{{ phone }} {{ location }}

Emergo by UL logo

         

評価

製品の開発段階からデザイン評価を実施することで、適切なユーザーインターフェースが作られ、使いやすい製品にすることができます。

製品評価の方法は数多くありますが、最適な方法は、製品開発段階や、利用できるリソース(例:時間、資金、プロトタイプ、完成品)によって異なります。エマーゴの評価方法の例:

  • 設計批評/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(使用シナリオに沿って)
  • 形成的(予備的)ユーザビリティ試験
  • 累積的(検証)ユーザビリティ試験

初期段階評価

さまざまな技法を駆使して早期設計コンセプトへのフィードバックを収集します。そのうちのひとつが、認知的ウォークスルーです。これは、製品の略図、簡易実物モデル、一連の静止コンピュータースクリーンなどを使って、回答者に、作業をどのように行うか考え、説明してもらう方法です。

例:

  • 複数のサンプル画面と「ブロックモデル」を使って、インスリン輸液ポンプの操作に関するワークフローを評価します。
  • 装着型心臓ポンプ(左心室補助装置)の外側形状に関し複数のコンセプト(例:バックパック、ウェストポーチ、メッセンジャーバッグ、肩掛けかばん)に対するフィードバックを収集します。
  • 複数の患者モニター設計コンセプトについて、三次元画像ソフトウェアと正確な重量で作成した3Dプリンタモデルを使って、使用者の嗜好を調査します。

中間評価

HFRDでは、製品批評のご依頼も受け付けています。これは、専門家レビューやヒューリスティック分析とも呼ばれます。弊社では、実証済みの設計原則や独自の判断を用いて、ユーザーインターフェース設計の強みや改善の機会を見極めます。こうした評価では、通常、時間や費用をそれほどかけることなく、価値ある結果を得ることができます。

弊社はまた、製品の形成的ユーザビリティ試験の実施のご依頼も受け付けております。この試験を実施することで、開発真っ只中の設計チームに対し、結果を迅速に連携することができます。あるいは、形成的ユーザビリティ試験をより正式なものとして、詳細な試験計画や報告を含めることも可能です。

例:

  • スマートフォン用フィットネスアプリのスクリーンに対し専門家レビューを行います。
  • 脳卒中の後遺症に苦しむ人たちの歩行をサポートする外骨格の形成的ユーザビリティ―試験を8人の患者で実施します。
  • 総括的(検証)ユーザビリティ試験に先立って行う、透析装置の「事前総括的」ユーザビリティ試験を、試験実施計画(プロトコル)に沿って、15人の患者で実施します。

製品評価では設計の強みや、製品を使用する機会が明らかになります。下記は、家庭用透析装置の例です。

調査結果サンプル

肯定的

否定的

  1. 視覚的アラームの表示が目につきやすい(注意を引きやすい)。
    [情報源:批評]
  2. 使用者は、設定ワークフローが直感的だと感じた。
    [情報源:認知的ウォークスルー]
  3. 手の小さい患者も大きい患者も、ハンドルをしっかり握ることができ、握りやすいと評価した。
    [情報源:形成的ユーザビリティ試験]
  4. 使用者の15人中14人が、患者側ラインと装置の接続に無菌法を用いた。
    [情報源:累積的ユーザビリティ試験]

 

  1. 体が小さく、力の弱い使用者にとっては、40ポンド(約18キロ)の装置を持ち上げるのが困難。
    [情報源:批評]
  2. 数人の使用者が、バックライト制御のシンボルの意味をわかっていなかった。
    [情報源:形成的ユーザビリティ試験]
  3. 試験参加者12人のうち4人がチューブセットを正しく装着できなかった。
    [情報源:形成的ユーザビリティ試験]
  4. 2人の患者が、ドレーンチューブをホルダーに付けるときにねじってしまった。
    [情報源:累積的ユーザビリティ試験]

 

 

最終段階評価

製品開発の最終段階では、累積的(検証)ユーザビリティ試験を行います。これは、医療製品にとって大変重要なステップです。製品が、対象とする使用者に安全に効果的に使用してもらうことができることを証明します。この種の試験は、FDA認証を取得する製品には必須要件です。このような試験は、従来からあるユーザビリティ試験ラボで行うこともできますし、高度医療シミュレータなどの先進的な環境で実施することもできます。

HFRDでは、このような試験を、サンプルサイズが小さい(n=15)ものから大変大きな(n > 200)ものまで、さまざまな規模で行ってきた経験があります。FDAガイダンスに基づいた試験プロトコルを常に作成していることで、クライアントがFDAに問題なく受諾されているケースがほとんどです。弊社のラボ、またはレンタルラボにおいて、世界中でユーザビリティ試験を実施しております。試験報告書には、要求に沿って、ユーザビリティ試験方法、試験結果、残存するインタラクション(相互作用)問題の根本原因を詳細に記述します。そして、複数の情報源(例:FDA、AAMI、IEC)から発行されているガイダンスに沿った方法に基づいた試験と報告を行います。

例:

  • ペン型インスリン注射機の総括的ユーザビリティ試験を75人の参加者で行い、製品が、若年者、成人、年長者、介護人、ヘルスケア提供者に安全に効果的に使用してもらえることを証明するデータを作成します。(注:FDAのサンプルサイズ要件は、検証調査によって指定されます。参照:Applying Human Factors and Usability Engineering to Medical Devices、2016年2月3日FDA発行)
  • 開心術中の患者の灌流を維持するため体外循環技師が使用する人工心肺装置の総括的ユーザビリティ試験を、15人の患者で行います。
  • 自動車整備士が電気的・機械的問題の診断及び修復に使用するタブレットアプリケーションの総括的ユーザビリティ試験を、12人の参加者で行います。

市販後評価

HFRDは、市販後の製品に対して、設計レビューやユーザビリティ試験などを含む、製品評価を実施します。このようなレビューは以下の目的で行われます。

  • 次世代製品や競争力のある製品を開発する基礎となるベンチマーク性能データを提供します。
  • マーケティング宣伝の基礎となる使用者とのインタラクション(相互作用)に焦点を当てた性能データを提供します。
  • 製品の苦情、返品、その他の不良事象につながるおそれのある、インタラクション問題の報告に関して実態を見極めます。

例:

  • 処置設定が簡単な市販済装置と比較した上で、透析装置のユーザビリティ試験を実施します。
  • 糖尿病患者への調査を行って、インスリン注入をするのにどの機器が最も簡単に使えて痛みが少ないかを判定します。
  • リコールされた手術器具のユーザーインターフェースに関するレビューを専門家が実施します。レビューにより危害を引き起こした誤使用の根本原因を突き止め、CAPA(是正措置・予防措置)の一環として設計変更を提案します。

Questions? Request more information from our specialists

CONTACT US >

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

FIND OUT MORE >

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.

 

 

United Kingdom

150, Cambridge Science Park
Milton Road
Cambridge CB4 0GN
+44 (0)1223 214 044

USA

205 W Wacker Drive
Floor 13, Suite 1300
Chicago Illinois 60606
847 664 1363

USA

300 Baker Avenue
Suite 200
Concord Massachusetts 01742
978 371 2700

Netherlands

Arthur van Schendelstraat 600-G
MJ Utrecht,
The Netherlands 3511
+31 263 764 985

Japan

Marunouchi Trust Tower Main Building 6F
1-8-3 Marunouchi, Chiyoda-ku,
Tokyo 100-0005
+81 3 5293 6041