From Concept to Clinic: Pre‐Clinical Testing and Regulatory Considerations in Spine Implant Development

Background: (DHF) through post-market surveillance, is essential to smoothly transform an innovative idea into a safe and effective clinical product. Methods: (FEA), bench testing, and fatigue studies, are integrated into the pre-market submission dossier. Discussion: trials, digital twins, and smart implants show promise, while global differences in classification, clinical requirements, and post-market expectations highlight the ongoing challenge of regulatory divergence. Conclusion: Understanding the biomechanical foundations of the development process is crucial for the safe and successful translation of spine implants into clinical use. Surgeons and implant designers should engage early, understand the critical steps, and advocate for rigorous validation aligned with regulatory expectations to deliver safer and more effective implants to clinical practice.