Se Habla Español: Lessons Learned from Conducting Usability Studies with Native Spanish Speakers in the U.S.

Medical device manufacturers in the U.S. routinely design devices with consideration for user characteristics such as hand dexterity, cognitive and vision impairment, and related disease state comorbidities. We have expanded these considerations during the device development process to include language as an additional distinct user characteristic within the U.S. and to ensure representation of non-English-speaking individuals when they are part of the intended user population. This has included adapting product labeling and training materials to account for idiomatic expressions needed for the interpreted language, device-specific terminology from the original language, and culturally appropriate practices applicable to study material development and participant interviews. This paper presents lessons learned from developing non-U.S. English materials using back translation, recruiting non-English-speaking participants, and conducting research to support shared understanding among participants, moderators, and clients. Although English materials are often assumed to be sufficient for the U.S. market, our findings suggest that well-developed materials in additional languages should be considered essential when products are intended for non-English-speaking users. More broadly, this paper highlights the importance of conducting usability studies that account for native language differences, as consideration of these user characteristics is essential to support safe and effective use across diverse populations.