Biomedical
Custody that stays with the device and the sample.
Medical devices carry a unique device identifier on their labels and packages. Samples and materials carry labels too. A label identifies an item. Nothing proves the item in hand was present at each handoff.
NOANE is designed to add that proof, alongside the identifiers and records you already keep.
Direct Answer
What NOANE does for biomedical custody.
NOANE is a patented custody protocol designed to bind a medical device, implant or biological material to a custody record. Each handoff is designed to need both the item and the authorized party, so a hospital, laboratory or manufacturer can check that the item in hand is the item the record describes. It is designed to work alongside FDA unique device identifiers and existing quality records, not to replace them.
The Exposure
A label can separate from the item.
Devices, implants and samples pass between manufacturers, distributors, hospitals, laboratories and couriers. Each step relies on labels and scans that identify an item but do not prove it was there.
Identification is not custody
The FDA's UDI system requires a unique device identifier on device labels and packages, in plain text and in machine-readable form. It identifies the device and, where relevant, its lot or serial number.
Loaner sets and consignment
Instruments and implants move between sites on loan or consignment. Each move is a handoff someone has to reconcile.
Samples and materials
A biological sample is only useful if its chain of custody holds from collection to use.
Identification says what an item is. Custody asks whether it was there.
Identified vs Held
Identified is not the same as held.
A unique device identifier says which device this is. Custody is a different question: who holds it now, and was the item itself present at each handoff.
Identification today
Custody, as NOANE is designed
NOANE adds custody evidence alongside the UDI. It does not replace it.
Designed for Every Party in the Chain
Who it is for.
Capabilities the protocol is designed to enable. Not all are built today.
Device and implant makers
Identity provisioned at manufacture. A custody record that starts at the source.
Distributors and consignment teams
Track loaner sets and consigned stock through every site they visit.
Hospitals and surgical teams
Confirm the device or implant at the point of use is the one on record.
Laboratories and biobanks
Handoffs for samples and materials that record who held them and when.
Couriers and cold-chain carriers
Custody that moves with the item, not just the shipment.
Quality, regulatory and recall teams
Narrow an investigation or recall to the items that were actually handled.
On the Record
An item's life on the record.
How the protocol is designed to follow a device or sample from source to use.
01
Register
The item receives its identity at manufacture or collection.
02
Bind
That identity is bound to a custody record.
03
Ship
Custody moves with the item, not just the shipment.
04
Receive
The receiver and the item both sign the handoff.
05
Use
The point of use is recorded.
06
Return
A returned or reprocessed item is checked against its record.
07
Retire
The record closes when the item is used up, implanted or destroyed.
Biomedical handoffs use continuous custody mode: every transfer is designed to require both signatures before custody changes. No deferred settlement.
Limits
What NOANE does not do.
NOANE does not replace FDA unique device identification, the GUDID database, labeling rules or your quality system, and it is not a temperature sensor. A chip signature is not proof that a device is safe or effective, or that a sample is viable. NOANE is designed to supply custody evidence those programs can use.
There is no biomedical deployment today. This page describes the protocol design and the scope we are developing toward.
FAQ
Frequently asked.
Does NOANE replace the UDI?
No. The UDI stays on the label and in the GUDID. NOANE is designed to add a custody event alongside it.
Does NOANE make us compliant with FDA rules?
No. Compliance stays with your existing systems and processes. NOANE is designed to supply custody evidence they can use.
Does every item need a chip?
Not necessarily. A secure chip fits where an item's value or risk justifies it, such as implants, loaner instruments or critical samples. Scoping that is part of a pilot.
What about patient data?
The record is designed to bind items, roles and organizations without collecting patient data.
More answers on the FAQ and in the Glossary.
Sources: US FDA, UDI Basics (opens in new tab).
BIND IT.
Bring your category into the design cohort.
Research: NOANE Infrastructure Response Paper V2 · SSRN (opens in new tab) · DOI: 10.2139/ssrn.6736141 (opens in new tab)