Swiss Tec Strives to Break through Barriers
Swiss Tec claims that its tube- and stent-cutting system is the fastest laser cutter for micro-machining in existence.
Renowned as a leader in the machining of small, complex parts, Switzerland seems to always be on the cutting edge of related technological advancements. A by-product of this national interest in micromachining, Swiss Tec AG (Zurich, Switzerland) was established in 2000 with the mission of developing high-precision, high-speed laser micromachining equipment that requires minimal maintenance and supervision.
During its initial few years, the company focused mainly on conducting research. But two years ago, Swiss Tec put an aggressive marketing strategy into action that introduced a branch in Asia last year and marketing and sales offices around the world this year, including Swiss Tec LLC (Miami, FL) to serve North American manufacturers.
The U.S. market holds the largest potential for the company, according to Armando Casanova, general manager of the Miami branch. And a portion of that potential profit could come from the medical device industry.
“In the foreseeable future, there is very large growth in this industry; this is an open secret,” Casanova says. “In the cutting and drilling of microtubes, a lot of expertise is required. You really need years of practical experience, research, and development to be a major player, and this is a strength that we have.”
Specializing in equipment for such micromachining operations as the cutting, drilling, and welding of microtubes, Swiss Tec’s equipment can machine tubes with diameters as small as 0.0004 in. The machines are also capable of cutting widths of about 10 µm with a positioning accuracy between 2 and 8 µm, depending on the material. Medical applications include such small devices as stents, guidewires, catheters, and biopsy needles.
“We try to expand the limitations that there are as a standard,” Casanova says. “We aim to break through barriers, and the barriers are in 3-D and in tubes where there are odd shapes. The repeatability and the precision [limitations] make it much tougher to get quality results.”
Breaking down barriers was achieved with the release of the Micro T15 tube- and stent-cutting system, which recently captured the world cutting speed record, according to the company. The micromachining laser cutter performed at a speed of 2000 mm/min on 1.4-mm-diam nitinol tubes; the average rate is between 400 and 600 mm/min, Casanova says.
Fast cutting speeds can improve productivity in shorter time periods, thereby reducing costs. But the system also offers repeatability as well as minimal heat-affected zone and discoloration, Casanova says. In turn, quality yields can potentially eliminate the need for secondary operations such as electropolishing.
“The savings are not just with the machining, but what can subsequently be eliminated due to the quality we can produce at the faster speed,” notes Casanova. “All of those following steps have a lot of human components involved, which are expensive and may be subject to error.”
Sealers and Surface Treaters Developed under One Roof
Enercon Industries provides induction heat-sealing equipment for containers as well as surface-treating technologies for flat materials and 3-D objects.
Enercon Industries (Menomonee Falls, WI) juggles several capabilities in its two manufacturing arms. The company provides induction heat-sealing equipment for capped and capless containers, and it offers corona, plasma, and flame surface-treating technologies for flat materials and 3-D objects. It has been working to improve technology in these fields since the company was incorporated in 1974.
The company continues to produce new systems and equipment to offer diverse and advanced atmospheric plasma-treatment delivery systems. “The industry’s need for marking, printing, coating, and bonding solutions on a wide variety of plastic objects in the medical industry has coincided with Enercon’s surface-treatment product development,” says Mark Plantier, vice president, marketing. “Since 2000, Enercon has introduced six new air plasma and flame plasma systems to meet the needs of the industry.”
To further accommodate industry needs, Enercon has also opened a new atmospheric plasma laboratory. The company introduced atmospheric plasma surface-treating technology for web-based applications to the converting market in the early part of the decade.
“Systems that introduce a gas chemistry into the treatment process—such as Enercon’s Dyne-A-Mite variable-chemistry plasma (VCP) system—are able to achieve treatment results that are impossible to obtain with traditional treatment methods such as corona,” says Plantier. “Traditional corona systems are ineffective at improving surface adhesion on most fluoropolymers. A variable-chemistry atmospheric plasma system is often effective with these materials,” he explains. Teflon, which is polytetrafluoroethylene, is an example of a material that is responsive to variable-chemistry plasma but not to traditional corona treatment, according to Plantier. The company allows customers to use its laboratory to develop new technologies and to test applications requiring atmospheric plasma surface treating.
Enercon will be exhibiting three of its Dyne-A-Mite surface treating systems at MD&M Minneapolis: HP blown-arc air plasma, VCP, and IT (ion treatment) CO2 plasma surface treater. The Super Seal Jr. cap sealer, one of the company’s most recent additions to its product line, is a portable induction sealer that will also be on display. “In the late 1990s, Enercon was setting the standards for air-cooled induction sealing systems,” Plantier says. “Prior to that time, water-cooled systems had been required. Today, Enercon’s air-cooled sealers are widely recognized,” he says.
Hardigg Makes a Case for Rugged Packaging
Transportation of medical equipment is nerve-racking. Often sensitive and expensive, medical equipment can be rendered inoperable when subjected to even the most minor impact or limited exposure to certain environments. To help allay worries and prevent mishaps, Hardigg Industries Inc. (South Deerfield, MA) offers rugged custom transport cases for maximum protection of industrial products.
Founded in 1954, the company claims the distinction of being the first to manufacture an airtight, watertight, and virtually indestructible protective container. These qualities established the product as a suitable fit for military applications.
Like the military, the healthcare industry demands transportation of sensitive and delicate equipment. Realizing this similar need, Hardigg translated its skills to meet the demands of medical applications. “We help medical companies with the packaging of delicate instrumentation that needs protection during transport, and that can be anything from parts to a specific instrument to whole systems,” says Matt Howell, product manager.
Hardigg constructs these robust cases using injection and rotational molding. “Rotational molding has inherent advantages when you’re making a rugged plastic container because when you mold a part, the corners end up being 20–25% thicker than the walls. So, when you drop a case, it typically lands on a corner or an edge and it is therefore stronger in that position,” Howell says.
The company’s rotational molding capabilities are not reserved solely for creating cases, however. Hardigg offers custom molding of medical devices and works with OEMs to design and make the parts.
Custom Metal-Clad Wire Offers Alternative to Costlier Products
Metal-clad wire can serve as an alternative to standard or plated wire in medical applications.
Known more for its work in other industries, Anomet Products (Shrewsbury, MA) has been quietly providing wire for medical applications for more than 15 years. Now, at MD&M Minneapolis, the company is ready to be heard.
“We’re trying to get a little more aggressive,” says Bob Gallant, the company’s general manager. “When you come to these shows, word gets around.”
In its first year at the show, Anomet hopes word gets around about its ability to design and manufacture custom metal-clad wire. Typically, choosing a metal wire requires tradeoffs. A wire might be biocompatible, yet lack strength, or a wire might be resistant to corrosion, yet lack good conductivity. But what if a specific design, say for a cardiac rhythm device, requires both corrosion resistance and conductivity?
Solid or plated wire made from a conductive and corrosion-resistant material such as gold or platinum is an option. Not surprisingly, however, these precious metals come at a high cost. This is where Anomet believes custom metal-clad wire can benefit OEMs as an alternative to standard or plated wire.
Metal-clad wire, made from a core of aluminum or steel, can provide the same benefits as standard or plated wire at a lower cost, and can even provide a reliability advantage, according to Gallant. It is made by bonding a core alloy to a surface metal or alloy that typically has good corrosion resistance. Since metals and alloys with good corrosion resistance—platinum, for example—tend to be more expensive than those with less resistance, a metal-clad wire that uses resistive material for its surface alone offers a potentially significant price advantage over a more-or-less equally functional standard or plated wire.
The company’s manufacturing facility in Massachusetts was built specifically for the manufacture of a wide variety of metal wires. Medical applications include cardiac and implantable devices. Electronic systems for medical instruments have also incorporated the company’s wire.
Custom Metal Fabricator Has a Need for Speed
Quality Tool applies principles of lean manufacturing to custom sheet metal fabrication and assembly.
At MD&M Minneapolis, representatives from Quality Tool (St. Paul, MN) hope to meet potential customers seeking not just quality, but speed. The company applies principles of lean manufacturing to custom applications, resulting in typical lead times of one-to-six weeks for production and one-to-two weeks for prototypes.
The company, a provider of custom sheet-metal fabrication and assembly services, has continually refined its production process over the years to be flexible, responsive, and, yes, fast, says Dave Krueger, vice president of sales. “Traditionally, lean manufacturing has been used for standard product, but we’ve applied many of the principles to custom product,” Krueger says. “We stock standardized materials, we fabricate different-sized metal parts out of the same metal sheet, anything that can potentially reduce setup time.”
Based on the quantity of an order, the company routinely migrates parts built on a soft-tool basis to stamping equipment for standardized runs. As for machining, the company features high-volume Swiss-type screw machines that can cut both standard and custom hardware. For custom applications, the machines can be used to run small lots of parts and hardware with long lead times.
Rapid prototyping is also offered. The opportunity to present its prototyping capabilities to a strong local medical device market in Minnesota is a primary reason for the company’s participation at the show. “The typical design process for medical instrumentation fits well with our particular design process,” Krueger says.
One feature of the prototyping service is that designs are programmed and fabricated on the same equipment used for production runs. Instead of having to translate programming from a prototyping department to a production department once a design is refined, the process is pared down, shortening the time to market.
Past medical applications for the company’s services have included card cages, control units, and frameworks for medical equipment as well as machining for ultrasound, x-ray, and diagnostic units.
Circle Medical Draws from a Well of Experience
An outsource engineering group, Circle Medical provides full product development capabilities.
Despite being only three years old, Circle Medical Devices (Los Gatos, CA) has six men at the helm who are “lifers” in the medical device industry. Their collective résumé boasts experience with a cornucopia of medical devices that run the gamut from combination products to cardiovascular implants.
They don’t shy away from hard work, either. Supported by this solid foundation of experience, the company’s founders banded together several years ago and pooled their respective knowledge to build an outsource engineering firm from the ground up. They wrote the business plan, funded the start-up themselves, and began offering their services exclusively to the medical industry. Since the company was established, it has expanded to include 65 employees. The company’s résumé has similarly grown.
The diverse backgrounds of the staff give the company an advantage over competition in such niche fields as combination products, according to Jerry Hansen, CEO. “We have three PhD chemists, we have a wet lab, and we’re experienced in devices that deliver drugs,” he says. “We’re not a pharmaceutical house, but we have an expertise that is unusual in that several of us have pharmaceutical and combination-product backgrounds, and we’re just comfortable in that area.”
But the company’s comfort zone extends far beyond combination products. Armed with full product development capabilities, Circle Medical can assist OEMs in every stage of the product development cycle, from design through sterilization. It offers a host of capabilities that encompass device history record generation, material procurement and control, process development and validation, and sterile package design, process, and testing services. Cleanroom manufacturing and full-service device packaging are also available. In addition to contract manufacturing, the company specializes in software, mechanical, and electrical engineering as well as in electrical safety testing and consulting.
Individual knowledge has propelled the company to where it is today; however, its collective experience in the past three years has already provided useful insight. As it turns out, so have the varying roles that Circle Medical has played. “We are competent on the technical side, but we’re also very good on the program management side, and I think that the client needs both of those,” Hansen says. “Circle Medical has been the client. We’ve hired the outsource company and we’ve been the big company, so we know what’s needed.”
CRO Helps OEMs Meet Safety Requirements
GLS offers research and testing services for the medical device, medical packaging, biotechnology, and nanotechnology industries.
NSF International, a not-for-profit, nongovernmental organization, formed a subsidiary company in 1999, Global Lifescience Solutions (GLS; Ann Arbor, MI), to satisfy increasing customer demand for consulting and noncertification testing services. GLS is an extension of NSF’s commitment to public health and safety. But, whereas NSF develops standards, GLS is focused on providing research and testing services to the medical device, biotechnology, and nanotechnology industries.
As a contract research organization, GLS acts as a consulting firm offering a range of testing services for medical devices and packaging, and performing preliminary audits of facilities for current good manufacturing practices. It is now working on further expanding and developing relationships in the medical device industry as a subcontract laboratory, according to Aline Lindbeck, general manager. “We are rapidly expanding our engineering laboratory and now offer a variety of chemical, physical, and mechanical testing services,” she says. “We are evaluating over 4000 products and materials each year for material properties, performance, and safety of the finished products,” she says. The company conducts its tests in compliance with industry standards and the methods dictated by organizations such as ASTM and ANSI.
The combined resources of GLS and NSF enable the organizations to offer a range of testing services that includes sterility, in vitro toxicity, material characterization, cleanability, and heat resistance.
Package testing—such as barrier protection, shelf life, and tensile strength—is offered. NSF provides product distribution studies as well. “The medical device community facilitates global trade for medical devices,” says Casey Coy, GLS technical product manager. “ISO 13485 provides assurance that products developed in other countries comply with quality assurance practices in the United States,” Coy explains. As part of the company’s aim to guide clients through regulatory requirements, NSF offers ISO 13485 registration through another branch of the company, NSF International Strategic Registrations, which provides management systems registration worldwide, according to Coy.
Founded in 1944 as the National Sanitation Foundation in the School of Public Health at the University of Michigan in Ann Arbor, the parent organization rebranded itself as NSF International in 1990. Since then, it has forged partnerships and relationships with standards and trade organizations and opened satellite offices around the world. “NSF is at the forefront of addressing critical public health issues,” says Kevin Lawlor, NSF chief executive officer. “With a new lab expansion just completed, NSF and GLS are positioned to compete in the biotechnology industry,” adds Lawlor.
Translation Company Helps the Medical Device Industry Cross Borders
Foreign to MD&M Minneapolis until this year, the Geo Group (Madison, WI) won’t have to brush up on the medical device industry. The company, offering full-service translation services, derives more than 25% of its business from translating medical-related documents.
The company contracts with more than 500 translators, according to Georgia Roeming, the company’s owner. Translators are screened and assessed based on linguistic skills as well as expertise in the medical field. Native speakers are available for all 40 languages that the company offers, a number that includes all members of the European Union. Of all translations, 97% are from another language into English.
The Geo Group translates a wide variety of documents. Past examples have included product user manuals, service manuals, exporting labels, safety warning information, marketing materials, technical documents, and business spreadsheets. If several different documents are being translated for a single company, the same translator is retained to aid communication through consistency of voice.
Regardless of the document type, the company aims for fast turnaround. “We believe the speed of our translations is what distinguishes us,” Roeming says. “What enables fast turnaround is our proprietary software translation tools that use a database of translated sentences and terms to reduce the need to retranslate repetitive text.”
The software was developed by the company’s in-house technical staff. The firm maintains a staff of 40 in-house employees. Though this is not a large number of employees compared with some of the other exhibitors at MD&M, it is a large number compared with other translation houses, says Roeming. One important service made possible by the in-house technical employees is the translation of a company’s Web site into other languages, a process known as Web localization. The staff works with a client’s computer engineers to combine the Geo Group’s proprietary translation tools with the client’s programming process to accelerate the translation of a site.
In addition, the staff operates an in-house video studio, which allows the Geo Group to provide voice-over translations for video content, an increasingly popular element of company Web sites. Real-time interpretation services are also available. These are usually conducted over the phone to enable business-to-business communication and transaction.—D.G.
Manufacturer Enhances Fasteners for Harsh Environments
Weld stud fasteners, such as those featured on this wheel chair hand rim, and application equipment can be used by medical OEMs to mount components on the inside of stainless-steel enclosures.
For nearly 70 years, Nelson Stud Welding (Bridgeview, IL) has been holding medical equipment together—or at least its products have. The company manufactures and distributes weld stud fasteners and application equipment used by medical OEMs to mount components on the inside of stainless-steel enclosures.
Founded in 1938 by inventor Ted Nelson, the company took flight when it produced a process that cut in half the production time and cost of securing wood planks to aircraft carrier decks. Since then, the company has branched out to serve other industries, supplying fasteners and fastening systems for use in high-stress environments.
“Nelson is currently enhancing our manufacturing capabilities of cold-formed and machined parts,” says Don Sues, the company’s north regional director. “We now have the capability to cold-form parts up to 15 in. in length and 1 in. in diameter. We have added dedicated CNC machining centers for special engineered fastener requirements,” he says. The company is also following industry trends for improving surface finishing and design, according to Sues.
The manufacturer specializes in welding stainless steel, aluminum, and mild-steel fasteners with minimal or no distortion. “This is very important to medical equipment where surface finishing is important,” says Sues. “The process utilizes solid-state equipment to provide one-sided fastening and eliminate drilling, punching, staking, or press fits, which may cause appearance objections or secondary finishing requirements,” he explains.
The company will be exhibiting its capacitor stud welding fastening process at MD&M Minneapolis. It will also be promoting its externally threaded fasteners, shear connectors, a variety of other weld stud and fastener products, and equipment used to apply, assemble, and weld such items.