Supply chain resilience in diabetic test strip manufacturing is uniquely challenged by the convergence of biological fragility and regulatory rigidity. Unlike standard electronics, test strips rely on unstable enzymes (GDH/GOx) that require strict cold-chain logistics and specialized conductive inks (Gold/Silver/Carbon) that dictate sensor accuracy.

A major structural risk is the geographic concentration of white-label manufacturing in Taiwan (e.g., ApexBio, Bionime), creating a single point of failure for many digital health brands. Furthermore, the industry suffers from Regulatory Lock-In; because FDA/MDR approvals are tied to specific material formulations, manufacturers cannot easily switch suppliers during shortages without triggering lengthy re-validation processes. Resilience strategies currently focus on vertical integration and the shift toward laser ablation manufacturing to reduce dependence on variable screen-printing pastes.