David Locke, Regional Sales Manager, ACSYS Lasertechnik US Inc.10.08.21
Laser vision systems, a key component of the laser application process, have the benefit of automating the laser marking, cutting, engraving, and/or welding processes in manufacturing. These systems deliver exceptional accuracy and enhanced quality control, particularly for products such as medical devices which are subject to regulatory scrutiny and approval.
This article will look at the key features that comprise a vision system: lighting, robotics, software, and cameras. The combination of these customized components will assure proper marking, reliability, and efficiency no matter the product being processed.
With the precise functionality necessary for medical devices, the industry benefits greatly from the application of a laser vision system. Quality control should always be a key consideration as laser processing provides a cleaner and more durable result than other cutting and marking processes. Guiding the process with verifiable representation of parts is critical.
Generally, marking of medical devices occurs at the end of a production process. That means it is even more critical to make sure that the marking process is absolutely accurate. At this final step in the process, incorrect, incomplete, or otherwise mis-applied markings that can’t be modified, can relegate the device to the scrap heap which is obviously a costly error.
Another challenge with medical device marking is that these devices vary in size and shape as well as are manufactured using various materials, each of which react differently to laser techniques. These marks must be permanent and completely readable and traceable throughout the entire life-cycle – from manufacturing to end point. For example, from the manufacturing plant to the operating room where the device is manually manipulated and finally even embedded into the patient where it is essential that the part be free of defects which could cause, e.g., bacteria build-up or other dire results.
The bottom line is that medical device manufacturers are looking for laser marking systems that will provide near or total defect-free results and safety standards. Therefore, a vision system approach with customized software combined with cameras, robotics, and lighting, provides the most accurate and precise method of gaining the most optimum results for the manufacturer and those involved in the ongoing chain of use.
Without vision systems, hard tooling or fixtures are used to hold parts in position for laser processing. These devices must be custom-made for every part to accommodate its geometry and to position it for laser marking. A vision system, on the other hand, can identify the part and automatically re-orient the laser path or instruct the axes to reposition themselves to correctly position the part before marking occurs, using only rudimentary fixtures. For example, laser marking of cylindrical parts, i.e., tubes where 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/tube to the appropriate position before any marking takes place.
High resolution cameras and versatile lighting systems support OCR and OCV processes that are to verify that a part is indeed in place and are able to inspect the part after processing to verify that a barcode is readable and of the appropriate grade.
David Locke is technical sales manager for ASCYS Lasertechnik US where he advises customers on their line of customizable laser systems for cutting, marking, welding, and engraving. He has been in the industrial laser industry since 1984. Locke has a degree in physics from St. Michael’s College.
This article will look at the key features that comprise a vision system: lighting, robotics, software, and cameras. The combination of these customized components will assure proper marking, reliability, and efficiency no matter the product being processed.
With the precise functionality necessary for medical devices, the industry benefits greatly from the application of a laser vision system. Quality control should always be a key consideration as laser processing provides a cleaner and more durable result than other cutting and marking processes. Guiding the process with verifiable representation of parts is critical.
Steps to Consider When Deploying a Vision System
There are several steps that need to be performed in order that the laser vision systems process is achieved successfully. First, it's important to consider the specifications for the project at hand. There is 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 should be developed with database connections, component recognition, the corresponding protocols, and read-back functions of barcodes, DataMatrix codes and plain text entries. The vision system is truly a customized approach in order to assure quality and regulatory initiatives. Finally, initial samples can be developed in an application lab where the right sensors, laser source, camera, software, and lighting can be assessed, modified, and finalized for production.Why Choose Vision Systems for Medical Device Markings
Marking medical devices can be challenging for a number of reasons, with one of the most important being the FDA’s standard for the UDI (unique device identifier) requirement. This means that the device marking must be readable and free of defects as well as be able to withstand severe post-production processes such as cleaning, sterilization, or passivation.Generally, marking of medical devices occurs at the end of a production process. That means it is even more critical to make sure that the marking process is absolutely accurate. At this final step in the process, incorrect, incomplete, or otherwise mis-applied markings that can’t be modified, can relegate the device to the scrap heap which is obviously a costly error.
Another challenge with medical device marking is that these devices vary in size and shape as well as are manufactured using various materials, each of which react differently to laser techniques. These marks must be permanent and completely readable and traceable throughout the entire life-cycle – from manufacturing to end point. For example, from the manufacturing plant to the operating room where the device is manually manipulated and finally even embedded into the patient where it is essential that the part be free of defects which could cause, e.g., bacteria build-up or other dire results.
The bottom line is that medical device manufacturers are looking for laser marking systems that will provide near or total defect-free results and safety standards. Therefore, a vision system approach with customized software combined with cameras, robotics, and lighting, provides the most accurate and precise method of gaining the most optimum results for the manufacturer and those involved in the ongoing chain of use.
How Vision Systems Work
Vision systems projects can be complicated so it is important that a laser processing partner has established a proven competency in this area. Vision systems include mechanical hardware, optical hardware, and customized software, all integrated into automated precision motion platforms. Particularly for medical devices, 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 are used to hold parts in position for laser processing. These devices must be custom-made for every part to accommodate its geometry and to position it for laser marking. A vision system, on the other hand, can identify the part and automatically re-orient the laser path or instruct the axes to reposition themselves to correctly position the part before marking occurs, using only rudimentary fixtures. For example, laser marking of cylindrical parts, i.e., tubes where 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/tube to the appropriate position before any marking takes place.
High resolution cameras and versatile lighting systems support OCR and OCV processes that are to verify that a part is indeed in place and are able to inspect the part after processing to verify that a barcode is readable and of the appropriate grade.
In Summary
For medical devices, there is a complex pathway to regulatory approval, particularly if compliance with global standards is in the mix. Whether the device is being utilized in the U.S. or abroad, manufacturers must meet a variety of rigorous guidelines related to quality and traceability. UDI markings need to be readable and able to withstand severe post-production useability processes throughout the product’s lifecycle. Laser marking using the customized benefits of the vision system approach offers production efficiency, less scrap, and a proven way to ensure that costly mistakes are not impacting product safety, or manufacturers’ liability, all of which can improve regulatory acceptance.David Locke is technical sales manager for ASCYS Lasertechnik US where he advises customers on their line of customizable laser systems for cutting, marking, welding, and engraving. He has been in the industrial laser industry since 1984. Locke has a degree in physics from St. Michael’s College.