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.
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Anke Adenwala
Partner
Anke has spent more than 7 years in the UX field. Much of her recent work has been in the healthcare space, specifically with medical device manufacturers to coordinate and execute human factors research programs. Her experience ranges from exploratory work, through small- and large-scale formative studies, to 510k validation studies, having supported successful submissions and several publications. With a background in social science, Anke enjoys interacting with people to better understand how the devices they interact with impact their lives, and how to optimize these tools to create better experiences. Anke has lived and studied in three countries and speaks German and French. Anke holds an MA in Social Science from the University of Chicago.
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- Bold Insight to launch AI research project at the 2024 HFES Health Care Symposium
- Bold Insight to showcase digital IFU design, remote testing, global research expertise at virtual human factors health care conference
- Bold Insight to showcase digital IFU design, global research expertise at human factors health care conference
- When designing an experience, are you really thinking about the customer first?
- Reclassifying diabetes: 3 implications for product design
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