Udi Laser Case Study: Dual-Head Laser Marking System

Through a case study of the use of UDI laser marking, this article will focus on the equipment selection, optimization of marking processes, and compliance with regulations in the medical device industry.The book covers the application of UDI laser marking in the tracing of surgical instruments and identification of implants, providing a reference for medical device manufacturers.

Why does medical equipment need dual-head laser marking?

We often run into the following problem in our medical device production: We need to apply serial numbers to orthopedic screws of different sizes, and we need to engrave anti-counterfeiting codes on the surface of minimally invasive surgical devices.Traditional single-head machines require constant material changes, which means a direct loss of at least half the efficiency.The advantages of the dual-head system are obvious: one head can be used to process the implant tubing while the other simultaneously processes the surgical clamps, doubling productivity.Even more critical is that the UDI marking on medical devices requires a precision of 0.1 mm. The dual-head configuration ensures that both stations meet medical-grade standards.

Udi laser marking in actual production.

When I was working on a project for a stapler manufacturer last year, I encountered a typical problem: titanium alloy staples and plastic handles require different parameters.We have installed a 20W fiber laser and a 3D dynamic focus module in our dual-head system, which ensures deep engraving on metal surfaces while avoiding damage to plastic parts.This flexible configuration is especially useful for the production of components for surgical robots.

These are the three factors that must be considered when selecting a laser marking system.

Matching laser types.

Medical devices come in all shapes and sizes, and the materials used to make them are just as diverse, ranging from stainless steel to PEEK (polyether ether ketone).He suggests that the laser be a combination of fiber and UV, which can handle 90 % of medical materials.One of our clients bought a single laser machine last year because it was cheap, but the ceramic hip joint cracked when the label was applied.

Software compatibility testing.

The medical device tracking system is no laughing matter, and we have to ensure that the marking software can connect seamlessly with the company's manufacturing execution system (MES).The key points are whether they support the HL7 medical data format, and whether they can automatically associate the production batch number.We have encountered cases where the system requires manual input of UDI information, and this loss of efficiency will certainly be a problem for the FDA.

Environmental adaptability.

A cleanroom isn't just for show: the laser system's cooling system had to be changed to positive-pressure ventilation.Once, when installing a production line, the fans that cooled the ordinary equipment blew dust directly onto the product, and the entire batch had to be scrapped.Nowadays, custom-made medical respirators all use HEPA filters. They're a little more expensive, but they're reassuring.

Hidden tips for the daily maintenance of UDI laser marking.

The medical industry is most afraid of downtime. Here are some maintenance tips: Every quarter, use an endoscope to check the cleanliness of the laser head's lens; prepare two sets of field lenses with different focal lengths to handle unexpected orders; and store parameter templates for different materials in the software.When a stent manufacturer received an emergency order recently, it was able to shave three days off its production time by using a pre-set cobalt-chromium alloy parameter package.

Emergency repairs for sudden breakdowns.

If the laser head on a production line suddenly fails at 2 a.m., don't panic. Instead of calling the repair service, try this: temporarily switch the control lines of the two laser heads, and use the backup head to do the work.Some clients have used this method to make it through the critical production period before a surprise inspection, and then dealt with the problem machines when it was time for routine maintenance, minimizing losses to the greatest extent possible.