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User Interface Requirements for Medical Devices

User Interface Requirements for Medical Devices PDF Author: Michael Wiklund
Publisher: CRC Press
ISBN: 1000471845
Category : Technology & Engineering
Languages : en
Pages : 229

Book Description
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.

User Interface Requirements for Medical Devices

User Interface Requirements for Medical Devices PDF Author: Michael Wiklund
Publisher: CRC Press
ISBN: 1000471845
Category : Technology & Engineering
Languages : en
Pages : 229

Book Description
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.

Designing Usability into Medical Products

Designing Usability into Medical Products PDF Author: Michael E. Wiklund
Publisher: CRC Press
ISBN: 1420038087
Category : Medical
Languages : en
Pages : 376

Book Description
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.

Medical Device and Equipment Design

Medical Device and Equipment Design PDF Author: Michael E. Wiklund
Publisher: CRC Press
ISBN: 9780935184693
Category : Technology & Engineering
Languages : en
Pages : 402

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.

Humanizing Healthcare – Human Factors for Medical Device Design

Humanizing Healthcare – Human Factors for Medical Device Design PDF Author: Russell J. Branaghan
Publisher: Springer Nature
ISBN: 3030644332
Category : Technology & Engineering
Languages : en
Pages : 395

Book Description
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.

Healthcare and Medical Devices

Healthcare and Medical Devices PDF Author: Jay Kalra and Nancy Lightner
Publisher: AHFE International
ISBN: 1958651559
Category : Technology & Engineering
Languages : en
Pages : 333

Book Description
Proceedings of the 14th International Conference on Applied Human Factors and Ergonomics (AHFE 2023), July 20–24, 2023, San Francisco, USA

Handbook of Human Factors in Medical Device Design

Handbook of Human Factors in Medical Device Design PDF Author: Matthew Bret Weinger
Publisher: CRC Press
ISBN: 1420063510
Category : Technology & Engineering
Languages : en
Pages : 844

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

Advances in Industrial Design

Advances in Industrial Design PDF Author: Giuseppe Di Bucchianico
Publisher: Springer Nature
ISBN: 3030511944
Category : Technology & Engineering
Languages : en
Pages : 1031

Book Description
This book addresses current research trends and practice in industrial design. Going beyond the traditional design focus, it explores a range of recent and emerging aspects concerning service design, human–computer interaction and user experience design, sustainable design, virtual & augmented reality, as well as inclusive/universal design, and design for all. A further focus is on apparel and fashion design: here, innovations, developments and challenges in the textile industry, including applications of material engineering, are taken into consideration. Papers on pleasurable and affective design, including studies on emotional user experience, emotional interaction design and topics related to social networks make up a major portion of the contributions included in this book, which is based on five AHFE 2020 international conferences (the AHFE 2020 Virtual Conference on Design for Inclusion, the AHFE 2020 Virtual Conference on Interdisciplinary Practice in Industrial Design, the AHFE 2020 Virtual Conference on Affective and Pleasurable Design, the AHFE 2020 Virtual Conference on Kansei Engineering, and the AHFE 2020 Virtual Conference on Human Factors for Apparel and Textile Engineering) held on July 16–20, 2020. Thanks to its multidisciplinary approach, it provides graduate students, researchers and professionals in engineering, architecture, computer and materials science with extensive information on research trends, innovative methods and best practices, and a unique bridge fostering collaborations between experts from different disciplines and sectors.

Introduction to Medical Software

Introduction to Medical Software PDF Author: Xenophon Papademetris
Publisher: Cambridge University Press
ISBN: 1316514994
Category : Business & Economics
Languages : en
Pages : 341

Book Description
A concise and accessible overview of the design, implementation and management of medical software.

Medical Instrument Design and Development

Medical Instrument Design and Development PDF Author: Claudio Becchetti
Publisher: John Wiley & Sons
ISBN: 1119952409
Category : Science
Languages : en
Pages : 612

Book Description
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.

Usability Testing of Medical Devices

Usability Testing of Medical Devices PDF Author: Michael E. Wiklund P.E.
Publisher: CRC Press
ISBN: 1466595892
Category : Medical
Languages : en
Pages : 477

Book Description
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