Presentation
Designing and Testing SaMD for Global Markets: Insights from Fieldwork in Saudi Arabia
SessionPoster Session 1
DescriptionDesigning and testing Software as a Medical Device (SaMD) for global markets presents challenges beyond meeting regulatory requirements or simply translating interface text. To create products that are genuinely safe and usable, their design must be informed and shaped by the contexts in which they will be deployed. These contexts can differ in ways that are invisible from afar yet have profound effects on product performance. This poster draws on fieldwork conducted in Saudi Arabia to show why in-country research is essential, how local realities influence both design decisions and human factors testing, and how adapting design for different languages (such as right-to-left languages like Arabic) introduces new challenges: including multi-lingual healthcare systems, presentation of data, and accommodating local customs and expectations.
These challenges are not edge cases—they are the reality of designing for a healthcare system that blends globalised professional practices with local cultural and linguistic norms. Without fieldwork, such mismatches would likely have gone unnoticed, potentially compromising both safety and user experience.
The lessons from Saudi Arabia extend far beyond the Middle East. Many healthcare systems operate in multiple languages, even within a single country, and many mix international clinical staff with local patient populations. The specific challenges will differ, but the principle is the same: the only reliable way to uncover them is to conduct human factors research in the environment where the product will be used. This means involving local users early, testing prototypes in-country, and adapting both design and test methods to reflect cultural norms, work rhythms, and language realities.
This poster will share practical approaches for integrating local fieldwork into global SaMD projects. Global deployment of SaMD demands more than translation—it demands localisation that is informed by the lived reality of its users. The insights from this fieldwork are intended to help teams anticipate and address the often-invisible factors that influence safety and effectiveness in diverse settings. By grounding design and testing in the local context, we can create devices that work as intended for all users, wherever they are.
These challenges are not edge cases—they are the reality of designing for a healthcare system that blends globalised professional practices with local cultural and linguistic norms. Without fieldwork, such mismatches would likely have gone unnoticed, potentially compromising both safety and user experience.
The lessons from Saudi Arabia extend far beyond the Middle East. Many healthcare systems operate in multiple languages, even within a single country, and many mix international clinical staff with local patient populations. The specific challenges will differ, but the principle is the same: the only reliable way to uncover them is to conduct human factors research in the environment where the product will be used. This means involving local users early, testing prototypes in-country, and adapting both design and test methods to reflect cultural norms, work rhythms, and language realities.
This poster will share practical approaches for integrating local fieldwork into global SaMD projects. Global deployment of SaMD demands more than translation—it demands localisation that is informed by the lived reality of its users. The insights from this fieldwork are intended to help teams anticipate and address the often-invisible factors that influence safety and effectiveness in diverse settings. By grounding design and testing in the local context, we can create devices that work as intended for all users, wherever they are.
Event Type
Poster Presentation
TimeMonday, March 234:45pm - 6:15pm EDT
LocationRhinelander Gallery
Digital Health