Spine Market: Are the Good Times Over?
The global market for spine implants and products will surpass $6 billion this year. While technological innovations continue to abound and industry proponents forecast sustained double-digit growth, the spine market is entering an unsettling phase of bureaucratic regulation and oversight from regulators and payors who appear intent on putting the breaks on this sector.
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Given how many start-up companies and their investors have rushed into spine over the past decade or so, one might assume that getting spine surgeons to adopt new technology is relatively easy. - But less than five years after the launch of the first artificial disc was supposed to usher in the era of motion preservation, surgeons are still arguing for the benefits of fusion over disc replacement--underscoring the tension between new devices and traditional therapy options. But one start-up, Vertos Medical Inc., has found a creative way around the adoption issue. Promoting a novel approach to spinal stenosis, Vertos' solution is to focus on the patient, rather than the surgeon, treating stenosis earlier in the continuum of care by reaching out to a new clinical specialty, interventional pain physicians.
SpinalMotion is one of a small number of second-generation companies that hope to follow in the path of the first artificial disc companies, with novel technologies and a more measured assessment of the market, especially the lumbar disc segment. The ultimate challenge for SpinalMotion may not be gaining market share, but finding an appropriate exit for its investors.
The push for transparency in the health care industry has moved beyond initial regulations focused on hospital safety disclosures and is now taking on longstanding marketing practices by manufacturers. This time, money trails are the focal point, and if medical device manufacturers start to feel as if someone is spying over their shoulders, it may be more than paranoid imaginations at work. A growing list of regulations and "codes of conduct" are popping up with guidelines for any type of gratuity passing from manufacturers to physicians or hospitals. These new laws and rules are meant to be stringent and they will impact every manufacturer in the device industry.