What is Usability Engineering in Medical Devices and how will the new Regulations impact my work?
The ability for a human to interact easily and relatively error-free with a system, product or procedure. Manufacturers are increasingly expected to provide a safe product that the user understands, minimizing errors. Terms such as ‘user-friendly’ and ‘intuitive’ have emerged as descriptors of usability which translate to subjective attributes regarding whether a system or device works and acts in the way the user expects, therefore avoiding frustration and annoyance in carrying out an intended action.
The expectations from both European Notified Bodies and FDA are increasing in this area and should now be considered a vital part of the medical device design process. The UK competent authority, MHRA, has recently published guidance on Clinical Human Factors/Usability; Notified Bodies assessments will need to demonstrate consideration of usability for all devices. Useability isn’t just a manual and training during the clinical evaluation anymore, but rather a practice in the whole device development process, evidence is required in the manufacturer’s quality management system.
This webinar will help you to:
- Identify the relevant directives, guidance, regulations and standard documents recommended to incorporate Usability into your design process.
- Overview of basic concepts from the key Usability standard IEC 62366-1:2015, and how you should be using this to improve your products, reducing risk. Apply your best usability practices by understanding the experiences of others through the examples presented.
- Awareness of changes arising from the new MEDDEV 2.7/1 Revision 4 and the MDR/IVDR and the impact of these over the next few years.
No matter what stage of development you are in, this webinar will help you to plan and launch your product efficiently according to the necessary requirements.
Presenter: Richard Stein
Richard has 20 years of experience in medical devices, from the entire development process of concept, design, hazard analysis, evaluation, regulatory submittal, market launch and ongoing product support. Much of his experience in medical device development is the basis of his usability contributions.
Richard was a contributing member of AAMI (Association for the Advancement of Medical Instrumentation’s Human Factors Committee where he contributed to the authorship of standards and publications and a member of AAMI’s Electrical Safety Committee. He is an advisor to the University of Minnesota’s Biomedical Engineering program for the Senior Design course and Panel Chair for Human Factors to the annual Design of Medical Devices Conference. He is an inventor of patents used today in pacemaker/defibrillator (ICD) programmers and patient diagnostic devices.