Project Overview: A European medical device startup approached Yude Technology with a prototype for a new CPAP breathing mask. They needed a reliable partner to transition their 3D-printed prototype into mass-producible Liquid Silicone Rubber (LSR) components, ensuring zero flash and strict biocompatibility compliance.
The Challenge
The client's initial design featured a complex undercut and uneven wall thickness, which posed significant risks for mass manufacturing:
- Uneven Shrinkage: The varying wall thickness would lead to deformation during the curing process.
- Parting Line Irritation: As a product in direct contact with human skin, any flash or harsh parting lines on the sealing edge would cause discomfort to the patient.
- Tight Tolerances: The mask needed to perfectly interlock with a rigid polycarbonate (PC) connector without any air leakage.
Our Engineering Solution (DFM)
Upon receiving the STEP files, the Yude engineering team conducted a comprehensive Design for Manufacturability (DFM) review and proposed three key modifications:
- Wall Thickness Optimization: We cored out the thicker sections and added supportive ribs, ensuring uniform curing and eliminating sink marks.
- Advanced Mold Tooling: Our CNC engineers designed a high-precision, multi-cavity steel mold with an automated cold runner system. The parting line was strategically relocated to the outer edge of the mask, completely away from the patient's face.
- Material Selection: We selected a biocompatible, FDA/ISO 10993 compliant Shore 40A LSR material that perfectly balanced flexibility and structural support.
— Lead Product Engineer, European Medical Startup
The Result
The first-off-tool (FOT) samples were approved on the first submission. The final product achieved:
- Zero Flash: Flawless parting lines ensuring maximum patient comfort.
- 100% Air-tight Seal: Perfect assembly compatibility with the rigid PC connector.
- Cost Efficiency: The cold runner system eliminated material waste, reducing the unit cost by 15% for mass production.
Today, Yude Technology manufactures over 50,000 units of this mask monthly, packaged in our ISO Class 7 cleanroom facility and exported directly to Europe.
