Vision systems assure accuracy in laser marking processes

Laser vision systems benefit from automated laser marking, cutting, engraving, and welding to deliver accuracy and enhanced quality control in manufacturing medical devices. A vision system features lighting, robotics, software, and cameras to assure proper marking, reliability, and efficiency no matter the product being processed.

The medical device industry benefits from laser vision systems as laser processing provides a cleaner, more durable result than other cutting and marking processes. Guiding the process with verifiable representation of parts is critical.

Deploying a vision system

To achieve a successful laser vision system, consider the project’s specifications. There’s no need to overdo it when working on a small project, but there can be tremendous benefits to performance, speed, and accuracy with a precise laser vision system that incorporates optical parts recognition (OPR) and optical character validation (OCV) software. Custom software offers database connections, component recognition, and corresponding protocols, barcode read-back functions, DataMatrix codes, and plain text entries. A customized vision system assures quality and regulatory conformance. Initial samples can be developed in an application lab where the right components can be assessed, modified, and finalized for production.

Vision systems for medical device markings

Marking medical devices can be challenging considering the U.S. Food and Drug Administration’s (FDA) standard for the unique device identifier (UDI) requirement. Device marking must be readable, free of defects, and withstand severe cleaning, sterilization, or passivation.

Marking of medical devices occurs at the end of production, and it’s critical to ensure the marking process is absolutely accurate. At this final step, incorrect, incomplete, or otherwise mis-applied markings that can’t be modified can relegate the device to scrap.

Medical devices vary in size and shape and are manufactured using various materials, each reacting differently to laser techniques. The marks must be permanent, completely readable, and traceable throughout the life cycle. From the manufacturing plant to the operating room where the device is embedded into the patient, it’s essential the part be free of defects to avoid bacteria build-up or other dire results.

Medical device manufacturers are looking for laser marking systems that provide near or total defect-free results and meet safety standards. A vision system with customized software combined with cameras, robotics, and lighting provides the most accurate, precise method of gaining optimum results for the manufacturer and those involved in the chain of use.

How vision systems work

Vision systems can be complicated, so it’s important a laser processing partner has experience. Vision systems include mechanical hardware, optical hardware, and customized software, integrated into automated precision motion platforms. The vision systems are an integral component of process accuracy, efficiency, quality control, and assurance of regulatory compliance.

Without vision systems, hard tooling or fixtures that hold parts in position for laser processing must be custom-made for every part to accommodate its geometry and position for laser marking. However, a vision system can identify the part and automatically re-orient the laser path or instruct the axes to reposition to correctly align the part before marking occurs, using only rudimentary fixtures.

When laser marking tubes, the position of the mark lengthwise and rotationally is important; a vision system can identify the part and orient it properly for marking. The system reads the position and then rotates or indexes the part to the appropriate position before any marking takes place.

High-resolution cameras and versatile lighting systems support OCR and OCV processes to verify a part is in place and inspect the part after processing to verify that a barcode is readable and of the appropriate grade.

Summary

There’s a complex path to medical device regulatory approval, particularly complying with global standards. Whether the device is being used in the U.S. or abroad, manufacturers must meet guidelines for quality and traceability.

UDI markings must be readable and able to withstand harsh treatment throughout the product’s lifecycle. Laser marking - using the customized benefits of vision systems - offers production efficiency with less scrap, ensures costly mistakes don’t impact product safety or manufacturers’ liability, and improves regulatory acceptance.

About the author: David Locke is a regional sales manager for ACSYS Lasertechnik US Inc. Locke can be reached at d.locke@acsyslaser.com.

ACSYS Lasertechnik US Inc.: https://acsyslaser.com