Laser marking in the medical industry represents a unique technological challenge that requires accuracy, reliability and compliance with strict regulatory standards. Medical devices require permanent traceability throughout their life cycle, with indelible codes that resist sterilization, passivation, and other aggressive treatments.
A Vanguard Laboratory for the Medical Sector
LASIT has developed a comprehensive technology laboratory specifically geared to the needs of the medical industry. With more than 27 laser systems of different technologies, the central laboratory is designed to address every challenge of laser marking and engraving on medical devices of any material and geometry. This center of excellence is supported by a network of satellite laboratories in Germany, Poland, France, UK, Spain, Milan, Mexico, and the USA, which enable local preliminary testing and demonstrations, reducing development time and costs for international customers.
What sets the LASIT laboratory apart is not only the variety of laser sources, but also the ability to scientifically verify the quality of markings through advanced metrology instrumentation. This integrated approach makes it possible to ensure results that meet the needs of the medical industry from the earliest stages of process development.
Laser Technologies Available
The laboratory is equipped with a full range of laser technologies, each suitable for specific medical applications:
- Picosecond lasers: Available in powers of 50W, 100W and 200W, ideal for anoxidic black marks on stainless steel, titanium and other alloys used in implantable medical devices. Pulse duration in the picosecond range (10^-12 seconds) enables energy transfer with minimal thermal effect, essential for critical components.
- Femtosecond lasers: For very high-precision micromachining with pulses on the order of 10^-15 seconds, enabling “cold” ablations with virtually no heat-affected zone (HAZ), ideal for temperature-sensitive materials.
- MOPA fiber lasers: With variable pulse time modulation from 4ns to 200ns, they allow the energy profile to be tailored to the specific application, optimizing contrast and minimizing thermal impact.
- UV lasers: With wavelengths of 355nm, available in picosecond and nanosecond pulse durations and powers from 1W to 20W. Their short wavelength allows photochemical interactions with polymeric materials without thermal degradation, ideal for noninvasive markings on medical plastics such as PEEK, PC, POM, and PP.
Technical Instrumentation for Control and Validation
What makes the LASIT laboratory truly unique is its ability to scientifically analyze and validate marking results with advanced instrumentation:
- Salt spray chamber: Allows accelerated corrosion resistance tests of up to 1,000 hours, essential for verifying the integrity of markings on implantable medical devices.
- 4K 3D Microscope: With vertical resolution down to 0.1μm and lateral resolution of 2μm, it enables complete topographical analysis of marked surfaces, Ra/Rz surface roughness measurement and precise determination of marking depth.
- Abrasimeter: Performs standardized abrasion tests with programmable cycles of up to 10,000 passes, which are essential for evaluating the wear resistance of markings.
- Optical blade co-op: For the analysis of surface optical properties and diffraction of treated surfaces, with angular resolution of 0.02°.
- Spectrophotometer: With spectral range 380-780nm and accuracy of ±0.01 absorbance units, for quantitative analysis of optical properties and verification of color contrast.
- CMM machine: With accuracy of ±2μm, enables high-precision dimensional verifications and metrological control of pre- and post-marking components.
- Colorimeter: For objective evaluations of color and contrast according to CIE Lab* color space.
Advanced Vision and Verification Systems
The laboratory is equipped with a wide range of vision systems for testing, setup and process validation:
- 7 Configurable DMC Readers: With different resolutions (1.3MP to 5MP), optical apertures (f/1.8 to f/8) and illumination configurations (coaxial, diffuse, directional LEDs), they allow any reading operating condition to be simulated.
- DMC Verifier: For objective validation of code quality according to international standards, with detailed verification reports on marking quality.
- OCR Verification System: With advanced character recognition algorithms to validate the readability of marked text and serial numbers.
- Auto-centering vision systems: With 5 different illumination configurations and algorithms for pattern matching, edge detection and blob analysis, they allow testing of automatic positioning protocols with accuracy up to ±0.05mm.
- Setup station with process simulation: Allows exact replication of field operating conditions to validate complete recognition, centering, marking and verification processes, minimizing risks in implementation.
Expertise in Medical Marking
The LASIT laboratory is designed to support the specific requirements of the medical industry, with a focus on:
- Unique Device Identification (UDI) marking according to specifications required by major markets
- Marking processes compatible with industry quality standards
- Testing the resistance of markings to sterilization and passivation processes
- Post-marking surface integrity assessment for critical components
- Development of reproducible marking and verification procedures
This systematic approach ensures that any marking process developed in the laboratory can be easily implemented in production lines, with full technical documentation to support medical device traceability needs.
Complete Process: From Analysis to Implementation
The excellence of the LASIT laboratory is expressed in its ability to provide a complete process:
- Technical analysis of the component: Physical and chemical characterization of the material, study of geometry, and definition of marking specifications
- Design of Experiment (DOE): Systematic planning of process variables according to Taguchi methodology
- Parametric marking tests: Creating sample arrays with systematic variation of laser parameters
- Instrumental analysis: Quantitative verification of results with complete battery of tests (microscopy, resistance, readability)
- Parameter optimization: Iterative process refinement based on instrumental evidence
- Durability testing: Verification of process robustness with stress testing (sterilization, passivation, abrasion)
- Technical documentation: Creation of a comprehensive technical dossier with parameters, protocols and test results
- Technology transfer: Implementation of the optimized process on the production solution with related training
This scientific methodology ensures fully traceable and reproducible medical laser marking processes aligned with industry quality requirements.
Practical Example: UDI Marking on Orthopedic Implants
An illustrative case of LASIT’s integrated approach involves the development of a Unique Device Identification (UDI) code marking process on Ti-6Al-4V titanium orthopedic implants.
The challenge was to create a high-contrast (L*≤35), perfectly legible black marking that would withstand passivation processes and hundreds of autoclave sterilization cycles (134°C, 2 bar) while maintaining the surface integrity of the device without stress areas or potential corrosion triggers.
The LASIT laboratory addressed this challenge using a 50W picosecond laser with a specific combination of parameters (frequency: 500kHz, pulse duration: 900ps, overlap: 85%, alternating scanning strategies), generating an anoxidic surface marking with controlled depth <5μm. Each sample was then subjected to:
- 3D microscope analysis to verify the depth and morphology of the marking
- Salt spray test for 500 hours
- 5 cycles of chemical passivation with 30% nitric acid
- Simulation of 250 autoclave sterilization cycles
- Verification of code readability with certified DMC readers
- Corrosion potential test
The result was an optimized process that ensures markings that meet traceability requirements, have excellent legibility, and are resistant to all the treatments provided in the life cycle of the device, without altering the mechanical properties or corrosion resistance of the base material.
LASIT’s Experience in the Medical Sector
The LASIT laboratory’s scientific approach and comprehensiveness reflect the company’s experience in the medical industry. Numerous medical device manufacturers have chosen LASIT as a partner to develop marking processes for critical components.
The main applications developed include:
- UDI marking on orthopedic implants (titanium, 316L steel, PEEK)
- Coding of surgical instrumentation with 2D codes resistant to numerous sterilization cycles
- Marking on cardiovascular devices with selective surface treatments
- Traceability on in vitro diagnostic components with high information density codes
- Precision marking on minimally invasive and microdevices
The ability to develop, test and validate complete processes within the same laboratory is a key added value, reducing the time and cost of implementing production processes and providing detailed technical documentation for each process step.
LASIT Solutions for the Medical Sector
The laboratory supports the development of comprehensive medical laser marking solutions, including:
- FlyPico: Picosecond laser system for anoxidic marking on metals
- FlyUV: UV laser marking system for medical plastics
- MediMark: Comprehensive system for marking and verification of medical devices
- CompactMark G7SP: Laser system with advanced loading station
The laboratory for the future
The LASIT laboratory represents a center of excellence for the development of laser marking processes in the medical industry, combining advanced laser technologies, scientific verification instrumentation and deep knowledge of traceability requirements. The presence of satellite laboratories in Europe and America also allows LASIT to offer timely local support for every phase of the project, from initial demonstration to final implementation.
This ability to manage the entire process, from prototyping to implementation, makes LASIT an ideal partner for medical device manufacturers who need robust and durable traceability solutions with a turnkey approach that ensures reproducible processes that can be fully integrated into production systems.