A Medical Device Daily

Health and Human Services Secretary Mike Leavitt said last week that the first FDA staff will be sent to China, India, Europe and Latin America before the end of 2008, according to an Associated Press report.

Saying "we're making steady progress to better safeguard our supply of food and medicines, though much work remains," Leavitt added, "In the past year, we've upgraded labs and equipment, hired additional staff, and begun implementing product safety agreements with key trading partners, including China."

He noted, "Increasing our presence overseas will provide greater protections to American consumers at home and benefit our host countries as well. Opening these offices will mark a key milestone in the globalization of our efforts to enhance the safety of imported food and medical products."

FDA Commissioner Andrew von Eschenbach said, "The globalization of the food supply and medical product manufacturing has demanded that we do things differently. Through our Beyond our Borders initiative, we won't have to send our experts to another country to work with foreign governments and regulated industry to improve our oversight — we'll have staff living there and working on the ground 365 days a year."

The AP report noted that first overseas office would be in China, with the U.S. government recently securing formal approval for such an office from the Chinese government.

The first FDA staff will be in place in Beijing this year, with additional staff to be posted to that office in 2009. Staff is also scheduled to be posted in Shanghai and Guangzhou next year. The department said it anticipates having a total of eight U.S. nationals at FDA offices in China.

Leavitt is scheduled to travel to China in November to meet with Chinese health officials to review their mutual efforts to ensure the safety of food and medical products consumed by the two nations, particularly imported goods.

FDA plans to establish its second overseas office in India, with staff first posting to New Delhi yet this year and at least one additional office to follow in 2009. Plans at present are for 10 U.S. nationals to be posted in India.

The U.S. government is in the process of pursuing India's formal approval for offices in that country.

In both nations, FDA staff is expected to work closely with local authorities as well as industries that ship food and medical products to the U.S. to improve safety efforts. Their activities will include providing technical advice, conducting additional inspections, and working with government agencies and private-sector entities interested in developing certification programs.

FDA also will be opening offices in Europe and Latin America before the end of 2008, with a fifth office in the Middle East to follow soon in early to mid-2009.

In a related effort, HHS officials are working to conclude memoranda of understanding with Belize, Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Nicaragua and Panama to work together on product safety.

Those collaborations could include information-sharing on regulatory systems and joint workshops and training on the safety of food and medical products.

China distribution deal for Pioneer Surgical

Pioneer Surgical Technology (Marquette, Michigan) and Bonovo Orthopedics (Beijing), a Chinese manufacturer and distributor of orthopedic products, have signed a comprehensive agreement that Pioneer said, "effectively opens the Chinese market for the distribution and sale of [our] full portfolio of spine products."

Bonovo will serve as Pioneer Surgical Technology's exclusive distributor of products for the Chinese spine market.

"The signing of this agreement with Bonovo Orthopedics is a milestone for our international expansion goals," said Pioneer Chairman/CEO Matthew Songer, MD. "Partnering with Bonovo secures the infrastructure and expertise necessary to be successful in the Chinese market"

Peter Slate, CEO of the Chinese firm, said, "We are thrilled to be working with a technology leader like Pioneer. Our shared desire to provide innovative, quality products to the Chinese market will provide many opportunities for future collaboration between Bonovo and Pioneer."

Lex Giltaij, MD, VP of Pioneer's European subsidiary, said the partnership "presents huge opportunities for both of our companies. With our shared vision, we will have the opportunity to train surgeons from China, the U.S. and Western Europe, to exchange knowledge and build a prosperous future together."

Details of the agreement were not disclosed.

Bonovo said it anticipates a November introduction of Pioneer's spine products at the Chinese Orthopaedic Association meeting in Suzhou.

Pioneer Surgical has a full line of motion-preservation devices, including its signature articulating P3 Technology(Pioneer PEEK-on-PEEK) in its NuBac disc arthroplasty system, BacJac interspinous decompression system and NuNec artificial cervical disc.

Wooridul to open new spine centers

Wooridul SpineMark International (WSI; San Diego), a joint venture between SpineMark of San Diego and Wooridul Healthcare of Korea, has identified sites for five planned WSI spine centers, which will be opened on four continents. Once opened, the centers will advance the treatment of patients who have suffered back injuries through global spine care best practices, clinical research and medical education.

SpineMark, a spine care services organization that partners with hospitals and physicians to develop spine centers and facilitate clinical research, and Wooridul Healthcare, a clinical operator providing total care in spine, established the international alliance in June to leverage and build upon the focus and expertise of each organization in the spine industry.

Under the WSI alliance, SpineMark and Wooridul plan to open minimally invasive spine Centers of Excellence and fellowship training programs, and set up collaborative clinical and spine research centers in the following locations: Sao Paulo, Brazil; Tijuana, Mexico; Singapore City, Singapore; Barcelona, Spain; and Ankara, Turkey.