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Emergo by UL logo

人因研究与设计

在更名为EMERGO by UL(仍为UL的一部分)后, 我们的人因研究与设计(HFR&D)团队在帮助客户将产品推向市场并确保最佳用户体验方面拥有丰富的经验。 我们在帮助客户实现其商业目标的同时,还致力于让医疗保健变得更安全、更有效。

UL于2012年收购了Wiklund Research & Design(总部位于美国)。在随后的六年中,其咨询业务增长了400%以上,反映了这一服务领域的强劲需求。 在2018年中期,UL收购了Medical Device Usability(总部位于英国)。 这两个咨询团队现已完全整合并为国际客户提供服务。

我们的咨询团队在医疗器械和组合产品领域拥有深厚的经验。 但其同时也为其他几个行业提供服务,帮助确保消费者产品、工业产品、软件应用程序和汽车产品能够提供出色的用户体验。 

我们通过以下方式,帮助我们的 客户在数百个开发项目 中取得成功: 

  •   确保人为因素研究和设计工作符合监管要求和 行业标准。
  •   确保以适当水平的创造力和精力,为产品创造卓越的用户界面。
  •   通过消除对用户界面设计返工的需求,加速产品开发过程。
  •   对适当水平的人为因素研究和设计投资加以引导,以实现商业目标。
  •   就如何利用内部和外部资源提供值得信赖的建议。
  •   以各种方式降低业务风险。

 


我们的设计理念

 


与客户间建立信任关系

我们希望客户把我们看作是他们值得信赖的顾问。 我们通过以下努力来达成这一目标:

  • 自由的分享我们的专业知识和诀窍。
  • 提供与匹配产品相关的具有优势的服务,满足人们的需求和喜好。
  • 在可能的情况下,提供有价值的工程选项。
  • 按时、按预算交付服务。
  • 帮助开发内部HFR&D能力(如果客户有此目标)。
  • 寻求反馈,帮助我们不断改进服务。

 

 

 

 


 

我们的成果

我们已成功帮助众多客户将优质的新产品推向市场,这其中的许多产品需要在美国和其他国家获得监管部门的审批。 以下是我们提供过服务的部分医疗器械、组合产品和IVD范例。  

体外自动除颤器 腹膜透析机 MS管理应用app
自动血液测试平台 医院病床 用于治疗PAH的雾化器
血糖仪 免疫系统测试套件 用于治疗RSV的雾化器
血液检测系统 用于治疗PD 的吸入器 神经刺激器
心脏导管 用于治疗COPD 的吸入器 手术室灯
圆形手术缝合器 胰岛素输液套件 病人监护仪
动态血糖监测仪 胰岛素笔式注射器 个人防护服
深部脑刺激器 胰岛素泵 治疗青光眼的预充式注射器
糖尿病管理应用程序 主动脉内球囊反搏泵 呼吸治疗背心
药品瓶贴标系统 静脉输液泵 机器人辅助手术系统
十二指肠镜 静脉输液泵药物库 血压计
脑电图监测器 大容量灭菌器 眼压计
健身应用app 用于治疗MS的自动注射器 通风机
血液透析机 显微镜 病毒测试套件

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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