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Medical Device Design

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Medical Device Design

Medical Device Design Book
Author : Peter J Ogrodnik
Publisher : Academic Press
Release : 2012-12-17
ISBN : 0123919436
Language : En, Es, Fr & De

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Book Description :

This book 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. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products

Medical Device Design and Regulation

Medical Device Design and Regulation Book
Author : Carl T. DeMarco
Publisher : Quality Press
Release : 2011-01-01
ISBN : 0873898168
Language : En, Es, Fr & De

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Book Description :

Download Medical Device Design and Regulation book written by Carl T. DeMarco, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Applied Human Factors in Medical Device Design

Applied Human Factors in Medical Device Design Book
Author : Mary Beth Privitera
Publisher : Academic Press
Release : 2019-06-15
ISBN : 0128161647
Language : En, Es, Fr & De

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Book Description :

Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodologies. The book begins with an overview of the design control process, integrating human factors as directed by AAMI TIR 59 and experienced practice. It then explains each method, describing why each method is important, its potential impact, when it's ideal to use, and related challenges. Also discussed are other barriers, such as communication breakdowns between users and design teams. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation. Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU) Explains technology development and the application of human factors throughout the development process Covers FDA and MHRA regulations Includes case examples with each method

Contextual Inquiry for Medical Device Design

Contextual Inquiry for Medical Device Design Book
Author : Mary Beth Privitera
Publisher : Academic Press
Release : 2015-05-29
ISBN : 0128018747
Language : En, Es, Fr & De

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Book Description :

Contextual Inquiry for Medical Device Design helps users understand the everyday use of medical devices and the way their usage supports the development of better products and increased market acceptance. The text explains the concept of contextual inquiry using real-life examples to illustrate its application. Case studies provide a frame of reference on how contextual inquiry is successfully used during product design, ultimately producing safer, improved medical devices. Presents the ways contextual inquiry can be used to inform the evaluation and business case of technology Helps users understand the everyday use of medical devices and the way their usage supports the development of better products Includes case studies that provide a frame of reference on how contextual inquiry is successfully used during the product design process

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

Handbook of Medical Device Design

Handbook of Medical Device Design Book
Author : Richard C. Fries
Publisher : CRC Press
Release : 2019-08-15
ISBN : 1000693872
Language : En, Es, Fr & De

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Book Description :

First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.

Medical Device Design for Six Sigma

Medical Device Design for Six Sigma Book
Author : Basem El-Haik,Khalid S. Mekki
Publisher : John Wiley & Sons
Release : 2011-09-20
ISBN : 1118210417
Language : En, Es, Fr & De

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Book Description :

The first comprehensive guide to the integration of Design forSix Sigma principles in the medical devices development cycle Medical Device Design for Six Sigma: A Road Map for Safetyand Effectiveness presents the complete body of knowledge forDesign for Six Sigma (DFSS), as outlined by American Society forQuality, and details how to integrate appropriate designmethodologies up front in the design process. DFSS helps companiesshorten lead times, cut development and manufacturing costs, lowertotal life-cycle cost, and improve the quality of the medicaldevices. Comprehensive and complete with real-world examples, thisguide: Integrates concept and design methods such as Pugh ControlledConvergence approach, QFD methodology, parameter optimizationtechniques like Design of Experiment (DOE), Taguchi Robust Designmethod, Failure Mode and Effects Analysis (FMEA), Design for X,Multi-Level Hierarchical Design methodology, and Response Surfacemethodology Covers contemporary and emerging design methods, includingAxiomatic Design Principles, Theory of Inventive Problem Solving(TRIZ), and Tolerance Design Provides a detailed, step-by-step implementation process foreach DFSS tool included Covers the structural, organizational, and technical deploymentof DFSS within the medical device industry Includes a DFSS case study describing the development of a newdevice Presents a global prospective of medical device regulations Providing both a road map and a toolbox, this is a hands-onreference for medical device product development practitioners,product/service development engineers and architects, DFSS and SixSigma trainees and trainers, middle management, engineering teamleaders, quality engineers and quality consultants, and graduatestudents in biomedical engineering.

Design Controls for the Medical Device Industry

Design Controls for the Medical Device Industry Book
Author : Marie Teixeira,Richard Bradley
Publisher : CRC Press
Release : 2002-09-20
ISBN : 9780203909386
Language : En, Es, Fr & De

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Book Description :

This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilize

Medical Device and Equipment Design

Medical Device and Equipment Design Book
Author : Michael E. Wiklund
Publisher : CRC Press
Release : 1995-02-15
ISBN : 9780935184693
Language : En, Es, Fr & De

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Book Description :

The key to profitability and success in both the medical device and the equipment markets often relates to how easy your products are to use. User acceptance and preference frequently is dependent upon ergonomic design. Medical Device and Equipment Design helps you enhance your product design, maximize user acceptance, and minimize potential problems in the marketplace. It provides practical guidance on how to plan and incorporate ergonomic design principles into medical devices and equipment so users intuitively feel comfortable with the product. Design engineers, usability and reliability engineers, software programmers, documentation specialists, product managers, quality engineers, and market/product managers will find this text invaluable in getting usability built into products from the very beginning.

The Design and Manufacture of Medical Devices

The Design and Manufacture of Medical Devices Book
Author : J. Paulo Davim
Publisher : Woodhead Pub Limited
Release : 2012
ISBN : 9781907568725
Language : En, Es, Fr & De

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Book Description :

Medical devices play an important role in the field of medical and health technology, and encompass a wide range of health care products. Directive 2007/47/EC defines a medical device as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. The design and manufacture of medical devices brings together a range of articles and case studies dealing with medical device R&D. Chapters in the book cover materials used in medical implants, such as Titanium Oxide, polyurethane, and advanced polymers; devices for specific applications such as spinal and craniofacial implants, and other issues related to medical devices, such as precision machining and integrated telemedicine systems. Contains articles on a diverse range of subjects within the field, with internationally renowned specialists discussing each medical device Offers a practical approach to recent developments in the design and manufacture of medical devices Presents a topic that is the focus of research in many important universities and centres of research worldwide

Design and Development of Medical Electronic Instrumentation

Design and Development of Medical Electronic Instrumentation Book
Author : David Prutchi,Michael Norris
Publisher : John Wiley & Sons
Release : 2005-01-28
ISBN : 0471681830
Language : En, Es, Fr & De

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Book Description :

Design and Development of Medical Electronic Instrumentation fills a gap in the existing medical electronic devices literature by providing background and examples of how medical instrumentation is actually designed and tested. The book includes practical examples and projects, including working schematics, ranging in difficulty from simple biopotential amplifiers to computer-controlled defibrillators. Covering every stage of the development process, the book provides complete coverage of the practical aspects of amplifying, processing, simulating and evoking biopotentials. In addition, two chapters address the issue of safety in the development of electronic medical devices, and providing valuable insider advice.

Six Sigma for Medical Device Design

Six Sigma for Medical Device Design Book
Author : Jose Justiniano,Venky Gopalaswamy
Publisher : CRC Press
Release : 2004-11-15
ISBN : 0203485742
Language : En, Es, Fr & De

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Book Description :

For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do

Reliable Design of Medical Devices Second Edition

Reliable Design of Medical Devices  Second Edition Book
Author : Richard C. Fries
Publisher : CRC Press
Release : 2005-11-21
ISBN : 9780824723750
Language : En, Es, Fr & De

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Book Description :

As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

Humanizing Healthcare Human Factors for Medical Device Design

Humanizing Healthcare     Human Factors for Medical Device Design Book
Author : Russell J. Branaghan,Joseph S. O’Brian,Emily A. Hildebrand,L. Bryant Foster
Publisher : Springer Nature
Release : 2021-02-21
ISBN : 3030644332
Language : En, Es, Fr & De

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Book Description :

This book introduces human factors engineering (HFE) principles, guidelines, and design methods for medical device design. It starts with an overview of physical, perceptual, and cognitive abilities and limitations, and their implications for design. This analysis produces a set of human factors principles that can be applied across many design challenges, which are then applied to guidelines for designing input controls, visual displays, auditory displays (alerts, alarms, warnings), and human-computer interaction. Specific challenges and solutions for various medical device domains, such as robotic surgery, laparoscopic surgery, artificial organs, wearables, continuous glucose monitors and insulin pumps, and reprocessing, are discussed. Human factors research and design methods are provided and integrated into a human factors design lifecycle, and a discussion of regulatory requirements and procedures is provided, including guidance on what human factors activities should be conducted when and how they should be documented. This hands-on professional reference is an essential introduction and resource for students and practitioners in HFE, biomedical engineering, industrial design, graphic design, user-experience design, quality engineering, product management, and regulatory affairs. Teaches readers to design medical devices that are safer, more effective, and less error prone; Explains the role and responsibilities of regulatory agencies in medical device design; Introduces analysis and research methods such as UFMEA, task analysis, heuristic evaluation, and usability testing.

Designing Usability into Medical Products

Designing Usability into Medical Products Book
Author : Michael E. Wiklund,Stephen B. Wilcox
Publisher : CRC Press
Release : 2005-02-11
ISBN : 1420038087
Language : En, Es, Fr & De

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Book Description :

Advocating a user-centered approach to medical technology design, Designing Usability into Medical Products covers the essential processes and specific techniques necessary to produce safe, effective, usable, and appealing medical systems and products. Written by experts on user-centered research, design, and evaluation, the book provides a range of alternative approaches to the subject. Wiklund and Wilcox explore how to make medical devices safe and effective by involving users in the design process. They discuss specific design and evaluation methods and tools, present case studies of user-friendly medical technologies and corporate human factors programs, and supply related resources for medical design professionals. The book conveys an in-depth understanding of the user-centered design process, covers design methods for FDA compliance, and offers guidance on performing a variety of hands-on user research, user interface design, and user interface evaluation. The authors make a compelling case for treating the user's needs and preferences as a top design priority, rather than an afterthought. They demonstrate that high-quality customer interactions with systems and products leads to effective medical diagnosis and treatment, increases the physical and mental well being of patients and caregivers, and leads to commercial success in a crowded marketplace.

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.”

Design of Medical Electronic Devices

Design of Medical Electronic Devices Book
Author : Reinaldo Perez
Publisher : Elsevier
Release : 2002-03-21
ISBN : 008049109X
Language : En, Es, Fr & De

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Book Description :

The design of medical electronics is unique because of the background needed by the engineers and scientists involved. Often the designer is a medical or life science professional without any training in electronics or design. Likewise, few engineers are specifically trained in biomedical engineering and have little or no exposure to the specific medical requirements of these devices. Design of Medical Electronic Devices presents all essential topics necessary for basic and advanced design. All aspects of the electronics of medical devices are also covered. This is an essential book for graduate students as well as professionals involved in the design of medical equipment. Covers every stage of the process, from design to manufacturing to implementation Topics covered include analogue/digital conversions, data acquisition, signal processing, optics, and reliability and failure

Foundations and Strategies for Medical Device Design

Foundations and Strategies for Medical Device Design Book
Author : Vikki Hazelwood
Publisher : McGraw Hill Professional
Release : 2021-06-22
ISBN : 126045696X
Language : En, Es, Fr & De

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Book Description :

Cutting-edge medical device design techniques, strategies, and insights A complete curriculum, this practical book provides the novice design engineer of devices with a rounded exposure to unique medical device design practices. The text contains key medical device design strategies and offers real-world insights, analysis, and rationale. Foundations and Strategies for Medical Device Design contains special and specific design approaches and clear discussions on why each method works―or doesn’t work―in various applications. The book includes a common vocabulary for communicating and understanding the scientific, regulatory, and business aspects of medical device design. Detailed case studies along with enlightening anecdotes demonstrate how proper oversight can avoid missed opportunities and catastrophic failures. Coverage includes: Key regulations and practices Thaldomide and the Dalkon shield Understanding today’s FDA Preparing a regulatory strategy Clinical and pre-clinical research Clinical study planning Kyphon and reimbursement Navigating codes for reimbursement Device-associated infections Designing for post-market safety Designing for biocompatibility Designing for the use case The 21st century design landscape

Medical Instrument Design and Development

Medical Instrument Design and Development Book
Author : Claudio Becchetti,Alessandro Neri
Publisher : John Wiley & Sons
Release : 2013-05-20
ISBN : 1118652460
Language : En, Es, Fr & De

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Book Description :

This book explains all of the stages involved in developingmedical devices; from concept to medical approval including systemengineering, bioinstrumentation design, signal processing,electronics, software and ICT with Cloud and e-Healthdevelopment. Medical Instrument Design and Development offers a comprehensivetheoretical background with extensive use of diagrams, graphics andtables (around 400 throughout the book). The book explains how thetheory is translated into industrial medical products using amarket-sold Electrocardiograph disclosed in its design by the GammaCardio Soft manufacturer. The sequence of the chapters reflects the product developmentlifecycle. Each chapter is focused on a specific University courseand is divided into two sections: theory and implementation. Thetheory sections explain the main concepts and principles whichremain valid across technological evolutions of medicalinstrumentation. The Implementation sections show how the theory istranslated into a medical product. The Electrocardiograph(ECG or EKG) is used as an example as it is a suitable device toexplore to fully understand medical instrumentation since it issufficiently simple but encompasses all the main areas involved indeveloping medical electronic equipment. Key Features: Introduces a system-level approach to product design Covers topics such as bioinstrumentation, signal processing,information theory, electronics, software, firmware, telemedicine,e-Health and medical device certification Explains how to use theory to implement a market product (usingECG as an example) Examines the design and applications of main medicalinstruments Details the additional know-how required for productimplementation: business context, system design, projectmanagement, intellectual property rights, product life cycle,etc. Includes an accompanying website with the design of thecertified ECG product (ahref="http://www.gammacardiosoft.it/book"www.gammacardiosoft.it/book/a) Discloses the details of a marketed ECG Product (from GammaCardio Soft) compliant with the ANSI standard AAMI EC 11under open licenses (GNU GPL, Creative Common) This book is written for biomedical engineering courses(upper-level undergraduate and graduate students) and for engineersinterested in medical instrumentation/device design with acomprehensive and interdisciplinary system perspective.

Pharmaceutical and Medical Device Validation by Experimental Design

Pharmaceutical and Medical Device Validation by Experimental Design Book
Author : Lynn D Torbeck
Publisher : CRC Press
Release : 2007-06-26
ISBN : 1420055704
Language : En, Es, Fr & De

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Book Description :

This title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design demonstrates why designed experiments are the most logical and rational ap