Biomedevice Boston 2020 Presentation Store
Welcome to the Biomedevice Boston Presentation Store. Here you can view and download conference presentations before, during, and after the event, as well as free content from the Center Stage. If you’re looking for a presentation from a specific session, go to that session, and if we have the presentation to share, you’ll see the file below the session description. If you are unable to find it here, it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.
Key Aspects of Usability Testing of Medical Devices to Increase Approval Success and Reduce Costs
Beth Loring (Founder & Principal, Loring Human Factors, LLC)
Location: Biomed Room 1
Date: Thursday, September 17
Time: 2:00pm - 2:45pm
Track: Track C: Surviving the Changing Regulatory Environment & Rising Costs
Vault Recording: TBD
The FDA and international regulatory bodies require usability testing of medical devices, software, and combination products during development and as part of validation. Manufacturers must demonstrate that all use-related hazards have been identified, prioritized, and mitigated. This is done by following a comprehensive human factors/usability engineering (HF/UE) process ending with validation (a.k.a. 'summative') testing. This presentation will discuss ways in which the appropriate application of HF/UE can increase approval success and reduce overall development cost and business risk.
- What a successful HF/UE process looks like and why it is required for regulatory approval
- Discuss what FDA reviewers expect to see at the end of the process
- Get answers to their specific medical device usability testing questions and challenges