In the world of medical implantology, traceability and permanent identification of components are not only regulatory requirements, but fundamental elements to ensure patient safety and device quality. LASIT has developed FlyRobot, a laser marking system particularly suited to the demands of the medical industry due to the integration of advanced robotics, precision lasers and custom software.
The challenge of marking in the medical industry
The manufacture of implantable medical devices faces complex challenges when it comes to marking. Components made of titanium, cobalt-chromium alloys or PEEK must maintain their structural integrity and biocompatibility, while MDR 2017/745 regulations in Europe and FDA’s UDI require permanent markings that withstand repeated sterilization. Add to this the often complex geometries of implants, with curved or irregular surfaces, and it is clear why traditional marking methods often prove inadequate.
In this context, LASIT developed FlyRobot, building on the experience gained from successful projects for leading companies in orthopedic and dental implantology.
FlyRobot: an integrated architecture for superior performance
FlyRobot is not a simple laser marking machine but a complete system that radically transforms the production process. At the heart of the system is an ABB 6-axis anthropomorphic robot that works in perfect synchrony with a rotating laser head capable of precise ±120° movements with a resolution of nearly 40,000 steps per revolution. This configuration allows the component to be oriented in any position relative to the laser beam, enabling marking on multiple faces without the need for manual repositioning.
The worktable integrates a 3-axis Cartesian XYZ system with large strokes (800, 500 and 400mm), creating an operating space where the robot can move with pinpoint accuracy. The entire system is served by a multi-column warehouse with ISO 15693 RFID technology that automates pallet handling, ensuring continuous working hours without human intervention.
“The combination of advanced robotics and precision lasers makes it possible to address one of the industry’s most complex challenges: multi-sided marking of components with complex geometries such as hip replacements or dental components,” explains Marco Ievoli, LASIT’s R&D manager. “With FlyRobot, a process that traditionally required multiple manipulations and several workstations is completed in a single cycle, with consistent accuracy and total traceability.”
Concrete results in the field of implantology
The implementation of FlyRobot at leading medical device manufacturers has demonstrated significant results. A major European manufacturer of orthopedic implants has registered:
- A 75% reduction in set-up times between different batches
- A 40% increase in productivity over previous systems
- Virtual elimination of marking errors through automatic verification
- The ability to mark complex components such as femoral stems and acetabular cups on multiple faces in a single cycle.
Picosecond lasers for medical applications
The choice of picosecond laser is a key determinant for medical applications. The ultra-short pulses, of about 3 picoseconds, interact with the material in a fundamentally different way than conventional lasers.
When the picosecond laser strikes a titanium or medical stainless steel surface, it creates a black marking with excellent visual contrast, but without the depth of etching typical of other technologies. This surface “annealing” keeps the passivation of the material intact, a crucial aspect for implantable devices that must withstand the corrosive environment of the human body.
In laboratory tests, markings made with FlyRobot demonstrated superior resistance to salt spray tests according to ISO 9227 (200-400 hours) and to citric and nitric passivation cycles according to ASTM F86, essential requirements for certification of implantable medical devices. The treated surface remains smooth to the touch, with no rough areas that could compromise the integration of the device into biological tissues.
An additional advantage of picosecond technology is speed: up to three times faster than conventional fiber lasers while maintaining excellent surface quality. This feature, combined with robotic automation, makes it possible to achieve productivity unthinkable with previous technologies.
A fully automated workflow
FlyRobot’s daily operation radically transforms production processes. The operator starts the shift by simply loading pallets with the components to be marked into the multi-column magazine. Each pallet is automatically identified by RFID tag, which tells the system the necessary machining specifications.
From this point on, FlyRobot operates completely autonomously. The system picks up a pallet from the warehouse and places it in the objectification station, where a sophisticated vision system verifies that the loaded components match the production specifications. This preliminary step ensures that each component is marked correctly, eliminating potential errors at the root.
Having passed the verification phase, the anthropomorphic robot goes into action, precisely picking each component from the pallet. Thanks to its 6-axis motion capability, it positions the part in the optimal orientation relative to the laser, allowing multi-sided markings without the need for repositioning.
During marking, automatic focusing compensates for any dimensional tolerances, ensuring consistent results even across different batches. At the end of the process, the TTL (Through The Lens) vision system automatically verifies the quality of the marking according to AIM DPM criteria, comparing it with predefined parameters.
This cycle repeats for each pallet component and for each pallet in the warehouse, allowing hours of uninterrupted production.
Software integration: the brain of the system
What really sets FlyRobot apart from other marking systems is its software platform, developed in-house by LASIT to meet the specific needs of the medical industry.
This platform goes far beyond simple marking management, integrating advanced capabilities to connect with enterprise management systems. Direct connection with ERP and MES environments enables automatic retrieval of lot and production information, dynamically generating UDI traceability codes that comply with FDA and European regulations.
The software also manages a comprehensive database of marking parameters, allowing settings to be optimized for each specific combination of material and geometry. For the medical industry, where process documentation is critical, the system automatically records all processing parameters, creating a complete audit trail that complies with FDA 21 CFR Part 11 requirements for each individual component produced.
Advanced diagnostics: assurance of consistent quality
A distinctive feature of FlyRobot is its integrated diagnostic system, which continuously monitors all critical parameters of the marking process. The system includes:
- A calibrated thermopile that measures the actual laser power “on the part,” taking into account the entire optical chain
- A three-dimensional laser beam analysis system that verifies the optimal Gaussian shape and effective diameter at the point of incision
- A focus verification system that ensures the highest accuracy on each component.
This continuous diagnostics, rarely found in traditional marking systems, ensures consistent results over time and allows preventive action before any drifts can affect marking quality, which is particularly critical in the medical industry.
The future of marking in the medical industry
LASIT continues to develop the FlyRobot platform, with a focus on artificial intelligence for automatic component recognition and adaptive optimization of marking parameters. These developments will also enable future challenges in the industry, such as the increasing miniaturization of devices and the introduction of new biomaterials.
FlyRobot represents the natural evolution of laser marking, transforming it from a simple identification process to an integrated strategic element at the heart of the medical production system, with tangible benefits in terms of quality, efficiency and regulatory compliance.