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.

While the mature hips, knees, and spine segments of the orthopedics industry are growing by low single-digit rates, some sectors of the extremity industry are growing by 13% to 14%. We profile three companies in different sectors of extremities: Conventus Orthopaedics, in the hand and wrist market; Nextremity Solutions, working on devices for the forefoot; and Cartiva Medical, with a cartilage platform and an initial focus on the great toe.

Stryker’s adoption of MAKO’s RIO (Robotic-arm Interactive Orthopedic) system could give the global medical supplier a competitive edge over other orthopedic implant makers if the company can win converts to robotic surgery by leveraging its own experience in selling capital equipment.