From Prototype to Clinical Practice: How to Validate Novel Instruments for Non-Invasive Erectile Dysfunction Diagnostics?

Erectile dysfunction (ED) diagnostics are in need of innovation, as traditional tools like the RigiScan face usability challenges and limited clinical adoption. Although several novel sensor systems have been proposed, none have undergone comprehensive clinical validation. This opinion article outlines a structured, three-phase validation framework comprising component validation, system feasibility testing, and clinical validation, aligned with European MDR requirements. Special attention is given to key aspects such as diagnostic accuracy, sleep-stage monitoring, and patient experience. By providing a clear validation pathway, this opinion article aims to support researchers in the development of reliable, patient-friendly, and regulatory-ready tools for non-invasive ED diagnosis.