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トレーニングとコンサルティング

機器事業者は、HFE(ヒューマンファクターエンジニアリング)をリスクマネジメントの取り組みに連携させて、規則や標準規格の厳しい要件を確実に遵守しなくてはなりません。

HFRDでは、HFEトレーニング、規制ガイダンス、ギャップ分析を取扱っています。状況に応じ、社内HFEプログラムの作成もサポートいたします。

HFEおよびユーザビリティトレーニングのワークショップとプレゼンテーション

弊社の目標は、医療機器コミュニティに、ヒューマンファクターエンジニアリングが使用者(例:ヘルスケア従事者)や患者にもたらす利益を学んでもらうことです。対面形式やウェビナーで、カスタマイズしたワークショップを実施することが可能です。また、業界の会議やその他の教育イベントにて弊社の見識を提供致します。

対面HFEワークショップ:お客さまのニーズに合わせてワークショップをカスタマイズいたします。たとえば、手術器具、診断用スキャナ、ドラッグデリバリー機器(コンビネーション製品)の製造業者向けや、電子カルテの作成業者向けにカスタマイズすることができます。ワークショップでは、技術的なトピックを、初歩レベルや上級レベルで取り入れることができます。

最近のワークショップのテーマ例:

  • ヒューマンファクターによる競争優位性の獲得
  • ヒューマンファクターのコストとベネフィット
  • ヒューマンファクターの社内プログラム設定
  • ユーザーインターフェース設計プロセスの基礎
  • ユーザー要件定義のための構造的アプローチ
  • 設計による誤使用防止
  • ユーザーインターフェースのプロトタイプ作成
  • 効果的なユーザビリティ試験の実施
  • 誤使用の根本原因分析
  • 使用関連残存リスク分析
  • ヒューマンファクターエンジニアリング報告の書き方

HFEの方針に関するご相談は、弊社が承ります。お客さまのチーム向けのトレーニングプログラムを作成いたします。

医療機器HFE規制ガイダンスとギャップ分析

規制当局のほとんどが、事業者のHFE活動の文書化のルールを詳細に定めています。たとえば、米国FDAとノーティファイドボディでは、要件が多少異なります。規制当局のガイダンス文書は膨大で、きちんと理解するには経験を要します。また、知っておかなければならない、文書化されていない要件も存在します。HFRDは、多くの登録申請サポートを経験しているため、必須となるHFEデータ等の知識をご提供することが可能です。

設計履歴文書に必要なHFE関連項目の準備も、弊社にてサポートいたします。たとえば、IEC 62366-1に準拠する使用上の仕様や、米国FDA提出用のHFE/UE報告書などです。また、お客さまの現行HFE活動および文書化の監査を行い、規制手続きの遅れの原因になりえるギャップを調査します。

医療機器事業者向け社内HFEプログラム開発

HFEコンサルタントとの協業は、医療機器・体外診断用医療機器のユーザビリティ要件を満たすために有効な手段です。しかし、協業せず社内でHFE活動を行うほうが良い場合もあります。エマーゴは、医療機器規制要件や各事業者の品質目標に適切なヒューマンファクターエンジニアリングプログラムの計画・導入を多くサポートしてきました。

ヒューマンファクターエンジニアリング関連のタスクをコンサルタントから社内の専門家に移行させる方法を、費用対効果を考慮しつつ計画できるようサポート致します。お客様が弊社のHFEプログラムを最大限に活用し、優れた製品を製作できるようアシストいたします。また、必要に応じ、お客さまの社内HFEチームに、インターフェース設計、設計監査、ユーザビリティ試験などのサービスを提供することも可能です。

Questions? Request more information from our specialists

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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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