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评估

在产品开发过程中,有效的设计评估是用户界面设计的核心 ,也是确保良好用户体验的动力。

评估产品的方法有很多种,最佳方式取决于产品开发阶段以及可用资源(例如:时间、资金、原型或完成产品)。 我们的评估方法包括:

  • 设计评论/专家评论/启发式分析
  • 认知演练(通过使用场景进行讨论)
  • 形成(初步)可用性测试
  • 总结(验证)可用性测试

早期评估

我们采用许多技术来收集有关早期设计概念的反馈。 其中一种技术称为认知演练。此方法会要求受访者对产品草图、简单的实体模型或一系列静态计算机屏幕进行研究、思考和解释他们会如何执行一项指定任务。

例子:

  • 通过查看多个样本屏幕和处理“块体模型”来对操作胰岛素输注泵的相关工作流程进行评估。
  • 获得关于与可穿戴心脏泵(左心室辅助装置)相关配件(例如背包、腰包、斜挎包、挎包)的多个概念的反馈。
  • 使用3D渲染软件和精确测量的3D打印模型,对多个医用监护仪设计概念中的用户偏好进行评估。

中期评估

我们经常会根据用户要求,对产品进行评估,也被称为专家评审或启发式分析。在这些情况下,我们应用既定的设计原则和我们自己的判断来找出用户界面的设计优势和改进机会。 这种评估通常可以快速地以低成本方式完成,但却能得出很有价值的结论。

我们会依需要对产品进行形成性可用性测试。这样的测试可以快速地为可能处于开发冲刺阶段的设计团队提供 研究结论。 形成性测试也可能是一项涉及详细测试计划和报告的更加正式的活动。

例子:

  • 对与智能手机上使用的健身App相关的屏幕进行专家评审。
  • 对外骨骼进行8人参与的形成性可用性测试,用于帮助中风患者重新获得行走能力。
  • 按照旨在用于随后的总结性(即验证性)可用性测试的测试计划,对一台透析仪进行15人参与的“预总结性”可用性测试。

产品评估可显示设计优势和改良机会,如下表关于一台假想的家用透析仪的相关事项所示。

样本调查结果

正面

负面

  1. 视觉警报以显眼(即,引人注目)的方式显示。
    [信息来源: 评论]
  2. 用户认为设置工作流程非常直观。
    [信息来源: 认知演练]
  3. 小手掌和大手掌 的测试参与者都认为手柄提供了安全、舒适的抓握感。
    [信息来源: 形成性可用性测试]
  4. 在把患者连接线接到机器上时,15名用户中有14名应用了无菌技术。
    [信息来源: 总结性可用性测试]

 

  1. 比较瘦小和身体较弱的用户要提举起40磅的机器可能有难度。
    [信息来源: 评论]
  2. 多名用户不清楚背光控制盘上的符号的含义。
    [信息来源: 形成性可用性测试]
  3. 12名测试参与者中有4名无法正确安装管线装置。
    [信息来源: 形成性可用性测试]
  4. 把引流管放到其支架上时,两名参与测试者将引流管扭结了。
    [信息来源: 总结性可用性测试]

 

 

后期评估

当产品几乎是最终产品时,我们可以进行总结性(即验证性)可用性测试。 对于医疗产品而言,这是一项至关重要的活动,可以证明预期使用者能安全有效地使用产品。这种测试也是 美国FDA入市许可的监管要求。这种测试可以在传统的可用性测试实验室,或更接近真实设定,例如在医疗模拟环境中进行。 

我们分别用 人数很少(n = 15)和人数非常多(n > 200)的样本进行过这样的测试。 我们的测试计划经常通过美国FDA的审查和默许。我们在自己的实验室、全球各地的工厂或租用的焦点小组场地进行测试。根据需要,我们的测试报告会详细描述可用性测试方法、测试结果以及任何长久以来所存在的互动问题根本原因。我们的测试和报告方法是以多个不同来源(例如FDA,AAMI,IEC)的可用指南以及最佳实践方法为基础。

例子:

  • 对胰岛素笔注射器进行75人参与的总结性可用性测试,以产生证明青少年、成年人、老年人、护理人员和医疗保健提供者可安全有效使用该产品的相关数据。(注意: 样本大小是由美国FDA验证研究结果所决定的。观察: 将人因工程和可用性工程应用于医疗器械,由美国FDA于2016年2月3日发布)
  • 对灌注师所使用的用于维持接受心脏直视手术患者生命的心肺机进行15人参与的总结性可用性测试。
  • 对汽车修理工使用的平板电脑应用程序(诊断并在有可能的情况下对有关电气和机械问题进行修复)进行12人参与的总结性可用性测试.

上市后阶段评估

我们经常对市售产品进行产品评估,包括设计评审和可用性测试。 此类审查可能有以下用途:

  • 提供基准性能数据,为开发下一代产品或竞争产品奠定基础。
  • 提供以用户互动为基础的性能数据,以此作为营销宣传的基础。
  • 深入了解可能导致产品投诉、退货和其他失败类型的已知产品使用问题。

例子:

  • 开展一项可用性测试,比较透析仪治疗在设定上的简易之处
  • 对糖尿病的患者进行一项研究,帮助确定哪种 穿刺装置的用法最简单并且带来的疼痛感最小。
  • 对被召回的手术设备的用户界面进行专家评审,以找出导致损伤的使用错误的根本原因,并就设计变更提出建议,作为纠正和预防措施(CAPA)的一部分。

Questions? Request more information from our specialists

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Meet our team at REGISTER NOW: Round Table for Medical Devices, Nov 22, 2018, in Cambridge, United Kingdom

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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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