Singular Focus, Purpose-Built Solutions: Your Partner in Life Science Insurance

Last year, Berkley Life Sciences’ Blog featured an important post on Preventing Medical Device Shortages Through Improving the United States Sterilization Supply Chain. That article highlighted potential supply chain constraints caused in-part by sterilization facility shutdowns and regulatory requirements to install or upgrade emission control equipment. What that post did not address—and what this article will explore—is the nationwide litigation that has impacted the sterile medical device industry over the past five years.

In the life sciences industry, innovation does not stop at the lab bench—it extends across the entire supply chain. As companies develop increasingly complex and sensitive products such as biologics, vaccines, and cell and gene therapies, the challenge of safely transporting these high-value assets has never been more critical. The journey from manufacturing site to end-user is fraught with risk, and even a minor disruption can result in significant financial loss, regulatory complications, and—most importantly—threats to patient safety.

Not long ago, tariff classification and associated payments were accepted as the cost of doing business. Trade professionals have long navigated free trade agreements, customs codes, and supply chain disruptions—often without specialized tools. But today’s global economy demands more.