The draft guidance covers technical considerations for additive manufactured devices. Among the top concerns of FDA and industry are post-processing, cleaning and sterilizing devices. 
Identifying high-value suppliers, gaining return on UDI implementation, acquiring surgeon perspectives on custom implants, additive manufacturing and bundled payments are just the beginning.  
Midwest Orthopaedics at Rush (MOR) is offering a flat fee payment option for treating common orthopaedic conditions, including ACL repair and shoulder, knee, and hip arthroscopy. MOR is listing the pricing structure on its website. 
Invibio, the first company to sell implant-grade polyetheretherketone or PEEK, agreed to settle Federal Trade Commission (FTC) charges that it violated antitrust law by using long-term, exclusive contracts to maintain approximately 90% of PEEK sales worldwide. 
Orthopaedic Market Share: Top 5 and All Others

The top 5 (DePuy Synthes, Zimmer Biomet, Stryker, Smith & Nephew and Medtronic) all with revenue near or above $3BB, claim 61% of the global orthopaedic market. Learn more about these market leaders by downloading the newest report from ORTHOWORLD.

From the Archives
When should you consider taking your parts from machined to molded? The simple financial decision is how quickly the part cost savings will pay for the mold. The three most important factors in this analysis are part complexity, material selection and the quantity of parts needed.  

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