Getting Fast-Tracked Complex Class III Orthopedic Device To Market On Time – And In Spec

A biotech company recently achieved fast-track status from the FDA for an innovative orthopedic device after a decade of prototyping. To bring their product to market, they required a contract manufacturing partner that was experienced in implantable materials and had strict processes.

After careful consideration, they selected Donatelle based on their track record of successful DFM processes, regulatory compliance, and punctual delivery. During the collaboration, some product design issues arose which needed to be resolved. The engineers needed to find a balance between size, form, and functional requirements while taking into account finishing, sterilization, assembly, labeling, and packaging operations.

With Donatelle's assistance, the biotech company was able to produce the device on schedule and within the necessary specifications to earn FDA approval.