Originally Published MPMN October
Originally Published MPMN October 2004
First Time Exhibitors
Acsion Reaches Out to Engineers and OEMs
Ready for prime time is the way account executive Lu Ann Sidney describes the feeling at Acsion (Pinawa, MB, Canada) about being a first-time exhibitor at MD&M Minneapolis. At the show, Acsion will let attendees know about its contract sterilization services and E-beam accelerator. The company would like to reach out to quality assurance professionals who make decisions about sterilization vendors, but also wants to educate the medical device industry about material-selection issues. We want to reach engineers in the early stages of designing and make sure they consider designing products for E-beam sterilization, says Sidney.
Acsion was formed in 1998 out of a Canadian national laboratory and grew to provide repair services to the aerospace industry and radiation sterilization services to the healthcare industry. Its national lab roots give the company a personalized service, as well as materials-testing and analytical capabilities. Acsion provides bioburden reduction and cross-linking services to the medical products industry, in addition to E-beam sterilization. Validation, expert advice, and consultation are all additional services the company offers.
There is a demand for E-beam sterilization and limited access to linear accelerators. Acsion meets that demand with its new, state-of-the-art accelerator. As the business grows, the company may move in the direction of also providing assembly or packaging services.
The company is working hard these days to make its presence known at shows such as MD&M and others in Medical Alley. It hopes to create more business opportunities with its traditional customers, and also make contact with OEMs for potential partnerships to provide full services. The MinneapolisSt. Paul area has been overlooked for a long time and the base of technical expertise is unbelievable, according to Sidney. There is plenty of opportunity and Acsion sees that.
Micro Control Is Ready to Assist with Electronic Manufacturing Services
Its impressive to be able to offer quality contract electronic manufacturing with fast turnaround to the medical device industry. Micro Control Co. (Minneapolis) goes above and beyond to also offer design and assembly services. The company prides itself on vertical integration; mechanical and electronic engineers work beside manufacturers in the in-house machine and sheet-metal shops to meet customers needs with full services and high standards of quality.
Started in 1972 by the present owner, Micro Control provided test equipment for memory boards and devices to the electronics industry. The company continues to offer test equipment and burn-in systems for the semiconductor industry, but expanded in 1994 to offer contract electronic manufacturing services to other markets. Micro Controls capabilities include high-speed surface-mount, through-hole, and mixed technologies; BGA placement with x-ray inspection; BGA rework; mechanical/box build; and large, high-density printed circuit boards.
We have customers for whom we manufacture circuit boards for prototyping of implantable equipment, and we deal a lot with prototypes for medical usage of circuit boards, says manager of electronics manufacturing Rafael Iglesias, but wed like to show the community that we have the capacity to assist anyone.
The ISO 9001:2000compliant company chose to educate MD&M attendees about its electronic manufacturing services because of its desire to continue expanding its client base. Micro Control exhibits at other trade shows throughout the year, but wants MD&M Minneapolis visitors to know it is a local company and everything needed to complete manufacturing jobs is locally obtained.
Air Squared Showcases Scroll Compressors for a New Audience
Manufacturer Air Squared (Hamilton, OH) has been attending trade shows for about five years, including the MD&M East and West shows, in an effort to meet new customers. In addition to its Ohio offices, the company has manufacturing facilities in Broomfield, Colorado. An interest in increasing exposure in the Midwest has led to its presence at the MD&M Minneapolis show.
Air Squared makes scroll-type air compressors, vacuum pumps, and expanders, primarily for medical OEMs. The scroll design enables clean, oil-free compressed air, high efficiency, and low noise for medical applications such as ventilators, portable oxygen concentrators, nebulizers, and dialysis equipment. The company began custom designing and licensing scroll technology for the medical industry in 1991, branching out 10 years later to accommodate its customers by manufacturing scroll devices. Visitors to Air Squareds MD&M Minneapolis booth can view its scroll compressors and vacuum pumps.
According to president Robert Shaffer, Air Squared is most proud of its small, efficient scroll compressors. Scroll compressors become more difficult to manufacture as they get smaller, he explains. Air Squared has developed proprietary technology that enables us to make a small, efficient compressor at a competitive cost.
Air Squared has contracted for the development of small, injection-molded compressors for medical applications. Future initiatives include expanding into other areas such as fuel cells. Manufacturing capabilities will broaden as its clientele base grows. The company owns eight patents and has applied for two more. It is currently preparing two patents covering scroll improvements that make the scroll cost-competitive and practical to manufacture.
Sanbor Medical Plans for Growth with New Facilities and Certifications
Before establishing its medical division a year ago, Sanbor Corp. was primarily focused on serving the appliance, automotive, and electronics industries. But increasing sales prompted the company to form Sanbor Medical (Allentown, PA). Sales to medical device manufacturers have grown to about 10% of the companys business over the past 10 years, says Joseph F. Horvath, vice president of sales and marketing. The division is now geared up and ready to grow.
Sanbor Medical is a fully integrated manufacturer, with design and production capabilities for custom cable and cable assemblies, printed circuit board assembly, injection and insert molding, and system assembly and subassembly. The division is ISO 9000 certified, and is pursuing ISO 13485 certification. In November, Sanbor will move production from its current facility in Xiamen, China, to a new 130,000-sq-ft location nearby. It plans to install a Class 100,000 cleanroom production area and seek FDA registration for the facility.
Though its production facility is in China, Sanbor Medical is a U.S. corporation. So while products are made offshore, our liabilities and customer accountability are here in the United States, says Horvath. Numerous levels of IP confidentiality are built into the Sanbor system for the protection of the customer. The company has U.S.-based engineering, project management, sales, customer service, logistics (with a Los Angeles distribution center), and accounting functions.
The divisions goal is to grow to be 25 to 30% of Sanbor Corp.s total business. We see a lot of opportunity for Sanbor Medical in certain niches within the market, says Horvath. In addition to electronic circuitry, its smart cables incorporate a number of molded components within the assembly. With 17 molding lines and an experienced group of plastics engineers, we have built an extensive capability in the manufacturing of precision molded parts, Horvath says.
The first trade shows for the division were MD&M East in June and OEM New England in September. At MD&M Minneapolis it will showcase custom cable assemblies, smart cables, molded components, printed circuit board assemblies, and subassemblies.
FMEA Software Makers Promise One-Study ROI
Though they are being increasingly embraced by device makers as a valuable way to maintain product quality, failure modes and effects analysis (FMEA) studies are grueling and time-consuming work. And up until two years ago, medical device engineers had nothing beyond spreadsheets to help them get that work done. At the time, there wasnt really anything out there supporting medical manufacturers, says Mark Chambers, senior manager of the reliability division of Dyadem International Ltd. (Toronto, ON, Canada).
Dyadem entered the medical market in early 2001 with the launch of its FMEA For Medical Devices 5 software, a tool designed specifically for medical device FMEA. The studies, an ongoing process carried out through the lifetime of a product, help define process control plans and record and prioritize continuous improvements.
This has been the companys first year attending medical trade shows, including MD&M East and MD&M West. At MD&M Minneapolis, Dyadem will showcase the newest version of its product, FMEA For Medical Devices 6, launched a year ago. New features in the upgrade include electronic records and signature capability, and linking of supporting documents. Sales are up 140%, compared with the first year we launched the product, says Chambers.
The software can reduce FMEA time by 65%, and pays for itself after the first study. Do one study with the software, and youll see your return on investment very quickly, Chambers says. FMEA6 is also intuitive and easy to learn. According to Chambers, 80% of its users dont require training, but he adds that the company maintains a full dedicated client-care group to assist users. FMEA6 has templates to cover several standards and processesincluding ISO standards, EN standards, MIL-STD-1629A, 510(k) premarket notification, and FDA quality system requirementsbut users can also easily customize their own templates.
FMEA6 is more expensive than competing products, but the customization features, reporting capabilities, ease of use, library of generic failure-mode information, and ability to integrate with third-party products make it the best product on the market, Chambers insists. We challenge anyone to find a better product than ours. www.dyadem.com
Titanium Stamping Is Business as Usual for Okay Industries
Some of the countrys biggest players in the medical device industry are located in the Midwest, which is why Okay Industries (New Britain, CT) is looking forward to being a first-time exhibitor at the MD&M Minneapolis trade show. Business development manager Jason M. Howey cites the companys expertise in stamping titanium as the main reason MD&M Minneapolis visitors will be interested in visiting the Okay booth.
Titanium components will be on display, and representatives will be on hand to discuss the companys stamping knowledge and its assembly and subassembly services. Okays trademarked process of prototyping a component mirrors the production process, so there are no worries, Howey explains. Its prototyped the way its going to be made in production, so there are no headaches.
The ISO 9002 and QS 9000certified company has an experienced engineering and research and design staff, as well as state-of-the-art equipment for prototyping and production. Okay prides itself on focusing on the initial design phases but offers full services through production. It also boasts a trademarked application for converting components into low-cost metal stamping, and a proprietary process for grinding surgical scissors and knife edges. Stamping press sizes up to 800 tn can be used to produce components for implantable devices and surgical stapling devices, in addition to surgical cutting instruments, drug-delivery devices, and other laparoscopic, endoscopic, and arthroscopic applications.
Okay Industries was originally known as B. Jahn Manufacturing. Founded in 1911, it was one of the largest tool and die shops on the East Coast. It has been serving the medical device industry since 1977 and is now based out of a 100,000-sq-ft facility, housing 135 employees. Planning for future endeavors, Howey says the company is looking more at assembly and titanium expertise for some products that are machined.
Despite Name Changes, Moog Components Groups Product Quality Remains
As a division of Moog Inc., Moog Components Group (Blacksburg, VA) has only been around about a year. But that doesnt mean it is a new company. Our company has been in business for more than 50 years, says Paul Murphy, group sales manager of commercial products. Were not a new kid on the block. However, because the division has been through a variety of corporate owners in recent yearsincluding acquisitions by Northrop Grumman in 2001 and Moog Inc. in 2003maintaining an industry reputation is a challenge.
Building name recognition for the division, formerly known as Poly-Scientific, is one reason behind a new focus on industry-specific shows, Murphy says. Exhibiting at the National Design Engineering Show, part of National Manufacturing Week in Chicago, has become less productive. Weve seen a steady drop in attendance for more broad-based shows, says Murphy. The quality and quantity of our leads has deteriorated.
Because medical is the largest and fastest-growing market for Moog Componentss productsincluding slip rings and fractional horsepower brushless dc motorsindustry shows are a better fit. Murphy says many of the companys regular customers are present at the MD&M West show, where they have been exhibiting for three years. That show, along with MD&M East and MD&M Minneapolis, will be the anchor of the companys trade show activities going forward. Our primary market focus for the commercial side of the business is the medical market, Murphy says.
At MD&M Minneapolis, Moog Components Group will showcase product expansions. These include digital drives using the latest digital signal-processing technology available, and motors with improved efficiency. We find that in many medical applications, the efficiency is very critical to promote the longest battery life, Murphy says. The company will also display its new miniature slip ring capsule, which has a through-bore that allows passage of cables through the center to facilitate mounting of the slip ring in a device.
Asahi Intecc USA Offers Custom Wire Manufacturing
In 1976, a wire manufacturer for industrial products opened its doors in Japan. Today, Asahi Intecc USA Inc. (Newport Beach, CA) has a reputation as one of the main suppliers of wire to the medical industry and boasts ISO 9001, ISO 13485, and EN 46001 quality management system certification. With more than 1300 employees in Japan, Thailand, and the United States, Asahi Intecc has been serving the needs of the medical device market for 10 years.
One of the keys to the companys success is being able to offer high-volume, full services in wire manufacturing. Asahi Intecc obtained FDA registration for its Japan and Thailand facilities in order to export raw materials to its U.S. location. This process cuts down on costs for the company and allows the U.S. facility to take care of making the finished product to customer specifications, as well as packaging and sterilization.
On exhibit at the MD&M Minneapolis trade show will be the companys most popular product, ACTONE cable tube, a stainless-steel cable with a hollow structure. The cable offers flexibility, kink-resistance, softness, and high torque transmission. Asahi Intecc also manufactures precision wire, miniature wire, miniature coil, torque transmission wire, torque transmission coil, braid-reinforced catheter tubing, and custom devices. The manufacturer has complete control over each wires mechanical properties, including tensile strength and elongation. Nitinol ties will also be on display at MD&M.
Yoshi Terai, the companys president, found the Anaheim and New York MD&M trade shows to be rewarding experiences, and is looking forward to the Minneapolis show for the citys large medical market and potential customer base.
CNC Machine Tools Are Second Nature for Haas Automation
No stranger to trade shows, Haas Automation (Oxnard, CA) makes its debut at MD&M Minneapolis this year in an effort to reach out to the Midwest market for CNC machine tools. The largest manufacturer of such machine tools in the United States, Haas provides milling and turning machines used to shape metal and other materials for medical device parts. The ISO 9000:2001certified company hopes to meet medical device and contract manufacturers who have a design Haas can turn into a finished product.
Haas will partner with its Minneapolis distributors to present a total of five machines at the MD&M show, as well as educate attendees about the rest of its product line. On display will be the TM-1 vertical machining center, a fully CNC machine without enclosure. The toolroom-series machine has built-in software with intuitive milling and turning, allowing novice medical companies to make a smooth transition from manual to CNC processes. Other machines on display are targeted at companies already familiar with CNC who need high volume and quick production. Two new machines are very small versions of milling machines already in existence. The machines are small enough for customers to place in an office facility with limited space.
Started in 1983, Haas Automation is a relatively young company in terms of machine tool standards. Spawned from owner and CEO Haass design of a product to increase production in his machine shop, the company began to manufacture products and expanded from there. Its 820,000 (and growing) employees take pride in having found a niche in an old market and commanding and maintaining a 40% market share in the United States, as well as having customers around the world. Haas is heavily targeting the medical industry lately to develop more niche-type products that meet the needs of specific device manufacturers.