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:


>
Read More

Finding Hidden Value in Your Portfolio—Selling Solutions Not Products

Posted by Matt Scheitlin on June 30, 2015

Medtech has always been known as an innovative industry. Most organizations are primarily focused on the next growth-driving product launch, whether it is an entirely new product category or a simple line extension. While this approach has been immensely successful in the past, many organizations are being forced to rethink their product strategy as the medtech environment changes.


>
Read More