Tom Novelli has a message for medical device manufacturers and their suppliers, and he delivered it at Medical Design’s Medical Silicone Conference (MSC) in Minneapolis. The message is simple: Don’t wait to get involved in the healthcare discussion and the political process.

Novelli is vice president of government relations at the Medical Device Manufacturers Association. He told his keynote-session audience that the regulatory environment, the device tax, and other reform-related measures are causing US medtech to be in danger of losing its position as world leader and as one of only two remaining US net-export industries. (The other is commercial aircraft—another disturbing story for others to write.)

During his presentation on “The Evolving Legislation and Regulatory Environment for Medical Device Manufacturers,” Novelli discussed the “Top 5 Industry Concerns”: transparency/sunshine laws requiring disclosure of cost payments as little as $10 by device and drug companies to physicians; comparative effectiveness research and questions surrounding the Patient-Centered Outcomes Research Institute; the Independent Payment Advisory Board (IPAB) for cutting Medicare costs; payment bundling of procedures, physician visits, etc; and potential shared savings via accountable care organizations (AOCs), involving collaborative efforts between physicians and hospitals, with built-in incentives for reducing costs.

Each of these, if poorly structured and executed, has the potential for hurting quality of care. If well executed, however, patients could benefit.

What’s really hurting our industry and patients alike right now is the snail’s pace FDA approval process, which is preventing some US startups from ever bringing their technology to market here, while others are finding it necessary to go to market in Europe first and then (or not) the US.

And then there are Novelli’s Top 5 Concerns for the Post-Senate Finance Committee: 1) medical device tax . . . 2) medical device tax . . . 3) medical device . . . Do I need to continue? The 2.3% excise tax on revenue, scheduled to begin in 2013, will surely hamper startups, whose only revenue is the venture capital they manage to raise in order to navigate the FDA regulatory process in hopes of getting to market before they run out of the venture capital, which will now be taxed. Only in America!

With regards to FDA, when staff appear at industry events and state FDA’s two-part mission as ensuring the safety of medical devices while fostering an environment for innovation, few, if any, doubt for a moment their sincerity. (See “Hearing addresses FDA funding”)

Yet, there is evidence (see “Study paints grim picture”) that EU nations are bringing medical devices to market faster—anywhere from three months to two years for low- and moderate-risk devices; for higher-risk devices, the US approval process takes three-and-a-half years, or five times as long as Europe. And the risks don’t appear to be quantifiably greater. This, of course, means OUS (Outside US) strategies cost companies less than investing and manufacturing here. (See "OUS strategy disturbs")

For US patients, that means technologies developed in their home states may be available to folks in the UK years before being made available here, if at all. That’s exactly what happened in a case involving a California woman who needed a spinal implant for a degenerative disk condition, Novelli said. The woman flew to the UK for treatment not yet approved in the US. The treatment and extended travel-related expenses set her back $30,000, forcing her to declare bankruptcy.

“We will continue to lose our edge as a global leader if regulatory policies like this and the device tax converge,” Novelli continued. “That’s why we’re raising the red flag now and we’re telling lawmakers, help us. The stakes are too high for all of us not to get involved. More importantly, the stakes are too high for patients, whom we all serve.

“The takeaway today is this: get involved. Call and write your congressmen and senators and say, “Hey, these are the issues of concern.”

But why stop there? Write an op-ed piece for your local papers. And make this a regular discussion topic when you’re withcollegues, neighbors, and friends. Because the truth is, until we get voters at large involved in the discussion, that’s all this will be—just another industry discussion.

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Please let us know if you’re involved in the healthcare discussion and political process by answering this month’s Reader Poll question at medicaldesign.com. And to download any or all of the MSC presentations, visit medicalsiliconeconference.com.

Joe Jancsurak, Editor
joe.jancsurak@penton.com