The demand for medical implantable devices (MID) continues to grow at an alarming rate.
Driven by technological advancements, the demand for medical implantable devices (MID) is increasing due to the wider application of diverse clinical needs, the increasing incidence of cardiovascular diseases, and the expanding elderly population. For example, the battery life of early pacemakers was only three hours. Now, more than 1 million pacemakers are implanted every year, and each pacemaker is designed to function for 20 years or more.
To cope with these developments, manufacturers must use new tools and technologies to expand the scale of production of smaller, more complex devices with durable, air-tight seals, while maintaining strict quality standards. The basic process of laser welding of titanium housings presents particularly difficult challenges.
Laser welding for hermetic sealing. Laser welding plays a vital role in the manufacture of MIDs. Although many internal components of the MID can be connected by brazing, brazing or welding, the entire device is usually encapsulated in two titanium parts (housings), and laser welding is the preferred method of sealing the two housings. These joints are often referred to as "helium sealed", which means that they will pass a leak test using helium.
In addition, laser welding is also used to seal the internal components of more complex equipment, such as pumps, pressurized gas cylinders, and fluid containers. The number of welds varies depending on the equipment layout, but for example, a single infusion pump may require 40 different welds.
Typical laser welding procedure. Traditionally, the closure of the titanium shell is done by seam sealing using a pulsed Nd-YAG laser. No continuous wave (CW) laser is used to avoid excessive heat transfer inside the device.
Before seam sealing, the two shells must be positioned, clamped and pre-fixed with a small laser welding seam for temporary or green strength fixation. The system required for this pre-fixation is called a laser pre-fixer.
When the argon atmosphere is used to seal the titanium enclosure, not only the airtightness of the package is important, but also the specified internal atmosphere of the welding equipment must be ensured because it will be permanently contained in the equipment.
For pacemakers, it is best to use a dry argon atmosphere for laser welding of titanium in an inert atmosphere. Argon is also suitable for long-term normal operation of equipment. A certain proportion of helium is usually added to detect leaks in subsequent product tests.
Therefore, laser welding of such equipment is relatively simple, because the pacemaker can be completely sealed in a glove box system containing argon or a mixture of argon and helium. This gas atmosphere is the same outside and inside the equipment.
Laser welding of nitrogen-containing equipment in a nitrogen atmosphere is more difficult. For equipment such as defibrillators with a much higher internal voltage, dry nitrogen is the most suitable gas for the internal atmosphere. Argon has a low ionization potential and may cause internal sparks, while nitrogen is the best gas to ensure that the internal ionization potential is at the required level.
However, it is impossible to seal titanium by laser welding in a nitrogen atmosphere because it produces hard and brittle titanium nitride. Therefore, the nitrogen-containing device is designed with filling holes. Before introducing nitrogen, the device was laser welded in argon and placed outside the glove box. Then the argon gas is extracted, and nitrogen is backfilled into the device through the small-diameter filling hole. The filling hole is then sealed with single-point laser welding.
New functions for laser welding of MID titanium housings With the rapid development of MID technology and manufacturers seeking higher levels of throughput, quality and profitability, laser system companies specializing in this field continue to respond by developing new functions. For example, AMADA WELD TECH has developed a number of laser welding innovations that enable MID manufacturers to simplify and automate the manufacturing process, eliminate the need for destructive testing, save energy and reduce gas consumption.
Adapting to thin-gauge titanium alloys. For example, automation makes it easier for MID manufacturers to handle thinner gauges and different thickness materials used in new devices such as smaller and leadless pacemakers. Need to adjust the size of the solder joints to adapt to different material thicknesses. Some laser systems do this by changing the optical components in the delivery optics ("welding head"). This is a technically sound approach, but this intervention may require careful recertification of the system.
The more advanced system has a motorized spot size converter designed for MID welding in a glove box environment. This function makes changing the spot size as easy as pressing a key, or you can program the spot size in the CNC motion system.
Gas atmosphere control MID manufacturers are improving profitability and output by better controlling gas consumption and reducing or eliminating the need for destructive testing of welding equipment to verify its internal atmosphere. The first step is to use only high-quality glove boxes with low leakage rates, good gas recirculation/washing and solid particle cleaning systems. The laser system with active gas monitoring and mixing unit can optimize gas replenishment and further reduce gas consumption. Actively monitor the moisture, oxygen content, helium percentage and hydrogen in the gas to ensure that every piece of equipment produced is in the correct atmosphere.
Automatic weld alignment MID Another way for manufacturers to increase profitability and yield is to automate the weld alignment process, thereby reducing operator input/cost, improving quality, promoting production traceability, and optimizing system output. When not automatically aligned, the weld is usually accurate, but the perfect welding result depends on the operator's compensation of the geometric tolerances of the stamped parts. Advanced systems automate this process through an image-based camera vision system, which has algorithms for detecting seams and aligning parts.
Tool-free clamping can also simplify the production process through "tool-free clamping". Traditionally, the clamping of the housing is performed with a set of customized tools that have a cavity that follows and supports the outer geometry of the housing. These tools are also called "tool nests" and this method is called "tool clamping". For this method to work, the tools must have the perfect shape, because they determine the alignment of the final product and the quality of the subsequent joints. When welding product combinations with equipment of different designs, the corresponding tools need to be replaced.
As an alternative, tool-less clamping replaces special tools. The part is sandwiched between two much simpler geometric shapes-usually simple flat plates. This simplifies the system. However, this method requires more from the MID and its titanium housing, because the shape and position of the two housings relative to each other are determined by the MID, not by external tools. Nothing can force MID shells into specific positions and forms.
Using PSO for laser welding part programming and optimizing the organic shape of the pacemaker circumference means that 5-axis simultaneous motion is required to create seam welds. Conventional systems rotate the pacemaker at a constant angular velocity. The linear velocity fluctuations over the length of the weld. If laser light is emitted at a constant repetition frequency, the distance between each solder joint will fluctuate. This can cause some parts of the seam to overheat, usually the sharp corners of the MID. In addition, the welding speed in all other areas will be slower than possible using this welding process. MID packaging quality and system throughput are not optimal.
These problems can be solved by Position Synchronization Output (PSO). The system triggers the laser based on the defined movement (vector displacement) of the part. This keeps the pulse-to-pulse distance constant and the thermal load on the weld, thereby maximizing the welding speed. The result is a significant increase in throughput. This system is also called (laser) "ignition on demand" in the literature.
Laser welding monitoring The advanced laser system provides real-time welding quality control through an automatic welding monitor, which is fast enough to work while the laser is emitting the laser, and provides instant feedback to the system and the operator. The laser welding monitor is usually integrated in the system itself. The monitor measures the infrared radiation emitted from the weld and compares it with a good weld. It uses an algorithm to "draw a parameter window" around the signal from a good weld and compare the measured signals in real time at high frequencies.
Looking forward to the future, with the continuous development and expansion of the medical implantable device industry, manufacturers will receive the best services from laser system suppliers that focus on their very professional requirements.
A groundbreaking new product will be unveiled at the highly anticipated digital launch event on June 23, 2021 at 5 pm Eastern Standard Time.
SLM Solutions invites the industry to participate in the disruptive product launch event at CEST on June 23 at 5 pm. The launch will be done digitally and everyone can visit https://www.slm-solutions.com/the-big-launch. The new products enable the creation of metal parts with previously impossible designs and unparalleled productivity, reducing overall material usage and minimizing the cost of final parts to achieve industrial-scale production.
Sam O'Leary, CEO of SLM Solutions, is passionate about the upcoming products. "Last year we launched the industry game changer-NXG ll 600-but we will not stop there. Today, after three years of manufacturing and maintenance Many of the most visionary engineers in the world, we are proud to be able to add a new technology to our product portfolio."
This groundbreaking product has had a record impact on part design, and has improved the productivity of the entire process by reducing powder consumption and waste and shortening post-processing time. Likewise, improved thermal management will significantly reduce build time while significantly reducing part stress. Therefore, the unique surface finish will soon become the new standard.
And-like almost everything they bring-it is holistic. On this topic, O'Leary added, “Why can most of the systems in our product portfolio use it? Because we strive to make every new technology meet the needs of every previously manufactured machine. We believe in creating A truly open architecture is the only way to enable additive manufacturing to realize its powerful potential."
More importantly, the basic subscription for this technology will be completely free. O'Leary explained: "Our goal is to innovate persistently. It's free because we want to support our partners and customer base. Why is this still true when it can benefit everyone? Support from a few people?".
O'Leary concluded: "This new technology is another milestone, not only for us, but for the industry as a whole. As a high-tech company, we are once again shaping the face of additive manufacturing with this product launch. This is the next time the manufacturing industry is disrupted, so it is worth participating."
What is the next disruption in additive manufacturing? Industry experts from SLM Solutions will explain at the CEST online product launch at 5 pm on June 23, which will include public discussions. Participation is free.
Orders in April 2020 are the lowest in ten years, but business as usual for the first three months.
According to the latest US manufacturing technology orders report released by the American Association for Manufacturing Technology AMT, the total US manufacturing technology orders in April 2021 were US$404.6 million, a decrease of 12% from March 2021, but an increase of 72% from April 2020. The total order book year-to-date in 2021 reached US$1.57 billion, an increase of 40% over the orders in the first four months of 2020.
"The April 2020 order is the lowest in ten years, but the first three months are business as usual, so a 40% increase over the previous year shows the true strength of the industry in 2021," said President Douglas K. Woods. Woods) said. AMT. “Parts that usually go to the processing shop are now produced in-house by larger manufacturers to increase their production capacity. This is not to say that production is shifting from the processing shop; they are still operating at close to capacity, and machine orders are increasing month by month, but Increasing consumer demand requires more capacity. Confidence in the sustainability of this demand proves that the capital expenditures of large OEMs are reasonable. Therefore, our members have seen multi-machine orders rebound near 2018 levels .
"Demand for metal cutting technology is strong in 2021, and orders for new forming technology have more than doubled from this point in 2020. Changes in car beauty design have promoted the growth of forming technology and helped stimulate demand for cutting technology. The mold industry. Due to the increase in market prices, the energy exploration and mining industry has expanded from Texas to nearby areas, and orders in April have been further strengthened. Orders in consumer goods-related industries have also increased in April, such as off-road vehicle manufacturing, electrical Equipment manufacturing and machinery for business and service industries.
"Another sign of optimism in the industry is that our members report that the number of attendees in the past few weeks has exceeded their expected number of open days. This marks a renewed call for face-to-face sales calls and regular maintenance (rather than emergency visits). Feel comfortable. However, supply constraints mean that new orders are added to the already growing backlog. The demand for manufacturing technology is there, and suppliers who can deliver on order will be able to strengthen competition in the short term."
This is just the latest move by Westfall Technik to expand its cleanroom capabilities in North America.
The fast-growing plastic molding and tooling specialist Westfall Technik Inc. is responding to medical device original equipment manufacturers (OEMs) who need to significantly improve their cleanroom capabilities to increase manufacturing capabilities in North America.
The Las Vegas-based company has just completely converted a brownfield structure and opened it as a purpose-built, 40,000-square-foot facility near Chicago with three Level 8 certified Clean room and a blank space that meets Good Manufacturing Practice (GMP) certification. It also expects that the clean room, which can accommodate up to 23 injection molding machines, will receive ISO 13485 certification in September this year. The GMP-compliant space can accommodate up to 15 molding machines. The clamping force of the press ranges from 35 tons to 400 tons.
According to Chief Operating Officer Mark Gomulka, the site also has a fully functional tool room with dedicated, climate-controlled mold storage space.
In addition, in the past 18 months, Westfall has tripled its clean room space in Riverside, California; doubled in Union City, California; Gomulka said, and in New Richmond, Wisconsin and A new clean room was installed in Tijuana, Mexico.
All of this is part of a growth spree, with the company acquiring or launching approximately 19 companies in North America in less than four years.
Gomulka pointed out that Westfall Technik is implementing a strategy of "if we build it, they will come" because it is related to medical molding capabilities, because "as long as we leave a footprint, we will immediately sell it."
The predecessor of the new plant was All West Plastics Inc., located in Antioch, Illinois, northwest of Chicago, with a long history of molding. MGS Mfg. Group Inc., a custom injection molder and tool manufacturer based in Germantown, Wisconsin, subsequently purchased the plant in 2006 and then closed the plant in 2020 to consolidate production in Wisconsin.
Technik purchased the factory enclosure and “completely refurbished” it. Gomulka said he had hired several experienced employees who had worked in MGS factories.
Westfall also plans to install three M3 micro-molding machines at the Chicago plant, making it a center of excellence for micro-molding. M3 is an all-electric precision micro-forming technology obtained by Westfall when it acquired Mold Hotrunner Solutions Inc. (MHS) in Ontario, Canada in December 2018. Resin is made of micro-sized parts.
In addition, Westfall is considering transferring the production of its NxtBio brand bioscience laboratory consumables to a new Chicago site. The company acquired NxTBio Technologies, headquartered in Claremont, California, in May 2019. Its product line includes pipette tips, filter tips, tubes and strips, vials, multiwell plates, and related shelf systems.
"Ultimately, we will invest millions of dollars in new all-electric machines for the site," Gomulka said. Although he has not yet promised which type of press they will buy, he said that Westfall's preferred electric brands are KraussMaffei, Sumitomo, Netstal and JSW.
Westfall's healthcare-related product portfolio includes medical devices, drug delivery systems, diagnostic tools, and consumer health products. This includes the molding of plastic parts for rapid testing of Covid-19 diagnostics for domestic and clinical use.
Gomulka pointed out that the new Chicago plant will help fill the company's regional production capacity. "This is a necessary location for us, right in the Midwest, in the middle of the medical corridor from Chicago to Wisconsin."
In the Midwest, the company already operates a tool manufacturing facility in Willerney, Minnesota; molding in New Richmond, Wisconsin; and molds and molding in Wakefield, Upper Peninsula, Michigan.
During this webinar, a panel of industry experts will discuss advancements in machine technology and the fastest growing industries.
You want to know the latest developments in global manufacturing, the latest developments in advanced machine technology, and how automation affects your machine capabilities?
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