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. Now the problem with the user interface 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.