According to leaders of Spinal Simplicity, one of the simplest explanations for why HA-coated devices have not received broader adoption into more procedure types has largely to do with the need for sterile packed implants.
"For companies to try to accomplish what we're doing retrospectively, they'd have to seek new clearances from the FDA. By switching to sterile pack processing—they'd have to start over with new inventory, requiring excessive time and money," said Jonathan Hess, vice president of business development. "With Spinal Simplicity integrating a sterile packed implant since its inception, we are able to offer a better solution to our customer surgeons and their patients.
