A Medical Device Daily

Alpine Biomed (Fountain Valley, California), a developer of specialty diagnostic devices, said that it has doubled its manufacturing capacity and expanded its worldwide network by opening a new facility in Vietnam.

The company said it will produce and distribute medical devices that are in increasing demand for diagnosing gastroesophageal reflux disease (GERD) from its new manufacturing facility located in Ho Chi Minh City. The manufacturing center will export diagnostic devices to customers throughout the world and have about 100 employees.

The new facility is Alpine Biomed's latest investment to expand its products and capabilities. In January, the company acquired Stellate Systems to increase its neurodiagnostics business and boost its presence in the rapidly growing sleep diagnostics market.

The company said that since partnering in 2007 with Water Street Healthcare Partners, a private equity firm focused exclusively on the healthcare industry, it has achieved record sales and revenue growth. It is anticipating sales growth of as much as 25% in 2009.

"Our new facility in Vietnam is another key component of our strategic plan to become one of the world's leading specialty diagnostic device companies," said President/CEO John Arnott. "It is a state-of-the-art facility featuring the most advanced technologies that connect our manufacturing centers around the world to provide our customers with the highest-quality devices that diagnose a range of gastrointestinal and neurological disorders."

The new facility has received Medical Device Quality Management System certification from the International Organization for Standardization. It also has been registered with the FDA.

Alpine Biomed is a global developer of specialty diagnostic devices for the gastroenterology and neurology clinical markets. The company produces diagnostic tools used for GERD, commonly referred to as acid reflux disease, as well as for neurological conditions such as sleep disorders.

Emergo Group has Mexican office

Medical device consulting firm Emergo Group (Austin, Texas) said it has opened an office in Mexico to meet increasing demand from clients to offer regulatory approval and in-country representation services for that market.

The company said Mexico is the second-largest medical device market in Latin America, behind Brazil.

CEO Rene van de Zande said, "Last fall we surveyed our 1,000 medical device clients and asked them which markets they wanted to enter in 2009. About 40% said they were interested in expanding into Mexico but needed our help to make that happen because the regulatory process can be challenging. We're responding to that need."

Emergo helps companies coordinate, submit and maintain Mexico medical device registrations with COFEPRIS, the agency within the Secretaria de Salud (Mexican Ministry of Health) that oversees medical devices in Mexico.

The company also provides Mexican Registration Holder representation, which allows a manufacturer to maintain control over their medical device registration(s) with COFEPRIS instead of having a local distributor fulfill that role. It said that as a result, the manufacturer can add or change distributors in Mexico at any time.

In addition to registration consulting, Emergo Mexico helps medical device companies find, evaluate, select and manage distributors in Mexico.

CAP accreditation for ICON labs

ICON (Dublin, Ireland), a provider of outsourced development services to the medical device, pharmaceutical and biotechnology industries, reported that its central laboratories in Singapore and Bangalore, India, have received accreditation from the College of American Pathologists (CAP).

ICON's Bangalore facility passing the rigorous accreditation process within only four months of opening. ICON now has a global network of CAP accredited laboratories in Farmingdale, New York; Dublin; Singapore and Bangalore, which it said helps ensure the highest standards of excellence in laboratory services.

"CAP is the gold standard by which all laboratories are measured and this is a great achievement," said Bob Scott-Edwards, president of ICON Central Laboratories. "The speed at which we received CAP accreditation, in particular for our Bangalore facility, is testament to our stringent quality standards, our state-of-the-art laboratory facilities and the expertise of our global team."

The CAP Laboratory Accreditation Program is an internationally recognized program that helps laboratories achieve the highest standards of excellence to positively impact patient care. The goal of the program is to improve patient safety by advancing the quality of pathology and laboratory services through education, standard setting and ensuring laboratories meet or exceed regulatory requirements.

In addition to its core facilities, ICON Central Laboratories works through affiliate laboratories in China and Japan.

Portugal distributor for Misonix

Misonix (Farmingdale, New York), a developer of minimally invasive ultrasonic medical device technology, which in Europe is used for the ablation of tumors and worldwide for other acute health conditions, has entered into a new, three year, exclusive distribution agreement with Ekrior, a division of Avanco Sistemas Medicos (Barcarena, Portugal), for the distribution of the SonaStar Ultrasonic Surgical Aspirator, the BoneScalpel Ultrasonic Bone Cutter, and the SonicOne Ultrasonic Wound Debrider.

Misonix said Ekrior is growing rapidly in the Portuguese market, largely by building a reputation as a distributor of high-tech medical devices and capital equipment, with special emphasis on radiation oncology and specialized surgery.

The SonaStar is used by neuro and general surgeons for quick and efficient removal of both hard and soft tumors while sparing most vessels. OsteoSculpt bone-sculpting technology can be employed with the SonaStar to safely remove osseous structures, thus providing access to the surgical site.

The BoneScalpel is a tissue specific osteotomy device capable of making precise cuts through bone and hard tissue while largely preserving delicate soft-tissue structures.

The SonicOne is an ultrasonic wound care system that offers tissue-specific debridement and cleansing for effective removal of devitalized tissue and fibrin deposits while sparing viable cellular structures.

No Comments