ATLANTA — For years medical device makers have fired off concerns and criticisms of the FDA's regulatory process – at times going so far as to call it unpredictable. Last week, during the Southeastern Medical Device Association's (SEMDA; Norcross, Georgia) annual conference held at the Georgia Institute of Technology Global Learning Center (Atlanta), med-tech firms got the chance to hear directly from the Center for Devices and Radiological Health's (CDRH) director – Jeffrey Shuren.

Earlier this week, I had the privilege of attending the Southeastern Medical Device Association's (SEMDA) annual conference. It was a tremendous opportunity to meet the players in the med-tech space that are located close to the office where  Medical Device Daily is published. I would have to say that this conference did not disappoint. The presentations were lively; the speakers were great and the topics were very relevant to the med-tech industry. Perhaps one of my most favorite speakers was Jon Ellenthal, a partner and President of TEDMED, a company focused on innovation and breakthrough thinking across all of health...

ATLANTA — Just what does it take to be a CEO of a successful med-tech startup? What does the journey look like for a CEO that has made it through the process of taking an idea and building a product and business around it? Those questions were answered during the CEO Roundtable, one of the more popular sessions at the Southeastern Medical Device Conference (SEMDA; Norcross Georgia) on Wednesday.