Sunday, November 8, 2009

Monday's Op Ed Piece

With NASS just days away, TSB took the time to reflect on the spine industry. With the near collapse of the U.S. economy, the dynamics of the industry has changed. This economic shake-up has left us with a few less companies, justifiably so, and some companies that are teetering on the brink of extinction, or looking for creative ways to survive. We have seen physicians become the target of the Government and the media, Wall Street realign the guidance for the industry, and companies evaluating their business models. So where is spine as we head into our annual party?

Over the last twenty years there has been an eruption of Vesuvian magnitude in the spine industry. Inevitably this has led to many changes in the way that companies and physicians view themselves. Today, they spend their days in a race, identifying and evolving product while finding new modalities of treatment, regardless whether a device truly benefits the patient. This is not to say that much of what has transpired over the last twenty years hasn't benefited the patient. Endless stories abound from patients who claim that their surgeon has been "God-like," or, that products from a specific company saved them from a life of pain. Sensible people do attribute this to the expanding commercialization of medicine. Yet, with this seismic explosion comes a dizzying array of treatments for all types of ailments.

Most of our readers understand the process to bring a product to the marketplace. This includes raising capital, developing or buying the technology, randomized trials (IDE), examining statistical significance, clearing the regulatory pathway, and peer review in academic journals. Yet, once we know that a certain modality of treatment works, we rely upon physicians to determine which patients the device should be used on, and when to use it. It becomes the surgeon's responsibility to make that determination, one that requires sound judgement. But what happens when a surgeon has a vested interest in the success of a product, or is an owner in a company, or is getting paid to use the device? Does this have the potential to obfuscate sound judgement? We know that human beings can be unduly influenced by having an interest in the success or failure of a product, especially when money is involved. This is not to say that money is bad, but it can obscure one's objectivity. Just look at what goes on Capitol Hill with lobbyist influence! It could be as deleterious as someone that writes about the industry and never questions the validity and efficacy of a product, the ethics of the industry, or has a financial interest in the success of a technology? Ever wonder why what is advocated by one surgeon, is frowned upon by another? Ever wonder why one surgeon has a greater surgical case load than another? Could it really be that one surgeon is that more talented than another? It does make you wonder!

Entrepreneurs have contributed to the success of spine, considering that without their interest some of the same technologies that we sell today would have never made it to the market. But, has this "mania" led to the unethical behavior that exists in today's industry? If surgeons become "salesmen" or public relations experts for a product that they have invested in, or are being paid by a company to use a product, is this good for medicine? TSB cannot answer that question, that must be answered by our readers and the American Public. The total disc boom created what many in our industry still call "Entrepreneurial Fever!" The dynamics of the economy has changed peoples expectations. It's interesting to sit around a dinner table and listen to surgeons criticize the TARP program and condemn Wall Street when their own behavior leaves much to be desired. Sometimes you feel like saying; "look at who is calling the kettle black!" Today, we even have the "the patron saint of spine surgery," Charles Rosen, M.D. being featured on television magazine shows like "Extra" discussing the effects of spinal surgery using specific products.

This past weekend the House narrowly passed a Healthcare Plan that will create a fierce debate and battle in the Senate before some type of public option is enacted. Based on what has transpired over the last few months it will be interesting to see the final version. Whether we believe in it or not, some form of an option is needed to salvage a system that needs major reconstructive surgery! Enough with the diagnoses, its time to operate! Unfortunately, no one is willing to make a concession whether it is the insurance industry, physicians, hospitals or device manufacturers. TSB sees a lot of finger pointing when the patient is on life support. Yet, Someone is going to have to pay the price for a healthcare system out of control. But will our industry suffer from a government run option?

Based on what Steve Findlay, a senior health policy analyst at Consumer Union in Washington said this weekend, "as more Americans get health care coverage and money flows into the system, new revenue streams will flow into the system for medical device companies." Not that different than industry visionary Robin Young stated a month ago. If our industry truly believes in resuscitating itself, the patient needs a new modality of treatment, it will take a new paradigm in human nature, and finding new and less expensive ways to bring emerging technologies to maximize our profitability. Until then the only person that suffers is the patient. So as you walk around the Moscone Convention Center, stop and smell the roses, because in all likelihood we will see a different industry the same time next year. See you all at NASS! TSB wants to know what our readers think?


  1. I just don't see how government intervention and management of healthcare will increase profitability for anyone. Were is the evidence in any other business model or industry that government intervention lowers cost, improves the quality of a service or good, and increases profibality?

    The assumption that all these newly magically convered patients will benefit out industry is based on the following wishful ideas:

    Increase (potential) profit will outpace the increase in new taxes to (ironically) cover the government costs of paying for our products to be put in patients. The number on the table is STARTING at 2-4Billion. Do you trust once they start taking an "existence" tax they won't stop?

    A significant number of newly insured will be eligible for spine care

    The cuts in Medicare, that cover our demographic sweet spot, won't affect our revenues

    The additional new regulatory burdens and bureaucratic mindset applied to innovation won't keep us from developing products that can effectively treat new patients and move us away from the commodity market of fixation products.

    These are RISKY assumptions.

    With all due respect, no one, NO ONE can estimate the unintended consequences of this legislation and Washington being in the OR. Such is the way of do gooders doing good with our money (that doesn't exist by the way), no one thinks of unintended consequences.

    It is easy to have a pie in the sky mentality that we are about to inherit this fabulous new customer base without critically analyzing all of the restrictions to our business freedoms that will follow.

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  3. pine Search: Great commentary! The only question that TSB poses is how do we know that it won't work? Because we don't believe it will? Because free-market enterprise has gotten us to this juncture? Because some talking head espouses socialism? Because it is in vogue to portray the government as the "bogeyman?" I cannot answer these questions for you because life's experiences shapes our opinions, makes us who we are, how we think, and what we believe in. Yet, I hold out hope that whatever the final outcome, it makes us a better industry, a healthier society, and motivates more people to take personal responsibility for their lives. For an industry that loves to tout itself as out-of-the box, we have trouble getting out of each others way. Thanks and keep reading!