San Jose, California-based Outset’s new sterilization method for the cartridge — utilized in the Tablo system — enables the company to start cartridge production through a manufacturing partner in Mexico. The move facilitates the localization of cartridge and Tablo console manufacturing in North America.
According to a news release, FDA clearance allows the new location to reduce the need for expensive and capacity-constrained air freight delivery of the cartridges, simplifying distribution and logistics for Outset, its customers and its patients.
Outset said another benefit to the FDA clearance is the ability to start using an eco-friendly cartridge sterilization method through E-beam non-ionizing technology. E-beam can be produced on-demand and does not involve toxic or potentially explosive chemicals, the company said.
The Tablo cartridge is a single-use disposable designed to work with Outset’s Tablo console to deliver dialysis treatment. It features a “one-touch” design to speed and simplify treatment set-up and take-down.
“This clearance is an important milestone on our roadmap to continued gross margin expansion,” Outset President & CEO Leslie Trigg said in the release. “In addition to cost reduction, we also are now better able to optimize our manufacturing process and mitigate current supply chain challenges around lead time, capacity and logistics.”