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Is Your Usability Engineering Geared for Market and Regulatory Success?
Abstract
You’ve developed an amazing, innovative technology solution that can improve patient outcomes. You’ve gone through multiple design and engineering iterations, down-selected, and created your Design History File. The first day of your animal trial arrives, and you’re excited. Then disaster strikes – the clinicians can’t figure out the user interface and make a mistake that could severely harm a patient. Why did this happen? Unfortunately, you were unaware of human factors engineering principles about how people process information. To further complicate things, you skipped usability testing because you thought it was too expensive and would slow down your process. But now, the problem with the UI has to be fixed and your time-to-market date is out the window. Don’t let this happen to you!
Beth Loring, Founder and Principal of Loring Human Factors, Inc. will explain why usability is so important, how to implement the FDA guidance, and how incorporating human factors speeds the development process rather than slowing it down. Innovative technology can come to market faster, your customers will be happier, and patients will be safer.
Manisha Rajaghatta, with a background in Systems and Biomedical Engineering, is a former client of Loring Human Factors. She will add insights into the value, as well as the challenges, of incorporating HF into PDP and risk management processes.
Time: 6:30 – 7:45pm – Online
Tickets: FREE
REGISTER HERE
Panelists
Beth Loring, MS, CHFP
Founder & Principal, Loring Human Factors, Inc.
Beth is a Certified Human Factors Professional with 35 years’ experience in product design and usability, with expertise in user requirements, ergonomics, user interface design, and usability testing. She is the founder and principal consultant at Loring Human Factors, a consultancy focusing primarily on the healthcare industry. Beth helps clients develop their usability engineering strategy and advises them on their FDA and CE Mark regulatory submissions. Beth holds an MS in Engineering Design and a BS in Engineering Psychology from Tufts University. She is a member of the AAMI Human Factors Standards Committee and co-author of the book Moderating Usability Tests: Principles and Practices for Interacting with Joe Dumas.
Manisha Rajaghatta
Associate Human Factors Engineer, Loring Human Factors, Inc.
Manisha is an Associate Human Factors Engineer at Loring Human Factors, passionate about user-centered design and testing, harmonizing her biomedical and systems engineering background with a passion for human factors and the user experience. Through user-centric design and testing, she seeks to ensure safety and efficacy, thus improving the quality of life of patients, clinicians, caregivers and the communities that use these products. Manisha has a bachelor’s degree in biomedical engineering with a minor in psychology from Drexel University. Prior to joining LHF, she worked for 4 years in Systems Engineering and Human Factors at a medical device manufacturer.