Bold Insight Managing Partner Korey Johnson will chair the Medical and Drug-Delivery Devices track throughout the event. He will also chair a panel session on March 10, 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). Johnson is a frequent presenter and active member in the human factors research community, and among other initiatives is currently supporting the Association for the Advancement of Medical Instrumentation® (AAMI) to revise ANSI/AAMI HE75.
On March 10, during the Medical and Drug-Delivery Devices track, Bold Insight Partners Anke Adenwala and Jackie Ulaszek will present with Ben Bartfeld, external consultant to Otsuka Pharmaceutical, identifying 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, 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.
Bold Insight is part of the ReSight Global family of companies, which will exhibit at this year’s conference and promises to deliver an exciting experience for attendees. Follow ReSight Global’s social media (LinkedIn and Twitter) for the latest information.
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 ReSight Global
ReSight Global is a family of curious researchers helping you deliver outstanding experiences to your customers. Our UX and human factors research agencies in the US (Bold Insight), Japan (Uism), China (XplusX), Germany and Switzerland (uintent), as well as our partners in over 40 countries offer a broad set of tools and methods, seamlessly extend your reach to understand users across borders, and reduce the challenges often associated with global user research. We also maintain an ISO-9001 certified quality system to ensure excellence in service delivery across all locations. Learn more about our locations by visiting http://resight.global.
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.org. Learn more or register for the International Symposium on Human Factors and Ergonomics in Health Care conference by visiting https://www.hcs2020.org/.
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