A “traditional” risk assessment does not meet the needs of FDA-required human factors analyses.
Is FMEA inadequate for human factors analyses?
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Kaitlin Stinson
Director
Kaitlin brings to Bold Insight over 14 years of experience as a human factors engineer at medical device manufacturers. She has extensive experience in diabetes care products, software as medical device (SaMD), and complex drug delivery systems. Kaitlin has a passion for meeting design control and regulatory requirements while executing agile human factors programs of research. She has a BS in Psychology from Ball State University and an MS in Human Factors from Bentley University.
Bold facts
Learn more about
Kaitlin
Something unique about you summed up in one sentence:
I cycled 2,750 miles in one year.
Your favorite part of working at Bold Insight:
The dynamic, knowledgeable, and fun culture.
In your spare time (or if you had spare time), you would absolutely do this:
Ride my bike or go kayaking.
Your favorite city in the world is...and why?
Indianapolis because that’s where I see my family and friends the most.
You cannot start the day without doing this:
Drinking 40 oz of water.
Your ultimate celebrity dinner party guest list would include:
Bethanny Frankel, Lisa Vanderpump, Gizelle Bryant, & Kyle Richards
Long-term personal or professional goal?
Visit as many wine regions across the globe as possible.
Favorite quote:
“What is the cost of lies? It’s not that we’ll mistake them for the truth. The real danger is that if we hear enough lies, then we no longer recognize the truth at all.” ~ Valery Legasov
Read Kaitlin's bold insights
- Bold Insight presents with Stryker, Genentech, and AbbVie at the HFES Healthcare Symposium
- Integrating FDA's new cybersecurity guidance into medical device human factors engineering processes
- Bold Insight and Eli Lilly and Company co-publish journal article on novel assessment tool to enhance medical device usability
- Bold Insight to launch AI research project at the 2024 HFES Health Care Symposium
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