Accelerating Innovative Medical Devices to Market
Case Study: Precision Overmolding and Rapid-Turn Manufacturing for an Ischemic Stroke Device Platform
Overview
Working closely with a medical device company, SMC Ltd. designed and molded critical components for an ischemic stroke device platform. The revascularization device platform includes three distinct products that help prevent aneurysms and strokes through precision extraction, packing, and blood therapy.
The Challenge
Developing a revascularization device platform for ischemic stroke treatment required a manufacturing partner capable of moving quickly without sacrificing precision or traceability. The project involved multiple products within a single platform, delicate materials, and strict production controls, all while meeting aggressive turnaround expectations and integrating into an existing production environment.
- Molding of multiple products within one device platform
- Small production lots with accurate lot traceability requirements
- Fast market turnaround expectations
- Difficult overmolding on delicate, flexible tubing
- Tool redesign to support overmolding success
- Integration into the partner company’s production system
The Solution
SMC applied its expertise in precision molding, tooling design, and medical manufacturing integration to create a reliable, production-ready solution. By redesigning tooling, optimizing machine setups, and aligning processes with the OEM’s systems, SMC delivered a flexible manufacturing approach that supported speed, quality, and documentation requirements.
- Redesigned and built customized overmolding tools to support reliable processing on challenging tubing materials
- Dedicated vertical injection molding machine setup for consistent, repeatable output
- Manufacturing workflows designed to integrate seamlessly into the OEM’s production system and documentation requirements
- Processes optimized for small-lot production while maintaining strong traceability and fast turnaround
The Results
The final manufacturing solution delivered both operational and business impact. SMC not only met the technical demands of overmolding on delicate materials, but also exceeded expectations for responsiveness, documentation quality, and system integration—supporting the OEM’s broader production and regulatory goals.
- Maintained a clean, accurate device history record (DHR)
- Seamless integration of SMC’s manufacturing process into the OEM’s production system
- Robust overmolding process delivering high quality and repeatability on challenging materials
- Accelerated turnaround—achieving shipment within 24 hours of receiving parts