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

Andrology, vol. 14, pp. 620–623

Abstract

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.

Authors 4

1. Hille J. Torenvlied corresponding Aachen Department of Urology Leids Universitair Medisch Centrum Leiden the Netherlands Department of Urology, Leids Universitair Medisch Centrum

   Leiden University Medical Center · St. Antonius Ziekenhuis · University of Twente

   Affiliation as printed

   BIOS Lab on a Chip Group University of Twente Enschede the Netherlands

   Department of Urology Leids Universitair Medisch Centrum Leiden the Netherlands

   Department of Urology St. Antonius Ziekenhuis Nieuwegein the Netherlands

   BIOS Lab on a Chip Group, University of Twente, Enschede, the Netherlands

   Department of Urology, Leids Universitair Medisch Centrum, Leiden, the Netherlands

   Department of Urology, St. Antonius Ziekenhuis, Nieuwegein, the Netherlands

2. Rob C.M. Pelger Aachen Department of Urology Leids Universitair Medisch Centrum Leiden the Netherlands Department of Urology, Leids Universitair Medisch Centrum

   Leiden University Medical Center

   Affiliation as printed

   Department of Urology Leids Universitair Medisch Centrum Leiden the Netherlands

   Department of Urology, Leids Universitair Medisch Centrum, Leiden, the Netherlands

3. Loes Irene Segerink

   University of Twente

   Affiliation as printed

   BIOS Lab on a Chip Group University of Twente Enschede the Netherlands

   BIOS Lab on a Chip Group, University of Twente, Enschede, the Netherlands

4. Jack J. H. Beck

   St. Antonius Ziekenhuis

   Affiliation as printed

   Department of Urology St. Antonius Ziekenhuis Nieuwegein the Netherlands

   Department of Urology, St. Antonius Ziekenhuis, Nieuwegein, the Netherlands