MEDICAL DEVICES


effects because they interact with the material for such a short timeframe. The stripping of wires is another requirement during some medical device manufacturing processes. Femtosecond green lasers, for instance, can be used for this as they can ablate polyurethane coatings of up to 20 micrometres thick without any risk of damage to the wire inside.


Marking devices for traceability With several countries recently instigating or set to bring in new labelling regulations, marking devices and components with unique identifying codes will be the biggest growth area for laser use in medical device manufacturing over the coming few years. For example the European


Medical Device Regulation (MDR), which came into force in 2020, specifies the corrosion- resistant labelling of all medical device products with Unique Device Identification (UDI). The UDI contains information on the manufacturer, product and batch numbers of devices and their components, and consists of human-readable characters together with a machine-readable two- dimensional data matrix code. This label must be clearly readable throughout the entire lifecycle of the medical device. Components requiring laser marking include bone screws and other metal implants, stainless-steel surgical instruments, the outer cases for heart pacemakers, endoscopes and dental tools. Laser marking originally began in the mid- to late-1980s, using pump flash Nd:YAG lasers, which had large power consumptions compared with current fibre lasers. Today, lasers working in the infrared,


“Unlike other types of laser, USP lasers minimise surface melting and vapourisation effects”


Ultrafast laser manufacturer Fluence’s femtosecond lasers can be used to cut commonly used medical materials such as bioresorbable polymer (polylactide) with negligible kerf (<1um) and no taper, ensuring their biocompatibility


UV and green wavelengths are used for marking – the choice of laser source being dictated by whatever material the laser needs to mark. Prior to the latest regulations, marking on the selected medical devices which previously required traceability was done via ink, or mechanical engraving or etching. One of the main advantages for laser marking is that it does not require the use of solvent-based inks. Also, although lasers produce the mark by changing the material’s characteristics, they do not make physical contact with the device or component.


The number of medical


items that now require marking is vast, simply because it is every individual component of a medical device that needs traceability. So, for instance, within a pacemaker, all of its internal components, including all the micromechanical parts, need to be marked in a specific way. A femtosecond laser is perfectly suited to marking parts such as these because unlike other types of laser, it minimises heat damage and consequent adverse effects on the functioning of the device or component. Femtosecond lasers are


also set to become the laser of choice for marking stainless- steel surgical instruments, which are subject to exposure to blood and other body fluids, wear and mechanical stress, as well as repetitive cleaning processes. Other types of laser would alter


28 LASER SYSTEMS EUROPE THE 2023 GUIDE TO LASER SYSTEMS


the composition and surface shape of the stainless steel, which can lead to corrosion at the mark site during the routine sterilisation procedures that surgical instruments undergo.


Prototyping and continued innovation According to Grand View Research, in 2021 the patient monitoring devices market size was valued at $47.0 billion worldwide[2]


. This


figure is expected to grow substantially with a rise in the use of monitoring devices driven partly by an ageing population and increasing numbers of us seeking to improve our own health and fitness. Healthcare providers moving towards using remote monitoring of patients, in order to provide care at home rather than in hospital, will also fuel this growth. Existing types of devices include sensors for continuous glucose monitoring, blood oxygen level monitors, and home blood pressure monitors. But the current range of home monitoring devices available to individuals and healthcare providers looks set to increase as companies are using laser- based technologies to prototype complex ‘lab-on-chip’ sensors. The aim of these devices is to enable localised testing and diagnosis of blood samples either at the surgeries of healthcare providers or even in the patient’s home. Currently, blood samples


need to be sent to a centralised


lab facility, which costs more and takes longer than a home test would. Since these lab-on- chip sensors have multi-modal functions – namely microfluidics, chemical mixing, and light guiding – on a single chip, each of which are made from different materials and have different structures, laser processing is promising to become increasingly important in their manufacture.


In the meantime, laser machining is being used to create prototypes of these home monitoring devices. Unlike using traditional mechanical techniques, fabricating with lasers avoids the need to order a minimum quantity of samples, which can be costly. Lasers also make prototype turnaround faster and cheaper, thanks to their ability to process multiple materials through their adjustable parameters and range of wavelengths. l


REFERENCES [1]


https://www.fortunebusinessinsights. com/industry-reports/medical-devices- market-100085


[2]


https://www.grandviewresearch.com/ industry-analysis/patient-monitoring- devices-market


For more information about laser systems in the medical device manufacturing sector, visit:


www.lasersystemseurope.com/ industries/medical-devices


@LASERSYSTEMSMAG | WWW.LASERSYSTEMSEUROPE.COM


Fluence


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