Medical device finance is hardware finance constrained by regulation and reimbursement. FDA 510(k), De Novo and PMA tracks, CE-mark transition under EU MDR, ISO 13485 quality, post-market surveillance and the CPT, HCPCS or DRG coverage decisions all sit in the same forecast. A single placement contract can produce a capital sale, a reagent rental, a service line and an embedded software module, each recognised on its own timeline.

The function looks closer to industrial accounting than software. Inventory, BOM costing and landed-cost work sit alongside revenue allocation between capital equipment, disposables and multi-year service plans, with installed-base utilisation and consumable pull-through driving the only meaningful unit economic. Capitalisation of clinical study and regulatory submission costs is a recurring judgement, and reimbursement decisions move volume forecasts more than any commercial input.

Flow provides financial modelling, FP&A and fractional CFO advisory to medical device companies across diagnostics and IVD platforms, surgical and interventional instruments, monitoring and wearable devices, implantables and capital equipment with reagent or disposable economics. Our startup CFO team handles the reimbursement-aware financial modelling and FP&A medtech corp dev tests against.