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디자인

기기의 사용자 인터페이스(UI)는 헬스케어 전문가 및 환자와 같은 사용자가 제품과 상호작용할 수 있도록 합니다. MRI 스캐너와 같은 대형 또는 혈당 측정기와 같은 소형기기에서도, 인터페이스는 디스플레이, 제어부, 기타 터치 지점으로 구성될 수 있습니다. 기기의 유형과 사용자 인터페이스의 규모에 무관하게, 좋지 않은 디자인은 유해한 사용 에러의 근본 원인이 될 수 있습니다.

저희 의료기기 UI 디자인에 대한 접근법은 사용자 인터페이스 디자인 요구사항을 결정하고 기능적, 심미적 목표의 균형을 맞추기 위해 상당한 양의 사용자 연구가 필요합니다. 저희는 다양한 콘셉트를 만들고 프로토타입을 제작하며 가장 유망한 콘셉트로 사용자 테스트를 진행하고 최고의 솔루션을 모아 개선된 디자인을 제작하기 위해 고객과 협력합니다.

의료기기 설계 및 프로토타입 제작 &

사용자 인터페이스 디자인 중에, 종종 실제 또는 가상 모델을 만들 수 있는 인터랙티브 프로토타입을 제작합니다. 프로토타입은 설계 강점과 개선 기회를 판단하기 위한 효과적인 디자인 제시와 사용 편의성 테스트를 가능하게 합니다. 또한, 서면으로 기록된 사양만으로는 판단하기 힘든 모호함을 없애는 최종 설계를 명시하기 위한 적극적인 수단입니다.

저희의 프로토타입은 제어부, 표시등, 전체적인 제품 형태와 같은 물질적인 요소뿐 아니라 정보, 파형, 아이콘, 메뉴, 대화창과 같은 가상 요소의 모델을 만들 수 있습니다. 며칠 안에, SolidWorks, Adobe Illustrator, HTML을 사용한 복잡한 기기와 소프트웨어 애플리케이션의 프로토타입을 제작하여 컴퓨터 기반의 물리적(예: 3D 프린트) 모델 또는 하이브리드 모델을 만들 수 있습니다.

라벨링과 사용 안내(IFU) 디자인 및 평가

의료기기 업계에서, 대부분의 규제 기관은 복합 제품을 포함한 기기에 인증된 라벨링을 요구합니다. 이는 보통 제품 부착 라벨과 사용 안내를 포함합니다. 제품의 물리적이거나 컴퓨터 기반 사용자 인터페이스 요소가 잘 설계되어 있더라도, 좋지 않은 디자인의 라벨링은 사용 오류를 유발할 수 있습니다. 저희가 이해하기 쉬운 디자인으로 사용자에게 올바르게 기기를 사용하는 방법을 전하고 다음과 같이 최적화된 특징을 포함한 라벨링을 따를 수 있도록 도와드립니다.

  • 단순한 인포그래픽,
  • 명확한 애니메이션,
  • 시각적으로 편안한 구성 요소,
  • 일관성 있고 작업 지향적인 정보 배치,
  • 사용자 지향적인 용어 및 기호 사용.

효과적인 라벨링을 개발하기 위해, 사용자 요구사항을 결정하고 다른 사용자 인터페이스 요소와 마찬가지로 유망한 콘셉트를 개발하는 것부터 시작합니다. 라벨링에는 확립된 인간 공학 원리와 개발 과정 전에 들인 수많은 노력에서 배운 노력을 반영합니다. 그 결과는 기기의 안전성, 효능, 만족스러운 사용을 보장하는 인증된 라벨링 계획입니다.

귀사의 의료기기 또는 IVD를 위한 사용자 인터페이스 디자인

하드웨어와 소프트웨어 사용자 인터페이스 디자인에 대한 저희의 접근법은 어느 정도 제품의 특성에 의존합니다. UI를 디자인하는 일반적인 접근법은 다음과 같습니다.

  • 사용자 연구를 진행하고 및 비전을 수립합니다.
  • 위험, 작업, 사용 관련 위험 분석을 진행합니다.
  • 설계 사양을 개발합니다.
  • 다양한 디자인 콘셉트를 개발합니다.
  • 고객과 사용자 입력에 기반하여 선호하는 디자인 콘셉트의 폭을 좁혀나갑니다.
  • 세부적인 디자인을 개발합니다.
  • 프로토타입을 제작합니다.
  • 형태 평가를 진행합니다. (예: 인식 검토, 형태 사용 편의성 테스트)
  • 개선 및 최종 디자인을 개발합니다.
  • 앞선 3단계를 적절히 반복합니다.
  • 인간 공학 및 디자인에 초점을 맞춰 최종 디자인을 인증합니다.
  • 실제 디자인을 문서로 작성합니다.

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User research leads to a richer understanding of the factors controlling the quality of user interactions with your product.

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Our human factors “toolkit” contains many types of analyses that focus on mental and physical interactions with products.

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Our medical device UI design approach leverages user research to achieve functional and aesthetic goals.

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Summative usability testing, formative usability testing, expert critiques, heuristic analyses, cognitive walkthroughs, and more.

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We want to make the world safer and better through HFE research, training, consulting, and program development.

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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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