Client Overview
- Geography: Global (India HQ)
- Market Segment: Minimally Invasive Surgery
- Engagement Model: End-to-End Design & Manufacturing Partnership
Business Objective
A leading global surgical devices company with a strong presence in minimally invasive surgery aimed to expand its portfolio with a differentiated, next-generation hernia fixation device. The objective was to strengthen competitive positioning and accelerate commercialization by developing a battery-powered hernia tacker for laparoscopic procedures–designed to meet high standards of performance, safety, and usability. This required a one-stop partner capable of managing the entire product lifecycle, from concept and engineering to manufacturing readiness and regulatory execution.
Our Approach
Requirements & Concept Engineering
- Defined product requirements and specifications
- Conducted Freedom-to-Operate (FTO) analysis
- Developed 3D concepts and early design architectures
Design & Development
- Delivered integrated mechanical, hardware, and firmware development
- Established robust system architecture for reliability and scalability
Tooling & Manufacturing Engineering
- Designed molds and production tooling
- Developed DFM-ready documentation and manufacturing processes
- Enabled seamless transition from development to production readiness
Regulatory & Compliance Execution
- Conducted compliance and biocompatibility testing
- Supported sterilization validation processes
- Initiated and managed CDSCO regulatory application
Results & Business Impact
- Achieved design-to-manufacturing readiness under a unified program
- Established scalable production frameworks with validated processes
- Strengthened the client’s surgical portfolio with a differentiated device
- Enabled faster time-to-market through integrated execution
