PRISM (“Pipeline for Reliable Integration of Sensor-based Biomarkers”) focuses on making step-count data from consumer wearables clinically usable through an MDR-compliant BYOD pipeline. The project combines preclinical, MDR-relevant evidence with a pragmatic field demonstration. In doing so, we bridge the gap between consumer sensor data and SaMD and work on a reusable foundation for future digital biomarkers.

Background and urgency

The Dutch healthcare system is under increasing pressure: demand is growing faster than supply, while personalized care requires frequent and accurate insights with minimal burden for patients and care teams. At the same time, consumer wearables and smartphones generate rich, continuous sensor data at scale, but to use these data for clinical decision-making, software must comply with the EU Medical Device Regulation (MDR 2017/745). The bottleneck is not the measuring itself, but the translation of consumer data into clinically usable and regulator-ready insights, in other words: a deterministic bring-your-own-device (BYOD) pipeline.

Objectives and approach

This practice-oriented project delivers preclinical, MDR-relevant evidence and documentation, plus a pragmatic field demonstration, with a focus on analytical/technical validation. We work toward: acceptance criteria and SOPs for step counting (O1); an operational BYOD data pipeline with risk assessment and a guardrails blueprint (O2); a field demonstration of the technical reliability, completeness, and usability of Orikami’s software (O3); and a consolidated report including an MDR-readiness memo (O4).