Machine Solutions Launches Build-to-Print Assembly Services Unit
If you (custom) build it, they will come.
That derivative of the famous whisper in the 1989 Academy Award-nominated film “Field of Dreams” was the inspiration behind the latest investment by Flagstaff, Ariz.-based Machine Solutions Inc., a designer and manufacturer of catheter, balloon and stent devices equipment. The company has created a Build-to-Print Assembly Services division in Phoenix, Ariz., and established an online presence touting its new service at www.MSIBuildToPrint.com.
Executives said the firm established its Build-to-Print business unit to better support the outsourcing requirements of medical device customers and those in other industries. In literature available on its website, the company outlines the steps it follows to customize solutions for clients: initial requirements review; proposal review; first article status updates and review; build plan updates and review; factory acceptance testing; and regular
status updates.
“Adding build to print assembly services is a strategic fit within the core engineering and complex assembly capabilities developed at Machine Solutions,” CEO Daniel Kasprzyk said.
Machine Solutions chieftains claim the firm’s new division provides various benefits to customers, including inventory reduction, limiting the need to staff for demand fluctuations, meeting aggressive lead time deadlines, and using experienced workers for both mechanical and electrical assembly.
“MSI has positioned itself with added value to the existing customer base by offering build-to-print services along with added value engineering,” noted John Philippi, MSI’s vice president and chief operating officer. “The Phoenix staff has over 75 years of combined experience which is inclusive of mechanical, electrical and software engineering.”
Helix Medical Building Latin American Manufacturing Plant
Helix Medical LLC is about to get closer to its Latin American customers. The Carpinteria, Calif.-based supplier of biocompatible silicone medical devices is building a manufacturing plant in Costa Rica that eventually will employ more than 100 people.
The company is spending more than $4 million on the new facility, which is expected to be operational in the first quarter of 2012. Helix is leasing property for the manufacturing plant in the Coyol Free Trade Zone and business park in Alajuela, the country’s second-largest city that is just 12 miles northwest of the capital, San Jose.
Helix executives did not disclose the size of the new plant, but said it will offer contract manufacturing services that include silicone extrusion, silicone molding, thermoplastic molding and assembly operations. It will be ISO 13485:2003 certified and have Class 7 and 8 cleanrooms as well. According to a news release, Helix is building the new facility to be closer to its Latin American client base.
“We chose Costa Rica to be close to our customers in Latin America,” said Andy Becker, vice president and general manager for Helix’s Carpinteria and Costa Rican operations. “The country offers a large medical device community with a skilled workforce as well as a good reputation for security and infrastructure.”
Helix is among a growing number of medical device companies in recent years to set up shop in Costa Rica, a country that virtually was unknown to device firms when Baxter International opened a manufacturing plant in Cartago 23 years ago. Since then, the industry there has grown to encompass nearly 10,000 employees from such companies as Boston Scientific Corp., Hospira Inc., St. Jude Medical Inc., Hologic Inc., Koros USA Inc., Arthrocare Corporation and Allergan Inc.
Overall, medical device exports have grown three times faster than the country’s other free trade zone exports. The device industry has grown so rapidly, in fact, that it is now the third largest exporter in Costa Rica; in 2009, the export of medical products generated more than $1.34 billion for the economy and accounted for 15.5 percent of the nation’s total exports, according to government data.
The construction of a Costa Rican manufacturing facility is the second expansion project for Helix within the last 12 months. In February 2010, the company opened Helix Medical Europe KG, a 55,000-square-foot facility in Kaiserslauten, Germany, that provides various services, including custom molding of silicone components, thermoplastics and thermoplastic elastomers (TPEs); multi-component molding; and close tolerance single and multi-lumen extrusion of silicone TPEs.
In addition to its manufacturing plants in Germany and Carpenteria, Helix maintains operations in Baldwin Park, Calif.; Gloucester, Mass.; Carrick-on-Shannon, Ireland; and Shenzen, China.
Johnson Matthey Ramps Up Capacity for Fine-Hole Micromachining
Johnson Matthey is thinking small. Fielding more customer demands for tiny precise parts, the San Diego, Calif., specialty chemicals company has increased its volume capacity for fine-hole micromachining.
The ability to perform more fine-hole micromachining, corporate bigwigs said, will allow the firm to better machine intersecting or cross-holes in various configurations. A complex array of fine holes typically is used for advanced medical applications such as electrophysiology catheters with irrigated tips. However, fine holes also can be used to facilitate a uniform cooling process during manufacturing.
Johnson Matthey can machine holes as small as 0.003 inches in diameter without burrs.
Using enhanced machining technology, the company can produce surface finishes as low as 5 microns while minimizing (or in some cases, eliminating) random tool marks, dings and dents. Fine-hole capabilities allow Johnson Matthey to exceed the precision micro-component demands of the medical device industry by maintaining dimensional tolerances ranging from 0.005 inches to 0.0002 inches, concentricity to 0.001 inch, edge breaks and corner radius/fillets from 0.002 inches to 0.005 inches and burr tolerances that can go as low as 0.0005 inches.
Johnson Matthey has manufacturing in San Diego and San Jose, Calif.; West Chester, Pa.; and the United Kingdom.
Titanium Industries Looks to China for Growth
Sometimes, life is all about timing. For medical device suppliers and material distributors, timing can be crucial, particularly when it comes to new growth opportunities.
Executives at Rockaway, N.J.-based Titanium Industries Inc. are hoping to capitalize on their own good timing with the opening of a sales office in Shanghai, China. While the company’s newest sales office only has been open for two months, executives said the move reflects Titanium Industries’ “determination and enthusiasm to service its Chinese customers” and keep abreast of the changing requirements of offshore companies that want to conduct business in China.
The new sales office opening also reflects the company’s desire to take advantage of the enormous growth potential that China presents to foreign firms. Last year, China knocked Japan off its economic superior perch to become the second-largest economy behind the United States. While Japan grew 3.9 percent last year—its first annual growth in three years—it was not enough to hold off China's ballooning economy. Japan's nominal GDP (gross domestic product) was $5.4742 trillion (£3.4 trillion) in 2010, significantly less than China's total of $5.8786 trillion, according to official data released by Japan.
“The Shanghai office is the next logical step in our strategic global expansion,” Titanium Industries President and CEO Brett S. Paddock said. “A physical presence in China will help facilitate growth more effectively by improving our presence in Asia as well as our alignment with key global customers and markets.”
The new Shanghai sales office reports to the company’s Taiwan bureau, which in turn, reports to Jeff Wise, vice president of sales and marketing. Once the company establishes a firm sales presence in Shanghai, executives hope to introduce distribution services and value-added operations there.
“Ti Industries will compete aggressively in China and the larger Asian market by bringing an understanding of value-added services and metal distribution to users of titanium and high-performance metals,” Wise said, noting that metal distribution channels in the country are still in the early stages of growth.
“Until a few years ago, the distribution of metals in China wasn’t even largely considered,” he added.
Wise said the decision to open a sales office in China was based on the company’s desire to serve its existing global customer base while exploring new business prospects. “There are core global customers whom we service and many of them are either expanding their own operations in China or sourcing more from that part of the world,” he explained. “We need to be there to support them.”
Titanium Industries is a global distributor of titanium, nickel-based products and other high-performance metals serving the aerospace, medical and industrial business markets. The firm has three other sales offices besides the one in Shanghai and eight service centers.
Creganna-Tactx Medical Partners with Boston Biomedical Associates
Creganna-Tactx Medical’s longstanding (and somewhat elusive) quest to become a full-service outsource provider finally is over.
The Galway, Ireland-based firm has partnered with Boston Biomedical Associates (BBA) to provide customers with clinical, regulatory and quality expertise and consulting services. The joint venture company will be co-located at BBA’s facilities in Northborough, Mass., and northern California.
Under the partnership agreement,Creganna-Tactx Medical now will provide a broad array of quality and international regulatory support to its customers, including the development of various regulatory and clinical strategies, regulatory submission development and liason services, management of clinical trials and associated consulting services to achieve product approval and commercialization support.
Creganna-Tactx Medical CEO Helen Ryan called the company’s partnership with BBA a natural progression in its quest to provide full service outsourcing solutions to customers.
“The new services to be provided under this joint venture partnership complement our current service portfolio and respond to the evolving requirements of our customers,” Ryan said in a news release. “We have designed and manufactured complete products on behalf of our customers for many years; therefore, managing the regulatory and quality process on their behalf is a natural progression.”
BBA president and owner Lauren Baker, Ph.D., said the alliance withCreganna-Tactx Medical will enable her firm to expand its customer base andintroduce new client companies to the firm’s methodologies.
“The joint venture with Creganna-Tactx Medical will allow us to introduce our methodologies and approach in an evolving market where outsourcing companies, in partnership with their customers, are assuming legal responsibility for a product’s manufacture,” she said.
“Creganna-Tactx Medical’s design and manufacturing capabilities, coupled with our regulatory, quality and clinical expertise, will provide Creganna-Tactx Medical customers with apathway for product approval and commercialization support in the United States and internationally.”
Creganna-Tactx Medical employs more than 1,000 people worldwide and maintains design and manufacturing operations in Campbell, Calif.; Plymouth, Minn.; and Marlborough, Mass.
Biotech in Brief
Cytomedix Inc. executives now can turn to a six-member Scientific Advisory Board for guidance with clinical trial data gathering and publishing, Medicare reimbursement, and product development. Board members include doctors, clinicians and researchers, some of whom have published or presented data about the platelet-rich plasma therapies the Gaithersburg, Md.-based regenerative medical technology company has developed (AutoloGel and Angel systems)…Biomedical Structures LLC achieved record growth last year, thanks to a private equity financing with Wellesley, Mass.-based Ampersand Ventures, the addition of a cleanroom for manufacturing polymer fiber materials, and an agreement with DSM Dyneema to process its ultra high molecular weight polyethylene fiber. Executives with Warwick, R.I.-based Biomedical Structures did not provide statistics for 2010; instead, President John Gray said in a news release that last year was a “tremendous” one for the biomedical textile provider…the California Healthcare Institute board has elected a new leader for 2011, choosing Carl Hull, president and CEO of San Diego, Calif.-based Gen-Probe Inc., a molecular diagnostics product manufacturer, to lead the 32-member group. The board also added two new members—Terry Hermiston, Ph.D., vice president of the U.S. Biologics Research unit within Bayer Healthcare’s worldwide pharmaceutical research organization; and Naomi Kelman, president of the North American division of LifesScan Inc., a Johnson & Johnson company. In addition, institute executives appointed Consuelo Hernandez as vice president of state government affairs. Hernandez most recently served as director of the Assembly Fellowship Program for California State University at Sacramento…India’s Department of Biotechnology (DBT) and the U.S. National Institute of Biomedical Imaging and Bioengineering are soliciting joint project proposals from scientists, engineers and scientific groups for the development of low-cost medical devices. Researchers in both countries can apply for grants; the U.S. component of collaborative projects will be funded through the U.S. National Institutes of Health research grant award mechanism, while money for the Indian component will come from the DBT…Italian medical diagnostics firm Silicon Biosystems of Bologna is basing the headquarters of a new U.S. subsidiary in San Diego, Calif. The newly-formed business will be led by Bob Proulx, who previously worked as director of marketing and business development at CryoPort Inc., a San Diego-based provider of cold chain logistics and shipping solutions to the life sciences industry. Silicon Biosystems executives said the new U.S. business will focus on the North American research and clinical diagnostics markets for its DEPArray technology, which can isolate and
manipulate cells.
ISO CERTIFICATIONS
• Adhesives Research Inc., a Glen Rock, Pa.-based developer and manufacturer of high-performance pressure-sensitive adhesives, tapes, specialty coatings, films and laminates, has achieved ISO 13485:2003 certification. Susan McIlnay, director of Quality and Compliance, said the achievement will help the company build confidence with its customers, which in turn, will enable the firm to become a stronger organization and better compete in the global market.
•American Scientific Resources Inc., a Weston, Fla.-based manufacturer and distributor of medical products and healthcare supplements, has received ISO 13485:2003 certification. Chairman and CEO Christopher F. Tirotta called the achievement an “exciting company milestone.”
•Guided Therapeutics Inc., a Norcross, Ga.-based developer of cervical disease detection technology, has achieved ISO 13485:2003 certification. “Receiving this certification is a very important milestone for the company and paves the way for the future sale of our products in the European Union and other countries that recognize the importance of the CE Mark,” President and CEO Mark L. Faupel said. LightTouch, the company’s rapid, non-invasive painless test for the early detection of cervical pre-cancer, currently is under review by the U.S. Food and Drug Administration.
• Homecare Medical Supplies Limited, an Irish supplier of furniture and medical equipment to the nursing home and healthcare markets, has achieved ISO 13485:2003 certification. General Manager John Doyle said the certification is critical to growing and developing the 23-year-old company: “This standard is vital to our business as it enables us to CE mark our own products and continue our efforts in developing our own branded medical consumables and equipment.”
• ISO 13485: 2003 and ISO 9001:2008 certification has been given to Spring-Set Health Solutions Ltd., a subsidiary of D. Medical Industries Ltd., an Israeli firm that develops, manufactures and markets drug delivery devices. CEO Efri Argaman expects the achievement to simplify and possibly shorten the regulatory approval process in the United States, Brazil, Canada, China, Europe, India, Mexico and Russia.
• Outsourcing solutions provider Summit Corporate Services Inc., has expanded its ISO 13485:2003 certification to include assembly, inspection and packaging services. Last spring, the Bozeman, Mont.-based company became certified (ISO 13485:2003 and ISO 9001:2008) strictly for distribution and servicing tasks.