AdvaMed, a Washington, D.C.-based medical device trade group that includes several Orange County executives, is hailing commitments won by the Obama administration to open Japan’s medical technology market.
A report commissioned by the U.S. and Japanese governments calls for Japan to increase the number of medical device reviewers in the next five years, boost training for reviewers and track their performance.
The goal of the measures is to speed up the review and approval of medical products in Japan.
Device industry leaders long have complained about Japan’s slow regulatory process, saying the Food and Drug Administration seems nimble and open by comparison.
Historically, Japan has been slow to sign off on medical technologies because of past scandals and potential fears about ballooning healthcare spending.
That’s led some device makers to hang on to older products in Japan longer than they normally would, according to device executives.
Michael Mussallem, chief executive of Irvine heart valve maker Edwards Lifesciences Corp., is AdvaMed’s executive committee chairman.
He met with President Obama in May about healthcare reform and other issues.
Edwards has been one of the louder voices seeking change in Japan during the decade.
Back in 2006, Mussallem shared stories with the House of Representatives’ Ways and Means Committee regarding how Japan approves devices.
“Although Japan is one of the wealthiest countries in the world,the second-largest economy in the world,its spending on healthcare is among the lowest of major developed countries,” Mussallem said.
The Japanese government compounds the situation by imposing what he called “more burdensome and costlier regulations” and lengthy approvals.
AdvaMed’s executive committee also includes James Mazzo, president of Santa Ana eye device maker Abbott Medical Optics Inc., and Scott Garrett, chief executive of Beckman Coulter Inc., the Fullerton maker of medical testing instruments and supplies.
‘Bet on Botox’
A British money manager recently called for investors to “bet on Botox,” Irvine-based Allergan Inc.’s bellwether wrinkle remover.
Robert Maltbie, who runs Stockjock.com, an investor Web site, said Allergan is benefiting from the global recession, even though Botox sales were down in the first quarter.
More patients are opting for less-expensive cosmetic treatments rather than surgeries, according to Maltbie.
Allergan’s first-quarter Botox sales were $297.3 million, down 6% from a year earlier.
The company is set to report second-quarter results on July 31.
Maltbie wrote that the economic slowdown was bringing more men customers for Botox. He mentioned a Financial Times report earlier this year about recession-hit London bankers’ usage of “redundancy packages,” or severance, to rejuvenate their appearances as they hunt for jobs.
“Driven by media influence, competition in the workplace and the example set by women, cosmetic surgery has become increasingly popular with men this decade,” Maltbie said.
He quoted statistics from Britain’s Harley Medical Group showing that there was a more than 50% rise in the number of men aged 35 to 55 having Botox treatments since 2007.
Bits and Pieces:
Irvine device maker Masimo Corp. said that three clinical studies showed that its Masimo PVI monitoring system was accurate and useful as a non-invasive, continuous measure of patients’ fluids and responsiveness. The studies were presented at the European Society of Anaesthesiology’s annual congress in Milan, Italy Cardiogenesis Corp., an Irvine heart device maker, named Paul McCormick executive chairman. McCormick is a former chief executive of Endologix Inc., an Irvine maker of minimally invasive treatments for ballooning blood vessels. Richard Lanigan, Cardiogenesis’ former president, now is executive vice president of marketing Irvine-based ChromaDex Corp. said it signed a distribution deal with LGC Promochem India Pvt. Ltd. ChromaDex makes research tools for dietary supplements and the food and beverage industries Kathy Dawson is the new chief nursing officer and vice president of patient care services at Saddleback Memorial Medical Center, which has campuses in Laguna Hills and San Clemente. Dawson succeeds Karen Ladley.
