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 orthopedic device professionals to pursue safe and effective technology for patients worldwide. Year after year, there’s a company, individual or product that never fails to impress.

But what about 2009?

As noted on this page many times before, enthusiasm isn’t enough to get the next great implant to market. It’s one part of a very large puzzle. Beyond the years of research, product development, clinical trials 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 companies of all shapes and sizes, but perhaps innovative startups most. It also requires a fair, thorough, transparent, knowledgeable and timely approval process. That process has come under increased scrutiny in recent days. Officials in the medical device branch of the FDA must be 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 it appears to be, the FDA will have to brace for impact, and 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 the agency. Americans are at risk, they said.

This, of course, raised additional red flags with a Congress already critical of the way the FDA has handled quality issues. In addition, a long-awaited report from the Government Accountability Office (GAO) was released in January that also targeted the FDA’s product. 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 GAO report added the FDA to a “high-risk” list because of its inability to properly ensure medical product safety, particularly overseas. (For more information, read News Front on page 12.) Frank Torti, acting FDA commissioner, told lawmakers that the agency would need Capitol Hill partnership to “reshape” the agency. Given the billions in bailout and stimulus bucks flowing out of government, we’ll have to wait and see where retooling the FDA falls on lawmakers’ to-do list. But it’s clear, especially with a Democratic majority, Congress will want action soon. Democratic members of the House of Representatives already indicated that they are planning for hearings and proposed medical device evaluation legislation.

And (though not FDA related), of particular note to orthopedic companies, which spent a good deal of 2007 and 2008 in government’s crosshairs, the Physician Payments Sunshine Act is back for 2009. Sens. Charles Grassley (R-Iowa) and Herb Kohl (D-Wis.) introduced a new version of the legislation that would require companies to publicly disclose all payments to doctors and gifts exceeding $100 per year. (See Regulatory Viewpoint on page 26). Companies could face stiff penalties for knowingly failing to report payments.

What does this mean? For starters, FDA will take a harder look at all areas of the medical device supply chain and not just the OEM’s finished product. Keeping on top of the latest information will be key. And every stakeholder plays a part. Suppliers and contract manufacturers will share the critical impact and inquiry of legislation with their customers and the FDA. The spotlight is a difficult place, but given what this industry is capable of, it also is another opportunity to impress.

Christopher Delporte, Group Editor