Ortho Companies Emphasize Software For Patient-Matched Instrumentation Guidance
This article was originally published in The Gray Sheet
Executive Summary
Orthopedic device companies say FDA should provide guidance on how software used to design and implant patient-matched instrumentation could be regulated. They note that while physician experience and training is the key factor for surgeries using such devices, software is critical to how patient data is collected, evaluated and shared among surgeons and pre-operative personnel.