Established a compliant manufacturing site, enabled regulatory approvals, and localized critical components procurement for advanced endoscopy systems to strengthen supply chain resilience and drive cost efficiency.
Key Impact Metrics
- Selected as best-fit CDMO from 64 evaluated manufacturing sites
- 95% audit evaluation score
- ~20% manufacturing cost reduction through localization
- CDSCO manufacturing license secured
- 5 additional products added under the localization program
Client Overview
- Geography: Global operations; new manufacturing site established in India
- Company Type: Global Endoscopy & Minimally Invasive Surgery Device OEM
- Market Segment: Surgical Visualization & Endoscopic Imaging Systems
The OEM initiated a Make in India program to establish a manufacturing base outside Europe and the United States, targeting replication of precision endoscopic assembly capabilities. The mandate: reduce supply chain complexity and deliver sustained manufacturing cost optimization.
Business Challenge
Strategic Challenge
Establish a qualified manufacturing site beyond traditional geographies, maintaining global quality benchmarks, audit readiness, and product integrity for advanced surgical visualization systems.
Technical Challenge
Replicate complex assembly lines for camera control units and imaging systems, integrating precision tooling, fixtures, test equipment, and validation protocols to ensure consistent performance.
Regulatory & Compliance Challenge
Complete First Article Inspection (FAI) for multiple products and secure local manufacturing licenses, aligning quality systems with OEM audit and compliance requirements.
Manufacturing & Scale Challenge
Transition from initial setup to multi-product expansion, add assembly lines including CO₂ integration, and implement structured component localization to reduce supply chain dependency and enhance cost efficiency.
Our Approach
Infrastructure Set-Up & Qualification
- Completed First Article Inspection (FAI) for Camera Control Unit (CCU) and Camera Head
- Established initial assembly infrastructure aligned with OEM specifications
Manufacturing Line Replication
- Replicated assembly lines, including tools, fixtures, test equipment, and machinery
- Added CO₂ line and expanded assembly capacity
- Ensured alignment with OEM production standards and documentation
Quality & Validation Framework
- Area qualification and equipment qualification
- Workforce training and qualification programs
- Product verification and validation (V&V) protocols embedded into production
Regulatory Enablement
- Secured CDSCO manufacturing license
- Completed FAI for 5 additional products
- Structured documentation supporting compliance and audit readiness
Localization & Cost Optimization
- Initiated component localization program
- Reduced supply chain complexity
- Achieved ~20% manufacturing cost reduction
Results & Business Impact
Measurable Outcomes
- ~20% manufacturing cost reduction
- 95% audit evaluation score
- Selected from 64 evaluated manufacturing sites
- Expansion from initial products to five additional localized products
Operational Impact
Replicated assembly infrastructure delivered consistent product quality beyond traditional manufacturing geographies and reinforced supply continuity.
Regulatory Outcome
Successful CDSCO manufacturing license secured with validated FAI completion across multiple products.
Market Outcome
Enabled OEM Make in India strategy by reducing supply chain dependency and strengthening regional manufacturing resilience.
Scale & Localize Complex Endoscopy Systems with Confidence
Our design-led CDMO framework integrates precision manufacturing replication, regulatory rigor, and structured supply chain localization, enabling global OEMs to expand production into new geographies while maintaining quality and compliance.
