사용자 연구를 통해 제품과 사용자 간의 상호작용 품질을 제어하는 요소를 더욱 풍부하게 이해할 수 있습니다. 사용자 요구사항 및 선호도에 관한 통찰은 사용자 인터페이스 요구사항으로 해석될 수 있으며, 이는 사용자 중심 디자인 솔루션에 반영될 수 있습니다. 저희는 다음과 같이 다양한 방법을 사용하여 연구를 진행합니다.
- 직장, 가정, 다른 사용 환경에서의 관찰,
- 일지 연구,
- 일대일 및 집단 면접,
- 기준 테스트.
관찰을 통해 귀사의 의료기기나 IVD에 대한 사용자 요구사항을 설정합니다.
직접 관찰은 새로운 기기나 제품에 대한 사용자 요구사항 및 선호도를 이해할 수 있는 중요한 방법입니다. 관찰 중에는 보통 구두 의견을 녹음하고 여러 작업에 걸린 시간을 기록할 뿐 아니라, 사람과 장비 사이의 마찰 지점을 기록합니다. 예를 들어, 마취의가 자신의 워크스테이션을 사용하는 방법을 관찰하면 의사에게 주사를 준비하고 서류 작업을 완료할 수 있도록 더 넓은 업무 공간이 필요하다는 것을 알 수 있습니다.
저희 팀에는 전 세계의 다양한 연구 실험실에서 온 50명 이상의 연구자와 디자이너가 있습니다. 저희는 미국 콩코드, 일본 도쿄, 네덜란드 위트레흐트, 미국 시카고에 연구실이 있을 뿐 아니라, 프로젝트에 필요한 경우 귀사의 시설에서 연구를 진행합니다.
인터뷰를 통해 종합적인 사용자 피드백을 받을 수 있습니다.
저희 연구팀은 다양한 인터뷰 기법을 사용하여 다음과 같은 여러 가지 사용자 피드백을 수집합니다.
- 일지 연구: 일지 연구와 같은 에스노그라피적 연구를 통해 사용자 행동과 제품 사용 추이에 관한 정성적 데이터를 수집할 수 있습니다.
- 맥락 연구: 인터뷰는 사람들이 작업를 수행하는 동안 피드백을 줄 수 있는 맥락 안에서 진행됩니다. 예를 들어, 의료진에게 처방 중에 전자 처방 패드를 사용하는 것에 대해 질문할 수 있습니다.
- 일대일: 대면 및 전화로 진행되는 개별 인터뷰를 통해 개별적인 요구사항 및 선호도를 “철저하게 분석”할 수 있습니다. 맥락 연구라고도 하는 이런 인터뷰는 직장에 있는 사람들과도 진행할 수 있습니다.
- 그룹: 그룹 토론은 관찰 및 개별 인터뷰를 탁월하게 보완해줍니다. 포커스 그룹이라고도 하는 그룹 인터뷰를 진행하여 빠르게 다양한 의견을 수집하고 특정 이슈에 관한 의견 일치에 도달합니다.
관찰과 기준 테스트를 통해 수집된 데이터는 인터뷰 결과를 통해 보완합니다.
기준 테스트는 추가 사용 편의성 테스트를 위한 시작 지점입니다.
기존 기기의 사용 편의성 테스트를 진행함으로써 사용자 요구사항과 선호도에 대해 많은 것을 알아냅니다. 때로는 기존 제품을 테스트하여 대체 제품을 설계하기 위한 선행 제품으로 사용하기도 합니다. 또는, 경쟁 제품의 성능을 테스트하여 기준을 확립하고, 그 후 사용자 인터페이스 요구 사항과 사용 편의성 목표를 위한 기반을 형성합니다.
의료기기 사용 편의성 연구는 인허가 및 환자 리스크를 줄여줍니다.
저희 팀은 생명에 중대한 영향을 미치는 의료 기술을 중심으로 방대한 양의 사용자 연구를 진행합니다. 이러한 연구는 인허가 승인을 받고 상업적인 성공을 거두는 측면에서 중심이 될 수 있는 중대한 설계 결정을 내리는 것을 촉진할 수 있습니다. 저희 연구팀은 귀사의 기기를 위한 최선의 연구 방법을 결정하고 귀사의 시설이나 저희 연구소에서 연구를 진행할 수 있도록 도와드립니다. 저희는 최신, 고위험 의료기기, 소비자 제품, 가전제품 등 다양한 제품 유형에 대한 경험이 풍부합니다.
The HFR&D team includes over 60 research, design, and evaluation professionals, many of whom hold advanced degrees in their field and are Certified Human Factors Professionals (CHFP). Learn more about this credential here.
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.
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.
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
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 firstname.lastname@example.org.