The line items nobody quotes you

A U.S. subsidiary handling its own devices needs far more than an office. It needs a registered establishment, a quality management system that survives inspection, trained personnel with documented records, product liability coverage, and someone accountable for adverse event reporting. Each of those is a recurring obligation, and most are invisible in a simple staffing model.

• Quality management: system ownership, document control, internal audits, corrective actions.
• Regulatory affairs: registration maintenance, labeling review, UDI submissions, entry support.
• Facilities: FDA-registered space, security, temperature control, validated monitoring.
• Insurance: product liability and general commercial coverage sized to device risk class.
• Systems: ERP or WMS configuration, EDI or API integration, validation documentation.
• People: leadership, warehouse operations, customer support, plus payroll taxes and benefits.

A realistic first-year range

For a small device line, a lean subsidiary typically lands in the mid six figures before any product moves: legal formation and filings, a lease with deposit, two to four hires, a quality system build, a validated warehouse setup, insurance, and accounting. Add a 510(k) submission or a serious marketing program and the number climbs quickly.

The more useful figure is cost to first shipment. A subsidiary launched from scratch usually measures that in six to twelve months, because registration, system validation and hiring run in sequence. A partner-led launch compresses those into parallel workstreams.

The cost of a slow launch

Every month between lease signature and first order carries full fixed cost with no revenue. It also carries opportunity cost: distributor conversations stall when you cannot commit to a U.S. delivery date, and competitor listings fill the shelf space you were targeting. In medical devices, the launch delay is usually the largest number in the model and the one most often excluded from it.

The comparison that matters

Compare total cost of ownership over twenty-four months, not monthly fees. A subsidiary carries capital expenditure, hiring risk, and obligations that persist through slow quarters. A U.S. operations partner converts much of that into variable cost tied to orders, which changes the shape of the risk rather than only the size of the invoice.