Efforts over the past decade by several of Orange County’s better-known medical device executives to change Japanese laws are bearing fruit.
“AdvaMed applauds the entry into force of Japan’s medical technology law, which regulates medical devices separately from drugs for the first time,” AdvaMed Chief Executive Stephen Ubl said in a statement.
Japan’s Pharmaceutical and Medical Device Law took effect Nov. 25. The regulation, passed a year ago, replaces its Pharmaceutical Affairs Law and is designed to continue what industry group AdvaMed calls “the tremendous progress” the country has made over the past six years in cutting review times and “allowing speedier patient access to innovative, life-saving and life-enhancing treatments and cures.”
Some of the changes the law brings about are the end of requirements that domestic Japanese device manufacturers obtain manufacturing licenses and foreign manufacturers obtain accreditations.
It also calls for more devices to qualify for third-party certification, something industry watchers say will lead to less-complex market pathways for some foreign device makers.
Japan’s device regulations were a longtime bête noire for several of Orange County’s device makers in the late 2000s.
Michael Mussallem, chief executive of Irvine heart valve maker Edwards Lifesciences Corp., was among the most prominent critics of Japan’s device regulatory process.
He shared stories in 2006 with the House of Representatives’ Ways and Means Committee regarding how Japan approved devices.
“Although Japan is one of the wealthiest countries in the world … its spending on healthcare is among the lowest of major developed countries,” Mussallem said.
He added that the Japanese government compounded the situation by imposing what he called “more burdensome and costlier regulations” and lengthy approvals.
Summit on Regenerative Medicine
Stem cell research and regenerative medicine will be examined on Wednesday at a summit presented by Aliso Viejo-based booster group Octane.
The Orange County Summit on Regenerative Medicine will be at Gross Hall at the University of California-Irvine.
Speakers include John Chi, cofounder and chief executive of Synova Life Sciences, a company that grew out of California State University-Fullerton research; Ryan Fernan, chief executive of Irvine-based PUR Biologics LLC; and Richard Sudek, UC Irvine’s executive director of innovation.
Octane said the summit combines keynote presentations with research, new startup company overviews, and “interactive discussions on translating academic research into practical application.”
Spine Device Cleared
Irvine-based device maker Interventional Spine Inc. said late last month that the Food and Drug Administration cleared its Lateral Opticage expandable intervertebral body fusion device.
Lateral Opticage is used with autogenous bone graft in patients with degenerative disc disease. Interventional Spine said in a news release that Lateral Opticage joins other devices previously cleared this year and is used with its PerX360 system.
“This new indication for the Opticage Expandable [devices] broadens the application of Interventional Spine’s technology to significantly more patients,” said Interventional Spine Chief Executive Walter Cuevas.
Bits & Pieces
A nonprofit organization called Save Saddleback San Clemente Hospital formed last month to fight the planned conversion of the hospital by its parent, Fountain Valley-based MemorialCare Health System. MemorialCare said in August that it was planning to convert the hospital into a medical office building, outpatient surgery, and urgent care center. … Laguna Hills-based Sonendo Inc. presented last week at the annual Piper Jaffray Healthcare Conference in New York. It is developing devices used in root canal procedures.
