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Articles from 2010 In June


Ximedica Plans to Expand

In response to steady growth in the design and manufacture of medical devices and consumer health products, Ximedica (Providence, RI) has announced that it will expand its facility's footprint to include new cleanrooms and expanded quality control, technical development, and prototyping space. Expected to be completed in early 2011, the new space will allow the company to better serve clients with greater flexibility to accommodate programs of a wider scale.

Ximedica provides contract research, product development, regulatory, and manufacturing services to medical device and healthcare companies. The ISO 13485:2003-certified and FDA-registered company currently maintains an 80,000-sq-ft integrated R&D and manufacturing center in Providence, RI, and a satellite office in Hong Kong.

The company provides integrated services, from exploratory research to final manufacturing. By combining expertise in research, design, engineering, regulatory, and manufacturing under a single roof, it assists clients in bringing new products to market faster with reduced risk. "With signs of the recovery in the economy and the increased confidence of many clients in these areas, we are seeking to stay ahead of the demand on our facilities, remarks Dan Reifsteck, Ximedica's chief operating officer. "Our clients are increasingly looking to us to provide the kinds of services that a lean development process demands: secure, dedicated space, fully equipped labs and cleanrooms--and a sufficient footprint to handle whatever size manufacturing is necessary, from pilot to full-scale assembly."

Chips: Good for the Brain

After analyzing the activity, the team develops algorithms to simulate healthy neuronal activity. These algorithms are then programmed into a microchip and delivered back into the brain.

"The chip itself can be implanted just under the skin, like pacemakers for the heart, ensuring that the brain is stimulated only when it needs to be," says Matti Mintz, one of the researchers on the project, which is part of a European consortium.

The Rehabilitation Nano Chip (ReNaChip) is connected to electrodes that are implanted in the brain, but it could eventually be miniaturized enough to be etched directly onto the electrodes.

Chip May Enable Targeted Deep Brain Stimulation for Neurological Disorders

Current deep brain stimulation technologies employed to treat neurological disorders such as Parkinson's disease or seizures lack precision and can actually overstimulate the brain, according to a team of researchers from Tel Aviv University in conjunction with a European consortium. A new chip in development by the researchers helps address this problem, however, effectively allowing for precise, targeted stimulation of the brain.

Dubbed the Rehabilitation Nano Chip, the flexible platform will be able to be programmed to treat specific disorders for targeted treatment, the researchers state. To do so, electrodes would be implanted into the affected areas of the brain and record activity. This information would then be used to develop algorithms that simulate healthy neural activity, which are then programmed into the chip and transmitted back to the affected areas of the brain.

Although the chip would work with electrodes that are implanted in the brain to begin with, the multidisciplinary research team speculates that, as chips continue to shrink in size, their chip could someday be etched directly onto the electrodes. To optimize future neurostimulator platforms equipped with the chips, the researchers are also examining the electrodes, which they hope to eventually miniaturize while adding more sensing functionality.

This Week In Brief: June 29, 2010

Humphrey Products (Kalamazoo, MI) has received ISO 13485:2003 certification in addition to its continued accreditation of ISO 9001 status. The company fabricates pneumatic valves and actuators for the medical device manufacturing market.
 
Engineered manufacturing solutions provider MGS Mfg. Group (Germantown, WI) has achieved ISO 13485:2003 certification at its Antioch, IL, cleanroom facility. The company says that this achievement, along with the construction of a Class 8 cleanroom at its headquarters, demonstrates its commitment to serving the medical device market. 
 
Measurement and inspection specialist Hexagon Metrology Inc. (North Kingstown, RI) has announced the official opening of HexagonStore.com, an e-commerce portal for the United States that offers online purchase of training classes, parts, and accessories for metrology systems. The store includes convenient purchasing of PC-DMIS and GD&T training class seats by date and location, a complete line of Tesa and Renishaw Styli products, CMM fixturing kits from R&R and Rayco, and Leica Geosystems laser tracker parts and accessories.  
 
Tegra Medical (Franklin, MA), a provider of contract manufacturing and assembly services to the medical device industry, has acquired a manufacturing operation in San Jose, Costa Rica, from Penn United Technologies Inc. The 20,000 sq-ft  facility is equipped for metal working capabilities along with electrical discharge machining, precision grinding, turning, milling, waterjet, stamping, and assembly operations. The company plans to add Swiss machining and a Class 7-controlled manufacturing environment for assembly and packaging during the next several months, as well as submitting for ISO 13485:2003 and  ISO 9001:2008 certification.

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Web Exclusive: Education, Innovation, and Experience give Michigan’s Medical Device Industry a Boost

Dow Corning  has capitalized on the skilled workforce found in Michigan to produce high-quality silicone products for the medical device industry.

Although it has played a major role in recent years, the automotive industry isn't the only factor moving Michigan's medtech sector forward. A convenient location, skilled workforce, and a long history of manufacturing have helped to cultivate a nurturing environment for medical device manufacturing. And it doesn't hurt that the people have a penchant for innovation, either.

Manufacturing from "the mitten," as the state's lower peninsula is affectionately called, allows for the state's suppliers to easily accommodate the demands of OEMs on both coasts, as well as those of its Midwestern neighbors. "From a national geography standpoint, the majority of the medical device manufacturing in the country happens in the Midwest, I think. You've got a hotbed in Minneapolis that we're just an hour and a half away from by plane, and you can drive that as well," says William Inman, Jr., elastomers manufacturing team leader for Dow Corning (Midland, MI), a materials supplier specializing in silicone-based technologies.

Along with a convenient location, the state boasts a bevy of universities intent on producing a skilled and educated workforce. In turn, innovation has been  steadily produced by Michiganders. "They're big on innovation," concurs Christophe Sevrain, CEO of the consulting firm CJPS Enterprises LLC (Troy, MI). "Michigan is third or fourth in the country in terms of the number of patents per inhabitant."

The University of Michigan, in particular, is at the forefront of medical technology innovation. A sampling of recent breakthrough research conducted at the university includes the creation of a microfluidic integrated circuit that could simplify lab-on-a-chip devices; a nanomachined liquid glass electrode that can power miniature devices; PEDOT nanotube-coated brain implants to better treat several neurological disorders; and a generator that efficiently converts natural vibrations such as those made by walking into a supplemental power source for body-worn and implantable devices.

And while innovation and education have proven helpful to the area's medtech sector, it is the skilled workforce and manufacturing roots that help to really set Michigan apart. After all, the state has a long history of manufacturing across a variety of sectors, which has created a base for skilled manufacturing as well as a supportive environment for the growth of medical device manufacturing.

Furniture fabrication carved a niche into the local economy beginning in the late 19th century, for example; Grand Rapids even earned the moniker, "The Furniture City." Most famously, of course, is automotive manufacturing, which has dominated the state's economy until the recent economic downturn. "We have certainly seen companies diversify from an automotive or manufacturing base into the medical area, so that capacity is being leveraged into life sciences and medical devices," observes Steve Wilkowski, new business market development leader for Dow Corning.

Michigan's medical device industry has further profited from a strong pharmaceutical industry presence for many years in terms of garnering support for the life sciences sector as well as contributing to a highly skilled workforce. More than a century ago, The Upjohn Co., a pharmaceutical manufacturer, was founded in Michigan; other pharmaceutical companies soon followed suit by planting seeds in the supportive state. However, Upjohn merged with Pharmacia in 1995 and then was purchased by drug powerhouse Pfizer in 2003. After this acquisition, Pfizer employed an estimated 9000 Michiganders.

In recent years, though, drug companies have diminished their presence in the state. Pfizer has slashed jobs and closed plants in the area, leaving skilled workers out of jobs. On the bright side, the medical device industry is benefitting from the available knowledgeable local workforce. "We rely today on some of the individuals that have separated with Pfizer and Upjohn to bring the talent we need to serve this industry in the best possible way," Inman says. "With Pfizer downsizing in Michigan, there are a lot of highly qualified individuals from a GMP and quality perspective, so we have taken advantage of bringing them into our fold where it makes sense."

Read more about Michigan's medical device manufacturing sector and the influence of diversification by suppliers to the automotive industry in a Regional Focus article in the June/July issue of MPMN.

Yaskawa America to Build New Motoman Robotics Facility

Yaskawa America Inc. (Dayton, OH) will construct a new facility for its Motoman Robotics division just south of Dayton. The 300,000-sq-ft building will house office and production facilities. Intended to serve as Motoman Robotics's new North American headquarters, the facility will combine a manufacturing plant and a warehouse. Employing approximately 250 to 275 employees, the company may eventually expand the facility by an additional 200,000 sq ft to support future growth.

"Motoman Robotics is extremely happy to be able to maintain its operations in the Dayton, Ohio, region at a premier location for business and retail operations," remarks Steve Barhorst, president and COO of Motoman Robotics. "With the unification of Yaskawa Electric America Inc. and Motoman Inc. into one company (Yaskawa America Inc.), which occurred effective June 1, 2010, and now the finalization of plans for our new state-of-the-art facility, which will allow Motoman Robotics to serve our customers more efficiently, we feel that we are exceptionally well positioned for future growth."

The building design for the facility is under way. Construction is contingent on the completion and approval of financing arrangements, as well as finalization of discussed or pledged Ohio incentives. Subject to resolution of these contingencies, construction is expected to begin in July 2010, with a move-in date of June 2011.

Laser Technologies Keep Manufacturers Beaming

Used for manufacturing microfluidic devices, Leister's Novolas laser equipment relies on mask technology, in which the laser welds all the surfaces of a substrate except for the microfluidic channels themselves.

Laser technology has been a mainstay of science and industry since its inception 50 years ago. Originally viewed as a tool for creating better light sources, strengthening military hardware, and improving telecommunications, the technology has also found its way into modern manufacturing--including the medical device manufacturing sector--because it offers a precise and clean method for cutting, machining, and welding.

By directing the output of a high-power beam at a substrate, laser technology melts, burns, or vaporizes materials, leaving a high-quality surface finish. Although not as widespread in the medical device manufacturing industry as more-traditional converting techniques, lasers offer many tangible advantages: They produce cleaner edge finishes than punching, form complex components without the need for expensive tooling, offer greater speed than other processing methods, and process a vast array of materials. Thus, in the medical device manufacturing space, laser technology is probably headed for another 50 years of service--if not more.

Laser Welding
Specializing in systems that utilize high-power diode lasers, Leister Technologies LLC (Itasca, IL) develops equipment for generating laser light that can be formed into a spot, a line, and many custom shapes. Contact-free, vibrationless, and stress-free, the company's laser systems for welding plastic materials enable localized energy application. The company offers several laser delivery methods to accommodate the needs of plastic welding applications, including contour, simultaneous, mask, and radial techniques.

"For bonding plastics, we make laser systems based on the diode because it's solid state, so there are no replenishables involved," comments Jerry Zybko, Leister's general manager. "In other words, there are no CO2 feeding tubes or lamps, as required in Nd:YAG laser technology." And to accommodate polymers that react at different wavelengths, diode lasers are available with 808- or 940-nm wavelengths. For these reasons, the company incorporates diode lasers into its through-transmission infrared plastic laser welding platforms.

"The plastics our systems process have two layers: a transparent one and an absorptive one," Zybko says. "The laser fires through the transparent layer and is absorbed into the layer below, and you create heat at the interface as the laser is absorbed."

Used for manufacturing microfluidic devices, Leister's Novolas laser equipment is based on patented mask technology, in which the laser welds all the surfaces of a substrate except for the microfluidic channels themselves. The desired weld area is defined by the use of  a chrome-coated glass mask from which the chrome has been removed from specific areas, allowing the laser to pass through.  The flat top component and the bottom component containing molded microfluidic channels are placed below the mask, and a clamp force is applied.  As the light passes through a stack-up, the mask prevents the light from striking the microfluidic channels. "Thus, the laser is used to hermetically seal the assembly, staying outside of the microfluidic channels," Zybko notes. "This technology lends itself to microfluidic plastic chip construction in that the weld geometries are limitless and the desired bond is achieved without vibration or the accumulation of particulate contamination."

In addition to playing a prominent role in microfluidic applications, laser welding is gaining ground in the area of tube-to-tube joining operations, according to Zybko. Leister's Novolas WC-C laser machine performs this process using a technology known as radial welding. In this technology, a part such as a valve is inserted into a plastic tube that rests inside a circular polished-metal enclosure with a cone-shaped inner diameter. When laser light emitted from above strikes the plastic parts, a simultaneous weld is made all around the perimeter of the tube. "The laser light does not spin or move," Zybko explains. "It's emitted in a ring shape, and it comes out at a slight angle with the aid of defractive optics. When it hits the polished cone, it deflects directly perpendicular into the tube-to-tube application."

While laser technology for such applications is becoming increasingly economical, laser-based products still typically require accurate movement control using an x-y device. In addition, while using such equipment, operators must be shielded from the laser, which adds to operating costs.

Nevertheless, laser processing has myriad advantages over other technologies, Zybko adds. For example, it does not generate particulates, contamination, or flash, and the weld is completely contained inside the part, preventing expulsion of extra material. In contrast, when a part is welded ultrasonically at 30 KHz, the vibrations can cause the polymer to break down somewhat, producing particles that must be vacuumed or washed out--especially in the case of microfluidic devices. "With lasers, we're just clamping plastic up against a piece of glass," Zybko says. "We're not moving or shifting or vibrating or using ultrasonics to move the material up or down. So the parts come out very clean, and the volume doesn't undergo collapse. If you need a 100-pl volume of space, that's what you'll get when the parts are stacked
and welded."

Laser Micromachining
"Laser micromachining is ideal for clean-cutting, drilling, and shaping polymer and other materials that are difficult to micromachine using other technologies," remarks Bill Kallgren, sales manager at JPSA (Manchester, NH). Capable of processing such materials as polycarbonate and polycycloolefins, the company's UV technology relies on a process called photoablation--volatilization caused by UV rays emitted by a laser--to remove very fine, measured amounts of material as a plasma plume. The result is a cleanly sculpted pore, channel, or feature, according to Kallgren.

Offering diode-pumped solid-state machines, laser micromachining equipment, and UV and vacuum UV laser-beam delivery systems, the company also provides a variety of laser systems, including the IX-3000 ChromAblate, a UV excimer laser system that can create micron-scale features with submicron tolerances.  Typical applications include stents, catheters, microfluidic devices, lab-on-a-chip biosensors, nozzles, and MEMS. JPSA's machines can process a range of materials, Kallgren notes, including polymers, ceramics, glass, metals, and other materials.

JPSA's UV excimer laser systems can create micron-scale features with submicron tolerances.

Many complex medical devices benefit from laser technology because it can create sharply defined features, smooth walls, optically clear surfaces, and other complex features. "Medical device manufacturing applications such as microfluidic designs often require complex holes, cones, channels, or sample chambers," Kallgren comments. "Features may be microscopic, and they may also be of a uniform and consistent size. Creating complex geometries repeatably is what UV excimer laser equipment does."

While the goal is to create complex geometries, different applications require different equipment customizations. "Our standard systems are highly engineered bits of equipment, but they're modular in design, so that I can add or subtract equipment based on the customer's requirements," Kallgren explains. For example, a system used to perform a simple process may have an x-y-theta stage, or perhaps a z-theta stage if focus adjustment is also required. At the other end of the spectrum, a customer may request a reel-to-reel-type platform and vision-alignment equipment for automatic high-volume production.

In the case of excimer laser systems, additional axes of motion may be required to perform motorized mask-changing functions for selecting different images and projecting them onto the target. Coordinated opposing motion, which allows the system to scan a mask across a beam while simultaneously scanning the part underneath, may also be appropriate in particular instances. "In short, systems can have just four axes of motion, or they can have as many as 16 axes of motion, depending on all the things the customer is trying to do," Kallgren says.

Looking to the future, wavelength and thermal control are areas requiring special attention, according to Kallgren. "Customers aren't just cutting metal stents anymore. They're showing a lot of interest in novel materials such as bioabsorbables. The problem is, many of these materials are thermally sensitive." For example, while stents have traditionally been cut using YAG, CO2, or continuous-wave lasers, these technologies create heat-affected zones that can impair stents made from new materials. But even the use of common UV lasers, despite their higher photonic energy and higher band gap on the material, are not ideal, according to Kallgren.

"We look toward pulse duration as another knob to turn to improve quality," Kallgren says. "By going to shorter pulses, we have a shorter time span for the light to interact with the material, which results in a colder process." For this purpose, companies are exploring the use of diode-pumped UV solid-state or excimer lasers operating in the picosecond or femtosecond laser-wave pulse regime. These technologies achieve multiphoton absorption and create little heat input into the target substrate, resulting in clean, high-resolution, high-fidelity micromachining, Kallgren adds.

While the heat generated by lasers can be problematic, laser technology can also result in minimal heat-affected zones because it melts and bonds plastic only where it is needed, according to Zybko from Leister Technologies. Thus, if a channel in a microfluidic device already contains a reagent or liquid, the heat from the laser will not affect it.

Laser Converting
Delta Industrial
(Minneapolis) offers yet another take on the use of laser technology for medical device manufacturing. Providing equipment based on four different types of technologies--CO2, UV, fiber, and IR lasers--Delta designs and manufactures custom machines. "We fit the laser to the part," comments Jason Newville, a design engineer at Delta Industrial. "For example, a CO2 laser would be used for more-general applications, such as cutting paper, labels, and various foams. We get more into UV and YAG lasers when we're developing equipment to laser-ablate metals, such as in metal-cutting processes."

Utilizing CO2 and other laser technologies, Delta Industrial's Mod-Tech systems can process a variety of medical products and materials.

Starting with a base platform called the Mod-Tech toolbox of modules and building from there, the company provides machines containing standard die stations, flexographic printers, and lasers. But like JPSA, Delta focuses on designing customized equipment to meet specific customer needs.

Among other things, customization involves determining the number of lasers to be incorporated into a single platform to achieve higher production throughputs. "Often, manufacturing lines have to go a lot faster than one laser can handle," Newville says. "Since we can only cut at a certain power level to get the right edge quality and to get the right part tolerance, we stack up multiple lasers in line so they each cut a certain portion of the product." The advantage of this configuration is that the use of several lasers working together--a growing trend in the industry--speeds up production across the board.

Although they represent the cutting edge of medical device manufacturing processes, lasers are still a work in progress. They can leave a burnt edge on various medical foams, for example, rendering them unsuitable for some types of wound-care applications. "We're always looking to use different styles of lasers that may produce a cleaner cut," Newville states. "This could mean lasers that operate at different wavelengths, or different laser technologies."

Cutting tighter-tolerance parts is also becoming a big issue for OEMs, converters, and their machine suppliers alike, according to Newville. To fabricate parts with tight tolerances, Delta has developed a vision system for inspecting products during processing. "The system even looks at the incoming web," Newville adds. "If there's something printed on the part, the vision system can tell the laser how much skew the incoming product has so that adjustments can be made."

Touch Technology Sensitizes Devices

The R8C/33T microcontroller in the haptic system performs peripheral functions, creating embedded systems that combine user interfaces with system control functions.

Haptics may not be a household word, but it's a concept known to one and all. Referring to the science of touch in real and virtual environments, it has concrete applications in the medical device realm--from surgical simulators to such medical devices as automatic electronic defibrillators (AEDs) and glucose monitors.

Renesas Electronics America has teamed up with Immersion Corp. to develop systems that provide haptic feedback, improving the interface between medical devices and patients. Based on Immersion's TouchSense technology and a library of vibro-tactile haptic effects for touch surfaces and touch screens, the systems allow users to experience feedback from medical devices.

"For patients with impaired vision, receiving visual feedback from a device is not enough," says Nelson Quintana, a senior marketing manager at Renesas. "Having tactile feedback provides added value." Haptic feedback, adds Hendrik Bartel, senior product manager at Immersion, includes buttons with simple clicks or alerts that are activated when you touch the screen. "These alerts give you a sense of urgency, buzzing, or transitions when you change a page in your user interface."

Immersion's haptic player and haptic effects library are integrated into the Renesas microcontrollers, which translate vibrations from the library into pulse-width modulated signals to drive the offset-mass motor in the player, creating the vibrations the user senses. The R8C/3xT Touch controller has an on-chip sensor control unit that provides touch detection while reducing the need for external components. Touch is fully programmable, supporting multiple configurations such as keys, wheels, and sliders. Another controller, the R8C/33T, performs peripheral functions, creating embedded systems that combine user interfaces with system control functions.

"What's unique about the Immersion/Renesas system is that it is prepackaged and ready for use by designers," comments Mark Rootz, a senior marketing manager at Renesas. "Using this system, designers don't have to come up with their own algorithms for vibrations, and they don't have to develop their own microcontrollers to drive the system's motor. The pulse-width modulation signals from the R8C controller drive Immersion's motor."

"We have been exposed to a wide variety of medical applications," Rootz adds. "In a hospital setting, haptic feedback can deliver quiet monitoring at the patient's bedside and in the surgical room." Examples of such applications include fluid-monitoring, drug-delivery, and infusion-pump systems. In the area of home-use devices, haptics could enable patients to monitor their health by providing tactile feedback from common devices. "AEDs are an application that can benefit from haptics," Rootz notes. "It could also help diabetics that have lost some of their senses."

Renesas Electronics America
Santa Clara, CA
www.am.renesas.com

Immersion Corp.
San Jose
www.immersion.com