Workshop on Connected Devices and Digital Health: How to Navigate the U.S. FDA Usability Engineering

SMi Reports: Workshop will include case studies related to emergent digital health innovations currently coming out of Silicon Valley, software apps connected to drug delivery platforms, and new applications for medical software.
By: SMi Group
LONDON - June 15, 2021 - PRLog -- Our conference co-chair Shannon Clark has conducted numerous workshops on human factors and usability testing throughout the world, from Stockholm to Shanghai. This year's workshop will discuss the U.S. FDA Human Factors Engineering Process in the context of digital health and connected devices, as well as unique U.S. FDA regulatory hurdles related to this domain.

Running alongside the main conference will be an interactive post-conference workshop on September 15th, 2021 on 'Connected Devices and Digital Health: How to Navigate the U.S. FDA Usability Engineering Requirements'

Why you should attend:
  • Review all applications for connected devices
  • Discuss the unique U.S. FDA regulatory requirements related to phone applications
  • and connected devices
  • Discover common software and device development pitfalls related to connected
  • devices and digital health
  • Walk through the unique considerations for your human factor's strategy and the
  • details of usability testing for Apps and connected devices

Visit the event website to learn more and download the brochure at

Key sessions discussed at workshop:

Session 1: Connected Devices and Digital Health - Current and Future Applications
  • What's the digital health landscape and latest buzz in Silicon Valley, California, as well as the rest of the world?
  • What innovations are currently tackling issues of medication adherence, medical product adherence, clinical decision support, and remote patient monitoring?
  • How are innovators solving patient needs via user centered design of digital health apps?

Session 2: Overview of applicable U.S. FDA usability engineering requirements & regulatory requirements for connected devices and digital health
  • What U.S. FDA Regulations and Guidance do we need to know about when developing connected devices and digital health applications?
  • What digital health applications are NOT governed by the U.S. FDA

Session 3: Review unique usability engineering considerations related to connected devices
  • Case Study: What are some unique human factors and usability engineering considerations when developing an app and connected device?
  • Case Study: What are some best practices and design considerations (i.e. heuristics) to take into account when developing digital health applications and connected devices?
  • Looking Ahead: What can we expect in 2029?

Register online:
Early bird offer register by 30th June and save $100

Sponsored by Almac | Boston Analytical | Zeon | ZwickRoell


For all media inquiries contact Jinna Sidhu on Tel: +44 (0)20 7827 6088 / Email:

Jinna Sidhu
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