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Compliance In Focus
Posted by John Lehmann on Fri, Mar 15, 2013

Do Device Companies Have it Worse Than Pharma?

While many have their tales of triumph and woes as part of the medical device industry orDo Device Companies Have it Worse Then Pharma pharmaceutical world, the question posed in the heading was recently covered in a Forbes post. The article, written by Dr. David Shaywitz, opens with a zinger, “Good news, early-stage biopharma companies: at least you’re not early-stage device companies.” But what exactly makes one more challenging than the other?

The whitepaper, “Drugs vs. Devices: The Difference is in the Details” is intended to provide a backdrop for the similarities and appreciating the differences in drug and device trials.  In addition to the whitepaper resource, for background it’s important to note:

  • The development of medical device and drug products has historically followed different pathways
  • The health impact of medical devices is beginning to rival drug therapy, especially with regard to the breadth and depth of indicated uses
  • Regulatory strategy towards device approval is evolving in response to convergence of device and drug “spheres” of therapeutic use

The article in Forbes points to a Medsider interview with Kevin Bitterman of Polaris in regards to the med-tech industry. The interview focuses on med-tech venture capitalists and medical device companies. In the interview Bitterman explains why device companies may have it worse then pharma companies.

“You more than likely have to go through the increasingly high hurdles of getting technical proof of concept, getting clinical proof of concept, taking out regulatory risk, getting onto the market, and then actually taking out commercial risk and reimbursement risk, showing that you can get this paid for, showing that you can build a business around it.”

However, the Forbes post author, Shaywitz does counter the statement, stating “I’m not sure I’d entirely agree with this characterization, and would argue that early-stage biopharma companies are increasingly facing many of the same challenges around commercial and reimbursement risk that device companies evidently confront.”  In addition, the author mentions the fact that while millions of molecules are tested, all efforts are focused to one promising molecule.

Of course this is quite a loaded question, but we would love to hear your thoughts on this topic. Please share below on which industry faces the most challenges.

Photo Credit: e-MagineArt.com

top 5 trial complications

Topics: Device Companies, Dr. David Shaywitz, Pharma, Forbes

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