-24
ISBN : 0128007966
Language : En, Es, Fr & De

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Book Description :

The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik’s Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library. Class 1 Devices is a companion text to Medical Devices Design: Innovation from Concept to Market. The intention of this book, and its sister books in the series, is to support the concepts presented in Medical Devices Design through case studies. In the context of this book the case studies consider Class I (EU) and 510(k) exempt (FDA) . This book covers classifications, the conceptual and embodiment phase, plus design from idea to PDS. These titles will assist anyone who is working in the medical devices industry or who is studying biomedical subject areas to design a successful medical device and avoid repeating past mistakes. Written by an experienced medical device engineer and entrepreneur, with real world experience of developing and commercializing medical products. Joins up theory and practice in an accessible style.

Handbook of Human Factors in Medical Device Design

Handbook of Human Factors in Medical Device Design Book
Author : Matthew Bret Weinger,Michael E. Wiklund,Daryle Jean Gardner-Bonneau
Publisher : CRC Press
Release : 2010-12-13
ISBN : 1420063510
Language : En, Es, Fr & De

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Book Description :

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

Medical Equipment Maintenance

Medical Equipment Maintenance Book
Author : Binseng Wang
Publisher : Morgan & Claypool Publishers
Release : 2012
ISBN : 1627050566
Language : En, Es, Fr & De

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Book Description :

In addition to being essential for safe and effective patient care, medical equipment also has significant impact on the income and, thus, vitality of healthcare organizations. For this reason, its maintenance and management requires careful supervision by healthcare administrators, many of whom may not have the technical background to understand all of the relevant factors. This book presents the basic elements of medical equipment maintenance and management required of healthcare leaders responsible for managing or overseeing this function. It will enable these individuals to understand their professional responsibilities, as well as what they should expect from their supervised staff and how to measure and benchmark staff performance against equivalent performance levels at similar organizations. The book opens with a foundational summary of the laws, regulations, codes, and standards that are applicable to the maintenance and management of medical equipment in healthcare organizations. Next, the core functions of the team responsible for maintenance and management are described in sufficient detail for managers and overseers. Then the methods and measures for determining the effectiveness and efficiency of equipment maintenance and management are presented to allow performance management and benchmarking comparisons. The challenges and opportunities of managing healthcare organizations of different sizes, acuity levels, and geographical locations are discussed. Extensive bibliographic sources and material for further study are provided to assist students and healthcare leaders interested in acquiring more detailed knowledge. Table of Contents: Introduction / Regulatory Framework / Core Functions of Medical Equipment Maintenance and Management / CE Department Management / Performance Management / Discussion and Conclusions

Medical Equipment Maintenance Programme Overview

Medical Equipment Maintenance Programme Overview Book
Author : World Health Organization
Publisher : Unknown
Release : 2012-08-01
ISBN : 9789241501538
Language : En, Es, Fr & De

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Book Description :

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 framework for health technology * medical device regulations * health technology assessment * health technology management * needs assessment of medical devices * medical device procurement * medical equipment donations * medical equipment inventory management * medical equipment maintenance * computerized maintenance management systems * medical device data * medical device nomenclature * medical devices by health-care setting * medical devices by clinical procedures * medical device innovation, research and development. These documents are intended for use by biomedical engineers, health managers, donors, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional or global levels. An effective medical equipment maintenance program consists of adequate planning, management and implementation. Planning considers the financial, physical and human resources required to adequately implement the maintenance activities. Once the program has been defined, financial, personnel and operational aspects are continually examined and managed to ensure the program continues uninterrupted and improves as necessary. Ultimately, proper implementation of the program is key to ensuring optimal equipment functionality.

Innovation and Invention in Medical Devices

Innovation and Invention in Medical Devices Book
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 : 2001-12-01
ISBN : 0309082552
Language : En, Es, Fr & De

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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.

Antimicrobial Coatings and Modifications on Medical Devices

Antimicrobial Coatings and Modifications on Medical Devices Book
Author : Zheng Zhang,Victoria E. Wagner
Publisher : Springer
Release : 2017-05-24
ISBN : 3319574949
Language : En, Es, Fr & De

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Book Description :

Based on a fundamental understanding of the interaction between bacteria and materials, this timely volume emphasizes the latest research in the antimicrobial interfacial design and provides an invaluable blueprint for improving antimicrobial performance on devices and products. Antimicrobial Coatings and Modifications targets reduction of microbial accumulation on biomedical and industrial materials through changing interfacial characteristics. Applying a viable antimicrobial coating or modification to resist alarming threats is a highly demanding requirement for many medical and engineering applications. Many contemporary books in the area of antimicrobial solution focus on applying antimicrobial agents or materials that can kill bacteria. The volume pays more attention to eliminating bacterial contamination and biofilm formation through surface characteristics with minimized bacterial resistance and environmental impact.