Quality Control
Due Diligence
We perform extensive due diligence on all of our suppliers, including in-person audits of factories and warehouses. In addition to performing basic confirmatory diligence on their certifications, registrations (i.e. FDA), licenses and permits, we also review our partners’ export records, suppliers’ records, litigation records and more.
Most factories fail our inspections due to failure to satisfy our documentary requests and, commonly, due to unauthorized outsourcing issues.
Direct Access
A common sourcing problem results from over-reliance on brokers claiming to be representatives of top factories. Prior to sourcing goods from a factory, we insist on direct, in-person communications with the firm’s top management.
Transaction History
We have a strong bias for factories who have long-standing manufacturing relationships with the most prominent global medical distributors, including McKesson, Medline, Cardinal Health, S2S (PremierPro) and Uline.
Regulatory Compliance
We independently confirm that each supplier and each product is properly registered with the FDA and other regulatory bodies, and we also confirm whether or not they are in compliance with the scope of their registration.
For example, an AAMI Level 3 gown requires a valid 510(k) premarket notification and must be produced in a dust-free plant, but we found some suppliers outsourced their orders to small factories that do not meet these qualifications.
We also found that many factories and distributors offer gowns falsely marketed as AAMI Level 3 but without a 510(k). Often the basis for their claims are that the gowns can pass the tests in a subset (but not all) of the critical zones required by the standard.
Suppliers and Independent Testing
We have dedicated substantial resources to understanding supply chains for the common materials used in making our products. Because the market experienced a glut of low-quality materials from fly-by-night factories during the peak of the pandemic, we insist that our suppliers use only high-quality materials from top brand vendors. We also independently test finished products on request.
