Designing Usability Into Medical Products

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Designing Usability into Medical Products

Author : Michael E. Wiklund,Stephen B. Wilcox
Publisher : CRC Press
Page : 376 pages
File Size : 49,5 Mb
Release : 2005-02-11
Category : Medical
ISBN : 9781420038088

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Designing Usability into Medical Products by Michael E. Wiklund,Stephen B. Wilcox Pdf

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.

Handbook of Human Factors in Medical Device Design

Author : Matthew Bret Weinger,Michael E. Wiklund,Daryle Jean Gardner-Bonneau
Publisher : CRC Press
Page : 844 pages
File Size : 45,8 Mb
Release : 2010-12-13
Category : Technology & Engineering
ISBN : 9781420063516

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Handbook of Human Factors in Medical Device Design by Matthew Bret Weinger,Michael E. Wiklund,Daryle Jean Gardner-Bonneau Pdf

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

Usability Testing of Medical Devices

Author : Michael E. Wiklund P.E.,Jonathan Kendler,Allison Y. Strochlic
Publisher : CRC Press
Page : 477 pages
File Size : 40,9 Mb
Release : 2015-12-23
Category : Medical
ISBN : 9781466595897

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Usability Testing of Medical Devices by Michael E. Wiklund P.E.,Jonathan Kendler,Allison Y. Strochlic Pdf

Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests.Since publication of the first edition, the FDA and other regulatory groups h

Medical Device and Equipment Design

Author : Michael E. Wiklund
Publisher : CRC Press
Page : 402 pages
File Size : 48,7 Mb
Release : 1995-02-15
Category : Technology & Engineering
ISBN : 0935184694

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Medical Device and Equipment Design by Michael E. Wiklund Pdf

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.

Applied Human Factors in Medical Device Design

Author : Mary Beth Privitera
Publisher : Academic Press
Page : 371 pages
File Size : 46,6 Mb
Release : 2019-06-15
Category : Science
ISBN : 9780128161647

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Applied Human Factors in Medical Device Design by Mary Beth Privitera Pdf

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

Humanizing Healthcare – Human Factors for Medical Device Design

Author : Russell J. Branaghan,Joseph S. O’Brian,Emily A. Hildebrand,L. Bryant Foster
Publisher : Springer Nature
Page : 395 pages
File Size : 47,5 Mb
Release : 2021-02-21
Category : Technology & Engineering
ISBN : 9783030644338

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Humanizing Healthcare – Human Factors for Medical Device Design by Russell J. Branaghan,Joseph S. O’Brian,Emily A. Hildebrand,L. Bryant Foster Pdf

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 for Safe Use

Author : Michael Wiklund,Jonathan Kendler,Jon Tilliss,Cory Costantino,Kimmy Ansems,Valerie Ng,Ruben Post,Brenda van Geel,Rachel Aronchick,Alix Dorfman
Publisher : CRC Press
Page : 588 pages
File Size : 51,7 Mb
Release : 2019-03-11
Category : Business & Economics
ISBN : 9781351579155

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Designing for Safe Use by Michael Wiklund,Jonathan Kendler,Jon Tilliss,Cory Costantino,Kimmy Ansems,Valerie Ng,Ruben Post,Brenda van Geel,Rachel Aronchick,Alix Dorfman Pdf

How do you prevent a critical care nurse from accidentally delivering a morphine overdose to an ill patient? Or ensure that people don't insert their arm into a hydraulic mulcher? And what about enabling trapped airline passengers to escape safely in an emergency? Product designers and engineers face myriad such questions every day. Failure to answer them correctly can result in product designs that lead to injury or even death due to use error. Historically, designers and engineers have searched for answers by sifting through complicated safety standards or obscure industry guidance documents. Designing for Safe Use is the first comprehensive source of safety-focused design principles for product developers working in any industry. Inside you’ll find 100 principles that help ensure safe interactions with products as varied as baby strollers, stepladders, chainsaws, automobiles, apps, medication packaging, and even airliners. You’ll discover how protective features such as blade guards, roll bars, confirmation screens, antimicrobial coatings, and functional groupings can protect against a wide range of dangerous hazards, including sharp edges that can lacerate, top-heavy items that can roll over and crush, fumes that can poison, and small parts that can pose a choking hazard. Special book features include: Concise, illustrated descriptions of design principles Sample product designs that illustrate the book’s guidelines and exemplify best practices Literature references for readers interested in learning more about specific hazards and protective measures Statistics on the number of injuries that have arisen in the past due to causes that might be eliminated by applying the principles in the book Despite its serious subject matter, the book’s friendly tone, surprising anecdotes, bold visuals, and occasional attempts at dry humor will keep you interested in the art and science of making products safer. Whether you read the book cover-to-cover or jump around, the book’s relatable and practical approach will help you learn a lot about making products safe. Designing for Safe Use is a primer that will spark in readers a strong appreciation for the need to design safety into products. This reference is for designers, engineers, and students who seek a broad knowledge of safe design solutions. .

Contextual Inquiry for Medical Device Design

Author : Mary Beth Privitera
Publisher : Academic Press
Page : 307 pages
File Size : 49,7 Mb
Release : 2015-05-29
Category : Technology & Engineering
ISBN : 9780128018743

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Contextual Inquiry for Medical Device Design by Mary Beth Privitera Pdf

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 Use Error

Author : Michael Wiklund,Andrea Dwyer,Erin Davis
Publisher : CRC Press
Page : 267 pages
File Size : 44,9 Mb
Release : 2016-01-06
Category : Medical
ISBN : 9781498705806

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Medical Device Use Error by Michael Wiklund,Andrea Dwyer,Erin Davis Pdf

Medical Device Use Error: Root Cause Analysis offers practical guidance on how to methodically discover and explain the root cause of a use error-a mistake-that occurs when someone uses a medical device. Covering medical devices used in the home and those used in clinical environments, the book presents informative case studies about the use errors

Usability Testing of Medical Devices

Author : Michael E. Wiklund P.E.,Jonathan Kendler,Allison Y. Strochlic
Publisher : CRC Press
Page : 378 pages
File Size : 48,7 Mb
Release : 2010-12-20
Category : Medical
ISBN : 9781439811849

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Usability Testing of Medical Devices by Michael E. Wiklund P.E.,Jonathan Kendler,Allison Y. Strochlic Pdf

To paraphrase a popular saying, usability testing should be done early and often. However, it doesn't have to be an onerous process. Informative, practical, and engaging, Usability Testing of Medical Devices provides a simple, easy to implement general understanding of usability testing. It offers a general understanding of usability testing and re

Medical Instrumentation

Author : Jack M. Winters,Molly Follette Story
Publisher : CRC Press
Page : 474 pages
File Size : 55,8 Mb
Release : 2006-10-31
Category : Medical
ISBN : 9781420006223

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Medical Instrumentation by Jack M. Winters,Molly Follette Story Pdf

Two of the most important yet often overlooked aspects of a medical device are its usability and accessibility. This is important not only for health care providers, but also for older patients and users with disabilities or activity limitations. Medical Instrumentation: Accessibility and Usability Considerations focuses on how lack of usabi

Usability Engineering and Human Factors for Medical Devices

Author : Bernadette White
Publisher : Independently Published
Page : 74 pages
File Size : 43,6 Mb
Release : 2022-02
Category : Electronic
ISBN : 9798680239209

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Usability Engineering and Human Factors for Medical Devices by Bernadette White Pdf

A short introduction to Usability in paperback- the perfect pocket book- Recent changes in regulation (e.g. MDR 2017/745) have increased the focus on usability requirements for medical devices. With stronger references to risks associated with use error and foreseeable misuse now requiring manufacturers to respond to foreseeable misuse. This short book introduces Usability Engineering and Human Factors Engineering providing a grounding in the principles of UE/HFE and the deliverables expected by manufacturers. As medical device vary in classification, complexity, cost and intended use, it is not feasible to provide a ready-made solution for device usability. However, if usability is integrated into the product development processes and risk management processes it can achieve devices that have minimal use related hazards. If medical devices are designed and developed without applying a usability engineering or human factors engineering, their use can be non-intuitive, difficult to learn, difficult to complete tasks and difficult to use. Furthermore, as technology and medical devices offer more innovative solutions, patients can now be tasked with using medical devices or administering their treatments, therefore usability becomes more important. While the goal of design should aim to provide medical devices that are inherently safe, as with most medical devices, residual risks remain once a product is designed, manufactured and validated clinically. Use errors or Usability errors contribute to those potential risk scenarios where medical device usability is an issue for the user. With the increasing abundance of medical devices is the observation, treatment and monitoring of patients, use errors must be assessed for medical devices and reduced to an acceptable level. In contrast to safety inherited by design, the least and often the last protective measures are warnings or contraindications provided on labelling or instructions for use. The strength of applying usability engineering principles (aka human factors engineering) medical devices is that use errors can be identified and mitigated through design and engineering practices, early-on in the product development and product realization cycle. Medical devices designed and developed devoid of usability engineering, are less intuitive, difficult to use and require focus and attention to learn to use them effectively. In addition, usability is a growing requirement from a regulatory perspective. A strength of this short book is its focus on the themes of usability, risk management and design control which interact together and if managed early-on in projects can benefit the user and deliver medical devices optimised for usability and human factors. At approx. 73 pages, this book does not intend to provide an expensive textbook solution to Usability, alternatively, it is a concise guide offering a 'to-the-point' reference at great value.

Design for Health

Author : Arathi Sethumadhavan,Farzan Sasangohar
Publisher : Academic Press
Page : 400 pages
File Size : 54,9 Mb
Release : 2020-01-29
Category : Computers
ISBN : 9780128166215

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Design for Health by Arathi Sethumadhavan,Farzan Sasangohar Pdf

Design for Health: Applications of Human Factors delves into critical and emergent issues in healthcare and patient safety and how the field of human factors and ergonomics play a role in this domain. The book uses the Design for X (DfX) methodology to discuss a wide range of contexts, technologies, and population dependent criteria (X’s) that must be considered in the design of a safe and usable healthcare ecosystem. Each chapter discusses a specific topic (e.g., mHealth, medical devices, emergency response, global health, etc.), reviews the concept, and presents a case study that demonstrates how human factors techniques and principles are utilized for the design, evaluation or improvements to specific tools, devices, and technologies (Section 1), healthcare systems and environments (Section 2), and applications to special populations (Section 3). The book represents an essential resource for researchers in academia as well as practitioners in medical device industries, consumer IT, and hospital settings. It covers a range of topics from medication reconciliation to self-care to the artificial heart. Uses the Design for X (DfX) methodology A case study approach provides practical examples for operationalization of key human factors principles and guidelines Provides specific design guidelines for a wide range of topics including resilience, stress and fatigue management, and emerging technologies Examines special populations, such as the elderly and the underserved Brings a multidisciplinary, multi-industry approach to a wide range of healthcare human factors issues

Design Controls for the Medical Device Industry

Author : Marie Teixeira,Richard Bradley
Publisher : CRC Press
Page : 258 pages
File Size : 50,7 Mb
Release : 2002-09-20
Category : Medical
ISBN : 0203909380

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Design Controls for the Medical Device Industry by Marie Teixeira,Richard Bradley Pdf

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

User Interface Requirements for Medical Devices

Author : Michael Wiklund,Erin Davis,Alexandria Trombley
Publisher : CRC Press
Page : 229 pages
File Size : 46,7 Mb
Release : 2021-11-16
Category : Technology & Engineering
ISBN : 9781000471847

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User Interface Requirements for Medical Devices by Michael Wiklund,Erin Davis,Alexandria Trombley Pdf

This book is a practical guide for individuals responsible for creating products that are safe, effective, usable, and satisfying in the hands of the intended users. The contents are intended to reduce the number of use errors involving medical devices that have led to injuries and deaths. The book presents the strong connection between user interface requirements and risk management for medical devices and instructs readers how to develop specific requirements that are sufficiently comprehensive and detailed to produce good results – a user-friendly product that is likely to be used correctly. The book’s tutorial content is complemented by many real-world examples of user interface requirements, including ones pertaining to an inhaler, automated external defibrillator, medical robot, and mobile app that a patient might use to manage her diabetes. The book is intended for people representing a variety of product development disciplines who have responsibility for producing safe, effective, usable, and satisfying medical devices, including those who are studying or working in human factors engineering, psychology, mechanical engineering, biomedical engineering, systems engineering, software programming, technical writing, industrial design, graphic design, and regulatory affairs.