Tandem Diabetes Care Inc's Comment on Supply Chain
The company sources raw materials, select components, and certain sub-assemblies for insulin pumps and cartridges from single or limited suppliers due to proprietary knowledge, quality, cost, or regulatory requirements. All currently marketed infusion sets are purchased from Unomedical A/S, a subsidiary of the ConvaTec Group, which is responsible for their manufacturing, testing, sterilization, and packaging. Sole and single source suppliers are managed through a supplier management program aimed at reducing supply chain risk. The company's quality department periodically evaluates and monitors suppliers to ensure compliance with specifications and policies. Manufacturing facilities and critical suppliers are subject to periodic inspections by the FDA, state agencies, Notified Bodies, and foreign regulatory authorities. The company holds certification from BSI Group, a Notified Body to ISO standards. Manufacturing and testing processes are verified and validated in accordance with regulatory requirements. The company collaborates closely with suppliers to maintain supply continuity and manages risks associated with sole sourced parts by maintaining inventory both in-house and at supplier locations. Additionally, many components and sub-assemblies are dual sourced across various geographies.
Tandem Diabetes Care Inc's Comment on Supply Chain
The company sources raw materials, select components, and certain sub-assemblies for insulin pumps and cartridges from single or limited suppliers due to proprietary knowledge, quality, cost, or regulatory requirements. All currently marketed infusion sets are purchased from Unomedical A/S, a subsidiary of the ConvaTec Group, which is responsible for their manufacturing, testing, sterilization, and packaging. Sole and single source suppliers are managed through a supplier management program aimed at reducing supply chain risk. The company's quality department periodically evaluates and monitors suppliers to ensure compliance with specifications and policies. Manufacturing facilities and critical suppliers are subject to periodic inspections by the FDA, state agencies, Notified Bodies, and foreign regulatory authorities. The company holds certification from BSI Group, a Notified Body to ISO standards. Manufacturing and testing processes are verified and validated in accordance with regulatory requirements. The company collaborates closely with suppliers to maintain supply continuity and manages risks associated with sole sourced parts by maintaining inventory both in-house and at supplier locations. Additionally, many components and sub-assemblies are dual sourced across various geographies.
Sources:
Tandem Diabetes Care Inc '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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