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Medical Device Usability ENGINEERING – Managing use related risk Helsinki 26.9.2019

Practical information

This training day is arranged in co-operation with USBIMED (Finland) and Curiolis, Inc., (USA). Persons below have co-operated first time at 2014. Based on great feedback from the audience of the training day at that time, USBIMED wanted to invite Jonathan Kendler to Finland again. USBIMED aims is to offer new perspectives for Finnish health technology actors also by inviting top experts from abroad.

  • Date and time: Thursday 26.9.2019, 8:30-16:30
  • Venue: Tapahtumatalo Bank, Helsinki
  • Practical organizer: USBIMED (Terhi Holappa)
  • Instructor: Curiolis, Inc. (Jonathan Kendler)
  • Minimum number of booked places needed at 29.8.2019: 20
  • Maximum number of places: 30
  • USBIMED reserves the right to cancel the course due to force majeure or due to teacher’s illness. Event might be cancelled also if number of attendees registred at 29.8.2019 is less than 20. No compensation will be paid for any additional costs.

Registration and cancellation policy

  • Fee: 390 € (alv 0%) per participant. VAT 24 % will be added to price. The fee includes: training, course materials, lunch and both coffee breaks. Participation fee will be billed after the event.
  • Registration by 29.8.2019 required.
  • Cancellation by 29.8.2019 at latest, free of charge
  • Cancellation during 30.8. - 13.9.2019 payment 50 %. Substituting colleague may be announced.
  • Cancellation 14.9.2019 or later – full payment. Substituting colleague may be announced.

Target group

Prioritized especially for medical device (including software) and digital health product companies or research projects and healthcare units developing these products as manufacturers. This training day is also suitable to design and regulatory professionals in general who work with medical safety critical systems theme in practice or are leading these activities.

Aim of training day

To refresh what is required from medical device usability by EU regulations and by US FDA shortly. To find out the status and content of relevant standards and guidance for compliance. To deepen the understanding of the relationship between risk management and usability. Training covers also overview of typical usability engineering techniques, concentrating more deeply and practically on medical device (including software) usability testing as a crucial method of evaluation. This down-to-earth training day includes best practice examples of medical device usability engineering and user interface design.

Program of the day

  • Course instructor: Jonathan Kendler, Curiolis, Inc.
  • Bio: Jonathan Kendler is a leading user interface designer and usability engineer specializing in medical devices. Jonathan has over 20 years of design and engineering experience working on a wide range of medical devices, which has resulted in the granting of multiple patents for his work. Jonathan has authored numerous articles on user interface design and usability engineering, as well as co-authored two books (“Usability Testing of Medical Devices” [2015] and “Designing for Safe Use” [2019]). In addition, Jonathan has taught graduate level university courses about user interface design at Tufts University in Boston, USA, and has delivered workshops and lectures throughout Asia, Europe, and North America.
  • 8:30-9:00 Registration and morning coffee
  • 9:00-9:30 Importance of medical device usability - introduction to the day and practical info - Terhi Holappa, USBIMED
  • 09:30-10:30 The relationship between medical device risk management and user interface design - Jonathan Kendler, Curiolis, Inc.
  • Introduction to the concepts of use safety and use error. Examples of user interface flaws that led to patient injuries, recalls, and regulatory challenges.
  • Overview of use-related risk management, including its similarities and differences from conventional risk management techniques.
  • Discussion of use error mitigation approaches and how manufacturers should think about optimizing use safety.
  • 10:30-10:45 Short Biopause
  • 10:45-12:15 Medical device usability engineering process - standards and guidance - Jonathan Kendler, Curiolis, Inc.
  • Overview of medical device standards and guidelines pertaining to usability engineering and user interface design.
  • Process and deliverables according to medical device usability standard IEC 62366-1.
  • Process and deliverables according to US FDA’s usability engineering guidance.
  • 12:15-13:00 Lunch
  • 13:00-14:30 Usability engineering techniques in practice - Jonathan Kendler, Curiolis, Inc.
  • Overview of different user interface evaluation methods, including both formative and summative evaluation.
  • Planning, conducting, and reporting on medical device usability tests.
  • 14:30-14:45 Afternoon coffee at conference room
  • 14:45-16.30 Best practice examples - Jonathan Kendler, Curiolis, Inc.
  • Best practices for scaling and adapting usability engineering processes, identifying and mitigating against potential use errors, evaluating user interface designs and documenting the usability engineering process.
  • 16:30 End of the event

More information

Terhi Holappa, +358 40 5595726, terhi.holappa@usbimed.fi

Since the founding of USBIMED in 2011 company has completed several expert projects, as well as organized and prepared numerous public and private training packages and presentations. Company wants to contribute to the advancement of the health technology and digital health communities also by inviting visiting instructors from abroad.

Created By
Terhi Holappa
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