Cautious optimism about the medtech business and goings-on at FDA peppered panel discussions at AdvaMed 2010 in Washington. The fourth annual event attracted a recordsetting 1,700 medical device and diagnostics executives from more than 360 companies representing 24 countries.

FDA Commissioner Margaret Hamburg praised the medtech industry during a breakfast speech for being “the No. 1 exporter of new technologies” and for “managing to expand and increase output during uncertain times.”

According to the Ernst & Young “Pulse of the Industry” report released during AdvaMed, revenues for publicly traded medtech companies in the U.S. and Europe grew slightly (0.3%) in 2009 to $294.1 billion, well below the 11% growth in 2008, while net income increased by 10.8% in 2009 to $13.2 billion, driven by a 29% jump in Europe vs. a 4.5% increase in the U.S.

She went on to address industrywide concerns at FDA, especially those involving 510(k) reform, which many fear will lengthen the approval process and limit innovation.

“All of us want safe, effective, and innovative products,” Hamburg said. “The strength of your industry and my agency depends on it.” She went on to say that with regards to the recommendations under review, “Our ultimate goal is to provide clear, predictable pathways that will foster new ideas and innovative products.”

During press briefings held later, industry leaders shared their opinions.

AdvaMed President and CEO Stephen Ubl cautioned the industry not to lose sight of other important issues while it tracks 510(k) reform, using value-based purchasing as an example. “We have to make sure the quality standards of care are flexible and keep up with the pace of innovation. If I have a heart attack today, the hospital needs to provide me with percutaneous coronary intervention (angioplasty) within 30 minutes. The hospital gets paid on how well it does when measured against the standard. But what happens if there’s a new technology or a new drug that isn’t a part of the standard?”

During a briefing on “The Golden Age of Innovation,” Josh Makower, chairman and CEO, ExploraMed Development LLC, a medical technology incubation company in Mountain View, CA, warned that while regulating for safety and efficacy is important, “right now the direction we’re headed isn’t right. We need to find ways for innovators at both large and small companies to be successful in delivering the therapies of tomorrow.”

Meanwhile, Medtronic Senior Vice President of Medicine and Technology Stephen Oesterle said while medtech struggles with important questions, “there’s no crisis in innovation in America. The ability to source from the microelectronics, IT, or biotech companies has never been better.”

Adding credibility to Oesterle’s statement was James Mazzo, president of Abbott Medical Optics and board chairman of AdvaMed. Mazzo touted the organization for attracting 111 new members, with more than 40 from the diagnostics sector, leading to the recent formation of AdvaMed DX, and advocacy organization for such companies.

Also among AdvaMed’s new members is Microsoft. “We’re thrilled to be branching out,” Mazzo said. “By aligning with members such as Microsoft, we’ll be able to put together a position for our members on areas such as EMRs (electronic medical records).”