Client Overview
- Geography: USA
- Market Segment: Ophthalmic Diagnostics / Imaging
- Engagement Model: End-to-End Development & Manufacturing
Business Objective
A medical technology company aimed to develop and manufacture a fundus imaging device for accurate retinal diagnostics. The objective was to build a high-precision, scalable system by leveraging a full-stack development approach – from prototype creation to production. This required optimizing designs for manufacturability, ensuring regulatory compliance, managing obsolescence risks, and validating processes through mold fabrication and pilot production—enabling long-term device support and commercial scalability.
Our Approach
Prototype Development & Validation
- Designed and built functional prototypes to validate product design and performance
- Ensured early-stage verification of optical accuracy and system functionality
Design for Manufacturability (DFM)
- Optimized injection molding processes for precision and repeatability
- Refined mechanical enclosure design for manufacturability and durability
- Improved assembly efficiency and cost optimization
Tooling, Mold Development & Pilot Production
- Developed high-precision molds to ensure quality and production consistency
- Conducted pilot production runs to validate manufacturing workflows
- Established robust processes for scale-up readiness
Precision Manufacturing & Cleanroom Assembly
- Set up Class 100 cleanroom manufacturing for lens assembly
- Ensured high optical precision and contamination-free production
- Enabled reliable and scalable manufacturing for imaging systems
Supply Chain & Obsolescence Management
- Implemented obsolescence management strategies for long-term sustainability
- Built resilient supply chain aligned with lifecycle requirements
Regulatory & Compliance
- Ensured compliance with CDSCO and global regulatory requirements
- Established documentation and validation frameworks for approvals
- Enabled smooth regulatory pathway for market entry
Results & Business Impact
- Reduced overall development cost by 20%
- Enabled manufacturing-ready design with validated production processes
- Established scalable, high-precision manufacturing for optical devices
- Strengthened long-term product sustainability through supplier partnerships and obsolescence strategies
