The company procures most raw materials on a purchase order basis and maintains supply agreements with select critical suppliers. Supplier evaluation is conducted according to industry standards and includes on-site audits. Several components depend on single-source suppliers, with backup sources qualified regularly. Manufacturing of the AeriSeal System is fully outsourced to a contract manufacturer. The LungTraX Platform’s QCT service is also outsourced, while the company manages the customer-facing web portal and employs a third-party cloud service provider for CT scan uploads. Final assembly, inspection, testing, packaging, and product release testing for the Zephyr Valve, the EDC, and Chartis System are performed at the Redwood City headquarters. Sterilization is carried out by qualified suppliers in California using ethylene oxide or E-beam methods. Domestic product shipments are handled by a third-party logistics provider in Memphis, Tennessee, or from Redwood City facilities. International shipments are managed through a third-party logistics provider in the Netherlands or shipped directly from Redwood City to distributors in the Asia Pacific and other markets. Compliance is monitored by the FDA and the British Standards Institute through inspections and audits. The Redwood City manufacturing facility holds ISO 13485:2016 certification, is licensed by the California Department of Public Health Food and Drug Branch, and is registered with the FDA as a medical device establishment.
Pulmonx's Comment on Supply Chain
The company procures most raw materials on a purchase order basis and maintains supply agreements with select critical suppliers. Supplier evaluation is conducted according to industry standards and includes on-site audits. Several components depend on single-source suppliers, with backup sources qualified regularly. Manufacturing of the AeriSeal System is fully outsourced to a contract manufacturer. The LungTraX Platform’s QCT service is also outsourced, while the company manages the customer-facing web portal and employs a third-party cloud service provider for CT scan uploads. Final assembly, inspection, testing, packaging, and product release testing for the Zephyr Valve, the EDC, and Chartis System are performed at the Redwood City headquarters. Sterilization is carried out by qualified suppliers in California using ethylene oxide or E-beam methods. Domestic product shipments are handled by a third-party logistics provider in Memphis, Tennessee, or from Redwood City facilities. International shipments are managed through a third-party logistics provider in the Netherlands or shipped directly from Redwood City to distributors in the Asia Pacific and other markets. Compliance is monitored by the FDA and the British Standards Institute through inspections and audits. The Redwood City manufacturing facility holds ISO 13485:2016 certification, is licensed by the California Department of Public Health Food and Drug Branch, and is registered with the FDA as a medical device establishment.
Sources:
Pulmonx Corporation's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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