Medical Device Design

Medical Device Design
Author: Peter J Ogrodnik
Publsiher: Academic Press
Total Pages: 376
Release: 2012-12-17
Genre: Technology & Engineering
ISBN: 9780123919434

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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

Contextual Inquiry for Medical Device Design

Contextual Inquiry for Medical Device Design
Author: Mary Beth Privitera
Publsiher: Academic Press
Total Pages: 307
Release: 2015-05-29
Genre: Technology & Engineering
ISBN: 9780128018743

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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 and Regulation

Medical Device Design and Regulation
Author: Carl T. DeMarco
Publsiher: Quality Press
Total Pages: 369
Release: 2011-01-01
Genre: Business & Economics
ISBN: 9780873898164

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The Design and Manufacture of Medical Devices

The Design and Manufacture of Medical Devices
Author: J Paulo Davim
Publsiher: Elsevier
Total Pages: 386
Release: 2012-10-16
Genre: Medical
ISBN: 9781908818188

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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

Handbook of Human Factors in Medical Device Design

Handbook of Human Factors in Medical Device Design
Author: Matthew Bret Weinger,Michael E. Wiklund,Daryle Jean Gardner-Bonneau
Publsiher: CRC Press
Total Pages: 844
Release: 2010-12-13
Genre: Technology & Engineering
ISBN: 9781420063516

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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

Applied Human Factors in Medical Device Design
Author: Mary Beth Privitera
Publsiher: Academic Press
Total Pages: 371
Release: 2019-06-15
Genre: Science
ISBN: 9780128161647

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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

Handbook of Medical Device Design
Author: Richard C. Fries
Publsiher: CRC Press
Total Pages: 491
Release: 2019-08-15
Genre: Medical
ISBN: 9781000696950

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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.

Reliable Design of Medical Devices

Reliable Design of Medical Devices
Author: Richard C. Fries
Publsiher: CRC Press
Total Pages: 490
Release: 2005-11-21
Genre: Medical
ISBN: 9781420027945

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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.