I’ve been involved with the medical device industry for almost 10 years, and I am constantly amazed at the level of innovation that medtech companies are able to achieve. The possibilities are endless, and so seems the enthusiasm of most medical device professionals to pursue safe, effective—often lifesaving—technology for patients worldwide. Year after year, there’s a company, individual or product category in the device industry that never fails to impress—in a positive way.

But what about 2009?

As noted on this page many times before, enthusiasm isn’t enough to get medical devices to market. It’s only one part of a very large puzzle. Beyond the years of research, product development, clinical trials (in many cases) and engineering, it takes an enormous amount of funding—which could be in short supply given the current tight credit markets. That will slow down startups and venture-backed companies trying to stay afloat long enough to get products into development. It also requires a fair, balanced, transparent, knowledgeable and timely regulatory review process. That process, at least in the United States, has come under increased scrutiny in recent days. The beginning of 2009 most likely has officials in the device branch of the U.S. Food and Drug Administration holding their heads and longing for the “good ol’ days” of user-fee negotiations and device approval milestones. If the coming storm on Capitol Hill gathers the strength in appears to be, the FDA is going to have to brace for impact. And medical device firms will be swept along for the ride.

As 2008 came to a close, a group of scientists within the FDA’s Center for Devices and Radiological Health sent letters to Congress and then-President-elect Obama, citing a “corrupt and distorted” scientific review process of medical devices at FDA. The scientists said the American people are at risk.

“Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices ... have ignored serious safety and effectiveness concerns of FDA experts,” the FDA scientists wrote. This, of course, has raised additional flags in a Congress already critical of the way the FDA has handled quality issues.

In addition to the letter, a long-awaited report from the Government Accountability Office (GAO) was released in January that also targeted the FDA’s review process. According to the GAO, FDA has allowed certain Class III  (higher-risk) medical devices to go through the approval process using the less-stringent 510(k) review. The GAO recommended that the agency quickly issue regulations that would require the toughest review for all Class III devices.

On top of all that, yet another report from the GAO, this one issued in mid-January, added the FDA to a “high-risk” list because of its inability to oversee medical product safety, particularly overseas. (For more detailed information, read Top of the News on page 12.)

Frank Torti, acting FDA commissioner, told lawmakers recently that the agency would need the partnership of Capitol Hill to “reshape” the agency. Undoubtedly, representatives of FDA and the U.S. Department of Health and Human Services are going to get plenty of opinion from lawmakers on both sides of the aisle, though with a new majority in Congress, Democratic representatives will be the most vocal in their cries for a restructured, better-funded FDA. Given the billions in bailout and stimulus bucks flowing out of government at the moment, we’ll have to wait and see where retooling the FDA (along with broader healthcare initiatives) falls on the new president’s agenda.    

But it’s clear the lawmakers aren’t waiting long. Democratic members of the House of Representatives already are planning for hearings and proposed medical device evaluation legislation. And the Physician Payment Sunshine Act is back for 2009. Sens. Charles Grassley (R-Iowa) and Herb Kohl (D-Wis.) introduced legislation in January that would require medical device manufacturers to publicly disclose all doctor payments and gifts exceeding $100 per year. Companies would face penalties as high as $1 million for knowingly failing to report the payments if the bill becomes law. A previous version that did not advance in the last congressional session required public reporting only if payments topped $500 per year.

What does this mean for medical device manufacturers and their suppliers? Well, there will be the usual “wait and see” as the dust falls. But the FDA certainly is going to take a longer look at all areas of the medical device supply chain and not just what comes out of OEMs. Contract manufacturers will share the critical gaze of legislation with their customers and the FDA. As one industry professional told me for this month’s feature on electronic manufacturing services outsourcing (page 52): “The new administration is somewhat of an unknown. Will new products be more difficult to get through the FDA? There are a lot of things that are swirling that companies are waiting to settle. But I think the growth will still be there.”

That kind of optimism may be hard to come by with the daggers flying, but I share it. After years of impressive performance—not just bottom line—2009 isn’t going to be any different.