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Formation et conseil

Les fabricants de dispositifs doivent lier les activités d'IFH à leurs efforts de gestion des risques afin d'assurer la conformité aux attentes et aux normes réglementaires rigoureuses.

Nous pouvons vous aider en vous proposant une formation en IFH, des conseils en matière de réglementation et en effectuant une analyse des lacunes. Nous pouvons même vous aider à mettre sur pied un programme d'IFH en interne si vous êtes prêt à passer à cette étape.

Présentations et ateliers de formation sur l'aptitude à l'utilisation et l'IFH

Notre objectif est d'enseigner à la communauté des dispositifs médicaux les avantages de l'ingénierie des facteurs humains pour les utilisateurs (c.-à-d. les professionnels de la santé) et les patients. Nous offrons des ateliers et des séminaires Web personnalisés et en personne, nous partageons également nos idées lors de conférences et d'autres événements éducatifs.

Ateliers IFH en personne : Nous adaptons nos ateliers en fonction des besoins de nos clients. À titre d'exemple, un atelier peut être adapté à un client qui fabrique des instruments chirurgicaux, des scanners de diagnostic ou des dispositifs d'administration de médicaments (c.-à-d. des produits combinés), ou à un client qui produit des dossiers de santé électroniques. Les ateliers peuvent présenter des sujets techniques à un niveau de présentation introductive ou de perfectionnement.

Quelques titres d'ateliers récents :

  • Gagner un avantage concurrentiel grâce aux facteurs humains
  • Estimation des coûts et des avantages des facteurs humains
  • Mise en place d'un programme interne de facteurs humains
  • Introduction au processus de conception de l'interface utilisateur
  • Adopter une approche structurée pour définir les besoins des utilisateurs
  • Éviter les erreurs d'utilisation par la conception
  • Construire des prototypes d'interface utilisateur
  • Réaliser des tests d'utilisabilité efficaces
  • Analyse des causes premières des erreurs d'utilisation
  • Analyse des risques résiduels liés à l'utilisation
  • Rédiger un rapport d'ingénierie des facteurs humains efficace

N'hésitez pas à nous contacter pour exposer vos objectifs en matière d'IFH et nous créerons un programme de formation pour votre équipe.

Orientations réglementaires en matière d'IFH et analyses des lacunes pour les dispositifs médicaux

La plupart des organismes de réglementation s'intéressent de manière particulière à la façon de documenter vos activités d'IFH. À titre d'exemple, la FDA des États-Unis et les organismes notifiés ont des attentes quelque peu différentes. Leurs documents d'orientation sont longs et les suivre correctement nécessite de l'expérience. En outre, il y a des attentes non documentées dont il faut être conscient. Nous pouvons partager les leçons que nous ont enseignées de nombreuses années de pratique et d'innombrables soumissions réussies qui comprenaient des données d'IFH essentielles.

Nous pouvons vous aider à préparer des composants liés à l'IFH comprenant un dossier complet de l'historique de conception, tel qu'une spécification d'utilisation pour satisfaire à la conformité à la norme IEC 62366-1 ou un rapport IFH/UE à soumettre à la FDA étasunienne. Nous pouvons également vérifier vos activités d'IFH existantes et la documentation relative afin de déceler toute lacune qui pourrait entraîner des retards réglementaires.

Élaboration d'un programme interne d'IFH pour les entreprises du dispositif médical

Travailler avec des consultants en IFH est un moyen efficace de répondre aux exigences d'aptitude à l'utilisation (utilisabilité) des dispositifs médicaux et des DIV. Mais il est parfois avantageux de faire passer vos activités d'IFH en interne. Nous avons l'expérience nécessaire pour aider nos clients à planifier et à mettre en œuvre des programmes internes d'ingénierie des facteurs humains à l'échelle appropriée, qui répondent aux exigences réglementaires et aux objectifs de qualité internes des dispositifs médicaux.

Nous vous aidons en vous expliquant comment faire passer les tâches liées aux facteurs humains des consultants à des spécialistes internes, dans un souci de rentabilité. Nous aidons ainsi nos clients à tirer le meilleur parti d'un programme d'IFH pour fabriquer des produits de qualité supérieure. Si nécessaire, nous pouvons soutenir les équipes d'IFH internes avec des services tels que la conception de l'interface utilisateur, les audits de conception et les tests d'aptitude à l'utilisation.

Questions? Request more information from our specialists

CONTACT US >

Meet our team at REGISTER NOW: Round Table for Medical Devices, Nov 22, 2018, in Cambridge, United Kingdom

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.

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

 

Michael Wiklund, CHFP, MS

General Manager, HFR&D
Allison Strochlic

Allison Strochlic, CHFP, MS

Research Director

Merrick Kossack, MS

Research Director

Mary Burton, MS

User Experience Director
richard-featherstone

Richard Featherstone

Managing Director
Mark Tavano

Mark Tavano, MBA

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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