The Global Unique Device Identification Database (GUDID) allows users to search for and download information submitted by device manufacturers, such as device name and version/model number.
Arthrex and Smith & Nephew lead the market, but we recommend you be aware of these smaller players that entered the segment in the past year with several innovative products.
FDA's draft guidance outlines what data it will and will not accept for PMA applications. Further, FDA describes ways to develop data that can be used to support U.S. approval or clearance.
Doug Kohrs, Past President and CEO of Tornier, asks, "As you look at your extremities businesses, do you see a place for robotics in some of the more complex surgeries?" and "What do you see in the future for orthobiologics?"
Globus and Branch, neighbors in southeast Pennsylvania, have worked together for a decade. Analysts at Canaccord Genuity noted that the acquisition favorably positions Globus to realize gross profit leverage, and the transaction offered insight on the operating and manufacturing profile between the two.
Manufacturers of Mobile Medical Applications bear the onus of having to prove their device's safety and efficacy to regulatory agencies. While barriers to market entry are high, the rewards can be higher if the manufacturer embraces proper strategy.
