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Compliance In Focus
Posted by John Lehmann on Fri, Feb 24, 2012

Should the Medical Device Industry Embrace Outsourcing?

MarketWatch recently had a news-release on “Markets and Outsourcing for Clinical Activities.” In the article, it’s noted that while in the US and Europe costs are continuing to rise for clinical activities, sales are not growing- or growing at an insignificant rate. This is in stark contrast to emerging markets, where the opposite seems to hold true. Not surprisingly,  this leads to  more medical device organizations evaluating an expansion of their clinical programs into emerging markets to cut costs and boost sales.

These factors are what a research and consulting firm, Best Practices, LLC, recently explored in a study they conducted.  According to their website, the research was prompted by the cost and regulation pressures which leave medical device organizations looking for less expensive avenues, like outsourcing, to perform clinical trial activities.

The research participants included executives and managers from medical device companies ranging in therapeutic areas and product classes. Critical outsourcing questions addressed in the research survey included:

  • What are the regions where medical device companies are conducting clinical trials and the percent of patients recruited annually from these regions?
  • Which clinical trial activities are best suited for outsourcing?
  • What is the appropriate staffing mix (in-house and outsourced) for clinical trials?
  • What are the most important competencies for clinical research associates, managers, and directors?

From “Key Findings” portion of the report summary, the results are pretty staggering.

  • 71% expect they’ll increase outsourced staffing during the next three years
  • 86% believe the number of trials done in emerging markets will increase as well
  • 85 % rated quality of trials outside the US with either medium or high satisfaction/success

What do you think of Medical Device CROs’ expanding their clinical activities outside the US? Do you think with the recent 2.3% sales tax will push more clinical study activities overseas? Share your thoughts on outsourcing and emerging markets below!

Topics: Emerging Markets, Outsourcing, Medical Device Industry


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