Japan’s aging population and tremendous national wealth should make the country a natural for medical device makers. Instead, selling there can be an exercise in frustration.
That was the theme of a recent Forbes story that found “Japan’s medical mandarins discourage innovation in what ought to be a rich race to bolster aging bodies.”
The article featured quotes from several device officials, including Huimin Wang, a Tokyo-based corporate vice president for Edwards Lifesciences Corp., the Irvine-based heart valve maker.
Wang talked about Japan’s medical device approval regulations, calling them farcical.
The subject of Wang’s irritation: After Edwards changed the color of a logo on a catheter, Japanese regulators insisted on reviewing the new pigment.
The delay forced Edwards 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 told Forbes. “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.”
Earlier this year, Edwards Chief Executive Michael Mussallem criticized Japan’s medical technology approval system at a congressional hearing, saying it “is the slowest and most costly in the developed world.”
Lengthy approvals equal higher costs for device makers, Mussallem said. Companies are forced to maintain out-of-date products in order to continue doing business in Japan, he said.
The Forbes story also included comments from Minneapolis-based Medtronic Inc., which has a heart valve plant in Santa Ana.
UCI Research News
Barbara Anne Dosher, dean of the University of California, Irvine’s School of Social Sciences, received a five-year, $1.6 million grant to look at how people process visual information and how training can improve performance when a task depends on visual analysis.
Dosher and a University of Southern California colleague are going to study people with normal vision. The goal is to better understand how the brain processes visuals and how that processing can be changed with experience or training.
The National Eye Institute is providing the grant. The findings could help people who suffer from conditions such as dyslexia and lazy eye, the researchers said.
Separately, UC Irvine researchers recently found that mutations of brain cell protein are linked to deafness and dystonia, a neural disease that causes twisting or jerking movements.
Vincent Procaccio, director of the university’s Center for Molecular and Mitochondrial Medicine, and his colleagues looked at brain tissue from deceased twins who suffered from developmental disabilities, including dystonia. Putting the samples through genetic analysis revealed mutations in the beta-actin gene that affected how proteins conformed in the brain.
The findings could make early diagnosis possible on such diseases, which could allow for early treatment opportunities, Procaccio said.
Results appeared in the June issue of the American Journal of Human Genetics.
Investor Forms Lab Company
Investor Parthenon Capital, which has offices in San Francisco and Boston, has set up a Santa Ana-based holding company, BioLabs, for two recently acquired medical laboratory businesses.
Parthenon bought Santa Ana-based Westcliff Medical Laboratories Inc. and Burbank’s Health Line Clinical Laboratories for undisclosed terms.
Westcliff provides clinical and anatomical laboratory services to doctors’ offices, clinics, subacute treatment centers, government agencies and homebound patients. Health Line originally started to serve doctors in the San Fernando Valley and expanded to other parts of Los Angeles and California and parts of Arizona.
Parthenon plans to keep Westcliff’s management, said Doug Harrington, BioLabs’ chief executive. Richard Nicholson, Westcliff’s chief executive, becomes president of BioLabs.
Combining Westcliff and Health Line “will enable the new company to provide outstanding service to its customers and also pursue selected acquisitions,” said Casey Lynch, a San Francisco-based principal of Parthenon.
Healthcare is one of Parthenon’s target investment areas. The firm provides funding and management to middle-market companies.
Bits and Pieces:
Beckman Coulter Inc. of Fullerton and Applera Corp. of Norwalk, Conn., said earlier this month they’ve finalized their settlement of lawsuits. Applera is set to pay Beckman $35 million to release claims of patent infringement. Beckman is going to pay Applera’s Celera Genomics Group $20 million for rights to some of Celera’s technology Jeff Flocken, a former chief operating officer with St. Joseph Health System, Orange, was named vice president of operations of Tenet California, a unit of Dallas-based Tenet Healthcare Corp. Flocken, who was most recently interim president and chief executive of Community Hospital of San Bernardino, will be based at Tenet California’s regional office in Santa Ana UCI Medical Center, Orange, is one of several backers of a Laguna Hills center for senior citizens who continue to drive.
