Medical Device Design Book

Medical Device Design


  • Author : Peter J Ogrodnik
  • Publisher : Academic Press
  • Release Date : 2012-12-17
  • Genre: Technology & Engineering
  • Pages : 376
  • ISBN 10 : 9780123919434

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Medical Device Design Excerpt :

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

Handbook of Human Factors in Medical Device Design Book

Handbook of Human Factors in Medical Device Design


  • Author : Matthew Bret Weinger
  • Publisher : CRC Press
  • Release Date : 2010-12-13
  • Genre: Technology & Engineering
  • Pages : 844
  • ISBN 10 : 9781420063516

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Handbook of Human Factors in Medical Device Design Excerpt :

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

Applied Human Factors in Medical Device Design Book

Applied Human Factors in Medical Device Design


  • Author : Mary Beth Privitera
  • Publisher : Academic Press
  • Release Date : 2019-06-15
  • Genre: Science
  • Pages : 368
  • ISBN 10 : 9780128161647

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Applied Human Factors in Medical Device Design Excerpt :

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

Handbook of Medical Device Design Book

Handbook of Medical Device Design


  • Author : Richard C. Fries
  • Publisher : CRC Press
  • Release Date : 2019-08-15
  • Genre: Medical
  • Pages : 774
  • ISBN 10 : 9781000693874

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Handbook of Medical Device Design Excerpt :

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.

Design Controls for the Medical Device Industry Book

Design Controls for the Medical Device Industry


  • Author : Marie Teixeira
  • Publisher : CRC Press
  • Release Date : 2002-09-20
  • Genre: Medical
  • Pages : 254
  • ISBN 10 : 0203909380

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Design Controls for the Medical Device Industry Excerpt :

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 Design and Regulation Book

Medical Device Design and Regulation


  • Author : Carl T. DeMarco
  • Publisher : Quality Press
  • Release Date : 2011-01-01
  • Genre: Business & Economics
  • Pages : 328
  • ISBN 10 : 9780873898164

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Medical Device Design and Regulation Excerpt :

Six Sigma for Medical Device Design Book
Score: 3
From 2 Ratings

Six Sigma for Medical Device Design


  • Author : Jose Justiniano
  • Publisher : CRC Press
  • Release Date : 2004-11-15
  • Genre: Science
  • Pages : 152
  • ISBN 10 : 9780203485743

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Six Sigma for Medical Device Design Excerpt :

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

The Design and Manufacture of Medical Devices Book

The Design and Manufacture of Medical Devices


  • Author : J Paulo Davim
  • Publisher : Elsevier
  • Release Date : 2012-10-16
  • Genre: Medical
  • Pages : 386
  • ISBN 10 : 9781908818188

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The Design and Manufacture of Medical Devices Excerpt :

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

Medical Instrument Design and Development Book
Score: 4
From 1 Ratings

Medical Instrument Design and Development


  • Author : Claudio Becchetti
  • Publisher : John Wiley & Sons
  • Release Date : 2013-05-20
  • Genre: Science
  • Pages : 600
  • ISBN 10 : 9781118652466

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Medical Instrument Design and Development Excerpt :

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 m

Reliable Design of Medical Devices Book

Reliable Design of Medical Devices


  • Author : Richard C. Fries
  • Publisher : CRC Press
  • Release Date : 2005-11-21
  • Genre: Medical
  • Pages : 504
  • ISBN 10 : 9781420027945

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Reliable Design of Medical Devices Excerpt :

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.

Contextual Inquiry for Medical Device Design Book

Contextual Inquiry for Medical Device Design


  • Author : Mary Beth Privitera
  • Publisher : Academic Press
  • Release Date : 2015-05-29
  • Genre: Technology & Engineering
  • Pages : 310
  • ISBN 10 : 9780128018743

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Contextual Inquiry for Medical Device Design Excerpt :

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

Foundations and Strategies for Medical Device Design Book

Foundations and Strategies for Medical Device Design


  • Author : Vikki Hazelwood
  • Publisher : McGraw Hill Professional
  • Release Date : 2021-06-22
  • Genre: Technology & Engineering
  • Pages : null
  • ISBN 10 : 9781260456967

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Foundations and Strategies for Medical Device Design Excerpt :

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 Device and Equipment Design Book
Score: 5
From 1 Ratings

Medical Device and Equipment Design


  • Author : Michael E. Wiklund
  • Publisher : CRC Press
  • Release Date : 1995-02-15
  • Genre: Technology & Engineering
  • Pages : 398
  • ISBN 10 : 0935184694

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Medical Device and Equipment Design Excerpt :

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.

Medical Device Design for Six Sigma Book

Medical Device Design for Six Sigma


  • Author : Basem El-Haik
  • Publisher : John Wiley & Sons
  • Release Date : 2011-09-20
  • Genre: Medical
  • Pages : 528
  • ISBN 10 : 9781118210413

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Medical Device Design for Six Sigma Excerpt :

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 and Development of Medical Electronic Instrumentation Book
Score: 4.5
From 2 Ratings

Design and Development of Medical Electronic Instrumentation


  • Author : David Prutchi
  • Publisher : John Wiley & Sons
  • Release Date : 2005-01-28
  • Genre: Technology & Engineering
  • Pages : 461
  • ISBN 10 : 9780471681830

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Design and Development of Medical Electronic Instrumentation Excerpt :

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.