When the CEO called in a panic,
the answer was already on the shelf.
How a Class II connected-wearable diagnostics brand replaced a 3PL it had outgrown, and turned inventory accuracy, unit-level serialization, and an FDA- grade quality system into a competitive advantage instead of a liability.
Same Day
Suspect LOT Located & Stages
99.97%
Shipment Accuracy
100%
Serial/ UDI Traceability
On Time Fulfillment
99.99%
A fast-growing diagnostics brand that had outgrown "good enough."
The brand designs a wearable, firmware-driven diagnostic device that patients use at home and clinicians prescribe at scale. Every unit carries a serial number, a firmware version, lot and expiry data, and a regulatory obligation that follows it from the receiving dock to the patient's hand. Demand was climbing fast across both channels. Their incumbent 3PL, a generalist that handled the device like any other consumer gadget, was starting to crack under the weight of compliance at scale.
The problems were the quiet kind that compound: a cycle count that didn't reconcile, a serial number that couldn't be traced to an order, a return that sat unlogged for a week. For a t-shirt, those are annoyances. For a regulated device, every one is an audit finding waiting to happen.
WHAT WAS ACTUALLY BREAKING
Inventory accuracy drifting to ~94%. Cycle counts and the system of record disagreed often enough that the ops team stopped
fully trusting either one.
Serial & UDI capture was partial. Units shipped without a reliable, queryable link between serial number, firmware revision, lot, and the order they went out on: the exact data a recall depends on.
No real quarantine discipline. Holds were managed by email and memory. There was no defensible, documented way to freeze and physically isolate a specific lot on demand.
Returns visibility was a black hole. Refurb-eligible and quarantine units mixed with sellable stock, putting traceability, and patients, at risk.
The account had no owner. The brand was a ticket in a queue. When something urgent hit, no one was accountable for the answer.
They didn't need a cheaper warehouse. They needed a partner that treats traceability and documentation as the baseline, not the upgrade. That's what brought them to Rush Order.
THE FOUNDATION
Accuracy stopped being a hope and became a number you could prove.
Onboarding with Rush Order meant moving the device onto a purpose-built WMS running healthcare-specific SOPs: FDA-aligned receiving and inspection, lot/batch/serial capture at the dock, FEFO pick logic, segregated and climate- appropriate storage, and barcode verification at inbound receiving, pallet storage movement within the warehouse, outbound pick, and outbound pack. Within the first full quarter on the floor, the metrics that matter for a regulated device moved from "roughly right" to "fully accurate and defensible."
WHY THESE THREE NUMBERS MATTER
Inventory accuracy is the difference between trusting your records and re-counting them. At 99.97%, the brand's finance and ops teams could finally plan against the system of record instead of hedging against it, and short-dated stock stopped slipping through on FEFO.
Order accuracy at 99.99% means a mis-picked unit is a genuine rarity, not a recurring exception. For a device that ships directly to patients, every mis-pick is a potential safety event and a CX failure at the same time.
Multi-point quality inspection and barcode verification at pick and pack closed the gap.
Serial / UDI tracking accuracy is the one auditors and recall plans live or die on. Rush Order captures the serial number, firmware revision, lot, and expiry at receipt and binds them to the outbound order, so any unit can be traced forward to the patient or backward to its production window. That single capability is the spine of both stories on the next pages.
Strong baseline numbers are table stakes. What turns a vendor into a partner is what happens on the two days a year when everything is on the line. The next pages are those two days.
An inbound lot got flagged. Nothing shipped that shouldn't have.
Mid-quarter, the contract manufacturer notified the brand of a labeling discrepancy on a specific production lot: a UDI/ label error significant enough to warrant an internal quality hold. Thousands of those units had already arrived at the fulfillment center and were in live, sellable inventory. With a generalist 3PL, that notification starts a frantic scramble. At Rush Order, it started a simple procedure.
Hold request received
The brand's quality lead flagged the affected lot number to their dedicated Rush Order account manager. No ambiguity about who to call.
Lot frozen in the WMS & physically quarantined
Because lot data was captured at receipt, the exact units were identified in the system and a hold flag blocked them from being picked. They were then physically pulled to a segregated quarantine zone, away from sellable stock.
Zero affected units shipped
The flagged lot, several thousand units, was fully contained before a single one could reach a patient or provider. FEFO logic and lot segregation meant no cross-contamination with good stock.
Audit-ready records produced on demand
Receiving inspection records, chain-of-custody logs, and quarantine documentation were retrievable on request: the paper trail the FDA review required, produced rather than reconstructed.
Controlled disposition
Once the discrepancy was resolved with relabeling per the approved procedure, the lot was released back to sellable status, documented end to end. Nothing left to memory.
No expired scramble. No "we think we caught them all." A defined lot, fully isolated, fully documented: exactly what your quality system is supposed to deliver, and exactly what most 3PLs can't.
"We may have a product quality problem." The hardest call a CEO makes.
A cluster of field complaints suggested the device might be producing an anomalous reading. For a diagnostic, that is the nightmare scenario: the kind of signal that, left unproven, ends in a recall, regulatory exposure, and lost patient trust. The CEO called Rush Order directly. The question was blunt: can you find the exact units from the suspect production window, the ones still in the building, today?
Pinpoint the suspect units
Using unit-level serial and lot traceability, Rush Order identified every unit from the implicated production window still on hand, by serial number, not estimate.
Located, pulled & staged for testing
The exact potentially-affected units were physically located in the warehouse, pulled, and staged the same day, ready for the brand's QA team, with no disruption to good inventory.
Hypothesis tested against real units
With the actual suspect units in hand, QA ran the device through the failure scenario rather than guessing from field reports.
The product was fine
Testing proved the units performed within spec. The anomaly traced to user error, a setup/placement step patients were getting wrong, not a device defect.
WHAT IT PREVENTED AND WHAT IT PRODUCED
No recall. A defect hypothesis was disproven with evidence in days, not chased on assumption for weeks.
A better product. The root cause drove a firmware revision adding a guided setup / placement check, and a revised quick start guide, fixing the actual problem, the human one.
A documented, defensible decision. Serial-level records showed precisely which units were evaluated and why the conclusion held.
The same traceability spine that contained the FDA hold turned a potential recall into a same-day investigation, and a product improvement. That is what unit-level accuracy is for.
Fulfillment stopped being a risk to manage and became a system to rely on.
The brand didn't just swap warehouses. It put a compliance-grade operating system underneath its most fragile obligations, and freed its leadership to spend its attention on growth and product instead of on whether the back office would hold.
RESULTS AT A GLANCE
Could your 3PL find the exact units today?
If the honest answer is “not in minutes, and not with documentation,” let’s talk. For 35+ years Rush Order has been the back office for the world’s most complex hardware and regulated-device brands, built for the days everything is on the line.