Key Impact
- Pilot production completed with 100+ devices
- FDA-cleared devices successfully launched
- Scaled manufacturing to 500+ units
- Full lifecycle manufacturing ownership
Client Overview
- Geography: USA
- Market Segment: Medical Aesthetics
- Engagement Model: End-to-End CDMO Partnership
Business Objective
The client aimed to accelerate entry into the aesthetics market with a high-performance microneedling device while ensuring full regulatory compliance and readiness for scale. This required developing a portable, customizable system integrating precision mechanical design, embedded electronics, and software controls, alongside meeting stringent global standards. In parallel, the program demanded establishing a robust manufacturing ecosystem–from component sourcing and precision processes to assembly and testing – while ensuring a smooth transition from pilot production to scalable volumes.
Our Approach
- Delivered a design-to-manufacturing integrated solution, bridging engineering and production seamlessly
- Developed a portable and customizable device architecture aligned with clinical and user requirements
- Managed end-to-end manufacturing operations, including:
- Component sourcing
- Precision thixomolding
- Injection molding
- PCBA and assembly
- Testing and packaging
- Executed risk management and parts validation aligned with regulatory expectations
- Conducted pilot production to validate design, process, and supply chain readiness
- Ensured full compliance testing across safety, software lifecycle, and EMI/EMC standards
Results & Business Impact
- Successfully delivered an FDA-cleared, IEC-compliant device
- Achieved scalable production ramp-up to 500+ units
- Completed pilot validation enabling smooth transition to production
