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.

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.