Supply Chain

Both Ethylene Oxide (EtO) and gamma radiation are highly effective sterilizers for medical devices, but they face significant supply chain vulnerabilities that have already led to shortages within the United States. To mitigate these risks and bolster the sterilization supply chain, the FDA recently approved a new “Established Category A” sterilization method and implemented three key programs designed to encourage medical device manufacturers to adopt alternative methods, all within the last five years (FDA, 2024).

Most life science organizations depend on efficient and uninterrupted supply chains. Manufacturers of pharmaceuticals, biologics, supplements, and devices rely on third-party relationships for component parts, active pharmaceutical ingredients, warehousing, and distribution services. Perhaps your organization depends solely on the manufacturing of your products by a third-party vendor. Research and Development operations rely on third-party relationships to provide crucial supplies such as specialized equipment, cell cultures, and genetically modified organisms.