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ヒューマンファクターリサーチ&デザイン

弊社はULグループ傘下となり、「EMERGO by UL」というブランドに一新されました。それに伴い、UL-Wilklund で提供していたヒューマンファクターズエンジニアリング(HFE)の部門が、「EMERGO by UL」のブランドへ移行し、ヒューマンファクターリサーチ&デザイン(HFRD)として新たに始動します。今後は一つのUL グループとして更に充実したサービスで従来通り、数多くの製品のサポートを手掛けてまいります。お客さまの製品がより良いユーザーエクスペリエンスを獲得できるよう、引き続きULグループとして、サポートしていくことが可能です。弊社は、ヘルスケアをより安全・効果的にするためのソリューションや、お客さまの商業的目標を達成するためのサポートを提供しています。

ULは米国のWiklund Research & Designを2012年に買収しました。以来6年間で、UL-Wiklindのユーザビリティエンジニアリングのサービスは400%超の成長を遂げています。2018年中旬、ULは英国のMedical Device Usabilityを買収しました。この2つの企業は一つのULグループと統合され、現在では全世界のお客さまに質の高いユーザビリティエンジニアリングのサービスを提供しております。

ULグループのHFRDのチームは、医療機器やコンビネーション製品に関して豊富な知識を携えています。その他の分野、消費生活用製品、産業用製品、ソフトウェア、自動車関連製品においても、優れたユーザーエクスペリエンスを提供することが可能です。

多くの製品開発プロジェクトを通じて手掛けてきたサポート内容は以下の通りです。

  •  規制要件や業界標準に即したヒューマンファクターリサーチ&デザインを適用いたします。
  •  製品のユーザーインターフェースを優れたものにするために、創造性や労力が適度に使われていることを確認します。
  •  ユーザーインターフェース設計見直しとなるようなリスクを防ぎ、製品開発効率を向上させます。
  •  商業的目標を達成するために必要なヒューマンファクターリサーチ&デザイン投資の程度についてアドバイスを提供します。
  •  社内リソース、社外リソースの活用方法についてアドバイスを提供します。
  •  さまざまな方法でビジネスリスクを軽減します。

 


弊社の設計指針

 


お客さまとの信頼確立

我々のゴールは、お客さまにとってより信頼できるパートナーになることです。目標達成のために、以下を実施しております。

  • 弊社の知識やノウハウをお客様と共有していきます。
  • 消費者のニーズや好みにマッチした製品を市場に送りだすために、様々なサービスを効果的に組み合わせて提供します。
  • また、追加オプションでお客さまそれぞれのご都合に合ったHFRDサービスの提示も可能です。
  • 期限内、予算内にサービスを提供します。
  • お客様の社内におけるHFRDの技能習得向上のサポートもいたします。
  • お客様からの声に常に耳を傾け、弊社サービスの向上を継続的に行ってまいります。

 

 

 

 


 

弊社のサービス例:

これまでHFRDチームは、お客様の素晴らしい製品を市場へと送り出すサポートを数多く手掛けてきました。その中で、米国やその他の国の規制当局からの承認が必要となるケースが多数を占めておりました。以下、HFRDチームが手掛けた医療機器、コンビネーション製品、体外診断用医療機器の製品群となります。

自動体外式除細動器(AED) 腹膜透析器 多発性硬化症管理アプリ
自動血液検査プラットフォーム 病院用ベッド 肺動脈性肺高血圧症(PAH)用吸入器
血糖測定器 免疫検査キット RSウィルス感染症治療用吸入器
血液検査システム 肺疾患治療用吸入器 迷走神経刺激装置
心臓カテーテル 慢性閉塞性肺疾患治療用吸入器 手術室照明
円形スキンステープラー インスリンポンプ注入セット 患者モニター
持続血糖測定器 インスリンペン型注入器 個人用防護衣
脳深部刺激装置 インスリンポンプ 緑内障治療用薬剤充填済み注射器
糖尿病管理アプリ 大動脈内バルーンポンプ 呼吸器治療用ベスト
薬瓶ラベリングシステム 点滴静脈注射輸液ポンプ ロボット支援手術システム
十二指腸内視鏡 点滴静脈注射輸液ポンプ用薬剤ライブラリ 血圧計
脳波モニター 大容量滅菌機 眼圧計
フィットネスアプリ 多発性硬化症治療用自動注入器 人工呼吸器
血液透析装置 顕微鏡 ウイルス検査キット

ご質問がある方はこちらまで弊社スペシャリストへお問合せがある方はこちらまで

お問い合わせ先 >

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Meet Emergo at Hospitalar , May 21, 2019 to May 24, 2019 in ,

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ユーザー調査では、製品とユーザー間のインタラクション(相互作用)の質を左右する要因について、理解を深めることができます。

もっと知る >>

弊社ヒューマンファクター「ツールキット」は、製品との心理的、物理的なインタラクション(相互作用)に重点を置いたさまざまな分析のパッケージです。

もっと知る >>

医療機器UI(ユーザーインターフェース)設計にはユーザー調査を活用し、機能面でも美観においても目標の達成を目指します。

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総括的ユーザビリティ試験、形成的ユーザビリティ試験、専門家レビュー、ヒューリスティック分析、認知的ウォークスルー、等。

もっと知る >>

エマーゴは、HFEのリサーチ、トレーニング、コンサルティング、プログラム開発を通して、より安全でより良い世界の実現に貢献します

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richard-featherstone

Richard Featherstone

調査ディレクター

Mary Burton

ユーザーエクスペリエンスディレクター
Allison Strochlic

Allison Strochlic

調査ディレクター

Merrick Kossack

調査ディレクター

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

Products have the capacity to evoke a sense of beauty or appreciation in us. Whether marveling over a new car, admiring the interface of our next generation smartphone, or wielding a perfectly balanced kitchen knife, we can appreciate perceiving their design. The features of an artifact, arranged and produced from following a plan. However, most of us are rarely aware of what exactly makes a certain product aesthetically appealing – or that aesthetically pleasing products are generally considered more usable as well. This thesis studies how our aesthetic appreciation of products is formed in the visual and tactile sensory domain. It identifies how unity (the degree to which a design comes across as ordered, coherent, and structured as one whole) and variety (the degree of differences, diversity, and number of elements in a design) can together explain our aesthetic appreciation for products. Furthermore, it identifies ways to influence unity and variety to create the most aesthetically pleasing designs.

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

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