| 29 Août 2014
Linda Tian, GlobalData’s Analyst covering Medical Devices, says that the lack of insurance coverage for patient-specific implants and insufficient reimbursement for complex trauma cases are deterring many CMF surgeons from participating in medical training for using pre-surgical planning and 3D-printed implants. These concerns follow the recent US Food and Drug Administration (FDA) approval of OsteoFab Patient-Specific Facial Device (OPSFD), manufactured by Oxford Performance Materials and now the only FDA-cleared, 3D-printed polymeric implant for both cranial and facial indications. Tian states: “The processing chain, from data acquisition to 3D printing of CMF patient-specific implants, has proven to be practical and uncomplicated. “However, 3D printing might continue to be plagued by a major weakness in terms of its future growth within the orthopedic industry, namely the need for hospital administrators to cut costs associated with high-volume surgeries, such as trauma.” The analyst notes that while 3D-printed implants may theoretically reduce the overall cost of facial implant ownership by reducing the operating time, hospital stay duration, and chance of procedure complications, there is a lack of clinical evidence suggesting the actual cost-effectiveness of 3D-printed implants in CMF surgeries. Despite this, GlobalData expects that OPSFD’s approval will lead to a further rise in the utilization rate of custom-made devices for mid-face reconstruction, mandible reconstruction, orthognathic surgeries, and possibly expanded indications. Tian continues: “Over the next five years, the medical devices sector will see more partnerships between small contract 3D-printing service firms and large orthopedic companies seeking to explore opportunities in this revolutionary technology. “This will occur as the clinical community increasingly acknowledges the efficiencies of a serviced-based approach to personalized surgery that combines expertise in medical imaging, surgical simulation and 3D printing.”
LONDON, UK (GlobalData), 27 August 2014 - While three-dimensional (3D) printing has been lauded as a game-changing development in the medical devices industry, the technology is battling to convince surgeons that it is a financially viable treatment for craniomaxillofacial (CMF) reconstruction, says an analyst with research and consulting firm GlobalData.
