05.17.10
Freudenberg Group Buys Stake in VistaMed Ltd.
The Freudenberg Group is expanding its footprint in the European medical technology market.
The Weinheim, Germany-based company and its affiliate Helix Medical Europe have purchased a 50-percent stake of VistaMed Ltd., an Irish manufacturer of complex medical tubing and medical devices. The company is based in Carrick-on-Shannon, a small town on the River Shannon that is world renowned for its fishing competitions. VistaMed employs 85 people and has two production plants in Ireland; it makes endoscopic components and mechanisms for catheters used in minimally invasive surgical procedures.
The deal, announced in April, advances Freudenberg’s move into the European medical market. Last year, the company set up a European headquarters for medical technology in Kaiserslautern, Germany. In a news release, Freudenberg executives said the alliance with VistaMed will broaden the companies’ range of materials and their product spectrum. Helix officials said the alliance with VistaMed “provides greater opportunities for both companies to develop and manufacture a broader range of innovative products.”
For Freudenberg, that means adding complete catheter systems to its line of seals, vibration control technology components, filters, nonwovens, release agents, specialty lubricants and mechatronic products. The company also develops software solutions and IT services primarily for small and medium-sized enterprises.
VistaMed, on the other hand, can now leverage the material test and analysis capabilities available through Freudenberg.
“The VistaMed team is very excited with this joint venture, which provides the platform to accelerate our product and process offering to our existing and new global customers,’’ Patrick Mulholland, VistaMed’s managing director, said in a news release. “VistaMed has positioned itself as a one stop solution provider for the design and manufacture of disposable medical devices and catheter tubing supplies. This alliance provides the scope for VistaMed to offer its customers a diverse range of silicone molded and extruded components.’’
Freudenberg has grown through acquisitions in the medical market, beginning in 2004 with its purchase of Jenline Industries Inc., a Gloucester, Mass.-based manufacturer of liquid silicone rubber products for the medical device and healthcare sectors. The company added Helix Medical in 2006 and Anura Plastics Engineering Corp. in 2008. The medical businesses have been integrated into one company—Carpenteria, Calif.-based Helix Medical LLC.
Helix Medical’s global manufacturing capabilities include silicone and thermoplastic molding, extrusion, assembly and packaging. The firm also makes silicone tubing and fluid handling components for the pharmaceutical and biotechnology markets.
PADT Finds a Permanent Home
Phoenix Analysis & Design Technologies (PADT) Inc. finally has a permanent home.
The Tempe, Ariz.-based provider of mechanical engineering services has purchased the building in which it has resided for the last eight years. Executives said the 48,000-square-foot facility in the Arizona State University Research Park will enable its medical device group (aptly named PADT Medical) to incubate a greater number of medical device startups.
“The ASU Research Park is a superb location for us,’’ said Ward Rand, PADT president. “The purchase lowers our operating costs and enables more freedom to offer incubation space to local startups.’’
PADT Medical provides startup device firms with research and development services to help accelerate product design, build clinical-use prototypes, perform validation testing and meet regulatory compliance. PADT formed the medical device group in 2006; the group has been compliant with U.S. Food and Drug Administration standards since 2007.
Founded in 1994 by aerospace engineers, PADT has helped nearly three dozen companies develop products and bring them to market. Customers include C.R. Bard Inc., Medtronic Inc., St. Jude Medical Inc., W.L. Gore & Associates Inc., Orthologic Corp., Kinetic Concepts Inc., GE Medical Systems, Accutron Inc., and C.R. Technologies Inc.
The number of medical devices PADT has helped bring to market is almost as long as the list of companies it has partnered with to offer its services. According to its website, PADT has contributed to the development of a heart valve stent, a blood filter device, an implantable pacemaker, a pediatric dentist drill, a bone implant and bone screw, a bone paste delivery device, a heated catheter and a heart valve implant, among others.
Lohmann Tech. Goes Green With New Adhesive Products
Lohmann Technologies Corp. has developed two new adhesive products that are environmentally friendly.
The DuploMED 2S and DuploMED 3S adhesive products can be cleaned and sterilized in a washing machine (without tape, of course) and then reused. Company executives said the reusable fabric portion of the product can reduce environmental waste by at least 95 percent compared with disposable products.
“This is one of the fastest growing market needs in Europe,’’ said Jim Perkins, Lohmann Technologies’ vice president of Medical and Converting. “Our German parent company has been a strong supporter of this green initiative by the European medical industry. Single use disposable medical products produce a large volume of waste that takes years to decompose.’’
Lohmann Technologies is a Hebron, Ky.-based custom adhesive coater that works with G&L Precision Die Cutting LLC, a full service converter in San Jose, Calif., to provide pressure sensitive solutions to the medical device industry. Both are member companies of Orange, Va.-based Lohmann Corporation USA, a wholly owned subsidiary of Lohmann GmBH of Germany.
Lohmann Corporation acquired G&L Precision last fall to expand its presence in the medical device market. G&L specializes in tight-tolerance rotary and flat bed die cutting, slitting, laser cutting, printing and multilayer laminating. The company has been a component supplier for more than 30 years to the diagnostic, medical device, specialty industrial, electronics and commercial markets. Lohmann Corporation President Steven De Jong said the acquisition filled an important role in the company’s global growth plans.
“We now have a base of operations to support our growth in the western U.S. while also gaining access to the growth market of point-of-care medical devices,’’ he said at the time of the acquisition. “With the existing coating and die-cutting capabilities we have in the U.S., it made perfect sense to expand our presence with the addition of G&L.’’
MCRA Forms Partnership to Maximize Clinical Trial Effciency
The medical device regulatory process often can be a complex beast.
But two companies have joined forces to simplify that process and determine the best clinical trial strategy for clients. Musculoskeletal Clincal Regulatory Advisors LLC (MCRA) recently announced its partnership with Biomedical Statistical Consulting (BSC), a Wynnewood, Pa.-based company that designs and implements regulatory clinical trials for orthopedic devices.
“Medical device regulations and pathways are constantly evolving,’’ noted Glenn Stiegman, vice president of regulatory affairs at MCRA. “MCRA’s clients require cost effective approaches to drive their technologies from conception to market as expeditiously as possible. We have previously worked with BSC on multiple PMA/IDE (pre-market approval/investigational device exemption) clinical trials and the combination of our skill sets will create efficiencies leading to best-in-class clinical trial execution.’’
Most clinical trials utilize the traditional statistical approach, otherwise known as frequentist. The frequentist philosophy is the cornerstone of classical mathematical statistics and hypothesis testing. Based on probability, it focuses on the relative frequency of the occurence of an event. Sometimes, however, a different approach is needed to increase the chances that a clinical trial will be successful. Such an approach is known as Bayesian and it involves collecting data from past events or experiences in order to reach a conclusion about future events. The Bayesian method has grown in popularity in recent years, though it can be controversial.
Officials at the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) issued a final Guidance on the use of Bayesian statistics in clinical trials in February. The Guidance states that Bayesian methods usually are less controversial when prior information is based on empirical evidence such as data from clinical trials. However, Bayesian methods can be controversial when the prior information is based mostly on personal opinion (often derived from “experts”).
The CDRH guidance document concluded that the Bayesian approach is not a substitute for sound science. “Scientifically sound clinical trial planning and rigorous trial conduct are important regardless of whether you use a Bayesian or frequentis approach,’’ the document read. “…remain vigilant regarding randomization, concurrent controls, prospective planning, blinding, bias, precision, and all other factors that go into a successful clinical trial.’’
BSC executives agree with the guidance document.
“A biostatistician’s toolbox should include frequentist, Bayesian and adaptive [clinical] design approaches,’’ said Greg Maislin, principal biostatistician at Biomedical Statistical Consulting. “BSC has specialized in applying statistical methodology in the orthopedics industry and our partnership with MCRA will enable us to bring solutions to the problems surrounding the clinical trial and U.S. regulatory processes.’’
The combined service offerings of MCRA and BSC include the strategy, development, and execution of regulatory submissions, as well as clinical trial set-up and implementation, in addition to quality assurance, reimbursement and compliance oversight, executives with both firms said.
Miniature Tool & Die Changes Its Name
Miniature Tool & Die has given itself a bit of makeover.
The Charlton, Mass.-based company has changed ist name to MTD Micro Molding and renovated its website. Executives said the new name better reflects a shift in demand for the company’s products. President Dennis Tully said the new moniker gives a nod to the firm’s past, “while still honoring our foundation.”
The company’s foundation was built in 1972 in the basement of Tully’s father’s house. After moving to a small facility in Worcester, Mass., the company made a name for itself making miniature connector molds for the electronic industry.
In 1998, MTD Micro Molding began designing and manufacturing tiny medical device components. Executives claim the company is the nation’s only firm devoted exclusively to micro applications, supplying products to the medical, electronics andmicrofluidics industries. Its customers include Abbott Laboratories, Boston Scientific Corp., Cardinal Health and St. Jude Medical Inc.
Among the products MTD Micro manufactures are micro endoscopes, a disposable automatic insulin pumping mechanism with a wall thickness of 0.005 inches and a length of 0.530 inches, and vascular connectors with a wall thickness of 0.0008 inches. Company officials attribute the ability to make such miniscule products to a Sarix Micro EDM Milling system that can achieve a level of 3D micro features and can create components that significantly are smaller than those made with conventional technology. MTD Micro is one of only two companies in the United States that have the Sarix Micro EDM system.
Increasing demand for miniature medical, electronic and microfluidic products has fueled MTD’s growth over the last four years. As a result, company officials are eyeing other facilities to accomodate the growth and developing micro liquid silicone moldings to satisfy customer requests.
Algoryx Gets Two Patents on Mold Characterization Sofware
Reducing cycle times and eliminating most, if not all, in-process measurement, statistical process control analysis and Cpk analysis to produce higher quality parts is the ultimate goal of most molders. While some industry experts may think such a goal is a pipe dream, one company is proving it is within reach.
Algoryx Inc., a Los Angeles, Calif.-based systems engineering company, has received its sixth and seventh patents for technology that can reduce injection-molding cycle times as well as improve process monitoring and control. Process monitoring, according to Algoryx officials, typically involves accepting good shots and rejecting bad shots.
“With the Algoryx Correlation Master software, a visual measurement system is used to measure only the one predictor dimension [PD] in one cavity instead of all dimensions in all cavities,’’ explained Steve Tuszynski, Algoryx president. “This makes it economical to do shot-by-shot monitoring in situations where it would otherwise be unfeasible. Simply, when the PD is in the operating range, it is a good shot. When it’s outside the operating range, it is a bad shot.’’
The operating target is the center of the operating range, Tuszynski said. Parts have the highest quality (Cpk), lowest scrap and the lowest reject rates when the PD is at the operating target. Planned applications of this technology use a vision system that measures the value of the PD and inputs the value into a closed-loop feedback control system that automatically adjusts press settings as needed, Tuszynski added.
Molding high-quality parts can be difficult without good control of the parameters involved in the manufacturing process. As a result, injection molding press settings are a critical part of the qualification/validation process, Tuszynski said. Algoryx provides companies with Mild Characterization Studies (MCS) that are independent of press settings and travel with a mold wherever it goes, enabling molders to revalidate the mold on a tonnage equivalent press anywhere in the world at a fraction of the time, cost and effort, according to Tuszynski.
“Algoryx’s customers require moldmakers to deliver the data-based MCS along with the mold as data-based proof that the mold is capable of handling normal press variation while still producing parts that meet customer Cpk requirements,’’ he said.
When press settings are changed, traditional methods can give conflicting results on ways to fine-tune the mold and the amount of relaxation required. Those trial-and-error results can create costly, time-consuming and performance-degrading mold and tolerance tuning cycles, Tuszynski claimed. Algoryx’s MCS use correlation charts with superimposed specification boxes to enable one single-step mold and tolerance tuning cycle that is independent of the press settings used to generate sample parts. Consequently, development costs are reduced, time-to-market is accelerated and “fire-fighting’’ travel is eliminated, Tuszynski said. It also reportedly reduces production costs by:
• Reducing cycle time to eliminate one to two shifts per week for round-the-clock operations;
• Reducing press energy consumption by 4 percent to 5 percent;
• Eliminating 99 percent of in-process dimensional inspections and analyses;
• Reducing automated assembly line shutdowns due to out-of-spec parts; and
• Mitigating risk during mild development and part production.
Tuszynski said his company’s injection molding technology currently is licensed to some of the world’s largest OEMs in the medical device, automotive, electronics and fluid management industries.
Biotech in Brief
Nearly two-thirds (64 percent) of California’s biomedical companies either maintained or expanded their workforce over the last year while other industries in the state experienced steep declines and the highest unemployment rates in 75 years, a new survey concluded. Biomedical firms are expected to buck the employment trend for the next two years, too: industry experts predict 81 percent of companies to maintain staffing levels or hire more workers, and 58 percent to expand their research and development teams outside of California, according to the survey conducted by the California Healthcare Institute and PricewaterhouseCoopers…The founders of biopharmaceutical firm Proteon Therapeutics Inc. in Waltham, Mass., have launched a new biopharmaceutical and medical device company in Lenexa, Kan. Novita Therapeutics LLC will develop drugs and medical devices to treat cardiovascular, renal and gastrointestinal diseases, according to published reports. The founders eventually hope to turn the company into an “innovation engine” that moves its most promising discoveries into separate companies to further their development…ECI Biotech Inc. of Worcester, Mass., has been awarded a $511,472 grant from the Small Business Innovation Research Program National Institute of General Medical Sciences at the National Institutes of Health. The company will use the grant to develop a handheld device that can detect infection in wounds…LifeScience Alley’s Board of Directors has elected two new members and two officers. Joining the Minnesota-based trade group’s board are Maura Donovan, Ph.D., vice president, therapy R&D at Medtronic Inc.; and Terry J. Kerby, vice president, strategy and Lean Six Sigma, 3M Health Care. Andy LaFrence is now board treasurer and Susan Paquette, is secretary…Linden LLC, a healthcare private equity firm based in Chicago, Ill., has acquired Hycor Biomedical Inc. from Agilent Technologies Inc., a Santa Clara, Calif.-based firm that designs and manufactures instruments and equipment for measurement and evaluation. Terms of the agreement were not disclosed. Hycor develops, manufactures and markets in-vitro diagnostic products for the allergy, autoimmune and urinalysis markets. Agilent executives said they sold the company because it did not fit the core focus of its life science business. Agilent acquired Hycor in 2007 through its merger with Stratagene, a company that developed products and technology solutions for life science researchers…The board of the Massachusetts Life Sciences Center, a quasi-public agency created in 2006 to oversee the Bay State’s $1 billion life sciences initiative, has approved up to $3 million in new matching grants to small businesses this year. The center will provide as much as $500,000 to startup medical device, biotechnology and diagnostic companies that have received federal funding from agencies such as the National Institutes of Health, the National Science Foundation, and the U.S. Department of Defense. Emerging life sciences firms with production-ready products and the potential to create jobs in Massachusetts will be the likely recipients of the grants.
ISO CERTIFICATIONS
• Advanced Mobility, a Monee, Ill.-based designer, manufacturer and renovator of custom mobile medical trailers and other specialty vehicles, has received ISO 9001:2008 certification. Bob Bachman, Advanced Mobility’s president, said the certification and the company’s recent approval as a preferred supplier to GE Healthcare will help the firm become a “market leader.”
• BioLife Solutions Inc., a Bothell, Wash.-based developer of hypothermic storage and cryopreservation solutions for cells, tissues and organs, has received ISO 13485:2003 certification. BioLife Chairman and CEO Mike Rice called the certification a “strategic quality milestone” for his company.
• ISO 9001: 2008 certification has been given to Coghlin Companies, a contract manufacturing and engineering services specialist. The Worcester, Mass.-based company also earned its ISO 13485:2003 recertification.
• Dilon Diagnostics, a Newport News, Va.-based manufacturer and supplier of high-resolution molecular imaging systems, has received ISO13485:2003 certification.
• ISO 13485:2003 certification has been granted to Endicott Interconnect Technologies Inc., an Endicott, N.Y.-based supplier of electronic interconnect solutions and electro/mechanical equipment.
• Evasc Medical Systems, a Vancouver, British Columbia-based company that specializes in vascular medical products, has received ISO 13485:2003 certification. Executives hope the certification will continue to open up new markets for the company.
• Ingen Technologies Inc., a Yucaipa, Calif.-based manufacturer of respiratory devices, has achieved ISO 13485:2003 certification. CEO Scott R. Sand said the certification will help his firm generate substantial revenue.
• ISO 13485:2003 and ISO 9001:2008 certification has been granted to LEUKOCARE AG, a biotechnology company headquartered in Munich, Germany.
• Sanmina-SCI Corporation, a San Jose, Calif.-based electronics manufacturing services provider, has achieved ISO 13485:2003 certification for its facility in Tatabanya, Hungary. Executives said the certification represents a “significant milestone” for the company’s European operations.
• A string of ISO certifications has been granted to Spectrum Plastics Group, a contract manufacturer based in Minneapolis, Minn. The company’s Ansonia, Conn., facility was awarded both ISO 9001:2008 and ISO 13485:2003 certifications, while its Dynacept Division (a rapid prototyping facility) in Brewster, N.Y., received ISO 9001:2008 approval.
• Summit Corporate Services Inc., a Bozeman, Mont.-based provider of customer service, inventory management and order fulfillment solutions for the life sciences industry, has achieved ISO 13485:2003 and ISO 9001:2008 certifications.