Healios Technologies · Game-Based Digital Biomarkers

Overview

Collaborated with neurologists and data scientists to design mobile games that generate clinical biomarkers from sensor data, and prepared full MDR compliance documentation.

The challenge

Design mobile games where the gameplay itself produces medically meaningful data, such as reaction times, swipe patterns, and device orientation, without users feeling like they are being tested. Full EU MDR compliance documentation was also required.

Design approach

Designed game UIs and interaction patterns across multiple platforms, optimising for data capture quality without compromising the feel of genuine gameplay. Developed UX frameworks for capturing sensor data so the experience felt natural while the underlying data met clinical validation requirements, then prepared the complete Usability Engineering documentation for EU Medical Device Regulation compliance.

Outcome

Delivered a compliant, validated product with biomarker capture embedded in engaging gameplay, contributing to the regulatory pathway for EU market entry.

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