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Denis Katz Medical Affairs

Denis Katz, MD

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.

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In an era where regulatory expectations, technological complexity, and global harmonization are accelerating, cross-functional excellence determines whether a device reaches patients on time—and with the safety and performance they deserve. Organizations that treat plans as living documents, invest early in collaborative risk management, and unify engineering, clinical, regulatory, and quality perspectives transform development complexity into meaningful patient impact.

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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.

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RBQM is now the prevailing approach to clinical trial oversight in regulated drug, biologic, and device development. The core idea is proportionality: monitoring intensity and quality controls are aligned to the risks that matter for subject safety and decision-making endpoints, rather than applying uniform, resource-intensive methods such as blanket 100% source data verification. RBQM centers on identifying Critical-to-Quality (CtQ) factors, establishing Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs), and using centralized analytics and targeted on-site activities to address high-priority issues.

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By implementing evidence-based methodologies encompassing standardized data collection, proactive stakeholder engagement, risk-stratified monitoring, and continuous improvement processes medical affairs leaders can transform regulatory requirements into competitive advantages. The Prevena case study illustrates how devices delivering continuous negative pressure therapy can achieve specific therapeutic clearances through comprehensive real-world evidence generation.

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