Design an AI-enabled software as a medical device that offers cutting-edge capabilities and earns the trust of healthcare professionals, ultimately improving patient care.
5 tips for designing AI-enabled SaMD that HCPs trust
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Coleen Long
Director
With a background in clinical, academic, and consumer research, Coleen brings to every project unique, creative insights and an eye for detail. Our clients benefit from her passion for understanding the needs of special populations to develop tools that improve overall quality of life. Coleen has leveraged multiple methods and approaches to lead research across a wide range of industries, including medical technology, commercial products, entertainment, and mental health. Coleen has a BS in Clinical Psychology from the University of Illinois at Urbana-Champaign.
Bold facts
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Coleen
Something unique about you summed up in one sentence
I have lived in all regions of the US.
Your favorite part of working at Bold Insight
The people! With such a diverse group of supportive, hardworking, and fun-loving individuals, I am constantly learning something new and ways to improve/grow.
In your spare time (or if you had spare time), you would absolutely do this:
Find any and all great food spots near by to go and try out. Or, if anything, scroll through pictures of food on yelp and wish I was eating it.
How long have you been in the UX field?
4 years
You cannot start the day without doing this...
Spend at least 10 minutes doing absolutely nothing and then making coffee.
Your favorite city in the world is...and why?
Taipei, Taiwan! It’s filled with rich culture and some of the best food around. I have family there and have been able to visit almost once every year; it’s like a second home.
Your ultimate celebrity dinner party guest list would include:
Alex Trebek, Ryan Reynolds, Meryl Streep, and Jenna Mourey.
Do you have a long-term personal or professional goal you'd like to share?
Make sure that no matter what I am doing, there’s always an opportunity to give back to my community.
Read Coleen's bold insights
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Human factors testing for OTC drugs and non-prescription medical devices
As the field of human factors continues to evolve, so must our approaches to testing and study design. While the FDA’s 2013 guidance laid the groundwork for study design and methodology, recent discussions and conference presentations have prompted a shift in how we approach OTC HF testing, leading to more comprehensive and realistic assessments of these products.