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分析

我们的人因专家会进行广泛的分析,这些分析有助于设计安全、有效和可用的产品,并且符合监管机构对于在产品设计中应用人为因素的期望。 我们的人为因素“工具包”包含许多类型的分析,重点关注人们与产品的心理和物理交互过程。 

进行与产品使用相关的全面风险分析,是开发出一项安全产品的核心,我们已经与客户协作或者代表他们完成了很多这方面的分析。

医疗产品和消费品与使用相关的风险分析

我们与使用相关风险分析的技术方法能够鉴别出可能发生的使用场景相关的可能发生的使用错误。我们会充分考虑到在存在各种性能塑造因素的情况下, 人们与一项产品进行互动的时候可能会犯错的所有方式。 比如护理人员一边照顾着正在经历气流颠簸的空中救护车上运送的重症患者,一边操作医用监护仪/除颤器时可能发生的错误。

我们通过多种方式来找到潜在的使用错误,包括:

  • 任务分析,
  • 危害分析,
  • 已知问题分析,
  • 培训师和用户访谈,
  • 基准可用性测试,
  • 和创造性的活动(例如,头脑风暴)。 

然后,我们会对由使用错误引起的潜在危害的严重性以及发生错误的可能性进行估计。 虽然潜在危害的严重程度和错误的可能性都被包含在风险评估因素之中,但决定 应采取何种风险缓解措施的最重要因素还是潜在危害的严重程度。

任务分析

我们可以研究与产品用户界面相关的用户任务流程,这些用户界面可能是初步的、改良的或最终的产品形式。 通常,我们的分析涉及到确定离散感知、认知步骤和行动的顺序和相互关系(通常称为PCA分析 并在美国FDA关于医疗器械开发的指导文件中被引用)。 通过该分析,具有降低使用错误以及提高交互效率潜力的部分变得更加清晰可见。

危害分析

我们的危害分析是对任务分析的补充。 危害分析不针对任务流程,也不考虑哪些使用错误可能导致损害,而是假设发生了某种损害,然后考虑何种错误可能导致了它的发生。  因此,我们可能会借着假设发生了下列形式的损害来开始分析:烧伤(热和化学)、电击、生物污染(即感染)、辐射暴露,以及各种类型的身体甚至情感创伤。 然后,我们的任务是分析何种使用错误或其他可能造成了这种损害的因素。

例如,我们可能会将造成电击的原因与用户将医用监护仪引线插入到电源插座链接起来,而非关联数据传输端口。在确认这是一种安全威胁后,我们的分析人员可以建议对引线的形状进行调整,使其不能插入到交流电源插座中,或只能插入到适当的传感器电缆端口中。

已知问题分析

考虑与正在开发产品相类似的产品失败的经验,以及人们在使用这些产品时犯了什么错误等因素,是一种明智的做法。 因此,开展已知问题分析(KPA)是非常有价值的,它可以作为以史为鉴的结构化新措施。

分析输入包括对可用不良事件数据库中发现的信息(例如, MAUDE )、客户投诉系统中的可用数据以及产品培训师和用户的见解等的审查(即报告)。

我们分析的最终产品通常是一系列问题,以用户界面功能如何引发使用错误的形式来阐明。 这些见解可以转换为旨在消除正在开发产品使用错误漏洞的设计规范。

不良事件分析

我们的人为因素专家经常根据客户需求,研究不良事件并找出其最可能的根本原因。 相关案例:

  • 确定一个手术抽吸系统的使用界面可能如何诱导手术团队成员对被动胸腔引流手术施加高压吸力,从而导致致命的肺损伤。
  • 确定血液透析机的使用界面如何诱导透析护士和技术人员忽视机器从患者身上抽走了过多的液体,从而引发血容量过高(体内缺乏液体)并导致死亡/
  • 确定自动体外除颤器的使用界面如何诱导用户对电池进行测试,导致在无意中使设备放电,无法在需要挽救心律失常并危及生命的病人时正常运作。

我们的分析 涉及对不良事件中的用户交互细节进行研究,对产品用户界面的人为因素适用性进行审查,还要考虑到其他性能塑造方面的因素,从而做出某项设计缺陷如何引发不良事件发生的假设。 有时候我们会发现这样的缺陷,有时候我们会得出结论:用户界面并非造成这种缺陷的原因。

人体测量分析

我们的专家精通历史悠久的人体测量分析科学。 我们利用人类身高、体型、强度、运动范围和其他物理特征方面的大量数据 来进行几何研究(2D和3D)。 这些研究有助于我们找出产品与预期用户身体特征的匹配程度。 在实践中,我们进行过这样的分析以确定以下事项:

  • CAT扫描仪操作员是否触摸得到位于不同倾斜度表面控制面板上的控制键。
  • 一位身体统计数据占5百分位的女性在紧急情况下可以使出多大的力气,利用杠杆作用打开故障的半自动喂药器。
  • 手术器械的适当尺寸,使得无论是双手非常大或小的人拿着它时,都能感觉舒适并且正常驱动。
  • 适当的尺寸和零部件可以组成坐立式工作站。工作站是执行机器人协助手术的外科医生操作的。

Questions? Request more information from our specialists

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Meet our team at Meet Emergo at Medica, Nov 12, 2018 to Nov 15, 2018 in Düsseldorf, Germany

FIND OUT MORE >

User research leads to a richer understanding of the factors controlling the quality of user interactions with your product.
Our human factors “toolkit” contains many types of analyses that focus on mental and physical interactions with products.
Our medical device UI design approach leverages user research to achieve functional and aesthetic goals.
Summative usability testing, formative usability testing, expert critiques, heuristic analyses, cognitive walkthroughs, and more.
We want to make the world safer and better through HFE research, training, consulting, and program development.

The HFR&D team includes over 60 research, design, and evaluation professionals, many of whom hold advanced degrees in their field and are Certified Human Factors Professionals (CHFP). Learn more about this credential here

 

Michael Wiklund, CHFP, MS

General Manager, HFR&D
Allison Strochlic

Allison Strochlic, CHFP, MS

Research Director

Merrick Kossack, MS

Research Director

Mary Burton, MS

User Experience Director
richard-featherstone

Richard Featherstone

Managing Director
Mark Tavano

Mark Tavano, MBA

Director, Sales - HFR&D

Coming soon: Designing for Safe Use (CRC Press, late 2018)

by Kimmy Ansems, Cory Costantino, Alix Dorfman, Brenda Van Geel, Jonathan Kendler, Rachel Aronchick, Valerie Ng, Ruben Post, Jon Tilliss, and Michael Wiklund

We – this book’s authors/designers – are members of the Human Factors Research and Design (HFR&D) at EMERGO by UL. In this book, we have consolidated the lessons we have learned about designing for safe use, that is, designing products that shield people from harm to the extent possible.

We settled on a target of 100 principles on how to make products safer. The principles pertain to hardware, software, document, and document design. Yes, settling on an even one hundred principles was a bit arbitrary and cliché. The myriad ways to design for safe use do not stop sharply at one hundred. But, we think we covered many of the key ones.

We elected to use the term “product” broadly to cover things one might consider to be systems, machines, equipment, instruments, tools, applications, manuals, and instructions. These are all things that need to be designed properly to eliminate or reduce the chance of harm due to normal use and foreseeable misuse.

Most of the design principles could be addressed in an expanded form; even an entire book of its own. We choose brevity for the sake of communicating core concepts with some fun facts to spice things up.

As you read the book, be mindful that the science and art of making things safe is ever changing and that some of the content we present is sure to age. So, complement our guidance with insights you may gain from other sources, ranging from books to technical articles to standards and more.

 


 

Usability Testing of Medical Devices - Second Edition

by Michael Wiklund, Jonathan Kendler, and Allison Strochlic

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 have modified their regulations and expectations regarding how medical device manufacturers should approach usability testing. Reflecting these changes, this Second Edition provides updated guidance to readers with an interest or direct role in conducting a usability test of a medical device or system. Key updates involve the 2011 FDA guidance on human factors engineering, requirements set forth by the third edition of IEC 60601 and closely related IEC 62366-1:2015, linking usability test tasks to risk analysis results, and analyzing root causes of use errors that occur during usability tests.

Written by seasoned human factors specialists, Usability Testing of Medical Devices, Second Edition is an informative, practical, and up-to-date handbook for conducting usability tests of medical devices. The book helps ensure a smooth and painless development process―and thus, safe and effective medical devices. Buy the book.

 


 

Writing Human Factors Plans and Reports for Medical Technology Development

By Michael Wiklund, Laura Birmingham, and Stephanie Larsen

This book provides the foundation for developing specific human factors engineering (HFE) work products that are needed to meet the FDA's human factors engineering (HFE) guidance. The authors have created a fictitious company and product to generate concrete examples of the plans and reports developed during various stages of HFE. The book includes an HFE project plan, a formative usability test plan and report, a summative (i.e., validation) usability test plan and report, and an HFE report. These work products and additional content outline the activities necessary to develop safe and effective medical devices, making this book an ideal resource for anyone interested in the medical technology field. Buy the book.

 


 

Medical Device Use Error Root Cause Analysis
by Michael Wiklund, Andrea Dwyer, and Erin Davis

This book 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 (mistakes) that people make when using a medical device, the potential consequences, and design-based preventions.

 

Using clear illustrations and simple narrative explanations, the text:

  • Covers the fundamentals and language of root cause analysis and regulators’ expectations regarding the thorough analysis of use errors
  • Describes how to identify use errors, interview users about use errors, and fix user interface design flaws that could induce use errors
  • Reinforces the application of best practices in human factors engineering, including conducting both formative and summative usability tests 

Buy the book

 


 

Handbook of Human Factors in Medical Device Design

Edited by Matthew Weinger, Michael Wiklund, and Daryle Gardner-Bonneau

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 on user-centric design supported by discussions of design issues, case studies, and examples. The book sets the foundation with coverage of fundamental topics such as aligning the interactive nature of medical devices to the expected use environments ranging from hospitals and ambulances to patients’ homes, drawing on anthropometric and biomechanical data to ensure that designs match the intended users’ bodies and physical abilities, and conducting usability tests and other evaluations to ensure that devices perform as intended. It then focuses on applied design issues, offering guidance on the design of specific types of devices and designing devices for particular use environments. Adapted in part from established design standards and conventions, the design guidance presented in this work distills professional judgment extracted from the contributing authors’ years of experience in applied analysis and design. Written in true handbook style, each chapter stands alone and includes tables, illustrations, and cross references, allowing you to quickly find the exact information you need. Most chapters begin with a general introduction to the selected topic, followed by the presentation of general and special design considerations and then specific, numbered design guidelines. The book also presents a listing of resources, literature, and website references. It not only focuses on the human factors issues that arise when developing medical devices, it supplies the necessary guidance to resolve them. Buy the book.

 


 

Designing Usability into Medical Products
by Michael Wiklund and Stephen Wilcox

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. Buy the book.

 


 

Usability in Practice

Editor: Michael Wiklund

This volume investigates how major corporations, such as Microsoft, Borland, Apple, Eastman Kodak, and Silicon Graphics, address usability issues. It presents case studies of each organization, outlining their program structures, program goals, and team members' responsibilities and resources. The book also addresses how usability is marketed inside the organization and to customers, as well as the lessons learned during the course of product development efforts. Each illustrated study includes advice that should help readers establish and manage their own program.

Out of print. Used copies might be available.

 


 

The Beauty of Unity-in-Variety

by Ruben Post

This thesis embarks from the idea that aesthetic appreciation of product designs is determined by simultaneously perceiving the two partially opposing dimensions of unity and variety. People actively avoid boredom by searching for variety because it challenges the senses and offers the potential of learning new information. Hence, people browse through thick catalogues, are attracted to colourful bouquets and let their eyes and hands explore a novel car interior. In doing so, these products offer stimulation to the senses. However, too much variety leads to confusion, as people fail to make sense of what they perceive. It is therefore that they appreciate perceiving unity at the same time, as it brings structure to variety; items in a catalogue are precisely ordered, flowers are neatly arranged and components of a car interior are carefully picked and organized. The above idea is captured in an age-old aesthetic principle, aptly named Unity-in-Variety (UiV). The principle states that perceiving a balance between the opposing forces of unity and variety is aesthetically preferred. While this principle has been argued to explain aesthetic appreciation for works of art, music and landscapes, little empirical research existed on this principle and, to our knowledge, none for product designs.

Available at Institutional Repository, Delft University in Delft, The Netherlands. Contact Ruben Post at ruben.post@ul.com.

 

 

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