Moving into Medical Manufacturing, Marking? Know the Challenges and Solutions

Like other sectors, the medical device industry experienced significant disruption in the wake of the COVID-19 outbreak. The demand for critical equipment surged, while manufacturers struggled to keep pace. With this market shift, some metal shops, in order to stay afloat, diversified into the medical instrument manufacturing space.  

As Beamer National Sales Manager Nicholas E. Kaczmarski​ noted, “Metal shops venturing into the medical industry while the automotive and aerospace industries recover from COVID setbacks must know that the medical space is regulated by different standards. Among these standards is the proper labeling of medical devices.” 

The U.S. Food and Drug Administration (FDA) administers labeling regulations on medical devices, from the manufacturer to the Unique Device Identification (UDI). The marking replaced legacy NHRIC or NDC numbers with a standard format that must be both human- and machine-readable. For devices used more than once and reprocessed between uses, this marking must be permanent, traceable from manufacturing through distribution and utilization.  

The change aimed to improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation. The FDA allowed existing inventory to naturally phase out through distribution and use so as not to cause supply chain shortages and set September 24, 2023, as the manufacturing deadline. 

Laser Marking by the Medical Standard

Laser marking has been used in medical equipment marking for decades for its advantages: permanence, high precision, and maintenance of surface integrity. Automated laser marking systems are also very speedy and easily integrated into existing production lines. 

According to Kaczmarski, “Medical device marking with a laser is based on the method of annealing, in which a defocused laser beam heats the metal locally, inducing a controlled chemical reaction that creates a permanent, high-contrast mark beneath the surface layer without removing any material, change in texture, or compromise in corrosion resistance and biocompatibility.” 

Materials that are used in medical device manufacturing are unique, Kaczmarski noted. “The industry usually uses stainless steel and biocompatible polymers like PEEK. The integrity of the material has to be maintained throughout the marking process and laser marking, when properly executed, has no impact on component performance.”  

While the FDA establishes and enforces the regulations, several FDA-accredited global UDI issuing agencies set the design syntax for the manufacturer. The two primary entities for equipment are GS1 for high-volume medical devices, and HIBCC for specialized clinical equipment, orthopedic implants, and surgical instruments. 

Navigating a New Market

There are specific challenges to job shops navigating the medical industry for the first time, Kaczmarski said. “The FDA requires that medical OEMs manage all the vendors in their supply chain and manufacturing process and each OEM may have a different standard.” 

So, how can a shop understand the validation process? 

“The ‘gold standard’ is currently one of the leading medical manufacturers,” Kaczmarski says. “They’re one of the largest – located in 150 countries – and their validation requirements are recognized internationally as the most stringent.” 

But that’s a lot to handle for a job shop looking to expand its business. Learning FDA regulations, understanding UDI standards and validation, and managing manufacturing operations. 

Beamer is equipped to help suppliers of any size. 

“Beamer thoroughly understands medical device manufacturing and marking,” Kaczmarski said. “We also understand the FDA standards for UDI marking and the requirements related to compliance and validation. Job shops looking to expand their business into medical device manufacturing and marking don’t have to be experts in the application of those regulations and standards – we can provide that expertise, along with the most reliable laser marking solutions in the industry.”