Medical Device Design

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Medical Device Design

Author : Peter J Ogrodnik
Publisher : Academic Press
ISBN 13 : 0123919436
Total Pages : 376 pages
Book Rating : 4.1/5 (239 download)

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Book Synopsis Medical Device Design by : Peter J Ogrodnik

Download or read book Medical Device Design written by Peter J Ogrodnik and published by Academic Press. This book was released on 2012-12-17 with total page 376 pages. Available in PDF, EPUB and Kindle. Book 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

Author : Matthew Bret Weinger
Publisher : CRC Press
ISBN 13 : 1420063510
Total Pages : 844 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Handbook of Human Factors in Medical Device Design by : Matthew Bret Weinger

Download or read book Handbook of Human Factors in Medical Device Design written by Matthew Bret Weinger and published by CRC Press. This book was released on 2010-12-13 with total page 844 pages. Available in PDF, EPUB and Kindle. Book 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

Author : Mary Beth Privitera
Publisher : Academic Press
ISBN 13 : 0128161647
Total Pages : 371 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Applied Human Factors in Medical Device Design by : Mary Beth Privitera

Download or read book Applied Human Factors in Medical Device Design written by Mary Beth Privitera and published by Academic Press. This book was released on 2019-06-15 with total page 371 pages. Available in PDF, EPUB and Kindle. Book 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

The Design and Manufacture of Medical Devices

Author : J Paulo Davim
Publisher : Elsevier
ISBN 13 : 1908818182
Total Pages : 386 pages
Book Rating : 4.9/5 (88 download)

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Book Synopsis The Design and Manufacture of Medical Devices by : J Paulo Davim

Download or read book The Design and Manufacture of Medical Devices written by J Paulo Davim and published by Elsevier. This book was released on 2012-10-16 with total page 386 pages. Available in PDF, EPUB and Kindle. Book 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

Contextual Inquiry for Medical Device Design

Author : Mary Beth Privitera
Publisher : Academic Press
ISBN 13 : 0128018747
Total Pages : 307 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Contextual Inquiry for Medical Device Design by : Mary Beth Privitera

Download or read book Contextual Inquiry for Medical Device Design written by Mary Beth Privitera and published by Academic Press. This book was released on 2015-05-29 with total page 307 pages. Available in PDF, EPUB and Kindle. Book 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

Medical Device Design for Six Sigma

Author : Basem El-Haik
Publisher : John Wiley & Sons
ISBN 13 : 1118210417
Total Pages : 528 pages
Book Rating : 4.1/5 (182 download)

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Book Synopsis Medical Device Design for Six Sigma by : Basem El-Haik

Download or read book Medical Device Design for Six Sigma written by Basem El-Haik and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 528 pages. Available in PDF, EPUB and Kindle. Book 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.

Medical Device Design and Regulation

Author : Carl T. DeMarco
Publisher : Quality Press
ISBN 13 : 0873898168
Total Pages : 369 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis Medical Device Design and Regulation by : Carl T. DeMarco

Download or read book Medical Device Design and Regulation written by Carl T. DeMarco and published by Quality Press. This book was released on 2011-01-01 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Humanizing Healthcare – Human Factors for Medical Device Design

Author : Russell J. Branaghan
Publisher : Springer Nature
ISBN 13 : 3030644332
Total Pages : 395 pages
Book Rating : 4.0/5 (36 download)

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Book Synopsis Humanizing Healthcare – Human Factors for Medical Device Design by : Russell J. Branaghan

Download or read book Humanizing Healthcare – Human Factors for Medical Device Design written by Russell J. Branaghan and published by Springer Nature. This book was released on 2021-02-21 with total page 395 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Reliable Design of Medical Devices

Author : Richard C. Fries
Publisher : CRC Press
ISBN 13 : 1420027948
Total Pages : 490 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Reliable Design of Medical Devices by : Richard C. Fries

Download or read book Reliable Design of Medical Devices written by Richard C. Fries and published by CRC Press. This book was released on 2005-11-21 with total page 490 pages. Available in PDF, EPUB and Kindle. Book 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.

Design Controls for the Medical Device Industry

Author : Marie Teixeira
Publisher : CRC Press
ISBN 13 : 9780203909386
Total Pages : 258 pages
Book Rating : 4.9/5 (93 download)

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Book Synopsis Design Controls for the Medical Device Industry by : Marie Teixeira

Download or read book Design Controls for the Medical Device Industry written by Marie Teixeira and published by CRC Press. This book was released on 2002-09-20 with total page 258 pages. Available in PDF, EPUB and Kindle. Book 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

Design of Medical Electronic Devices

Author : Reinaldo Perez
Publisher : Elsevier
ISBN 13 : 008049109X
Total Pages : 294 pages
Book Rating : 4.0/5 (84 download)

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Book Synopsis Design of Medical Electronic Devices by : Reinaldo Perez

Download or read book Design of Medical Electronic Devices written by Reinaldo Perez and published by Elsevier. This book was released on 2002-03-21 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Handbook of Medical Device Design

Author : Richard C. Fries
Publisher : CRC Press
ISBN 13 : 1000693872
Total Pages : 795 pages
Book Rating : 4.0/5 (6 download)

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Book Synopsis Handbook of Medical Device Design by : Richard C. Fries

Download or read book Handbook of Medical Device Design written by Richard C. Fries and published by CRC Press. This book was released on 2019-08-15 with total page 795 pages. Available in PDF, EPUB and Kindle. Book 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 and Development of Medical Electronic Instrumentation

Author : David Prutchi
Publisher : John Wiley & Sons
ISBN 13 : 0471681830
Total Pages : 479 pages
Book Rating : 4.4/5 (716 download)

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Book Synopsis Design and Development of Medical Electronic Instrumentation by : David Prutchi

Download or read book Design and Development of Medical Electronic Instrumentation written by David Prutchi and published by John Wiley & Sons. This book was released on 2005-01-28 with total page 479 pages. Available in PDF, EPUB and Kindle. Book 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.

Medical Instrument Design and Development

Author : Claudio Becchetti
Publisher : John Wiley & Sons
ISBN 13 : 1119952409
Total Pages : 612 pages
Book Rating : 4.1/5 (199 download)

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Book Synopsis Medical Instrument Design and Development by : Claudio Becchetti

Download or read book Medical Instrument Design and Development written by Claudio Becchetti and published by John Wiley & Sons. This book was released on 2013-07-29 with total page 612 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains all of the stages involved in developing medical devices; from concept to medical approval including system engineering, bioinstrumentation design, signal processing, electronics, software and ICT with Cloud and e-Health development. Medical Instrument Design and Development offers a comprehensive theoretical background with extensive use of diagrams, graphics and tables (around 400 throughout the book). The book explains how the theory is translated into industrial medical products using a market-sold Electrocardiograph disclosed in its design by the Gamma Cardio Soft manufacturer. The sequence of the chapters reflects the product development lifecycle. Each chapter is focused on a specific University course and is divided into two sections: theory and implementation. The theory sections explain the main concepts and principles which remain valid across technological evolutions of medical instrumentation. The Implementation sections show how the theory is translated into a medical product. The Electrocardiograph (ECG or EKG) is used as an example as it is a suitable device to explore to fully understand medical instrumentation since it is sufficiently simple but encompasses all the main areas involved in developing 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 (using ECG as an example) Examines the design and applications of main medical instruments Details the additional know-how required for product implementation: business context, system design, project management, intellectual property rights, product life cycle, etc. Includes an accompanying website with the design of the certified ECG product (www.gammacardiosoft.it/book) Discloses the details of a marketed ECG Product (from Gamma Cardio Soft) compliant with the ANSI standard AAMI EC 11 under open licenses (GNU GPL, Creative Common) This book is written for biomedical engineering courses (upper-level undergraduate and graduate students) and for engineers interested in medical instrumentation/device design with a comprehensive and interdisciplinary system perspective.

Design, Execution, and Management of Medical Device Clinical Trials

Author : Salah M. Abdel-aleem
Publisher : John Wiley & Sons
ISBN 13 : 9780470475904
Total Pages : 296 pages
Book Rating : 4.4/5 (759 download)

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Book Synopsis Design, Execution, and Management of Medical Device Clinical Trials by : Salah M. Abdel-aleem

Download or read book Design, Execution, and Management of Medical Device Clinical Trials written by Salah M. Abdel-aleem and published by John Wiley & Sons. This book was released on 2009-08-19 with total page 296 pages. Available in PDF, EPUB and Kindle. Book excerpt: An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the author's and other researchers' previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured. Additional coverage includes: Qualification and selection of investigators Study monitoring visits Definitions and reporting procedures for adverse events The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints The roles and responsibilities of all members of a clinical research team The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic. Design, Execution, and Management of Medical Device Clinical Trials is an excellent book for clinical research or epidemiology courses at the upper-undergraduate and graduate levels. It is also an indispensable reference for clinical research associates, clinical managers, clinical scientists, biostatisticians, pharmacologists, and any professional working in the field of clinical research who would like to better understand clinical research practices.

Designing Usability into Medical Products

Author : Michael E. Wiklund
Publisher : CRC Press
ISBN 13 : 1420038087
Total Pages : 376 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Designing Usability into Medical Products by : Michael E. Wiklund

Download or read book Designing Usability into Medical Products written by Michael E. Wiklund and published by CRC Press. This book was released on 2005-02-11 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS

Author : Vernon Geckler
Publisher : Wasatch Consulting Resources LLC
ISBN 13 : 0692835415
Total Pages : 441 pages
Book Rating : 4.6/5 (928 download)

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Book Synopsis DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS by : Vernon Geckler

Download or read book DESIGN CONTROLS, RISK MANAGEMENT & PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS written by Vernon Geckler and published by Wasatch Consulting Resources LLC. This book was released on 2017-02-11 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA & ISO 13485 design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 20-40 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.