How the FDA's New 510(k) Guidelines Could Help or Hurt Medtech

Posted by Sundeep Karnik on January 14, 2019

Matt Singer co-wrote this blog post with Sundeep Karnik.

Recently, the FDA announced new steps to modernize its 510(k) regulatory clearance pathway. This is the first major overhaul of a process that has been in place since 1976. The FDA intends to implement three major changes:


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From Collision to Collaboration: How Diagnostics, Pharma and Patients Can Succeed Together

Posted by Jim Adelizzi on August 31, 2017

Pavan Anne co-wrote this blog post with Jim Adelizzi.

In this new era of personalized medicine, matching the right patient with the right targeted therapy requires pharmaceutical and diagnostic companies to reach across industry lines and collaborate long before launch. Together, they need to create a strategy that enables the companion diagnostic to differentiate and accelerate the therapy rather than impede its growth. I’ve witnessed a few ways that these entities can create a go-to-market strategy in unison and carry that tight-knit collaboration all the way to market. To illustrate the inherent challenges, let’s consider the case of two fictional oncology companies that have entered into a research and commercialization agreement: Pharma Depot Co. and Diagnostics “R” Us Inc. 


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Five Reasons Your Global Sales Aren’t Growing

Posted by Bret Caldwell on September 28, 2015

With growth rates slowing for U.S. medical device sales, many American companies are exploring investment opportunities outside the country. Abroad, we find approximately 95% of the world’s population, 75% of the GDP, 65% of medtech spend, and 60% of healthcare spend. So with numerous U.S.-based medtech firms achieving more than half their sales domestically, it’s easy to understand why many are exploring and investing in global opportunities. However, their non-U.S. sales performance hasn’t always met expectations. Many find that products don’t perform as well as planned, penetration takes much longer than expected and commercial productivity is underwhelming.


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Who’s Running Your Launch Strategy Anyway? Avoiding Mediocre Results From Poor Targeting Execution

Posted by Brian Chapman on July 14, 2015

The new thing is coming. Finally, a product we can sell. This thing really changes the game. Everyone wants it. The plans are written, training is locked, messages are pure brilliance. As soon as we get CE and FDA, as fast as the factory can make it, we will sell it. The national sales meeting is coming, we are all going to hit the road and sell! Sell! Sell!


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