Key Impact
- 20-25% reduction in total device cost through localization and redesign
- An India-centric supply chain established to reduce import dependency and shorten lead times
- DFM-driven tooling upgrades and enhanced component reliability
- Predictable scale-up achieved through dedicated plastics manufacturing infrastructure
Client Overview
- Geography: USA
- Market Segment: Neonatal Respiratory Care
- Engagement Model: Design Transfer, Manufacturing Scale-up & Regulatory Enablement
Business Objective
A leading neonatal care innovator aimed to transition its Bubble CPAP respiratory device into scalable, cost-efficient, and compliant manufacturing ecosystem. The objective was to optimize the design for manufacturability, localize the supply chain, and establish robust tooling, validation, and regulatory frameworks – enabling reliable production, reduced costs, and improved supply chain continuity for neonatal care deployment.
Our Approach
Design for Manufacturability (DFM) Optimization
- Conducted detailed DFM review to improve part manufacturability and tooling architecture
- Enhanced process repeatability and reduced defect risks through design refinements
- Optimized component design to improve reliability and reduce overall production cost
Tooling & Plastics Manufacturing Enablement
- Developed and validated high-precision molds for medical-grade plastics manufacturing
- Established robust processes for consistent part quality and scalable output
Regulatory & Compliance Support
- Supported CDSCO registration and regulatory documentation alignment
- Integration with QMS for traceability and audit readiness
Scale-Ready Production Framework
- Validated production processes to enable predictable scale-up
- Optimized supplier coordination and assembly workflows
Results & Business Impact
- 20-25% reduction in total device cost through localization and redesign
- Significant lead time reduction achieved through the India-based supply chain
