Pro-dex

CEO's Unplugged: Tech and Regulatory

Solution-focused approach key to FDA-MedTech future

You’d expect there to be finger pointing and an undertone of hostility at a “CEO’s Unplugged” panel at AdvaMed 2011—especially on the topic of technology and regulation.

But instead of talking about what’s not working and what’s not happening, the CEO panelists used the opportunity to tone down the rhetoric and acknowledge what is working.

These industry leaders voiced that both sides (FDA and MedTech) have come to the conclusion that beating each other up isn’t productive. At least for now, they are ready to play nice—or at least nice-er.

One example of this is the credit the CEO panelists gave to the FDA and their overall appreciation for the role the Administration has to play in the midst of all the limitations and bureaucracy it too must deal with.

The goal, it seems, is to focus on actionable, productive items and come together to improve the medical device innovation and regulatory challenges in the U.S.

It was made clear that, at the end of the day, if both MedTech and the FDA agree that the goal is to attain the best and safest possible outcomes for patients, positive change can be fostered.

While both sides may have different approaches to getting there, keeping that as the destination will hopefully allow for more predictability and consistency from the FDA and more quality innovation from MedTech.

Otherwise, the U.S. will continue to see innovation flourish … outside its borders.