Industries worldwide have been disrupted by COVID-19, and the medical device industry has been especially disrupted. However, this hasn’t been completely negative for the industry.
There is significantly increased demand for critical equipment, but with that, there are related shortages as manufacturers have struggled to keep pace with demand. With this market shift, some job shops, in order to stay working while waiting for other manufacturing to return to pre-COVID levels, are shifting to medical instrument manufacturing, according to Nicholas E. Kaczmarski, National Sales Manager – Beamer Laser Marking Systems®.
“They’re beginning to venture into medical marking as the automotive and aerospace industries still recover from the hit they’ve taken due to COVID,” he says. “And while there are manufacturing similarities between industries, in the medical space regulations and standards are different, especially when it comes to marking regulations.”
The U.S. Food and Drug Administration (FDA) enforces regulations regarding marking of medical devices. The FDA established the Unique Device Identification (UDI) system to adequately identify medical devices sold in the U.S. When the regulations are fully in place, most devices will include a UDI, in human- and machine-readable form, from manufacturing through distribution to patient use. That will improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation.
In May of this year, the FDA issued new guidance regarding use of National Health Related Item Codes (NHRIC) and National Drug Code (NDC) numbers on device labels and packages.1 The guidance explains that the FDA does not intend to object to the use of legacy NHRIC and NDC numbers on device labels and device packages for finished devices that are manufactured and labeled prior to September 24, 2023. But just because the regulatory deadline has been moved, doesn’t mean manufacturers shouldn’t upgrade to laser marking systems now, according to Kaczmarski.
Laser marking – the medical standard
“Laser marking is the standard means of marking medical equipment and devices and has been for decades” he says. “The advantages of laser marking, called annealing, in this space are its permanency, accuracy and anti-corrosiveness.”
Materials that are used in medical instrument and device manufacturing are unique, Kaczmarski notes. “The industry usually uses stainless steel and often biocompatible polymers like PEEK. The integrity of the material has to be maintained throughout the marking process and laser marking, when properly executed, can have no impact on component performance.”
If the FDA establishes and enforces the regulations, who manages the standards of medical device marketing? There are several FDA accredited UDI issuing agencies, Kaczmarski says.
GS1 is a UDI issuing agency/entity based on many regulations worldwide – the United States, the EU, China, South Korea, and Saudi Arabia, meaning that manufacturers supplying regulated medical devices to these markets can use the GS1 standards to meet and implement the UDI requirements.2
Navigating a new industry
There are specific challenges to job shops navigating the medical industry for the first time, Kaczmarski warns. “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 Laser Marking Systems is equipped to help suppliers of any size.
“Beamer thoroughly understands medical device manufacturing and marking,” Kaczmarski says. “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 providing the best, most reliable laser marking solutions in the industry.”
About Beamer Laser Marking Systems®
Beamer Laser Marking Systems, a part of ARCH® Cutting Tools, means American-made quality in a full range of fiber laser marking machines providing an industry-leading 100,000+ working-hour span. In industries from automotive to aerospace and defense, medical and more; save production time and boost productivity with these affordable solutions.Beamer offers user-friendly off-the-shelf standalone turnkey solutions as well as custom fully automated solutions with extremely fast turnaround times. Whatever your direct part marking needs – Beamer has a solution that will enhance your product quality and give your operation a competitive edge. www.beamerlasermarking.com
Stacey Eeman, Director – Marketing & Business Development