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研究

用户研究可以帮助我们更加深入地了解控制用户与产品互动质量的因素。 有关用户需求和偏好的调查结果可以转化为用户界面要求,并反映在以用户为中心的设计解决方案中。 我们使用各种方法进行研究,包括:

  • 在工作场所、家庭和其他使用环境中进行实地观察;
  • 日记研究;
  • 一对一和分组访谈;以及
  • 基准测试。

利用观察来建立用户对您的医疗器械或体外诊断器械的需求

直接观察是了解用户对新器械或产品的需求和偏好的关键所在。 在观察过程中,我们通常会记录口头评论和花在各种任务上的时间,同时记录人与设备之间的不和。例如,我们可能会观察麻醉师是如何与其工作站进行互动的,并注意到临床医师其实需要更大的工作表面来进行注射准备和完成相关的文书工作。

我们的工作团队由50多名研究人员和设计师组成,在全球 多个不同研究实验室开展工作。 我们可以在 康科德、东京、乌得勒支和芝加哥的实验室 或根据项目需要在您的设施nbsp4]开展研究工作。

访谈可以获得全面的用户反馈意见

我们的研究团队使用一系列访谈方法来收集不同类型的用户反馈,包括:

  • 日记研究: 日记研究等人种学方法能帮助我们收集有关用户行为和产品使用情况的定性数据。
  • 情景调查: 我们在人们执行工作任务时对其进行访谈,以便在相应的情景中获得其反馈意见。 例如,我们可能会在医生写处方的时候询问其是否能使用电子处方平板来处理工作。
  • 一对一访谈: 面对面或通过电话进行的个人访谈可以深入了解个人需求和偏好。 这种访谈(也称为情景调查)可对正在工作的人员展开。
  • 分组访谈: 分组讨论是对观察和个人访谈的有价值补充。我们开展分组访谈(也称为焦点小组),以快速收集许多意见,并就具体问题达成小组共识。

访谈结果经由观察和基准测试对收集到的数据进行补充。

基准测试是开展更进一步可用性测试的起点

通过对现有的医疗器械进行可用性测试,我们能学习到很多用户需求和偏好方面的信息。有时候,我们会对现有产品进行测试,以帮助设计其替代产品。 而有时,我们则会测试竞争对手产品的性能以确定一个基准值,从而确定用户界面要求和可用性目标的基础。

医疗器械可用性研究降低了监管和患者风险

我们的团队开展大量的用户研究,专注于关乎重要的生命医疗技术。此类研究有助于推动关键设计决策,这些决策在获得监管机构批准和实现商业成功方面可能至关重要。 我们的研究团队可以帮助您找到适合您的器械的最佳研究方法,并可以在您的设施或我们的实验室中进行该研究。我们拥有许多不同产品类型方面的经验,包括新型和高风险性医疗器械、消费品、家用电器等。

有任何问题? 向我们的专家获取相关信息

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REGISTER NOW: To Err is Human: A Documentary Film Screening and Discussion on Preventing Human Errors in Medical Technology, Dec 6, 2018, in ,

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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.

Wiklund, Michael

General Manager, HFR&D
Allison Strochlic

STROCHLIC, Allison

Research Director

Merrick Kossack

Research Director

Mary Burton

User Experience Director
richard-featherstone

Richard Featherstone

Managing Director
Mark Tavano

Mark Tavano

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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