Experts call for culture change, standards to fulfill the promise of RWE

Experts at the 2026 MedTech Conference called for a cultural shift and development of standards to build trust between regulators and the medtech industry in using real-world evidence (RWE) to support medical device marketing. The FDA's 2025 guidance on RWE, ongoing work by the Medical Device Innovation Consortium's NEST, and the European IDHERA partnership emphasize creating standardized approaches for reliable RWE use.

This Wire brief sits within Fusion42's coverage of Medtech.