An executive at Irvine heart valve maker Edwards Lifesciences Corp. is taking on Japan’s treatment of foreign medical device makers through a U.S. association.
The American Medical Devices and Diagnostics Manufacturers’ Association, which was started this month, is made up of 62 device makers with Japanese operations. Huimin Wang, Edwards’ corporate vice president of Japan and intercontinental, is the group’s chairman.
In a statement, Wang said the group’s goals include establishing an “environment where the value of advanced medical technology is fully appreciated.”
The group said its advocacy activities would include providing regulatory issue policy recommendations, dealing with national health insurance reimbursement pay-ments and reforming the healthcare system in Japan.
Members of the U.S. association provide 13,000 jobs in Japan and generate $8.5 billion in revenue, which the association says represents 40% of the Japanese medical device market.
Other OC-based member companies include eye device maker Abbott Medical Optics Inc. of Santa Ana, Fullerton-based medical testing instrument and supply maker Beckman Coulter Inc. and Masimo Corp., an Irvine maker of patient monitoring equipment.
Both Wang and his boss, Chief Executive Michael Mussallem, have expressed frustration with the Japanese medical device regulatory process. In a 2006 Forbes article, Wang referred to Japan’s approval regulations as farcical.
Wang vented to the magazine after Edwards changed the color of a logo on one of its catheters and Japanese regulators insisted on reviewing the new pigment. The delay forced the company to gather old catheters from around the world to keep its Japanese customers supplied until the new logo color was approved.
“There’s a very big risk (aversion) generally among the bureaucrats or the examiners,” Wang said. “In some cases, it’s almost ridiculous. Products are used in humans for three years already, and then we’re sometimes required to do animal tests.”
Mussallem, for his part, once called Japan’s medical device approval system “the slowest and most costly in the developed world.”
Mussallem told lawmakers in 2006 that lengthy approvals equal higher costs for device makers and that they are forced to maintain out-of-date products in order to continue doing business in the country.
SenoRx Device Cleared
SenoRx Inc., an Aliso Viejo maker of breast cancer treatment devices, has received European regulatory clearance for its Contura catheter.
Contura delivers radiation to the tissue surrounding a lumpectomy hole following breast cancer surgery that removes just a small part of the breast. Lloyd Malchow, SenoRx’s chief executive, said that the company is going to launch Contura in several countries outside the U.S. this year. Having European clearance, he said, “further strengthens our long-term international growth opportunities.”
SenoRx already sells EnCor, its breast biopsy device, and GelMark, a line of tissue markers, in Europe.
Separately, SenoRx said that two peer-reviewed journal articles supported its belief that cancer patients treated with Contura receive a more targeted dose of radiation, while minimizing radiation exposure to healthy tissue such as skin and ribs. One article was published in Brachytherapy, while the other has been accepted for publication in the American Surgeon.
HMO Price Hikes
Managed care companies, including UnitedHealth Group Inc., which has a major operation in Cypress, are planning price hikes for their Medicare Advantage HMO customers, according to a recent article on the Motley Fool investor Web site.
In a piece called “Thanks for Nothing, CMS,” author Brian Orelli said that the Centers for Medicare and Medicaid Services’ recent 0.8% payment increase will lead UnitedHealth and its competitors to raise prices in order to keep their profits at similar levels.
The increase is partially due to an expected 21% slide in Medicare payments to doctors, Orelli wrote. But he said there is hope for managed care companies, saying that if Congress hikes payments, the centers would increase insurance company payments.
Bits and Pieces:
Alpine Biomed Corp., a Fountain Valley maker of gastroenterology and neurology diagnostic devices, said it has opened a plant in Ho Chi Minh City, Vietnam. The facility will produce and distribute acid reflux disease devices TriZetto Group Inc., a Newport Beach healthcare information technology company, said it added CareMore, a Cerritos-based managed care company, as a customer. Financial terms weren’t disclosed. CareMore, which is run by former PacifiCare executive Alan Hoops, provides Medicare Advantage HMOs for 32,000 seniors, mostly in California College Hospital Costa Mesa, a 122-bed psychiatric hospital, said it reached a settlement with the Los Angeles city attorney’s office that arose from a patient discharge case in 2008. As part of the settlement, College Hospital will donate $1.2 million to groups that assist homeless people and those with mental health needs.
