Multifunctional nanoplatforms nanomedicine-device combination products: a translational maturity framework spanning nanocoated implants, theranostic platforms, wearable nanosensors, drug-eluting devices, intratumoral nanoparticle injections, and inorganic hybrid nanoplatforms.

Nanomedicine-device combinations are a heterogeneous product class integrating nanoscale materials with implantable, wearable, and interventional medical devices. Although prior reviews have examined individual technological, regulatory, or clinical aspects of these products, an integrated framework for systematic cross-category comparison is lacking. This review addresses that gap by proposing a Translational Maturity Framework (TMF) synthesizing technology readiness levels (TRLs), regulatory pathway complexity, manufacturing scalability, and clinical evidence strength across six categories: (1) nanocoated and nanostructured implants, (2) theranostic nanoplatforms, (3) nanosensor-integrated wearable devices, (4) drug-eluting devices with nanoparticle payloads, (5) nanoparticle-based intratumoral injections, and (6) inorganic and hybrid nanoplatforms. Using the TMF, we show that intratumoral nanoparticle injections (NBTXR3, NanoTherm) have achieved the highest translational maturity, reflecting their simple design and physics-based mechanisms that ease regulatory classification, while multifunctional theranostic and hybrid platforms face the steepest barriers due to structural complexity and dual diagnostic-therapeutic classification challenges. We identify manufacturing scalability and regulatory classification ambiguity as universal bottlenecks across all six categories, propose a regulatory decision tree for combination-pathway selection, and outline priority research directions for accelerating clinical translation. This framework gives developers, regulators, and investors a structured tool for benchmarking progress and allocating resources in this rapidly evolving field.