Tool Handle Mechanism for Hemostatic Forceps

Project Overview

In 2021, the team collaborated with the client to design and manufacture a precision tool handle mechanism for hemostatic forceps. 

The product aimed to enhance surgical efficiency in minimally invasive procedures by improving grip ergonomics and sterilization compatibility. 

As an OEM project, the client required strict adherence to CFDA certifications and medical-grade manufacturing standards. 

The final product was destined for the Chinese market, with a forecasted production volume of 5,000 units per month.

Technical Challenge

Material Compliance: The handle needed to withstand repeated sterilization cycles (e.g., autoclaving) without degrading. Initial resin prototypes failed durability tests.

Cleanroom Contamination Control: Achieving consistent quality in a Class 10k cleanroom environment posed challenges, particularly during injection molding.

Mechanical Precision: The mechanism required tight tolerances (±0.05mm) to ensure smooth operation of the forceps’ clamping function.

Our Approach and Solution

Material Optimization: Partnered with a resin supplier to develop a proprietary medical-grade polymer that retained structural integrity after 500+ sterilization cycles.

Process Automation: Implemented robotic arms for mold handling to minimize human intervention in the cleanroom, reducing particulate contamination.

Tooling Redesign: Utilized multi-cavity molds with real-time thermal monitoring to ensure dimensional accuracy during high-volume production.

Results & Outcomes

The product achieved CFDA certification within six months of development.

Production yield improved from 78% to 95% after process automation.

A 30% reduction in surgical procedure time due to the ergonomic design.

The project established a repeatable framework for OEM medical device manufacturing, later applied to similar projects like the Ultrasonic-Surgery Mechanical Parts.