{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T20:41:23Z","timestamp":1777581683138,"version":"3.51.4"},"reference-count":11,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T00:00:00Z","timestamp":1761004800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T00:00:00Z","timestamp":1761004800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Andrology"],"published-print":{"date-parts":[[2026,3]]},"abstract":"ABSTRACT<\/jats:title>\n \n \n 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\u2010phase 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\u2010stage monitoring, and patient experience. By providing a clear validation pathway, this opinion article aims to support researchers in the development of reliable, patient\u2010friendly, and regulatory\u2010ready tools for non\u2010invasive ED diagnosis.<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/andr.70135","type":"journal-article","created":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T15:43:59Z","timestamp":1761061439000},"page":"620-623","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["From Prototype to Clinical Practice: How to Validate Novel Instruments for Non\u2010Invasive Erectile Dysfunction Diagnostics?"],"prefix":"10.1111","volume":"14","author":[{"given":"Hille J.","family":"Torenvlied","sequence":"first","affiliation":[{"name":"Department of Urology St. Antonius Ziekenhuis Nieuwegein the Netherlands"},{"name":"BIOS Lab on a Chip Group University of Twente Enschede the Netherlands"},{"name":"Department of Urology Leids Universitair Medisch Centrum Leiden the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rob C. M.","family":"Pelger","sequence":"additional","affiliation":[{"name":"Department of Urology Leids Universitair Medisch Centrum Leiden the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Loes I.","family":"Segerink","sequence":"additional","affiliation":[{"name":"BIOS Lab on a Chip Group University of Twente Enschede the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jack J. H.","family":"Beck","sequence":"additional","affiliation":[{"name":"Department of Urology St. Antonius Ziekenhuis Nieuwegein the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,10,21]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0022\u20105347(17)34871\u20101"},{"key":"e_1_2_9_3_1","volume-title":"EAU Guidelines on Sexual and Reproductive Health","author":"Salonia A.","year":"2024"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40618\u2010023\u201002015\u20105"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/0090\u20104295(85)90243\u20102"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/rfc2.84"},{"key":"e_1_2_9_7_1","volume-title":"MDCG 2021\u201024: Guidance on Classification of Medical Devices","author":"Medical Device Coordination Group","year":"2021"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1209978"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41746\u2010024\u201001016\u20109"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.smrv.2024.101951"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/andr.70017"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/1475\u20106773.13187"}],"container-title":["Andrology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/andr.70135","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/andr.70135","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/andr.70135","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T11:45:07Z","timestamp":1772970307000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/andr.70135"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,21]]},"references-count":11,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,3]]}},"alternative-id":["10.1111\/andr.70135"],"URL":"https:\/\/doi.org\/10.1111\/andr.70135","archive":["Portico"],"relation":{},"ISSN":["2047-2919","2047-2927"],"issn-type":[{"value":"2047-2919","type":"print"},{"value":"2047-2927","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,21]]},"assertion":[{"value":"2025-07-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-07","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-21","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}