Bold Insight to showcase digital IFU design, remote testing, global research expertise at virtual human factors health care conference

May 19, 2020

While the March conference in Toronto, Canada, was cancelled, the International Symposium on Human Factors and Ergonomics in Health Care is still being held this week. The virtual format ensures the world’s leading human factors practitioners in healthcare still have a forum to discuss challenges facing the industry, share insights and best practices, and improve collaboration between industry and the Food and Drug Administration (FDA). This year, the Bold Insight team tackles multiple topics throughout the conference.

Bold Insight Managing Partner Korey Johnson will chair the Medical and Drug-Delivery Devices track throughout the event. He will also chair the panel session, Human factors submissions: Strategies for preventing and responding to FDA requests for additional information, focused on highlighting trends in interactions between industry and regulators. The panelists are comprised of industry-leading drug delivery device manufacturers, as well as the FDA Center for Drug Evaluation and Research (CDER). Additionally, new to the virtual program, Johnson is co-presenting on the panel, Remote and Safe In-Person Testing of Medical Devices, with industry colleagues Charles Mauro (Mauro Usability Science), Anthony D. Andre (Interface Analysis Associates), Michael Wiklund (Emergo UL), and Allison Strochlic (Emergo UL).

On May 19, during the Medical and Drug-Delivery Devices track, Bold Insight Partners Anke Adenwala and Jackie Ulaszek will present with Ben Bartfeld, Associate Director Human Factors & Industrial Design Device Group, External Consultant to Otsuka Pharmaceutical Development & Commercialization, Inc, Designing the First Digital IFU, that will identify best practices and key takeaways when designing digital instructions for use (IFUs). As medical devices are becoming more digitized, digital instructions for use will become increasingly common. Digitizing IFUs presents challenges different from optimizing printed instructions; the presentation will highlight the team’s experience, the challenges encountered, and key takeaways that may be applicable to other digital IFUs.

Bold Insight’s global research expertise will also be featured in a Poster session on May 21, Best practices for international HF studies: Key points to consider when testing here and abroad. Authored by Anke Adenwala from Bold Insight (USA) and Matthias Gasser from uintent (Germany and Switzerland), the poster will highlight study logistics, from deciding requirements and understanding local regulatory constraints to planning and executing research in multiple countries. Research teams from the USA and Germany frequently came across the same questions and limitations when managing multi-country research. While from a methodological perspective, there are usually no or only minor differences between testing in the USA and in the EU, there are some important points to consider which will be featured in the poster.

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 Learn more or register for the International Symposium on Human Factors and Ergonomics in Health Care conference by visiting