Proposed Innovation Ecosystem for Prolapse Surgery: Delphi Consensus on Roles and Responsibilities Across Innovation Lifecycle.

INTRODUCTION AND HYPOTHESIS: Surgical management of primary uterovaginal prolapse is undergoing rapid transformation, driven by novel devices, meshes, minimally invasive approaches, and digital tools. Yet the legacy of transvaginal mesh, device withdrawals, and litigation has exposed major gaps in how new prolapse technologies are conceived, evaluated, adopted, and monitored. We hypothesize an ecosystem that defines optimal roles and interactions among key parties in the innovation ecosystem for surgical management of primary uterovaginal POP.

METHODS

We conducted a Delphi consensus study with patients, clinicians, academics, and industry representatives to define optimal roles and interactions across the innovation continuum-from concept generation through post market surveillance. We identified seven separate domains of healthcare innovation and preformed literature searches for each based on a PICOTS framework. This informed an iterative process to develop the sequential rounds of the Delphi survey.

RESULTS

The panel achieved consensus on patient centered needs finding, staged and transparent evaluation aligned with the IDEAL framework, competency based training and credentialing, and continuous, socially responsible post market surveillance supported by high quality registries. There was also consensus on priorities for innovation, including identifying predictors of recurrent POP and developing training techniques to overcome perceived barriers to vaginal surgery.

CONCLUSIONS

This commentary synthesizes the resulting concepts into a framework that could help rebuild trust and support safer, more effective innovation.