September Newsletter

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September's Issue: Home based Human Factors evaluations

A message from Jessie Huisinga, PhD: Wouldn’t it be wonderful if the engineers who designed a medical device for home use could regulate exactly how the device was used once it got to a patient’s home?!? We all know that is a reality that will never exist, so let’s instead innovate ways to better understand how a medical device is used in a patient’s home. In-home observation of medical device use provides invaluable insight into real user performance that could greatly improve device usability.

HUMAN FACTORS DURING HOME USE


FDA has already identified 3 challenges related to home use of medical devices: caregiver knowledge, environmental unpredictability, and device usability. The implementation of home use studies is unique and requires expertise in both human factors study design and in-home study design. How can we best develop medical devices for use at home? Read Now

9 MORE DAYS TILL RAPS CONVERGENCE


Agilis is doing a one-day, pre-conference, workshop on Sunday, Sept. 22nd. "Integrating Human Factors into Your Next Regulatory Submission" See Agenda and do not forget to Register

Email Us to schedule a face to face meeting!

INDUSTRY NEWS: XCERTIA GUIDELINES
 

Mobile apps have become a go-to platform for both patients and healthcare providers to manage medical care. Applying human factors and usability principles to the development of such apps is critical. Xcertia, and mHealth collaborative have been working to develop industry guidelines Learn more

We invite you to CONTACT US to discuss how we can be

your trusted human factors partner for the global medical market.

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