Abstract

Robotic systems for pediatric rehabilitation must provide precise mechanical assistance while ensuring clinically appropriate risk control for vulnerable populations. In low- and middle-income countries (LMICs), academic medical robotics projects frequently fail to progress beyond intermediate Technology Readiness Levels (TRLs 3–5) due to limited translational planning. This study proposes and evaluates an integrated governance framework for academic pediatric rehabilitation robotics in LMIC settings, applied through the development of the AMCOR robotic orthosis for pediatric arthrogryposis multiplex congenita (AMC). The framework combines multiple national and international medical devices development standards and a dual regulatory pathway separating academic development from future translational stages. The framework is structured around four principles—auditability, TRL-proportional documentation, binding decision criteria, and regulatory separation—and is operationalized through a six-gate process. Across the first two gates (G0–G1), 38 traced requirements and 12 failure modes were documented. Five internal audits confirmed operational implementation of the quality management structure. The framework application also shaped core engineering decisions. The low amplitude and poor signal-to-noise ratio of sEMG signals observed in pediatric AMC patients rendered the original single-layer control strategy inadequate, prompting a framework-governed redesign toward a three-layer adaptive architecture based on signal quality thresholds and fallback safety logic. These findings demonstrate that a prospective, multi-standard governance model can improve early-stage academic medical robotics in resource-constrained settings. Generalizability beyond the single-center, two-gate application reported here requires further validation; however, the framework provides a replicable foundation for adoption in comparable LMIC contexts.

IPC Classification

Keywords