Decades-long involvement with numerous FDA inspections has given John Gagliardi a unique perspective on design control trends. Eight major design issues are summarized herein. 
Optimal outsourcing involves collaboration and integration with your suppliers early in the design phase. It requires participation from multiple departments at the OEM and the supplier. Maximizing early engagement with your partners can mean superior design and cost.
NASS 2015 Recap

Companies seek to develop unique structures with greater porosity. Startup Vertera Spine announced a new perspective on PEEK with its FDA 510(k) clearance for COHERE™, reportedly the first FDA-cleared spine device to be manufactured entirely out of PEEK and contain porosity. 


Not all surgeons and industry believe that PEEK improvements are the best path forward. A debate on the use of PEEK, bone, ceramic and titanium prompted questions and insights.



With limited information, it's hard to see how FDA will leverage a "big data" focus in a timely and meaningful way, and what this will require from device makers. But major companies like Medtronic and Johnson & Johnson are on the move, having announced big data partnerships with IBM.
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