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分析

弊社のヒューマンファクタースペシャリストは、有効性と安全性を兼ね備えた製品を設計するのに役立つ、多様な分析を実施致します。また、製品設計におけるヒューマンファクターの適用が、規制当局の要件を遵守しているかどうかも分析致します。弊社ヒューマンファクター「ツールキット」には、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、さまざまな分析を実施することが可能です。

総合的な使用に関するリスク分析は、安全な製品を開発するうえで重要です。弊社はこれまでにクライアントに代わって、もしくは協業して、多くの分析を行ってきました。

医療製品、消費生活用製品向け使用関連リスク分析

弊社の使用に関するリスク分析では、使用シナリオから、発生し得る使用ミスについて確認します。さまざまなPSF(行動形成因子)を想定し、人々が製品とのインタラクション(相互作用)のなかでミスをおかす可能性のあるあらゆる状況について考察します。たとえば、夜間、乱気流の中、救急ヘリで重症患者を輸送中、救急医療隊員が患者用モニター/除細動器を操作しているときに、起こる可能性のある誤使用を考察します。

下記のような複数の手法を使用して、潜在的な誤使用を特定します。

  • タスク分析
  • ハザード分析
  • 既知問題分析
  • トレーナーと使用者のインタビュー
  • ベンチマークユーザビリティ試験
  • ブレインストーミングなどのクリエティブエクササイズ

その後、誤使用から起こりうる事象の重大度を特定します。リスク評価には、潜在的危害の重大度並びにエラー因子の発生可能性が含まれます。どちらのリスクを重点的に軽減すべきかを決定するための一番重要な要素は、潜在的危害のレベルです。

タスク分析

準備段階、改善段階、最終段階の製品で、使用者がユーザーインターフェースと関わる作業のフローを研究します。HFRDでは、知覚(Perception)、認識(Cognition)、行動(Action)におけるフローでの行動分析から相互関係を分析、特定します。(PCA分析と呼ばれる手法で、FDAの医療機器開発ガイドラインでも言及されています。)この分析では、使用ミスを減らしたり、インタラクション(相互作用)効果が向上する可能性のある箇所を明確にします。

ハザード分析

エマーゴでは、ハザード分析は、タスク分析の補完として行います。ハザード分析では、タスクフローを観察したりどの使用ミスが危害につながるかを考察するのではなく、危害を先に想定したうえで、どのエラーが原因となるのかを考察します。この分析は、以下の通りに危害を仮定することから始めます。熱傷(温熱、化学)、感電、生物学的汚染(感染)、放射能暴露、さまざまな種類の物理的、心的外傷。危害の仮定後、どの使用ミスやその他要因がその危害につながるのかを分析します。

一例を挙げると、感電が起きたのは、ユーザーが患者モニターの配線を、データ転送ポートではなく電源コンセントに挿してしまったからだと考察します。弊社アナリストは安全性を損なう脅威については、先の例で言えば、配線の形状を電源コンセントに挿せないようなものにし、適切なケーブルポートだけに挿入できる形状にすることを推奨します。

既知問題分析

類似製品の使用中に起きたミスと、ミスが起きた原因を開発中製品に考慮することは、賢明な判断です。実際過去にどのような有害事象が起きているかを調査する、既知の有害事象の分析(KPA)は、医療機器の設計段階で非常に重要な作業となります。

既知問題分析では、有害事象データベース(例:MAUDE)から入手できる情報(報告書)のレビュー結果、顧客苦情システムからのデータ、また製品トレーナーや使用者からの声を用いて分析します。

ユーザーインターフェースがどのような使用ミスを引き起こす可能性があるか、問題点を明確に記述したリストを最終成果物として作成します。このような情報や見識を設計仕様に反映させることで、開発段階で製品の使用ミスに対する脆弱性を取り除くことができます。

有害事象分析

弊社ヒューマンファクタースペシャリストは、有害事象研究とその原因となる可能性の高い事象を特定いたします。例:

  • 手術担当者が、胸部の受動的ドレーンに高圧吸引を用いて致命的な肺損傷を起こした場合は、外科用吸引システムのユーザーインターフェースが、どのように当該ミスを誘発したのかを解明します。
  • 血液透析装置が患者の体内から体液を過剰に取り除いてしまい、致命的な体液量減少を引き起こした場合について、使用者(看護師や技術者)が"なぜ過剰な体液除去に気づけなかったのか、その理由を血液透析装置のユーザーインターフェースの観点から特定します。
  • 自動体外式除細動器(AED)の使用者がバッテリーテストを行った際、うっかり機器が充電されていない状態のままにしてしまったことで、生死にかかわる不整脈を発症した患者に対していざという時に使用できなかった場合、なぜ肝となる充電についての確認が見落とされたのか?AEDのユーザーインターフェースの観点から特定します。

HFRDの分析では、有害事象とユーザーとのインタラクション(相互作用)の調査、製品ユーザーインターフェースのヒューマンファクターの適切性のレビュー、その他行動形成因子の考察を行い、設計の欠陥から生じる有害事象について仮説を立てます。製品設計の不備を発見することもありますし、ユーザーインターフェースは使用ミスの原因にはならないという結論に至ることもあります。

人体測定分析

HFRDは、長年にわたって確立されてきた人体測定分析について熟知しております。人体の寸法、形状、強度、可動域、その他の身体的特徴の広大なデータを使用して、幾何学的調査(二次元および三次元)を行います。この調査により、製品が、意図したユーザーの身体的特徴に合っているか確かめることができます。弊社が実際に実施した分析の例は以下の通りです。

  • CATスキャナーオペレーターが、さまざまな傾斜面にとりつけられたコントロールパネルのボタンやつまみに届くことができるか。
  • 5パーセンタイルの女性が、緊急時に、故障中の半自動ドラッグデリバリー機器のレバーを開けるのに加えられる力はどの程度か。
  • 手術器具では、手が極端に大きな人でも小さな人でも持ち易く、適切に使用することが可能な寸法。
  • ロボット支援手術を行う外科医が操作する、座位・立位両用ワークステーションを構成部品の適切な寸法と位置。

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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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