Background
A US-based diagnostics company developed a compact point-of-care device using digital microfluidics technology to enable rapid testing from small-volume samples. Initially targeted for glucose-6-phosphate dehydrogenase (G6PD) deficiency screening in newborns and pediatric populations, the device was designed as a cartridge-based system integrating electronics, fluidics, and embedded software.
The client engaged us to transition the prototype into mass manufacturing to improve scalability, ensure production consistency, and support regulatory approvals for market entry in India.
Objectives
- Transition from prototype to high-volume production with no cost increase, and ideally, cost reduction
- Optimize the design for manufacturability without compromising performance
- Establish a scalable, cost-efficient manufacturing model
- Enable CDSCO registration for Indian market entry
Challenges
- Commercializing a complex digital microfluidic system for newborn/pediatric diagnostic use cases
- Ensuring high-throughput manufacturability while preserving fluidic and diagnostic precision
- Identifying and mitigating risks related to component obsolescence and supply chain volatility
- Managing regulatory documentation and CDSCO approval
Our Turnkey Solution
DFM | Value Engineering | Scalable Production | Regulatory Submissions
To support successful design transfer, we deployed an integrated, agile approach:
- Design Optimization: Conducted in-depth DFM reviews and provided targeted redesign suggestions to improve assembly efficiency, testability, and cost structure.
- Lifecycle & BOM Analysis: Evaluated component lifecycle risks and introduced sourcing alternatives to improve availability and reduce long-term obsolescence/end-of-life concerns.
- High-Precision Production: Achieved mass manufacturing through robust PCB assembly, fluidic-electronic integration, and quality-controlled packaging.
- Custom Validation: Developed custom test protocols for the diagnostic cartridge, fluidic subsystems, and integrated electronics to ensure consistency and reliability.
- Regulatory Support: Led end-to-end management of CDSCO registration, including compliance, documentation, and certification for test license and manufacturing license.
Key Outcomes
- Reduction in development-to-manufacturing cycle time 45%
- Reduction in development-to-manufacturing cycle time 20%
What Was Accomplished
- Scalable, Cost-Effective Manufacturing: Enabled mass production of high-precision diagnostic platforms without increasing unit cost—supporting affordable deployment at scale.
- Faster Time-to-Market: By integrating design reviews with parallel manufacturing setup, the device achieved operational readiness in under 6 months.
- Regulatory Compliance & Certification: Full support for CDSCO certification accelerated go-to-market in India’s IVD landscape
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