Bold Insight

What happens when a patient uses a medical device at home, alone, at 6 a.m.? Almost certainly something different than what happens in a usability lab.

Our latest newsletter tackles the real complexity of in-home medical device ethnographies: why they matter for patient safety, what makes them logistically and ethically challenging, and how to do them right. Bold Insight Partner Courtney Roberts draws on lessons from the field, including her recent presentation at the 2026 HFES International Symposium on Human Factors and Ergonomics in Health Care.

Read the full article here:

Navigating the messy reality of in-home medical device ethnographies 🔎 Research spotlight When a patient manages a chronic condition at home, they are not doing it in a clean, well-lit room with a researcher watching from behind a one-way mirror. They are doing it at 6 a.

Something new is coming to Chicago's innovation scene, and we're excited to be part of it. 🙌

Our Managing Partner, Gavin Lew, will take the stage Nivan: Innovation Across Time, Together on May 21 for a lightning talk on AI and the choices shaping what comes next.

Nivan is a full-day dive into innovation across past, present, and future, with keynotes, debates, and workshops at the Institute of Design at Illinois Tech in Chicago.

We're proud sponsors, and we'd love to connect if you're attending.

Bold Insight to present at Nivan, a new Chicago innovation conference Gavin Lew will present at Nivan, a new innovation conference exploring AI, UX, and technology across the past, present, and future.

Summer internship alert! We're looking for someone who wants to actually build something this summer.

You'll own a project from start to finish: designing the system we use to manage research participants. That means talking to our team, evaluating tools, building the integration, and launching it in 9 weeks.

Remote, 40 hrs/week, June 1 to July 31.

If you (or someone you know) is studying marketing, information systems, CS, or business, check it out!

Careers What’s a career at Bold Insight like? Explore opportunities and our Bold culture to discover why what we do matters.

Big week for the Bold Insight team! Our team members are presenting three sessions at EPIC Learning Week (May 4–8) on AI and media, creative production, and multilingual research workflows. Sessions are free for EPIC members. Come learn with us! 👇

Bold Insight presents AI guidance for multilingual global research during EPIC Learning Week Bold Insight will present three sessions spanning some of the most pressing topics in UX research and design at EPIC Learning Week.

A great study with poor communication is a zero-impact study. 👀

Our latest edition of The Bold Approach is here! This month, Bold Insight Director Larry Becker shares highlights from presenting at the UXinsight Festival in the Netherlands, and it's a perspective every researcher and stakeholder should hear.

Research doesn't drive change just because it's rigorous. It drives change through human judgment, listening, and partnership that occur long before the final report lands.

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We're presenting at the UXinsight Festival 2026, April 20–22, in Leiden (NL).

Our Director Larry Becker will take the stage with 'From Data Provider to Chief Insights Marketer', a session built around one core idea: even the highest-quality research loses its impact when communication falls flat.

Drawing on more than 25 years of experience, both delivering research and receiving it as a client, Larry will share practical frameworks for shaping how insights land at every stage of a project. From classical rhetoric to modern digital strategy, the goal is to help researchers earn a seat at the strategy table.

Visit the event website to learn more and register. Link in comments.

Bold Insight to present techniques to improve research communication at UXinsight Festival Bold Insight Director Larry Becker will present practical techniques for shaping research communication at the UXinsight festival.

Our team had an incredible time at HFES HCS 2026 in NYC! Here's a look at what made it magic:

🌏 Hosted a panel alongside our global partners from Japan, South Korea, and China
🎤 Presented on multiple topics covering FDA submissions, SaMD for global markets, and patient ethnographies
🪄 Performed magic tricks at our booth to make use-related risks vanish
🍪 Gave away classic black & white cookies (big thanks to William Greenberg Desserts. They disappeared fast!)
🖊️ Sent attendees home with disappearing ink pens as a little reminder to "shine a light on use-related risk"
🤝 And most importantly, connected with our amazing HF community

Our posters and presentation slides from the conference, along with a quick reference guide to HF testing in Japan, South Korea, and China, are available for download at boldinsight.com/hfes2026

If you connected with any of our team members and want to chat more about your next study, send us a message at boldinsight.com/contact. We're currently offering our most competitive rates of the year for projects booked by end of month.

Until next year! 🎩

Call now to connect with business.

Did you know that in Japan, a checkmark can signal a warning? Or that participants in China may apologize for a design flaw rather than report it?

These aren't just interesting cultural footnotes. In HFE research, details like these directly affect your data quality and your regulatory submission.

Our latest newsletter breaks down what medical device companies need to know before running HFE studies in China, Japan, and South Korea: why localization is a regulatory requirement (not a courtesy), and why logistics alone can triple your per-participant costs.

📋 New: Asia Quick Guide — a market-by-market reference covering recruitment lead times, facility requirements, sample size expectations, and IRB pathways for all three markets.
Also available: downloadable HFES posters and presentations on Asia HFE studies, FDA submission strategies, SaMD testing for global markets, and patient ethnographies in healthcare research.
All in one place!

Adapting human factors strategies for Asian medical device markets 🔎 Research spotlight Expanding your medical device to China, Japan, and South Korea is a critical growth milestone. However, applying your US human factors strategy will likely result in stalled timelines and rejected regulatory submissions.

We're two weeks out from the 2026 HFES Health Care Symposium in New York!

This year we're presenting on:
💡 Conducting HFE studies in China, Japan, and South Korea (with local experts from Hankook Research, XplusX, and Uism)
💡 Designing and testing SaMD for global markets, featuring fieldwork examples from Saudi Arabia
💡 Recruiting and learning from patient ethnographies in healthcare research
💡 Navigating FDA human factors submissions under the latest guidance

Whether you're deep in global device development, navigating regulatory strategy, or curious about what it really takes to run studies across cultures, come hear from our team.

⭐ BONUS! Stop by our booth for a New York classic sweet treat -- come early because our supply is limited!

Bold Insight covers global research, Asia HFE, and FDA strategy at the 2026 HFES Health Care Symposium This month, Bold Insight will present on multiple topics at the 2026 International Symposium on Human Factors and Ergonomics in Health Care.

Where does a therapy actually get used?

Not in a lab. At 7am before work. By someone managing three other conditions. By a caregiver who's exhausted.

Bold Insight's Gavin Lew co-authored a chapter on the patient ecosystem in Patient-Focused Development of Biopharmaceutical Products, published by Springer as part of the AAPS Advances in the Pharmaceutical Sciences Series. The chapter, written alongside Paul Blowers of AbbVie, explores how understanding a patient's full world, including caregivers, healthcare providers, digital tools, and real-life context, is what makes safe and effective therapy design possible.

The book is available open access: https://link.springer.com/book/10.1007/978-3-031-98253-8

https://boldinsight.com/news/bold-insights-gavin-lew-co-authors-chapter-on-patient-ecosystems-in-new-springer-biopharmaceutical-resource

Bold Insight’s Gavin Lew co-authors chapter on patient ecosystems in new Springer biopharmaceutical resource Gavin Lew contributes chapter on patient ecosystems in a new Springer book on patient-focused biopharmaceutical development.