The objectives of Human factors engineering are:

  • To meet regulatory expectations by designing safe and effective user interfaces
  • To highlight users needs and wants to achieve greater efficiency and user satisfaction

The aim of Tessier Biomedical Consulting is to provide assistance to acheive those objectives.

User research

  • Documenting the knowledge about users, their abilities and limitations which could affect their interactions with the device
  • Documenting the knowledge about use environments to understand relevant characteristics which could affect safety and effectiveness
  • Collecting the known issues on existing and competition devices

Risk control

  • Task analysis to describe how users interact with the interface, to identify the critical tasks and use errors (perception/cognition/action analysis)
  • As part of the risk management standard, some risk control measures (RCMs) must be put in place in order to achieve acceptable risks. Those RCMs should be primarily "Inherent safeties by design" but also protective measures and information for safety

Evaluate

  • The user interface evaluation must be planned. This evaluation must take place all along the design process through various technics and the user interface must be refined accordingly
  • Once the design is satisfactory, it must be formaly validated with representative users from each user groups
  • A complete human factors and usability engineering report ("HFE/UE report") must be produced to meet regulatory expectations, stating that the device is safe and effective to use

Process

  • The usability engineering process applies to any medical device. The level of effort is in function of the device's complexity and risk levels. Tessier Biomedical Consulting can help designing a robust process to address usability engineering requirements, and provide training and mentoring accordingly

Need compliance to those standards and guidances? 

Please contact Tessier Biomedical Consulting by email or call +33 6 5881 8544

(*): The author thanks the International Electrotechnical Commission (IEC) for permission to reproduce Information from its International Standards. All such extracts are copyright of IEC, Geneva, Switzerland. All rights reserved. Further information on the IEC is available from www.iec.ch. IEC has no responsibility for the placement and context in which the extracts and contents are reproduced by the author, nor is IEC in any way responsible for the other content or accuracy therein. 

IEC 62366-1 ed.1.0 “Copyright © 2015 IEC Geneva, Switzerland. www.iec.ch” - IEC TR 62366-2 ed.1.0 “Copyright © 2016 IEC Geneva, Switzerland. www.iec.ch”

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