The company’s products are primarily manufactured by third-party suppliers that comply with its manufacturer qualification standards. MD Ortho produces specialized clubfoot bracing products on-site in Iowa. The Boston O&P facility manufactures various braces, including the Boston Brace 3D®, DF2 brace, and cranial helmets. C-Pro Direct Ltd., a recently acquired UK entity, manufactures many of its own products. All manufacturing entities and contract manufacturers are required to hold ISO 13485 certification and be registered with the FDA. The company performs comprehensive on-site inspection audits of suppliers and is subject to periodic unannounced regulatory inspections. While it maintains certain long-term contracts with key suppliers, most suppliers do not require guaranteed minimum purchases. The company has redundant manufacturing capabilities and reports no significant difficulties in obtaining necessary materials, considering its manufacturing capacity sufficient to meet global demand for the foreseeable future.
Orthopediatrics's Comment on Supply Chain
The company’s products are primarily manufactured by third-party suppliers that comply with its manufacturer qualification standards. MD Ortho produces specialized clubfoot bracing products on-site in Iowa. The Boston O&P facility manufactures various braces, including the Boston Brace 3D®, DF2 brace, and cranial helmets. C-Pro Direct Ltd., a recently acquired UK entity, manufactures many of its own products. All manufacturing entities and contract manufacturers are required to hold ISO 13485 certification and be registered with the FDA. The company performs comprehensive on-site inspection audits of suppliers and is subject to periodic unannounced regulatory inspections. While it maintains certain long-term contracts with key suppliers, most suppliers do not require guaranteed minimum purchases. The company has redundant manufacturing capabilities and reports no significant difficulties in obtaining necessary materials, considering its manufacturing capacity sufficient to meet global demand for the foreseeable future.
Sources:
Orthopediatrics Corp'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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