Laser processing provides automation and efficiencies that help meet FDA regulations and produce superior medical device components.
David Locke, ACSYS Lasertechnik US
Laser systems have become essential to the production of better-designed medical devices. The precision, repeatability and scale needed to manufacture next-generation medical products rely heavily on the advantages that lasers bring to contract manufacturers and medtech manufacturing. In fact, the laser technology market size is expected to grow from $11.7 billion in 2020 to $ 17.6 billion by 2025, due to the growing demand from healthcare coupled with the performance lasers achieve compared with legacy material-processing procedures.
In this article, we will review how laser cutting, engraving, welding and marking enhance medical device designs. We’ll look at the various applications as well as the qualifications all medical device manufacturers should be familiar with before planning and building a complex laser system to manufacture their product.
Lasers have numerous applications in medical device and surgical instrument manufacturing. For example, endoscopes, surgical knives and probing devices, wire stents, vascular clamps and stent markers rely on welding, engraving and cutting operations. Laser processes can provide precision engraving, welding and cutting needed to make more compact implantable devices such as pacemakers, due to the significant reduction in heat output from laser welding.
Laser welding delivers a very small heat-affected zone, which typically leads to less need for follow-up processes such as trimming and grinding than devices welded through traditional methods need. It also means tighter welds to produce smaller micro-pieces and allowing welds to occur in smaller physical footprints. A smaller heat-affected zone also enables rapid cooling. Curtailing the amount of heat annealing that goes on over the surface contour of a piece will deliver fewer chances of deformation as well as less scrap.
Laser-welded joints in a medical device can withstand high-temperature sterilization, possess pore-free surfaces and typically eliminate the need for secondary finishing operations processes, which is a crucial requirement for biocompatible components. Laser welding can be optimal when physical contact with the actual parts must be limited. This is especially true when additional methods are required, such as through transmission laser welding, in which parts are clamped together and treated with the laser beam for specific weld results. Processes like through transmission lasering help with hermetic sealing and precision in seam welding.
Medical equipment manufacturing often involves challenges such as hermetic sealing and butt-welding and addressing challenging materials such as titanium. Lasers can play a key role here. For instance, pulsed welding is commonly used to seal titanium cans for implantable devices. Laser welding can also hermetically seal microelectronic systems containing electrodes, such as pacemakers, auditory implants and pumps.
Lasers have helped to advance the production of next-generation endoscopic instruments, bellows and diaphragms. Lasers can also mark serial numbers on bone screws, medical instruments, surgical devices and blades that require permanent marking before they can go to market. Laser marking and engraving also produce marker bands, bar codes and 2D data matrix codes for the medical device industry. There are also notable laser drilling applications on microfluidic sensors, thin-file sensors and sensor disposables.
Laser processing can also help medtech manufacturers comply with the FDA’s unique device identification (UDI) and patient protection program, which is designed to enable regulators to trace safety and efficacy data through a device lifecycle.
Process validation and qualification of laser systems
Process validation serves as a form of documented verification to show that a product can be manufactured in a defined process sequence in addition to making sure all required characteristics are addressed. The qualification of laser processing systems for the manufacture of medical products is a clearly defined requirement from the “Rules of Good Manufacturing Practice ” (GMP). The laser systems provider and medical device manufacturer often collaborate during process validation to ensure that functional requirements of the component are met reliably and consistently.
Several regulations govern process validation, especially in terms of ISO 9001, ISO 13485, and 21 CFR Part 820. While validation can be a complicated and laborious process, it can also produce some meaningful benefits. The data derived from validation can help troubleshoot issues and reduce validation efforts during inspection, saving time in the manufacturing process.
Validation also assures complicated processes remain consistent and reliable and mitigates risk to both the device maker and the patient. Technical expertise and deep experience in laser systems must encompass not only quality engineering know-how but a comprehensive understanding of the laser process itself.
Lasers’ impact on the future
Laser technology is transforming the way medical devices are manufactured today. Contract manufacturers and medical device OEMs benefit from more efficiency, accuracy, reliability and capability to scale at much lower costs than before — all while achieving higher-quality, less expensive tools for healthcare providers to use.
Precision laser systems excel in the creation of corrosion-resistant black marks and surface texturing with new ultra-short pulsed (USP) lasers while permanent UDI and other marking with short-pulsed lasers of various wavelengths continue to expand. There are advancements in cutting and welding thin materials with pulsed, continuous-wave fiber, and USP lasers resulting in high-quality edges and minimal thermal distortion.
Many parts are now being produced via 3D printing from metal powders. This creates the ability for mass-customization with the possibility of using other laser systems to selectively polish surfaces to very high smoothness. Advances in automation through robotic loading and vision system to locate, orient and confirm parts and processes mean longer-term lights-out production. The ability of systems builders to apply and integrate laser technologies enables advancements in technology that translate into increased capabilities and throughput for medical device manufacturers.
David Locke is technical sales manager for ASCYS Lasertechnik US, where he advises customers on customizable laser systems for cutting, marking, welding, and engraving. He has a degree in physics from St. Michael’s College and has worked as been in the industrial laser industry since 1984.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design and Outsourcing or its employees.