Minnesota StarTribune Conversation with Navigant's Joe Galatowitsch
Medical technologies often take years to transform from an inventor's idea into a government-approved product. But getting Food and Drug Administration (FDA) approval is no longer the end game. In this Star Tribune interview, Navigant's Joe Galatowitsch discussed how medtech buyers want scientific proof that a device will work as intended often enough to justify the expense.
"Device companies face an increasingly complex job in creating the "post-market" demand for medical devices after securing FDA approval," said Galatowitsch. "Once you get through your early animal work and pivotal trials and prove safety and efficacy, then of course you have to go through the red-tape process to get everybody to agree that your device is safe and efficacious. But once that's done, then the real work starts. That is the part that people just don't think about."