Handbook of Human Factors in Medical Device Design PDF Download

Author: Matthew Bret Weinger
Publisher: CRC Press
ISBN: 1420063510
Category : Technology & Engineering
Languages : en
Pages : 822

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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

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Publisher: Academic Press
ISBN: 0123919436
Category : Technology & Engineering
Languages : en
Pages : 369

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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

Author: Mary Beth Privitera
Publisher: Academic Press
ISBN: 0128161647
Category : Science
Languages : en
Pages : 371

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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

Author: Bon Ku
Publisher: MIT Press
ISBN: 0262358913
Category : Design
Languages : en
Pages : 226

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Book Description
Applying the principles of human-centered design to real-world health care challenges, from drug packaging to early detection of breast cancer. This book makes a case for applying the principles of design thinking to real-world health care challenges. As health care systems around the globe struggle to expand access, improve outcomes, and control costs, Health Design Thinking offers a human-centered approach for designing health care products and services, with examples and case studies that range from drug packaging and exam rooms to internet-connected devices for early detection of breast cancer. Written by leaders in the field—Bon Ku, a physician and founder of the innovative Health Design Lab at Sidney Kimmel Medical College, and Ellen Lupton, an award-winning graphic designer and curator at Cooper Hewitt Smithsonian Design Museum—the book outlines the fundamentals of design thinking and highlights important products, prototypes, and research in health design. Health design thinking uses play and experimentation rather than a rigid methodology. It draws on interviews, observations, diagrams, storytelling, physical models, and role playing; design teams focus not on technology but on problems faced by patients and clinicians. The book's diverse case studies show health design thinking in action. These include the development of PillPack, which frames prescription drug delivery in terms of user experience design; a credit card–size device that allows patients to generate their own electrocardiograms; and improved emergency room signage. Drawings, photographs, storyboards, and other visualizations accompany the case studies. Copublished with Cooper Hewitt, Smithsonian Design Museum

Author: J. Paulo Davim
Publisher: Elsevier
ISBN: 1908818182
Category : Technology & Engineering
Languages : en
Pages : 382

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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

Author: Michael E. Wiklund
Publisher: CRC Press
ISBN: 1040295363
Category : Technology & Engineering
Languages : en
Pages : 402

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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.

Author: Carl T. DeMarco
Publisher: Quality Press
ISBN: 0873898168
Category : Business & Economics
Languages : en
Pages : 369

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Book Description

Author: Mary Beth Privitera
Publisher: Academic Press
ISBN: 0128018747
Category : Technology & Engineering
Languages : en
Pages : 307

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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

Author: Marie Teixeira
Publisher: CRC Press
ISBN: 9780203909386
Category : Medical
Languages : en
Pages : 258

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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

Author: Jose Justiniano
Publisher: CRC Press
ISBN: 0203485742
Category : Science
Languages : en
Pages : 152

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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