DiffMag Probe

The DiffMag is a handheld probe for sentinel lymph node biopsy (SLNB) that uses SuperParamagnetic Iron Oxide Nanoparticles (SPIONs) instead of radioactive tracers. Developed by the University of Twente, this magnetic alternative avoids radiation exposure, simplifies logistics, and ensures longer shelf-life and tracer stability in patients.

As part of a Biomedical Engineering course at the University of Twente, I collaborated with a multidisciplinary team to analyse and improve the device’s compliance with Medical Device Regulation (MDR). Our focus was on risk analysis, safety-by-design, and pre-certification evaluation. Using Failure Mode and Effects Analysis (FMEA), we proposed safety improvements.

Three major design changes were implemented: rubber feet and a probe holder to prevent the device from falling, a sterile protective sleeve with a notch to avoid contamination, and a multi-functional LED ring for error communication and usability. These interventions reduced clinical risk and aligned the device with MDR and ISO standards.

This project illustrates how design can enhance both safety and usability in complex clinical tools, an essential step toward regulatory approval and real-world implementation. It integrates US through user-focused risk mitigation, MDC in FMEA and data-supported evaluation, CA in the ergonomic and redesign of interactions and BE by addressing compliance and market readiness as essential steps toward medical innovation.