Industry News
Emergo Group Opens Three New Offices in North America, Europe
There are very few companies in the medical device industry—any industry, for that matter—that have not been affected by the recession. In most cases, these companies have felt the effects of the recession in the place it hurts the most: the corporate pocketbook. A few firms have even been forced to close.
Some companies though, are still growing despite the financial fiasco of the last nine months. Emergo Group Inc. is one of a handful of companies that has defied the odds.
Based in Austin, Texas, Emergo Group has averaged 30 percent annual growth since 2000 and is generating annual revenue of $7.5 million to $8 million. The medical device consulting firm claims more than 1,000 clients in 40 countries and operates offices in the United States, Europe, Japan, China, Canada, Mexico and Australia.
The medical device consulting industry has become a lucrative one as more OEMs and large device firms outsource the compliance process to hasten approvals. Demand for international consulting services is expected to remain strong in the foreseeable future, as foreign governments continue to demand oversight of device manufacturers that conduct business outside the United States, experts said.
In the last two months, Emergo opened three new offices to better serve its clients. The offices are located in Paris, France; Minneapolis, Minn.; and Mexico City, Mexico. “Last fall, we surveyed our 1,000 medical device clients and asked them which markets they wanted to enter in 2009,” Rene van de Zande, Emergo Group CEO, said. “About 40 percent said they were interested in expanding into Mexico but needed our help to make that happen because the regulatory process can be challenging. We responded to that need.”
Apparently, Mexico isn’t the only geographic location in need of the company’s services. According to a newsletter posted on Emergo’s Web site, the Paris office will enhance the company’s ability to “offer quality assurance and regulatory services such as ISO/GMP quality system implementation, audits, EU Technical File/U.S. Food and Drug Administration 510(k) preparation and more to European clients.” Franck Martin, a former lead auditor for Notified Body LNE/G-MED, has been appointed director of the Paris office.
Emergo’s office in Mexico City helps clients coordinate, submit and maintain medical device registrations with COFE-PRIS, the agency within the Secretaria de Salud (the Mexican Ministry of Health) that oversees devices in Mexico. Van de Zande said Mexico is the second-largest medical device market in Latin America, following Brazil.
Besides working with COFEPRIS, Emergo’s office south of the border provides customers with Mexican Registration Holder representation, a service that allows manufacturers to maintain control over their medical device registration. This service also lets manufacturers add or change distributors in Mexico at any time.
The proliferation of clients in the Midwest prompted Emergo to open a sales office in Minneapolis.
Emergo executives expect the company’s growth to continue next year with expansions into Asia and South America.
Cirtronics Corporation Marks Anniversary, Adds Floor Space
Gerardine Ferlins has always believed in the power of the human spirit.
When she founded Cirtronics Corporation in 1979, Ferlins had a degree in sociology and a determination to build a company based on a value system.
She wasted no time in implementing a value system that let workers contribute to the company based on their individual strengths rather than traditional job roles. In addition, Ferlins crafted a company philosophy known as DUO—Do Unto Others. “Treat people in the manner you want them to treat you,” the credo states on the company’s Web site. Thirty years after its founding, the DUO philosophy, as well as the value system, are thriving at Cirtronics, a full-service contract electronic manufacturer based in Milford, N.H. As a reward to her 174 employees for their dedication and commitment to Cirtronics’ customers, Ferlins has transitioned 30 percent of the corporation into an employee stock ownership program.
To mark its 30th birthday, Cirtronics added 75,000 square feet of space to its production floor at the Milford Technology Center office park to accommodate future growth and existing customers requiring high-level printed circuit board assembly, box-builds and testing. Cirtronics relocated its manufacturing operations and administrative offices to the 189,000-square-foot technology center in January 2001.
“We’re excited to expand and streamline our production floor areas such as SMT [surface mount technology] and test as well as our box-build area,” Ferlins said in a news release about the expansion. “Cirtronics is prepared for growth as the economy starts turning around. Our success really has come from our involvement in the community and our reputation.”
Cirtronics’ expansion featured the separation of its production floor into two distinct areas for leaded and RoHS (Restriction of Hazardous Substances directive). The company implemented additional Lean manufacturing measures, and expanded its box-build area to accommodate current and future growth in that sector.
Merit Medical Completes Purchase of Stent Manufacturer
Merit Medical Systems Inc. has closed two deals that will enable the firm to enter the gastroenterology and pulmonary markets.
In February, the company announced an agreement to acquire the assets of Alveolus, a Charlotte, N.C.-based manufacturer of stents, the tiny mesh or plastic tubes surgeons use to prop open blood vessels that have been cleared of plaque. Alveolus produces stents for esophageal, tracheobronchial, and biliary stenting procedures. Merit executives estimate the market for these types of products to be worth more than $200 million.
“For several years, we have discussed the prospects of entering the gastroenterology and pulmonary markets,” Fred P. Lampropoulos, Merit’s chairman and CEO, said in a news release touting the $19 million Alveolus deal. “We believe this acquisition will enhance our future corporate growth with products that are well accepted in the United States.”
Merit executives promised to maintain relationships with Alveolus’ outsourcing partners after the deal closed. Lampropoulos said it was important to maintain “operational consistency” during the transition of ownership.
In addition to the Alveolus acquisition, Merit negotiated a $1.6 million deal to acquire two products from Biosearch Medical Products Inc., a Somerville, N.J.-based subsidiary of Hydromer Inc. The company develops, manufactures and commercializes specialized polymer and hydrogel products for medical devices and other items. Company executives did not specify the products that were purchased but said they “go hand-in-hand with the strategy of building a strong product offering in the gastroenterology market.”
With both acquisitions complete, Merit must now create a new business unit for the products. The South Jordan, Utah-based company expects to hire an additional 30 to 40 people over the next 12 to 18 months. Merit’s management has said that revenues from the Alveolus and Biosearch deals would contribute about $11.8 million to the company’s coffers for the current fiscal year that ends Dec. 31.
Prent Breaks Ground on European Thermoform Packaging Facility
Medical thermoform packaging provider Prent Corporation has broken ground on a new facility in Holbaek, Denmark, to meet worldwide customer demand.
The thermoform packaging facility in Holbaek, a commercial seaport, would be Prent’s sixth.
Its other facilities are located in China, Malaysia, Puerto Rico, Arizona and Wisconsin.
Joseph Pregont, Prent president and CEO, said the new packaging plant is being built to meet customer requests for “global suppliers.”
“Several of our current customers have expressed great interest in Prent completing the global supply chain. Our Denmark facility will give us direct manufacturing in Europe to meet the needs of global customers,” Pregont said in a news release about the expansion.
Company executives expect the new plant to be completed by year’s end. It will contain the same thermoforming equipment and software systems that are in Prent’s other facilities, according to the Janesville, Wis.-based firm.
Pregont called the Denmark venture a “comprehensive design-through-production thermoforming facility” that will include capabilities for product development, design, tool engineering and tool building. It also will have Class 100,000 clean rooms that contain thermoforming equipment designed, built and produced at the company’s American headquarters.
“The development of Prent-Denmark—like our other global expansion initiatives—has been through organic growth, not acquisition growth,” Pregont noted. “This growth has been generated entirely within our own organization.”
Product development will initially be completed at Prent’s Wisconsin facility.
Peter Bay, a Danish engineer and plastics specialist, has been hired as managing director of Prent’s new facility.
Bay has worked for the past 15 years in the plastics industry, assuming positions with the Plastic Federation of Denmark and WUPPI, a nonprofit plastic recycling consortium of Danish plastic manufacturers.
Biotech in Brief
The U.S. Department of Defense has awarded $1.7 million grant to CryoLife Inc. to further develop its protein hydrogel technology. The Kennesaw, Ga.-based manufacturer of medical tissues, heart valves and oncology drugs is almost finished with preclinical studies of its BioFoam Surgical Matrix, a product that can help seal organs…Beckman Coulter Inc., based in Fullerton, Calif., has agreed to acquire the Cogenics division of Clinical Data Inc., headquartered in Newton, Mass., for $17 million. The deal complements Beckman Coulter’s Agencourt Biosciences business,which provides customers with genomic services and nucleic acid purification products…Hawaii Gov. Linda Lingle is setting aside $2.5 million to design a Pacific Regional Biosafety Laboratory at the University of Hawaii at Manoa. The 25,000- square-foot structure—which will contain 8,000 square feet of laboratory space—is expected to be completed in June 2012…WaBio.com has been renamed WashingtonLifeScience.com to “better reflect the broad diversity of the biotechnology, medical device, nanotechnology, pharmaceutical and related industry in the State of Washington,” according to the organization’s Web site…A district court in Düsseldorf, Germany, has ruled that Irvine, Calif.-based Edwards Lifesciences Corporation did not infringe upon a transcatheter valve patent held by Cook Inc., located in Bloomington, Ind. A counter-suit by Edwards claiming invalidity of Cook’s German patent is expected to be heard in Munich next year…Translational Accelerator LLC, a venture fund formed to invest in Arizona biotech companies, has invested $1.5 million in SalutarisMD, a Tucson, Ariz.-based firm that has developed a product designed to address a “worldwide issue in ophthalmology,” according to the company’s CEO…Arizona’s non-hospital bioscience sector accounted for $3.6 billion in revenue and more than 13,500 jobs in 2007, according to data presented recently at Biozona 2009, an annual conference of the Arizona BioIndustry Association.
Editor’s note: For a roundup of news from BIO 2009, the Biotechnology Industry Organization’s annual conference last month in Atlanta, Ga., please visit MPO’s Web site, www.mpo-mag.com.
ISO CERTIFICATIONS:
• Avo Photonics Inc., a designer and contract manufacturer of opto-electronic components and assemblies, has achieved ISO 9001:2008 certification. The certification was issued for Avo’s corporate headquarters in Horsham, Pa., as well as for its design verification center in Toronto, Canada.
• ISO 13485:2003 and ISO 9001:2000 certification has been granted to Enzymatics, a Beverly, Mass.-based contract manufacturer of recombinant enzymes used in instruments that map and analyze DNA. The three-year-old company achieved both certifications on its first attempt.
• Neuro Kinetics Inc., a manufacturer of medical equipment used to test balance and screen for vestibular, neurological and other disorders, has been awarded ISO 13485:2003 certification for its products that record and measure the movements of eyeballs. The federal government has used the company’s products in recent months to test soldiers returning from combat for traumatic brain injuries, said Neuro Kinetics CEO Howison Schroeder. The certification, he added, will enable the Pittsburgh, Pa.-based firm to build its customer base and help more patients.
• The quality management system at Reglera LLC, including the firm’s consulting services and its outsourced solutions, has been granted ISO 13485:2003 and ISO 9001:2000 certification.
• Tegra Medical, a manufacturer of wire and tubular products for the medical device and life sciences industries, has been awarded ISO 13485:2003 and ISO 9001:2000 certification for the quality management system at its Franklin, Mass., facility. The company was certified to both standards at its Holliston, Mass., facility, but was forced to become recertified after it consolidated operations in Holliston and Cranston, R.I., to the Franklin plant.