Closed-loop biomanufacturing: data-driven design, monitoring, and validation of medical systems

The reliable manufacture of medical devices, implants, and scaffolds depends not only on the materials used, but on how the manufacturing process itself is designed, monitored, and validated. Even with well-characterised materials, batch-to-batch variability, limited in-process visibility, and manual quality control continue to slow the path from laboratory prototype to approved clinical product. Advances in artificial intelligence, digital modelling, in-line sensing, and data-driven process control now make it possible to treat biomanufacturing as an intelligent, self-correcting system rather than a fixed recipe. Realising this shift requires reproducible data pipelines, robust process–property–performance models, and validation strategies that regulators and clinicians can trust.This Research Topic aims to advance intelligent, data-driven approaches to the biomanufacturing of medical systems, with an emphasis on process rather than material discovery. We welcome original research, reviews, and perspectives addressing, but not limited to:• Digital/virtual process models for medical device and scaffold manufacturing• Artificial intelligence and machine learning for process design, optimisation, and control• In-line and real-time sensing, monitoring, and defect detection during manufacture• Closed-loop and self-correcting (autonomous) manufacturing workflows• Quality-by-design and process–property–performance relationships• Data pipelines, standardisation, and traceability across the manufacturing chain• Predictive modelling of manufacturing reproducibility and batch variability• Multi-scale and multi-physics simulation linking process parameters to function• Scale-up from prototype to reproducible clinical-grade production• Regulatory, quality-assurance, and validation frameworks for data-driven manufacturing• Translational case studies connecting manufacturing intelligence to clinical outcomes Topic editors: Fengyuan Liu, Cian Vyas Source: https://www.frontiersin.org/research-topics/86492/closed-loop-biomanufacturing-data-driven-design-monitoring-and-validation-of-medical-systems