Since the 1970s, medical device manufacturing has been revolutionized by the advent of laser processing technology. This innovative approach employs focused laser beams to alter materials, whether it's through removal, bonding, or surface reforming.

At the heart of this transformative process is the laser marking machine, a tool that has elevated efficiency, compliance, and design within the medical device industry.

The Multifaceted Role of Laser Technology in Medical Device Manufacturing

The appeal of laser technology is its remarkable versatility, precision, efficiency, and permanence. These attributes have led many medical device manufacturers to adopt laser processing as a cornerstone of their operations.

From marking unique device identifiers (UDIs) to cutting and assembling devices, laser medical marking technology spans the entire manufacturing spectrum - from raw materials to final products.

Pavel L Photo and Video/ Shutterstock | Theodore Maiman was the first to develop a laser used for clinical application

Companies like KEYENCE have been driving the growth of the laser marking industry for medical devices by introducing comprehensive machines. Their offerings include cutting-edge features like 3-axis technology that ensures autofocus and autocorrection, ensuring uniform marking across surfaces of varying shapes.

The intuitive software accompanying these machines simplifies creating precise marks, cuts, or 2D codes/UDI marks. Equipped with internal cameras, these machines enable the development of custom programs tailored to each medical device and its design, ensuring personalized, permanent, and high-contrast marks.

Laser technology's versatility finds application in marking various components and parts of medical devices, such as tubes, bolts, catheter wires, needle hubs, instrument covers, drills, catheter connections, small steel objects, and even 2D codes.

Laser Marking: Setting the Medical Standard

Laser marking has firmly established itself as the gold standard in medical device manufacturing. Its popularity is rooted in its seamless alignment with the stringent standards of the U.S. Food and Drug Administration (FDA).

Laser marking ensures permanent and accurate device marks and is an anti-corrosive solution. Furthermore, the precision of laser beams and the utilization of cold marking techniques prevent any distortion or compromise to the integrity of the devices.

FDA/ Shutterstock | The FDA has broad regulatory authority over not just food and drugs, but also biologics such as vaccines, medical devices, tobacco products, certain cosmetics, and some veterinary products

Navigating the UDI Directives with Laser Marking

The FDA's implementation of the Unique Device Identifier (UDI) system in 2013 aimed to centralize traceability data for all medical devices. The recent revision in 2022 mandated traceable UDIs readable by humans and machines for connection to the Global Unique Device Identification Database (GUDID).

The GUDID stores comprehensive device information accessible through AccessGUDID, empowering manufacturers, healthcare professionals, and patients with device-specific information.

Laser marking is the ideal solution to meet UDI directives in this era of accountability, anti-counterfeit measures, and enhanced safety. Its ability to deliver permanent, high-contrast, and easily readable UDIs, while being impervious to contamination, positions it as the future of UDI directives. Laser processing offers the reliability and consistency required, even as medical devices become more compact and sophisticated.

Advancing Device Design

The evolution of modern medicine towards personalized patient approaches is seamlessly complemented by laser processing. Innovative devices like personalized cochlear implants, neuromodulation devices, and cardiac pacemakers owe their success to laser processing.

These devices are intricately cut down to minuscule dimensions, ensuring a perfect fit. Laser welding is employed to seal pacemaker packaging without compromising the device's integrity.

UCSF/ Stock Image | Laser treatment uses an intense, narrow beam of light to remove or destroy abnormal tissue

While these advancements were already underway, the manual and microscopic assembly was laborious and time-consuming. Laser processing has eliminated manual drudgery, allowing medical advancement to gain momentum by keeping pace with new ideas.

Efficiency Enhancement in Healthcare

Enhanced efficiency in healthcare manifests across multiple domains - manufacturing, recalls, and patient experiences.

Manufacturing: Laser processing machines offer exceptional precision and repeatability, ensuring uniformity across all devices through automated tasks, which human processes cannot achieve.

Recalls: Quick product recalls are a critical facet of the UDI implementation. Laser marking's traceability enables swift identification of devices through a database based on their marks. Transparency about the device's life cycle expedites recall investigation and rectification.

Patients: The precise cutting achieved by lasers in devices like stents, implants, and surgical tools leads to more efficient and patient-friendly products. These devices fit patients better, minimize invasive surgeries, and ultimately enhance the quality of patients' lives.