Background

A leading U.S.-based diagnostics company had developed a working prototype of a compact digital microfluidics-based point-of-care (POC) device. The platform was intended for glucose-6-phosphate dehydrogenase (G6PD) deficiency screening in newborns and pediatric populations, a critical test to identify enzyme deficiencies that can cause severe neonatal complications.
The prototype was built as a cartridge-based system integrating fluidics, electronics, and embedded software and required manufacturing optimization to achieve commercial scalability. With a strategic goal of expanding in low- and middle-income countries, the company partnered with Syrma Johari MedTech Ltd. (SJML) to transition the prototype into high-volume, regulatory-compliant production while ensuring cost efficiency and readiness for CDSCO registration in India.

Objectives

• Scale from prototype to mass production while achieving targeted cost reductions
• Optimize the design for manufacturability without compromising performance
• Establish a scalable, cost-efficient manufacturing model to support long-term production growth
• Facilitate CDSCO registration to enable timely market entry in India’s IVD segment

Challenges

• Scaling a complex digital microfluidic system requiring precise fluidic control and assay accuracy
• Identifying and mitigating risks related to component obsolescence and supply chain volatility
• Coordinating documentation and CDSCO submission processes within tight commercialization timelines

Our Turnkey Solution

To support successful design transfer, SJML deployed an integrated, agile approach:

Design for Manufacturability (DFM)

• Conducted comprehensive DFM reviews and implemented targeted redesigns to enhance assembly efficiency, improve test coverage, and reduce overall cost of production.

Value Engineering

• Performed detailed BOM analysis and introduced alternate sourcing solutions to reduce costs and mitigate component obsolescence risks.

Scalable Production & Custom Validation

• Established robust PCB assembly and electro-fluidic integration processes, complemented by automated inspection and quality-controlled packaging to ensure reliability and consistency at scale.
• Developed and executed device-specific test protocols for the diagnostic cartridge, fluidic subsystems, and integrated electronics to ensure consistency and reliability across production batches.

Regulatory Submissions

• Managed the end-to-end CDSCO registration process for both, test and manufacturing license approvals: Documentation preparation and submissions, coordination with regulatory authorities, and query and deficiency management.

Value Delivered by SJML

KEY OUTCOMES

• 45% Faster development-to-manufacturing cycle
• 20% Cost savings achieved through BOM cost optimization and lean manufacturing

• Scalable, Cost-Effective Manufacturing: Achieved cost-efficient mass production of the digital microfluidic platform, enabling affordable deployment in limited-resource regions.
• Faster Go-to-Market: Integrated design optimization with parallel manufacturing setup, achieving full operational readiness in under six months.
• Accelerated Regulatory Approval: Comprehensive CDSCO documentation and submission support expedited regulatory clearance and enabled faster market entry in India’s growing IVD sector.