Embracing Human Factors and Usability for Medical Devices:
Practical Advice For Implementing a Usability Strategy in all Phases of the Lifecycle Process

As medical devices mature and grow more capable they also become more complex, requiring focus on usability aspects from both a user experience (UX) design, human factors engineering (HFE)  and regulatory perspective. 

But what does it actually take to implement a usability strategy in your product development lifecycle? 

This panel will explore the importance of having a UX strategy and what to do if you have been surprised by regulator feedback and need to invest in HFE. We’ll also look at how usability engineering can be viewed as a product lifecycle process and effectively integrated with an overall systems engineering approach. We will provide practical advice and distill the context, process, and intended outcome of the FDA guidance. 

We will discuss:

• Customizing a UX strategy for your product  
• Practical advice for getting started with Human Factors Engineering
• How to effectively mitigate usability risks from a systems engineering approach
• Tips for navigating the FDA guidance 

Dorothy Shamonsky, Ph.D, Chief UX Strategy Officer for ICS and Boston UX
Dorothy has 30+ years of experience in a broad range of UX skills, including UX strategy, user research, interaction design, visual design, and programming.
Topic: Why you need a UX strategy

Alex Therrien, Director Of User-Centered Design, Sunrise Labs
Alex has led industrial design, interaction design, and human factors engineering programs to develop medical devices for home dialysis, connected drug delivery, digital health/mobile medical apps, and surgical procedures.
Topic: Investing in Human Factors Engineering for your device

Kathleen McHugh, Project manager and lead systems engineer, MPR Associates
She has experience leading all aspects of the usability engineering process, including planning and executing formative and human factors validation studies and developing all aspects of the usability engineering file for medical devices.
Topic: Systems engineering perspective on usability

Milton Yarberry, Director of Medical Programs at ICS & Boston UX
He is a certified PMP with a background in software architecture, medical device product development and program management.
Topic: The essentials of usability for medical devices: context, process, and intended outcome