Rapid Supply Chain Scalability Positions Medical Test Kit Company to Master the Waves

To accommodate unpredictable market demand and irregular deliveries from Lucira’s Caribbean-based manufacturer, the company needed an extraordinarily agile and highly scalable supply chain solutions provider — one that possessed trusted medical industry supply chain expertise and was committed to positioning the organization for growth.

“In ALOM, we found a supply chain services partner that was nimble enough to ramp up quickly and flexible enough to scale so we could meet peak demand,” says Neil Savedge, Director of Global Supply Chain and Fulfillment for Lucira Health. “For our customers, there’s only a small window when we can service and get the product to them.”

In less than a month, ALOM retooled its operations for a customized supply chain solution that handled Lucira’s procurement, inventory, production, kitting, fulfillment, and distribution of the company’s Check-It COVID-19 test kit. With the success of this initial program, ALOM expanded to handle Lucira’s COVID-19 All-In-One test kit.

Meeting stringent regulatory requirements

Lucira’s Check-It COVID-19 test kit is the only single-use molecular test authorized for at-home use by the U.S. Food and Drug Administration (FDA). The company’s COVID-19 All-In-One test kit is available via prescription and approved for use in healthcare settings.

Familiar with ALOM’s medical test kit domain expertise, Lucira reached out early in the pandemic. The company wanted to leverage ALOM’s 20+ year expertise in medical industry regulatory compliance and its exceptional operational record in meeting erratic pandemic-driven demand.

Prior to partnering with ALOM, Lucira relied on its manufacturer for all assembly, kitting, and fulfillment. The vendor not only struggled to perform these critical activities, but also to source essential components. Such manufacturing missteps created delays in every part of the supply chain when fast delivery was critical.

ALOM, with multiple FDA-registered facilities across North America, helps Lucira manage these unexpected manufacturing challenges. Whenever test kit supplies arrive at ALOM’s receiving docks, the company safely and rapidly scales operations so Lucira can meet tight shipping deadlines and grow its market share in North America.

Additionally, ALOM’s quality processes are ISO 13485 certified to ensure every test kit always meets the strictest standards regardless of fast changing order volumes and high speed, high volume assembly.

Achieving traceability with real-time data

Lucira’s test kits have a 12- to 18-month shelf life, which requires ALOM to meticulously track lot and expiration dates, and to provide temperature-controlled storage to ensure optimized product performance. Serialization and integrated real-time monitoring provide the visibility needed for first expired, first out (FEFO) management.

ALOM’s business intelligence-powered client dashboard monitors Lucira’s supply chain operations and displays key performance metrics in real-time. These analytics provide actionable visibility, traceability, and back-end reporting.

Tracing each individual kit generates a vast amount of data, and even more traceable data is generated during shipping, when each kit is sent to consumers, companies, health systems, and government organizations.

“Every functional group within our company has pulled data from ALOM’s system,” Savedge notes. “Being able to access data in real-time and use it to make decisions has been absolutely critical. It keeps our business running.”

Protecting consumers’ privacy and health information

American and Canadian consumers can purchase Lucira test kits via the company’s website, and ALOM is committed to protecting their information and health privacy.

To ensure the highest operating standards, ALOM maintains a strict data privacy policy built on HIPAA compliance and SOC 2 certification.