Thanks! You've successfully subscribed to the BONEZONE®/OMTEC® Monthly eNewsletter!

Please take a moment to tell us more about yourself and help us keep unwanted emails out of your inbox.

Choose one or more mailing lists:
BONEZONE/OMTEC Monthly eNewsletter
OMTEC Conference Updates
Advertising/Sponsorship Opportunities
Exhibiting Opportunities
* Indicates a required field.

Laser Marking: Suppliers, OEMs Both Reaping Benefits of Versatile Technology

The implementation of unique device identification (UDI) requires orthopaedic device companies to identify methods to comply with the permanent marking requirement. Though no specific method has been set by FDA, several options are available—the most viable may be with lasers, as both OEMs and suppliers see real benefits to using the technology for device marking. A marking made with a laser can withstand the many cleaning and sterilization processes to which medical devices are subjected.

In addition, digital programming options can help give manufacturers the freedom to create an FDA-compliant UDI mark based on several factors, including geometry, size and surface texture of the device, quickly mark products and ultimately release them to market in a timely manner. Along with UDI compliance, lasers allow for permanence through a device’s lifecycle and bring flexibility, simplicity, versatility, speed, efficiency and accuracy to the device marking process.

In what other ways can laser marking be beneficial to manufacturers? What are other areas of focus with the technology? We spoke with several experts on the supplier side to find out. 

Autocam Medical

Experts Interviewed: Matt Davis, Area Leader; Chad Tyndall, Product Manager; Kyle Roberts, IT Specialist; Greg Coberly, Global Director of Quality

Why is laser marking a preferred marking technology?
It is precise, versatile, relatively simple to implement and provides a permanent mark. That mark is legible and very repeatable, part after part and time after time. The process can be used to mark different material types (metal and plastic), part geometries and sizes of text, logos and bar codes. Depending upon the brand and type of laser marking equipment purchased, entry point can be expensive, but implementation is relatively easy. The mark is etched into the material, and if done correctly, even if the color of the mark fades over time and use, the etching will remain present. To be permanent, the mark cannot be on the outer-most surface of the part only, where it may be easily rubbed off or removed by normal use. To meet customer requirements, it also cannot be a deep enough etch or mark that the surface finish of the part is noticeable or compromised. Instructions on use of the part can also be marked with lasers, along with depth indications, entry points, assembly points, etc. Lot numbers, serial numbers and bar codes can also be marked on parts to enable traceability of the product. Parts can be designed with laser marking in mind to help improve aesthetics, assist the physicians in use of the product and meet marketing, trade and regulatory requirements.

What trends are you observing in laser marking?
We’re starting to see the implementation of quality assessments of the marks made by the laser marking equipment. The ability to measure locations and dimensions of laser-marked text and grading of 2D bar codes while the part is still in the machine are newer adaptations we have seen. We are also observing smaller, more versatile laser marking equipment entering the market, which lends itself to integration into lean work cells.

Flex-Cell Precision

Experts Interviewed: Brian Kohler, Quality Engineer; Steve Fanning, Operations Manager

What are the best applications for laser marking and how does it help products stand out?
One of the best is the application of lines of text over an abnormal surface. In the terms of small medical components, there may not be enough room for a cutting tool to mark the part. This is where the laser steps up and marks the part with ease. Also, the absence of a burr is beneficial on a part that is near completion. As with all technology, things seem to keep getting smaller and more precise. This could lead to markings smaller than the naked eye can see, that still maintain a wealth of information. Except for the electricity to run the machine, there is no raw material, waste or scrap.

What do companies need to consider when laser marking?
Occasionally, we run into challenges regarding the size or orientation of the part to be laser marked. Some areas that are laser marked require custom fixturing to repeatedly and accurately mark these areas. These custom fixtures are required to hold the parts to get a repeatable and operator-friendly load. Any device that can be laid flat and laser marked complete, on a single plain, is always easier and cheaper. In other instances, the laser marking that applies to a family of parts may be very compressed when the part size gets too small. But overall, laser marking is a relatively fast process that ensures lot integrity and traceability for the run of parts, especially if the assembly contains multiple components.

Orchid Orthopedic Solutions

Experts Interviewed: Adam Hebert, Manufacturing Engineer; DJ Galganski, Manufacturing Engineering Manager

What are some challenges associated with laser marking?
The process generates heat that can cause warping, especially on thin or small diameter products. Heat also reduces the corrosion resistance of the base material where laser marking is performed. Most materials can be marked using lasers, but no single laser is suitable for all applications. Many options must be considered when selecting a laser; it is best to involve the manufacturer to verify that the correct one is selected for the desired application. Many variables go into creating laser marking programs. These allow flexibility for various applications, but can also make it difficult to achieve the desired results. It is best practice to perform multiple engineering studies to determine how variables will react with the given application to obtain a quality mark.

How does laser marking’s versatility factor into adoption?
The adoption of new laser marking equipment is generally a simple process due to the user-friendly programming and machine setup. The CAD software used to generate the desired laser mark is intuitive and practical, even for a first-time user with minimal CAD experience. The aesthetically appealing mark, coupled with the rapid cycle time, makes laser marking a cost-effective process for a wide range of applications.

Trumpf

Experts Interviewed: Salay Quaranta, Industry Manager, TruMark; Jon Sadowitz, Product Manager, TruMark

How does laser marking assist with UDI compliance?
We have systems that are able to take UDI information from a database and place it into the desired 1D or 2D bar code, with the associated human readable data that is required for the UDI format. Then, of course, that information is marked on the product itself. Furthermore, our vision packages can read the marked content (bar code, etc.), grade and verify that it is marked correctly, and finally communicate this result to the manufacturer’s location of choice. This is the complete solution. In our understanding, to be UDI compliant, not only do you have to put down the label, you also have to verify that you have the correct data. Laser marking systems can do all of that in one setup and at one station.

What makes laser marking attractive to OEMs?
The laser is one of the most versatile tools that an engineer has. Lasers can not only be used for traceability and company identification (logos, names, etc.), but also incorporate anti-counterfeit measures by having permanent markings on products. This helps to ensure that end users are utilizing the product that you intended. In that way, laser marking really has a broad number of applications to it. For example, if you utilize infrared, green or UV wavelength lasers, you can mark a wide variety of materials. In addition, harnessing an ultrashort pulse laser allows for the creation of markings that are corrosion and passivation resistant. For our medical customers, this is an incredible challenge; almost as big as UDI. These laser platforms have shown to withstand these post-processes of which OEMs must complete for the manufacturing of their devices.

Supplier Talks is a year-long BONEZONE series in which topics chosen are based on the most-searched capabilities in the ORTHOWORLD® Supplier Directory. We’ll cover Milling in August, Sterilization in October and Micro Machining in December.

Photo courtesy of Trumpf

4 COMMENTS

Security code
Refresh