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Dukane’s industry-leading Laser & Ultrasonic Plastic Bonding Technologies are Leading the Way in High-Volume Medical Device Manufacturing
Leading Where Others Follow
The global demand for high-precision/high-accuracy plastic joining solutions in the medical market has never been higher. Designers and manufacturers of high-value medical device assemblies and components are continually challenged to deliver products that meet the stringent demands of FDA and MDR requirements, including safety, reliability, and functionality. The need for advanced production equipment that reliably produces high-quality assemblies at high rates of speed with integrated traceability features is on the rise and, in almost all cases, required as part of the development and product life-cycle.
Dukane's industry-leading engineering and manufacturing expertise provides the most advanced and flexible plastic bonding solutions, specifically developed to meet the stringent manufacturing requirements of Medical Device Manufacturers worldwide.
The global medical device market, as a whole, continues to grow rapidly as aging populations, the prevalence of infectious and chronic diseases, and a growing global middle-class push medical device manufacturers to produce significantly higher volumes while still maintaining stringent quality requirements. More than ever, Design Engineers are now required to work with diverse materials, develop smaller components, and adhere to strict DFM standards to meet specific program objectives. For this reason, global device manufacturers have gravitated towards more advanced and highly repeatable plastic bonding technologies to meet the demands of these unique challenges. Here, we will discuss two market-changing plastic bonding technologies, servo-ultrasonic welding, and clean laser welding, along with their implications for medical device engineers and manufacturers.
SERVO-ULTRASONIC WELDING: The Motion Of Plastic Welding
Ultrasonic welding is a fast, energy-efficient method for fusing a variety of rigid plastic components in many industries, including medical devices. The technology has been used for over 60 years and has proven to be a reliable and stable manufacturing process for global medical device manufacturers. Dukane's advancements in efficiency (sustainability), processing (servo + melt-match technologies), and traceability (data & security management) have made ultrasonic welding a top choice for advanced plastic bonding technologies today.
In ultrasonic welding, high-frequency vibrations are applied to two parts or surfaces by a vibrating tool called a horn or sonotrode. Welding occurs due to heat generated at the interface between the parts. The ultrasonic vibrations are created by a series of components — the power supply, converter, booster, and horn — that deliver mechanical vibration to the parts. A highly repeatable servo press actuator accurately controls force and velocity as the two parts are pressed together. After the servo actuator has reached an accurate ending position, the ultrasonic energy is terminated, and the components are statically held in place for a brief period until the plastic has re-solidified.
Dukane Ultrasonic welding technology is widely used to join a variety of medical-related plastic assemblies as the process eliminates the need for chemical solvents and adhesives, which can raise biocompatibility concerns. The process also eliminates the need for mechanical fasteners, reducing costs and improving manufacturing efficiencies. Dukane Ultrasonic welding technologies integrate easily into high-volume part production and automation, offering fast and controllable production cycles (in some cases milli-seconds), secure and sophisticated data collection for validated processes, and traceability to meet regulatory demands and requirements.
Dukane's Infinity line of advanced SERVO-controlled ultrasonic welders is designed to meet the stringent quality and traceability requirements of global medical device designers and manufacturers. Over a decade ago, Dukane pioneered the servo-controlled welding process and now has tens of thousands of servo welders installed globally and hundreds of millions of servo cycles successfully run. For more information regarding our Infinity Servo Welders or to schedule an educational webinar outlining the ultrasonic welding process in more detail, please click the following link: MORE INFORMATION.
LASER WELDING: Putting A Light On Plastic Bonding
The demand for in-vitro diagnostics and implantable medical sensors, analyzers, and drug-delivery devices is exponentially increasing. Laser welding is often the best alternative for applications such as these, where the vibration required for ultrasonic welding might be undesirable. Dukane Laser welding provides an ultra-clean and cosmetically attractive weld that efficiently provides precisely aligned parts and hermetic seals without flash or particulate contamination. Systems are clean-room friendly and can weld a variety of plastic materials, both opaque and transparent in color.
The process itself is pretty simple. Traditional laser welding (980 nanometers or 1 micron) does not introduce mechanical motion between the welded components. Instead, the near-infrared heat needed for part welding is provided by a laser light source that is transmitted through the top component (transmissive/" transparent") and absorbed in the bottom component (absorptive/" black"). The assembly is clamped together at a pre-determined force, and the laser is precisely programmed to trace the desired weld path. The "Contour" or "Quasi-Simultaneous" method of laser welding is flexible and less complex than using bundled fibers, and systems can efficiently be designed with multiple laser heads to achieve fast/automated cycle times.
For applications where colorants are not desired, the use of a different wavelength laser (1180 nanometer or 2 Micron) allows for the welding of clear plastics to one another without the use of expensive mixed-in or sprayed-on absorptive layers. Clean/hermetic seals can also easily be achieved in this frequency, which offers the same flexible advantages as the traditional 1-micron systems.
Dukane's NRG line of advanced Laser Plastic welders (1-micron & 2-micron) is designed with robustness and flexibility. Typical medical device applications that require laser welding are either small in size, require complicated weld paths, or include electronics or sub-components that are susceptible to damage if vibrated (i.e., ultrasonic welding). The NRG systems utilize our advanced LightSync programming software and UI to easily modify weld paths and energy level inputs during development and validation. This flexibility allows our partners to fine-tune the welding process and optimize validated settings before implementation into high-volume manufacturing environments. With laser engineering labs in the US, China, Germany, and Czk, Dukane is uniquely positioned to assist our clients in developing sustainable laser plastic welding solutions. For more information regarding our NRG Plastic Laser Welders or to schedule an educational webinar outlining the laser welding process, please click the following link – MORE INFORMATION.
ENGINEERING SOLUTIONS
The most successful plastic welding programs are those in which conversations regarding product development requirements are discussed in-depth and early on. From initial design and validation to high-speed/high-volume production integration to after-market support and calibration requirements, It is critical that you choose a partner with industry experts who understand the unique challenges medical device manufacturers face during each step of the program's life cycle. Dukane's experienced global medical segment applications and engineering teams provide responsive support to ensure our clients meet all design, development, regulatory compliance, and production requirements critical to the overall program's success.
Choosing the right welding solution for your unique application is also critical. Some suppliers offer only one joining technology, limiting their ability to suggest the "right" process for your application. This is equivalent to pounding square pegs into round holes. While eventually the peg goes through, it is a mess coming out the other side. Choose a supplier that is well-versed and offers production solutions for a variety of welding technologies. This should be at a minimum ultrasonic and laser welding. A partner who is also versed in thermal welding (heat/IR/Hot-Gas), as well as spin and vibration welding, can offer alternative joining solutions that may be a better fit for your particular application. Dukane provides the most extensive array of plastic joining technologies within the Medical Device Market segment. This allows Dukane the flexibility to GUIDE our partners into the RIGHT joining solution based on their unique medical device assembly requirements. Integrating the proper process and the right tool early in the development process ensures a successful long-term program.
In addition to choosing the "right" solution, it is essential that these solutions include features and tools to assist your manufacturing teams in meeting stringent regulatory requirements by the Federal Drug Administration (FDA) and European Union's Medical Device Regulation (MDR) that require every medical device to be traceable in the event of a product failure or recall. Dukane welders integrate FDA-CFR-11 protocols, data control, and management tools, as well as calibration and ongoing PM services to meet the demands.
CONCLUSION
The global demand for high-precision/high-accuracy plastic joining solutions in the medical market segment has never been higher, and choosing the right global partner has never been more important. A true end-to-end process partner can provide valuable guidance from proof of concept to prototype development, scalability, data collection, regulatory compliance, and more.
Involving an experienced engineering partner in the early stages will help a manufacturer determine the best joining technology for a particular product process. For medical device manufacturers that operate on multiple continents, it is advantageous to partner with an engineering/technology supplier with global capabilities that can provide local expertise and support wherever device assembly is performed. Dukane does that. Leading Where Others Follow!
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