NAMSA Opens Office in China

NAMSA Opens Office in China

Medical device research organization NAMSA has opened its newest office in Shanghai, China. The company is headquartered in Northwood, Ohio.

The new office is intended to provide NAMSA’s China-based clients with convenient access to its services, as well as increased efficiency. Company officials hope the Shanghai office will allow NAMSA to better support Chinese manufacturers in meeting European and U.S. regulatory requirements. Additionally, the company also is better positioned to assist device manufacturers outside China to meet the necessary standards for marketing products in China.

“Chinese manufacturers can trust in our proven ability to successfully support meeting European and U.S. regulatory requirements, while those manufacturers outside China aiming to distribute products within China can rely on our expertise and proximity for convenient assistance in meeting the country’s regulatory demands,” said An Liu, general manager of NAMSA China.

In his new role, Liu is responsible for establishing and developing NAMSA China business. He previously served as director of biostatistics and data management for NAMSA. Before joining the organization, Liu served as statistics manager for Medtronic Inc.

“NAMSA is pleased to be in a position to expand and better serve our partners with world-class expertise in regulatory, non-clinical and clinical research services,” said Terence Langenderfer, director of global marketing, NAMSA. “It has always been our intention to provide the best strategic guidance and tactical support in the most cost-effective and seamless manner. This expansion in China supports that mission.”

NAMSA is a global contract research organization that provides regulatory, clinical, and compliance services to medical device and healthcare product manufacturers.

Danaher to Acquire Iris International
Danaher Corporation has come to an agreement to acquire Iris International Inc. for $19.50 per share in cash, representing an approximate 45 percent premium over Iris’s closing price on Sept. 14. Since then, the common stock price has risen, and as of Sept. 18 hovered around a value of $19.50. The total purchase price will be $338 million, including debt assumed and net of cash acquired.

Chatsworth, Calif.-based Iris is a manufacturer of automated in-vitro diagnostics systems and consumables. Upon closing, the company will become part of Danaher’s Beckman Coulter Inc. diagnostics business.

Iris chalked up a total revenue of $118.3 million in 2011, and the company projects a 9 percent increase for 2012.

As of press time, an affiliate of Danaher was expected to commence a tender offer for all of Iris’s outstanding common stock, and the offer was expected to remain open for a minimum of 20 business days following its commencement.

The Iris board of directors unanimously has recommended that Iris shareholders accept and tender their shares into the offer which is subject to customary conditions. The merger is expected to be completed during the fourth quarter of 2012.

“Iris will benefit from being a part of a larger organization with significant resources to enable the acceleration of its diversified product pipeline strategy,” said César M. García, chairman, president and CEO of Iris.

Washington, D.C.-based Danaher is a science and technology company that designs, manufactures, and markets products for a variety of industries including medical devices. Beckman Coulter, which is owned by Danaher, develops, manufactures and markets products for biomedical testing. Its diagnostics headquarters is in Brea, Calif.

Two Organizations Join to Set Standards for Medical Device Interoperability
The Association of Medical Instrumentation (AAMI) and Underwriters Laboratories (UL) have joined forces to develop a suite of standards on medical device interoperability, which industry experts say is one of the biggest challenges facing the healthcare industry.

This is a first time collaboration between AAMI and UL, and comes at a time when many healthcare facilities and manufacturers are grappling with how to achieve interoperability. In its broadest terms, interoperability has the potential to improve patient care by enabling clinicians to work with integrated systems of diagnostic and therapeutic devices and sharing data with electronic health records, thus providing enhanced clinical decision support safely and effectively.

“Interoperability is a huge space still under development,” said AAMI President Mary Logan. “It will take multidisciplinary commitment and collaboration to achieve meaningful management of the space and the issue.”

That is why AAMI and UL have signed a memorandum of understanding to develop the suite of consensus-based standards, which will be drafted to help manufacturers design safer interoperable products and aid healthcare facilities in implementation.

“This suite of standards is not intended to replace or supplant existing interoperability implementation standards or profiles,” said Terenzio Facchinetti, D.Pharm., business development manager for UL’s life and health business unit. “This family of standards instead aims to map existing implementation practices into a risk management framework and to address further safety issues where applicable.”

AAMI, a standards development organization, and UL, a testing, certification, and standards development organization, are well suited for the task, said Carol Herman, AAMI senior vice president for standards policy and programs.

“What makes this particular collaboration between AAMI and UL unique is that we each have deep experience with medical devices, and yet the two organizations bring different expertise to the table, so that the sum truly will be greater than the parts,” Herman said.

UL writes standards on products such as video cameras and tests new medical devices for manufacturers. Organization officials have expressed that safety is paramount to success in the emerging interoperability market.

“The medical device interoperability sector is a new development with extraordinary expectations. Its success is linked to the quality and the safety of the products and their interoperability. This agreement will support the achievement of these targets,” Robert Williams II, vice president of standards, and Anil Patel, vice president of the life and health business unit at UL, said in a joint statement.

AAMI is headquartered in Arlington, Va., while UL is based in Northbrook, Ill.

Helix Medical Opens Costa Rica Plant
Helix Medical LLC has opened a new manufacturing facility in Coyol Free Zone and Business Park in Alajuela, Costa Rica, just outside San José. The location is situated 10 minutes from the international airport and one hour from the sea port.

Helix Medical supplies contract manufacturing services to medical device OEMs worldwide. The Costa Rica facility is the company’s ninth operation and the first in Latin America. Services offered at Helix Medical Costa Rica include design and development, engineering services, silicone extrusion, silicone and thermoplastic molding, assembly and sub-assembly, custom packaging, and full validation capabilities.

The firm’s grand opening event was hosted by Costa Rica Minister of Science and Technology Alejandro Cruz; Costa Rica Investment Promotion Agency’s Investment Director Irving Soto; Helix Medical President/CEO Jorg Schneewind, D.Eng.; and Martin Stark, D.Eng., managing partner of Freudenberg & Co.

“The pro-business environment, skilled workforce, and strategic location made Costa Rica a natural choice for our company,” said Schneewind.

“This confirms Costa Rica’s high standards of quality and its sophisticated workforce, which allow medical companies to perform complex manufacturing,” Cruz added in formal remarks.

“We are deeply satisfied with the investment of renowned medical companies such as Helix which contribute to the growth and consolidation of the life sciences sector,” said Soto. “This sector has grown from eight companies in 2000 to 41 companies in 2011; multinational ventures have created employment for 13,561 Costa Ricans. This number is six times higher than in 2000, when only 1,500 people worked in the sector.”

Helix Medical is a division of the Freudenberg Group, and is headquartered in Carpinteria, Calif. The company operates U.S. Food and Drug Administration-registered medical device facilities that also are certified ISO 13485 with Class 7 and 8 cleanrooms. Helix has locations in the United States, Europe and Asia.