Dave Fawcett: High demand for small, single-use devices with ever-increasing reliability requirements has created a need for more sophisticated manufacturing technologies. Amada Miyachi has more than 65 years of experience in the field, and works closely with its medical device customers to identify the right fit of advanced manufacturing technologies for the customers' applications.
Leading the way with its comprehensive range of resistance and laser welding, laser marking, and laser cutting technologies, Amada Miyachi also has a vast storehouse of value-added process knowledge - like the company's patented motion and laser control techniques (position-based firing), and new metals-joining production methods made possible by the availability of "green light" (532nm) pulsed welding lasers.
MDB: Among Amada Miyachi's areas of expertise, what do you consider the company's major focus? What types of medical devices are produced using the company's equipment?
Fawcett: Our specialty lies in designing and manufacturing the equipment and systems needed to produce small or delicate parts used in implantable medical devices or surgical tools. Our capabilities include systems for resistance welding, laser welding and cutting, laser marking, hot-bar reflow soldering, and hermetic seam sealing.
Cardiac pacemakers, defibrillators, guidewires, catheters, cannulae, hearing aids and implants, brachyseeds, orthodontic appliances, prosthetics, and endoscopic surgical tools are just a few types of regulated medical products produced using equipment and systems designed and developed by Amada Miyachi.
MDB: Especially when they are life-preserving products, implantable medical devices impose quality demands like no other products. How do Amada Miyachi's manufacturing equipment and systems help manufacturers meet and demonstrate compliance with such high quality requirements?
Fawcett: Implantable devices demand the highest level of quality, which is assured by the premium process-monitoring features found in many of our systems and products. For example, Amada Miyachi's latest resistance weld monitoring technology, the MG3 digital weld monitor, provides precision real-time dynamic measurement of all welding variables. This new technology responds to the increased emphasis on accountability in the medical marketplace, offering process development, production monitoring, data collection, and analysis tools. The technology supports compliance with FDA's quality systems and good manufacturing practices regulations, with a company's total quality management initiatives, and with the quality systems standards developed by the International Organization for Standardization.
MDB: For some types of devices, miniaturization is seen as a way of making a product easier for surgeons to implant or for patients to use. What special requirements for precision and quality do miniaturized products impose on manufacturing systems?
Fawcett: Recent years have brought increasing needs for higher accuracy and repeatability in our systems for manufacturing smaller devices. While Amada Miyachi has always been the globally recognized brand for micro welding, we have developed a number of additional options - including granite-mounted gantry motion stages and through-the-lens vision prealignment checking - along with many other features that support the most process-critical applications.
MDB: Laser marking has long been seen as a key solution for meeting FDA requirements for unique device identification (UDI), which are being phased in over the next several years. How do Amada Miyachi systems help manufacturers comply with these requirements?
Fawcett: Laser marking is ideal for meeting the new federal requirements for passivation and corrosion-resistant UDI. It offers a non-contact process; makes a permanent contrasting mark on metals and many plastics; is capable of marking text, codes, or graphics; and is a highly flexible and reliable implementation.
Amada Miyachi developed its versatile new fiber laser marker workstation (LMWS) to meet manufacturers' need for a benchtop system designed for lean manufacturing. The user-optimized LMWS is being successfully utilized in the medical device industry for both R&D and low-volume production. The LMWS can also cut, drill, ablate, and weld thin materials.
MDB: In your experience, how common is the adoption of lean manufacturing principles among medical device manufacturers? How has this trend influenced the types of systems that Amada Miyachi is creating for medtech manufacturing?
Fawcett: In recent years, we have seen many of our medical device customers adopt lean production principles, following the earlier lead of our automotive customers. One of the most important building blocks of lean manufacturing is creating a partnership between customer and supplier. Amada Miyachi can help at every step of the process; its range of technologies makes the company uniquely positioned to help customers define, design, and deliver flexible production platforms, enabling them to respond quickly to market demands.
MDB: Precision cutting of thin metal tubular structures is one area where medical device manufacturers continue to demand faster, more reliable, and more cost-effective manufacturing solutions. How is Amada Miyachi responding?
Fawcett: Over the years, Amada Miyachi has developed a range of fine laser cutting systems for high speed precision cutting of thin metals, such as those used for stents and other tubes. These systems are fully integrated, with up to 5 axes of motion.
Most recently, Amada Miyachi introduced the Sigma femtosecond laser tube cutting system. Developed in partnership with laser source provider Jenoptik, the Sigma expands Amada Miyachi's cutting capabilities by adding an ultra-short pulse disc laser platform, offering a unique ability to process a wide range of materials without thermal effects.
The Sigma provides unrivalled edge quality for both metals and plastics, including a wide range of diameter tubes and stents. What's more, the process significantly reduces post-processing steps, including cleaning and de-burring, both mechanically and chemically.
MDB: Materials selection can be an ongoing challenge for device manufacturers, especially if biocompatibility could be an issue, if joint design is especially complex, or if it is difficult to process the materials needed for proper device performance. How does Amada Miyachi help device manufacturers with such issues?
Fawcett: Amada Miyachi is dedicated to providing customers with a comprehensive application solution, rather than just equipment. Our experienced application engineers provide the equipment match from our wide range of products that best addresses the needs of a customer's specific applications. In addition to sample evaluations, we are a resource for part design and materials selection knowledge, as well as know-how to optimize component manufacturability.
MDB: Has Amada Miyachi developed other processing systems that are especially suited for medical device manufacturing applications?
Fawcett: : One area in which we've noticed tremendous interest is the use of lasers for automated wire stripping. Many medical device applications require stripping outer layers of polymers from small diameter wire, and the laser is well suited for this material removal task. Offering a non-contact process that is very repeatable, lasers can selectively remove wire layers or areas.
Amada Miyachi recently developed a laser ablation system that includes high-speed galvo beam steering and a custom wire feed, with a rotating mechanism that achieves accurate and repeatable wire positioning. The system also includes several proprietary features that manage heat balance in the part, and facilitate clean removal of the insulation material, while fully protecting the delicate metal wire substrate.
MDB: What challenges do medtech manufacturers face when integrating processes and equipment in order to manufacture a new product? What is the manufacturer's best strategy to ensure that all the elements of the processing system perform as expected?
Fawcett: Successful laser manufacturing processes depend in large part on successful laser system integration. Process engineers need to develop systems in which the motion, laser, software, and tooling work in concert with one another, and are integrated into a whole that supports the desired process flow. Putting all the pieces together can be a challenge.
The integration challenge is often compounded by another difficulty: many integrators don't understand lasers, so they rely on the laser manufacturer to integrate the system. If a problem arises, or if changes are needed to accommodate a new product design, the integrator is in no position to repair or modify the integration of the laser system.
Amada Miyachi not only manufactures laser welders but also engineers and integrates laser systems, providing product designers and process engineers with a one-stop shop for system integration. This service includes running samples of the process in-house to ensure that it does the entire job as specified, and answering in-depth application questions.
MDB: How has Amada's acquisition of the Miyachi Group affected the company's personnel and products?
Fawcett: Although our name has changed to Amada Miyachi America, we remain the same great company, maintaining our personnel, products, locations, and capabilities. Our mission continues to be focused on understanding needs and investing in solutions.
Managed as an independent company and maintaining the well-known Miyachi Unitek, Miyachi Peco, and Miyachi Eapro brands, Amada Miyachi America will continue to serve its medical device customers with the products and services they have come to trust and rely on. Medtech customers can rest assured that the name change will have no effect on regulatory approvals or validation requirements.
Our customers do not buy machines, they buy end-to-end production solutions. In turn, our commitment to meeting this expectation is a key element of the entire value-added process at Amada and Amada Miyachi - from the time a system is specified right through its entire life cycle.
Amada's global presence as a leading manufacturer of metalworking machinery brought about an exchange of expertise in all our fields of activity, from laser and welding applications through metalworking solutions. This means that our new organization is now ideally equipped to develop new technologies and products for our medical device customers, whatever their manufacturing needs may be.
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