Real-world evidence (RWE) has emerged as an essential complement to clinical trials, offering continuous insights into implant durability, safety, effectiveness, and economic value across actual care settings. This white paper reviews the importance of RWE in orthopedics, key data sources including national registries and the Orthopedic Coordinated Registry Network (Ortho-CRN), regulatory context, advanced analytical methods, and future directions involving AI and federated data networks. Strategic guidance is provided for manufacturers aiming to integrate RWE into product development, regulatory compliance, market access, and innovation.
