Some local medical device executives are betting on passage of healthcare reform this year.
But what reform will look like is an “absolute uncertainty,” according to Michael Mussallem, chief executive of Irvine-based heart valve maker Edwards Lifesciences Corp.
Mussallem, James Mazzo, senior vice president of Abbott Laboratories and president of its Santa Ana-based Abbott Medical Optics unit, and Joe Kiani, chief executive of Irvine-based Masimo Corp., addressed the prospect of healthcare reform and other issues earlier this month at Chapman University in Orange.
“This is one of those rare times in history that you might actually be able to get something so complicated done,” Mussallem said.
Some sort of reform is expected because the Obama administration “is so much behind this and has staked everything” on accomplishing it, he said.
Mussallem, who also is chairman of AdvaMed, a Washington, D.C.-based trade group for medical device makers, spoke on his industry’s efforts to offer input on healthcare reform.
Medical device makers had to speak up after industry representatives weren’t invited to a planning meeting at the beginning of the year, he said.
Mussallem and others eventually won a meeting with Obama and his advisers in the spring.
“Because of this role I’ve taken on as chairman of (AdvaMed), I have a chance to be in the front seat of healthcare reform,” Mussallem said.
Device makers have argued that medical technology can cut healthcare costs and be “a key part of the solutions,” he said.
Audience: No Reform
The executives’ contention that healthcare reform will be enacted this year wasn’t shared by the audience of about 50 invited device executives, venture capitalists and others.
Fifty-seven percent of audience members polled said they didn’t expect healthcare reform this year.
Mazzo, whose Abbott Medical Optics makes eye surgical devices, lasers for vision correction and contact lens solutions, followed Mussallem’s reform talk with a few thoughts about research and development spending and return on investment within the industry.
In particular, Mazzo said that larger device makers could “learn a lot from smaller companies.”
Smaller companies follow a “fail fast and kill early” philosophy if a device isn’t going to work, instead of a “tendency to try and save it” at big companies.
“I’m a perfect example. I made numerous mistakes,” Mazzo said of his time as chief executive of Santa Ana-based Advanced Medical Optics Inc., which Abbott bought earlier this year for $2.8 billion. “We did not want to fail fast. We wanted to save everything.”
Kiani, whose company makes devices and sensors for monitoring breathing and other key patient indicators, talked about challenges that device makers face getting into markets abroad.
“I’m going to start with a bunch of questions,” Kiani said, then asked the summit attendees about how hard they found it to get their devices into markets such as Japan, China and Brazil.
Japan
Japan, in particular, got a lot of attention. Device makers long have complained about the country’s regulatory process, saying the Food and Drug Administration seems nimble and open by comparison.
Mazzo also weighed in on the Japan matter, saying Abbott Medical and other device makers have had to keep products that have become obsolete in other parts of the world because of Japan’s regulators.
Earlier this year, the Obama administration won commitments from the Japanese government to open up that country’s medical technology market, something that was praised by AdvaMed.
A report commissioned by the two governments called for Japan to increase its number of medical device reviewers, boost reviewer training and track their performance.
