Bold Insight to present on global medical device testing, in-person research logistics during COVID at HFES Health Care Symposium

April 9, 2021

Bold Insight will feature two trending topics during the 2021 International Symposium on Human Factors and Ergonomics in Health Care. Sharing lessons learned when managing in-person research with vulnerable populations during COVID, Michelle Jahn Holbrook, Senior UX Researcher at Bold Insight, and Mick Rakauskas, Principal Human Factors Research Engineer at AbbVie, drafted tips and best practices to conduct this research safely and effectively. Holbrook also teamed up with Bold Insight UX Researcher Stephanie Wiltman to identify and synthesize local regulatory guidance as it relates to medical device testing in key global markets.

With their work, Tips and best practices for conducting in-person user experience research with vulnerable populations in the COVID-19 era, Holbrook and Rakauskas aim to provide medical and pharmaceutical practitioners with techniques to conduct successful in-person, user experience research with vulnerable populations in the COVID-19 era when a risk-benefit analysis concludes that such research is warranted. By employing a multi-pronged approach to recruitment, communication, and protective measures, there is a higher likelihood of participant show rates and completing test sessions. The techniques presented in this work were used successfully to facilitate several in-person human factors studies with vulnerable patient populations and can assist other practitioners looking for proven techniques to incorporate into their practice.

Holbrook and Wiltman address the complex process of tailoring medical device requirements across multiple countries in their presentation, Medical device human factors submissions: identifying and understanding key differences in regulatory guidance across the globe. They reviewed requirements for complete human factors submissions for medical devices adhering to local regulatory guidance from regions across the globe. This analysis was based on harmonized global standards (IEC 62366-1&2) and relevant local regulatory guidance from Therapeutic Goods Administration (Australia), National Medical Products Administration (NMPA) (China), European Union Medical Device Regulation ​(EU MDR)​, Medicines and Healthcare products Regulatory Agency (MHRA) (UK), and the US Food and Drug Administration (FDA). The output of this work will be a framework for human factors practitioners to quickly compare and contrast key similarities and differences across regulatory guidance when planning for upcoming human factors submissions with multi-country launch objectives.

Held virtually from April 12-16, this year’s poster session is enhanced to better cater to the online experience. To register, visit Don’t miss the ReSight Global virtual booth to play the claw game and win one of 600 prizes.

About Bold Insight
Bold Insight is a user experience (UX) and human factors (HF) research agency based in Chicago. We span the product development life cycle; our research informs early product design to human factors validation. Specializing in large-scale and global research in a variety of testing environments, including in-lab and simulated-use, we work with digital, next-generation technology—medical devices to mobile apps, IFUs to websites, back office systems to end-to-end customer journeys. Our team has been UX consulting for almost 20 years which offers unique insight to avoid project pitfalls; saving time, money, and resulting in better data.

About HFES
The Human Factors and Ergonomics Society, founded in 1957, is the world’s largest scientific association for human factors/ergonomics professionals. HFES serves the needs of members and the public by promoting and advancing the discovery and exchange of knowledge concerning the characteristics of human beings that are applicable to the design of systems, products, tools, and environments of all kinds. Learn more about HFES by visiting http://hfes.orgLearn more or register for the International Symposium on Human Factors and Ergonomics in Health Care conference by visiting