Redefining "Level of Involvement": A Stage-Based Governance Framework for Pelvic Organ Prolapse Innovation

Innovation in pelvic organ prolapse surgery depends on early, iterative collaboration among clinicians, engineers, companies, universities, and professional societies. After past device-related harms, many organizations adopted restrictive rules to prevent undue influence, but these can unintentionally exclude the physician innovators best positioned to guide safe progress. We propose a proportional governance framework that scales with technological maturity (technology readiness level, TRL), clinical validation (clinical readiness level, CRL), and physician financial or decisional influence (level of involvement, LOI) across four stages: discovery, translational innovation, clinical validation, and commercial deployment. A practical governance scorecard and a standardized research lexicon (completed, ongoing, planned) support management rather than exclusion, preserving transparency and patient protection while enabling responsible innovation.