Generic Orthopedic Implants Time has Come
Blair A Rhode
Abstract
Blair A Rhode
Abstract
Submit Manuscript | http://medcraveonline.com orthopaedic market, and they defend their pricing by stating that they have to pay for R&D and regulatory approvals for their products. Pharmaceutical companies spend about 20% of revenues on R&D. Orthopaedic companies spend 6%. Pharmaceuticals require lengthy development processes and regulatory approvals that cost hundreds of millions of dollars. Most orthopaedic implants, in contrast, receive FDA clearance through the 510(k) process, a regulatory pathway that takes only six to nine months and costs an order of magnitude less than drug approvals. When new drugs eventually lose patent protection and go generic, prices to the consumer decrease by 90% or more. Despite competition between companies, despite a commoditization of the core hip and knee implant product line, and despite a near-doubling of procedure volumes, prices are 60 percent higher today than they were in 2000.
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Submit Manuscript | http://medcraveonline.com orthopaedic market, and they defend their pricing by stating that they have to pay for R&D and regulatory approvals for their products. Pharmaceutical companies spend about 20% of revenues on R&D. Orthopaedic companies spend 6%. Pharmaceuticals require lengthy development processes and regulatory approvals that cost hundreds of millions of dollars. Most orthopaedic implants, in contrast, receive FDA clearance through the 510(k) process, a regulatory pathway that takes only six to nine months and costs an order of magnitude less than drug approvals. When new drugs eventually lose patent protection and go generic, prices to the consumer decrease by 90% or more. Despite competition between companies, despite a commoditization of the core hip and knee implant product line, and despite a near-doubling of procedure volumes, prices are 60 percent higher today than they were in 2000.
Key concepts: Orthopedic surgery, Orthopedic trauma, Foot and ankle surgery, Chondroplasty, Carpal tunnel release, Medicine, Knee replacement, Arthroplasty