NESTcc Test-Case company Johnson & Johnson has nearly completed a proactive post-market surveillance for safety and effectiveness of Class II lumbar interbody system device procedures. Real-World Evidence gathered from this and other Test-Cases promises to open the door to new opportunities for device stakeholders to work together to share and leverage powerful real-world data—and shift the paradigm for how medtech innovates.
Real-world data (RWD) and real-world evidence (RWE) aren’t new concepts, but with the rapid uptake of digital health technology and clinical data that is routinely collected from advanced medical devices, a whole new world of opportunity is coming into play. High-quality, “real-world” information is becoming more accessible and is being used by stakeholders including regulators, providers, payors, device manufacturers, and patients, to bring forward technologies that improve health. And, there is even the opportunity to substitute reliable RWE in place of mandatory, expensive, large-scale trials which, considering the continuously evolving nature of medtech, may be more sustainable over time.