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Building a Basic Good Clinical Practice Foundation to Weather the Storm

OMTEC 2012 opening panel presenters, consisting of David Floyd, Bill Plovanic, Bill Kolter and Brian Moore, painted a compelling picture of the current status and upcoming challenges facing the orthopaedic industry.  According to the panel, orthopaedic sales, which saw a decline in 2010, now appear to be increasing, especially in the knee and sports medicine areas.  In addition, the market remains primed for growth due partly to the fact that bone and joint disease continue to be the leading reasons for disability.  Discussion regarding the challenges facing the orthopaedic industry centered around two key areas: the medical device excise tax, which has the potential to threaten the viability of small device manufacturers and decrease the resources of large device manufacturers, and impediments to gaining market clearance, which will require an increase in resources.  

In short, a primed market coupled with an increase in financial and regulatory burdens has created a perfect storm that has the potential to threaten innovation at a time when it is most needed. 

In preparation for this perfect storm, two main areas stand out from my perspective.  The first is the additional clinical data requirements being placed on device manufacturers, and the second is an increase in scrutiny of how clinical trials are being conducted.  Clinical trial work can be daunting and expensive, so once it is clear that clinical data is needed, running a well-controlled clinical study, compliant with applicable regulatory requirements, is critically important.  In doing so, patients are protected, data is accurate, and the scrutiny put on your orthopaedic company will result in the desired outcome.  So where do you begin?  The best place to begin is with education – in most cases, we don’t know what we don’t know!

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