Creganna-Tactx Opens Facility at the Cleveland Clinic
Creganna-Tactx Medical is opening an office at the Cleveland Clinic’s Global Cardiovascular Innovation Center (GCIC). The GCIC, located on the healthcare facility’s main campus in Cleveland, Ohio, is an incubator facility supporting the development and commercialization of cardiovascular innovations and medical technologies.
Made possible through a $60 million grant from Ohio’s Third Frontier Project, the GCIC was founded in 2007. The consortium is led by the Cleveland Clinic and comprises Case Western Reserve University, Ohio State University, the University of Cincinnati, the University of Toledo and University Hospitals of Cleveland, along with leading industry economic
development partners.
According to Creganna-Tactx officials, the decision to open an office in the new incubator was intended to support companies commercializing innovative medical device technology.
The office will provide product development support to early stage companies, in addition to linking Creganna-Tactx’s customers to the leaders in medical innovation and healthcare delivery.
“Having Creganna-Tactx Medical as part of the clinic team is an important milestone for us. They will provide benefit to GCIC companies and will collaborate with Clinic innovators as we jointly work to develop products that benefit patients in need,” said Chris Coburn, executive director of Cleveland Clinic Innovations.
From this location, the company can facilitate connections to industry-leading physicians and provide customers with enhanced design and development support, end-user feedback, device testing and support for pre-clinical studies and clinical trials. This service further will be bolstered by the company’s recent joint venture agreement with Boston Biomedical Associates (BBA), which will work in partnership with Creganna-Tactx Medical to support customers with clinical, regulatory and quality affairs.
“This move strategically positionsCreganna-Tactx Medical to offer our customers complete support along the full-product life cycle. Working with Cleveland Clinic’s GCIC, we can help bridge the gap between the designer and end-user physician in the development process,” saidRandall Sword, business developmentdirector at Creganna-Tactx Medical
Headquartered in Galway, Ireland,Creganna-Tactx Medical provides contractdesign and outsourced manufacturing services to medical device companies. The firm has design and manufacturing operations in the United States, Singapore and Korea.
Jabil Investing in New Molding Facility in China
Jabil Circuit Inc. just might be on to something. Rather than watch its customer base slowly erode from the tides of foreign competition, the electronics manufacturing services provider is following clients overseas to emerging markets that are providing medical device makers with low-cost alternatives (and in many cases, easier regulatory pathways) to their domestic operations. To stay competitive, Jabil reportedly is investing $10 million in a new injection-molding factory in Shenzhen, China.
The facility, according to a published report, is being constructed within a larger existing manufacturing campus that Jabil operates for electronics customers and those in other markets. The molding factory will house 18 Japanese Fanuc injection molding presses to start, though the company plans to increase the number of machines to 50 within two years. Gaet Tyranski, business unit director for the healthcare and life-sciences business of St. Petersburg, Fla.-based Jabil, told Plastics News that the investment was driven by cost pressures amongmedical device manufacturers.
“I would maintain that the excise tax on medical devices coming out of the most recent [U.S.] healthcare reform act is causing OEMs to look for lower costs to maintain their margins,” he told the weekly newspaper during a January interview at the Shenzhen facility.
“If they predominantly have facilities in Europe and the U.S., they are looking a lot more closely at both moving production overseas and outsourcing more production. I think it is an industry that is experiencing more outsourcing and the outsourcing is moving outside the United States.”
Jabil’s newest facility in Shenzhen will manufacture drug delivery devices for export to the United States and Europe. The facility, however, also will be licensed to make products for the domestic Chinese market, a strategy that eventually could help the company achieve significant future growth. “We are starting to see our customers with an eye toward the domestic markets, China for China and eventually India for India,” Tyranski told Plastics News.
The Shenzhen factory will be able to manufacture 12.5 million disposable drug delivery devices annually, and will be certified to Class 8 clean room manufacturing. The operation will be highly automated to help cut down on labor costs, which have been rising quickly in recent years. Jabil employs more than 20,000 people in China, at factories in Tianjin, Suzhou and Wuxi.
Biomedical Structures Buys Concordia Medical
Two Rhode Island-based medical textile firms have merged in a move that company officials said sets the stage for future expansion opportunities.
Biomedical Structures LLC, a provider of biomedical textiles for medical devices and other advanced clinical applications, purchased textile manufacturer Concordia Medical LLC, a division of Concordia Manufacturing. Concordia Medical provides medical implant technology using biomaterials for tissue engineering and regenerative medicine. Both firms are located in Warwick, R.I.
Biomedical Structures has expertise in knitting, braiding, weaving and nonwoven technology. The company uses implantable-grade absorbable and non-absorbable biomaterials in orthopedic, general surgery tissue engineering, cardiovascular, bariatric, cosmetic surgery, and veterinary applications, including implantable devices and drug-delivery technologies.
With the addition of Concordia Medical’s textile expertise and volume manufacturing capabilities, Biomedical Structures is targeting “rapid growth” in the fields of orthopedics andregenerative medicine.
According to a 2009 report, the total market potential for tissue engineering and regenerative medicine products is projected to exceed $118 billion by 2013.
Biomedical Structures received an investment from Ampersand Ventures in 2010 with plans to pursue a growth strategy that included equipment and facility investment, expanded engineering capabilities, and product R&D to broaden its reach into core markets. At present, the combined company has 50 employees.
“Since our capital investment in mid 2010, we have committed to increasing our capacity for highly precise and customized manufacturing,” said Biomedical Structures CEO and President John Gray.“With the acquisition of Concordia Medical, not only are we improving our biomedical textile engineering expertise and medical device market penetration, but we are increasing our manufacturing capacity to deliver on complex, sophisticated device applications at the volume our customers require.”
Concordia Manufacturing will retain an ownership stake in Biomedical Structures, and Randal Spencer, the CEO and president of Concordia, will serve on Biomedical’s board and continue to assist the business development of the combined operation.
Terms of the deal were not disclosed.
Medicine Lake Extrusions Bought by Optinova
Onneksi olkoon! Or congratulations, as most of English-speakers might say.
The management at Medicine LakeExtrusions might want to brush up on their Finnish or Swedish. The Plymouth, Minn.-based supplier of medical-grade thermoplastic extrusions was acquired by Optinova AB, an extruder that specializes influoropolymer medical tubing.
Medicine Lake Extrusions, which was founded in 2004, now will be known as Optinova MLE. The added U.S. capacity will add to Optinova’s facility in Godby, Finland, which is 63,000 square feet (30,000 of which is class 100,000 clean-room space), includes 27 extrusion lines, 140 employees, an in-house automation department, as well as tooling design and manufacturing.
According to officials of the newly expanded enterprise, the company will offer research and development services; rapid prototyping runs; small-, medium- and high-volume production extrusions; and will position itself as a single-sourcesolutions provider.
Biotech in Brief
A private cell-based therapeutics company and a biomaterials business have merged to create a firm that will focus on cell-based therapy for regenerative medicine. The fusion of Cambridge, Mass.-based Pathfinder LLC and SyntheMed Inc. of Iselin, N.J., has resulted in the birth of Pathfinder Cell Therapy Inc., a company headquartered in Cambridge and led by new CEO and President Richard Franklin and Board Chairman Joerg Gruber. The original Pathfinder discovered a type of mammalian cell found in the kidney, liver, pancreas, lymph nodes, myometrium, bone marrow and blood that one day could help treat diabetes, renal disease and myocardial infarction. SyntheMed developed surgical implant materials and anti-adhesion products…Pathfinder’s neighbor, InVivo Therapeutics Corp., recently signed a lease to open its first manufacturing and development facility across the Mystic River in Medford, Mass. The company, which develops technologies for the treatment of spinal cord injuries, plans to use the manufacturing plant to produce a polymer scaffold device that treats open wound spinal cord injuries. The company is waiting for clearance from the U.S. Food and Drug Administration (FDA) to begin human clinical trials on the scaffold…Across town, Semprus BioSciences Corp. is preparing to seek FDA approval for a process that would make implantable devices more resistant to bacterial infections over long periods of time. Three months ago, the company received an infusion of $18 million from SR One, the corporate venture capital fund of GlaxoSmithKline PLC and Foundation Medical Partners of Norwalk, Conn. Semprus executives claim the technology the firm developed can add a specially bonded layer to medical devices such as catheters to prevent clotting and fend off bacteria and fungus. “It’s not a coating, but a physical extension of the device itself, which means it lasts much longer than any coating could,” CEO David Lucchino told The Boston Globe…Its biotechnology business sector may not be as robust as that of the Bay State, but northeast Ohio is quickly becoming quite the hub for neurotechnology firms. BioEnterprise Corp., a nonprofit group that helps northeastern Ohio companies grow their business, attributed the region’s strength in neurotechnology to collaboration between local research and clinical organizations. Some of the key neurotechnology players in the area include NDI Medical LLC and its spinoffs, Checkpoint Surgical and SPR Therapeutics LLC; Neuros Medical Inc.; Neurowave Systems Inc.; and Synapse Biomedical Inc…North Carolina, meanwhile, is hoping to create a biotechnology cluster of its own. The Tar Heel State has signed an agreement with Chinese officials to create a biosciences gateway in Research Triangle Park for pharmaceutical, biotechnology and other businesses that want to expand in either country. The agreement calls for a 150,000-square-foot research facility that is expected to open in 2013 on the Research Triangle Park campus of Hamner Institutes for Health Sciences. The nonprofit Hamner will work with Chinese investment firm XY Group to identify opportunities for companies, universities and other organizations…Over in Wisconsin, bioscience firms are prepared to increase employees’ salaries this year, according to survey results released by QTI Consulting and BioForward, the Badger State’s bioscience group. Bioscience firms that participated in the survey indicated they would increase employees’ salaries an average 4.3 percent in 2011, with the highest raises going to executives (4.6 percent) followed by technical exempt workers (3.4 percent) and managers (3.3 percent). The projected 4.3 salary hike is a significant jump compared with last year’s increase of 2.7 percent. The survey collected data on 21 jobs in Wisconsin’s bioscience industry and was completed by local firms last summer.
ISO CERTIFICATIONS
• Blue Ocean Biomedical, a Pembroke Pines, Fla.-based developer and manufacturer of automated load and go cell analysis systems for immune monitoring and related applications, has achieved ISO 13485:2003 certification. President Ernie Thomas called the achievement a “significant milestone” in the company’s overall strategy.
• Delcath Systems Inc., a New York, N.Y.-based specialty pharmaceutical and medical device company focused on oncology, has received ISO 13485:2003 certification. President and CEO Eamonn P. Hobbs said the certification will help the company win CE Mark approval for its Hepatic ChemoSAT Delivery System, a product designed to administer high dose chemotherapy and other drugs to diseased organs or regions of the body while controlling the exposure of the medicine.
• Ellsworth Adhesives, a global distributor of specialty chemicals and equipment, has achieved ISO 9001:2008 certification for its Germantown, Wis., and Tustin, Calif., facilities. “Obtaining this certification shows our commitment to quality and continual improvement,” said Brett Carlin, the company’s quality manager.
• ISO 13485:2003 and ISO 9001:2008 certification has been granted to
IncellDx Inc., a Menlo Park, Calif.-based molecular diagnostics company. President and CEO Bruce Patterson, M.D., said the achievement demonstrates the firm’s commitment to its customers.
• Kerecis Limited, an Icelandic tissue regeneration firm, has achieved ISO 13485:2003 certification for the design, development and production of wound and hernia treatment products. G. Fertram Sigurjonsson, the company’s co-founder and board chairman, said the certification validates Kerecis’ commitment to quality and strengthens its ability to enter worldwide markets.
• ISO 13485:2003 certification has been granted to the Georgetown, Mass.-based manufacturing facility of UFP Technologies Inc., a provider of specialty packaging, device components and turn-key product solutions for various medical industry sectors. The certification is the second for UFP—its facility in Rancho Dominguez, Calif., is ISO 13485:2003 certified as well. Rich LeSavoy, UFP’s vice president of manufacturing, said the certification will strengthen his company’s ability to become a valuable partner for medical customers.
• Volex Group plc, a global designer and manufacturer of interconnect solutions and power cords for the healthcare, industrial, consumer and telecommunications customers, has received ISO 13485:2003 certification for three manufacturing facilities in China, India and Poland. John Conroy, vice president of the company’s healthcare sector, said the achievement has encouraged the firm to be increasingly sensitive to risk assessments and ensures that workers dedicate themselves to the “best possible quality, from new product integration through the product life cycle.”