ImplantChain
Surgical Implant Tracking
Surgical-grade traceability for every implant, every patient.
ImplantChain connects every participant in the surgical implant supply chain — manufacturer, distributor, hospital, OR nurse, infection prevention team, and regulator — on a single, shared, tamper-proof blockchain ledger. Every device is tracked from the manufacturing facility to the patient's body.
When the FDA issues a Class I recall, hospitals must identify every patient with that device implanted immediately. Today that process takes 3–7 days of manual cross-referencing. ImplantChain makes it one second. Every lot is traceable, every implant event is permanently recorded, and recall response that takes days today takes one query.
Launch Interactive Demo
Click to activate · ImplantChain walkthrough
Recall Response Time
1 Second
Today's Reality
3–7 Days
Regulatory Frameworks
8 Covered
MVP Status
✅ Live
Logic Layer
Manufacturer
Lot created on-chain — requires valid FDA clearance + ISO 13485 cert enforced by smart contract
Distributor / Rep
Consignment records placed at specific hospital locations with real-time inventory visibility
Hospital Supply
Live consignment dashboard with low-stock alerts and backorder visibility — no rep calls needed
OR Nurse
UDI barcode scan auto-populates lot/serial; implant record on blockchain within seconds
Infection Prevention
Query any lot → instant patient list with body location, procedure date, serial number → CSV export
FDA / Regulatory Authority
Register medical devices with full FDA UDI-DI identifiers. Issue and manage 510(k) and PMA clearances. Issue and revoke ISO 13485 manufacturing certificates. Initiate Class I/II/III recalls with immediate effect across the entire network.
Manufacturer
Create production lot records linked to a valid FDA clearance and ISO 13485 certificate — both validated by the smart contract before any lot can be created. QC release lots and flag backorders with estimated resupply dates visible immediately to all downstream participants.
Distributor / Device Rep
Create consignment records placing specific lots at specific hospital locations (OR Suite 1, Spine Cart, Cardiac OR). Real-time inventory usage visibility across all accounts. Instant billing trigger when a device is implanted — no more manual reconciliation.
Hospital Supply Chain
Real-time consignment inventory view across all hospital locations. Automatic low-stock alerts below 20%. Backorder and recall alerts — all without calling a rep or counting a tray.
OR Nurse
Fast UDI scan interface — point a Bluetooth barcode scanner at device packaging, lot and serial number auto-populate. Add patient ID, procedure type, and body location. Complete implant record on the blockchain within seconds of implantation.
Infection Prevention / Risk Management
Enter a lot number and instantly see every patient with a device from that lot implanted — patient ID, hospital, procedure, body location, date, serial number. Export to CSV for immediate notification. What takes 3–7 days today takes one second.
UDI compliance built in
Every device registered with its FDA UDI-DI. Every lot captures the Production Identifier (PI) — lot number, serial number, manufacture date, expiry date. The GS1 UDI standard the FDA mandates, read and recorded automatically.
Consignment model support
Built around how the medical device industry actually works — rep-owned inventory on consignment at hospitals. Tracks ownership, location, and usage of consigned inventory in real time. No hospital has a system that does this today.
Dual-gate compliance enforcement
A lot cannot be created unless the manufacturer has both a valid FDA clearance for that device AND a valid ISO 13485 certificate. Enforced in the smart contract — cannot be bypassed by the UI or the API.
EPCIS 2.0 event chain
Every supply chain event recorded in GS1 EPCIS 2.0 format. Commission → Quality Release → Consign → Implant → Explant → Recall. Complete, auditable, tamper-proof.
Explant tracking
When a device is removed — revision surgery, infection, recall, malfunction — the explant event is recorded with reason and device disposition. Critical for post-market surveillance and FDA Medical Device Reports (MDR).
Tamper-proof audit trail
Every transaction cryptographically signed with the identity of the person who performed it. Records cannot be altered, backdated, or deleted. In device liability litigation arising 10–15 years post-implantation, this is the difference between defendable records and discoverable gaps.
Device registration, lot tracking, consignment model, implant/explant recording, recall management, public verification.
Full FDA UDI support, ISO 13485 tracking, EPCIS 2.0 events, infection prevention recall query, OR nurse scan interface, supply chain inventory dashboard, cloud deployment.
Multi-organisation Fabric network (separate peers per hospital/manufacturer), Epic/Cerner HL7 FHIR integration, 21 CFR Part 11 validation, pseudonymous patient IDs (HIPAA), monitoring and alerting.
Mobile app for OR nurses, manufacturer ERP integration (SAP/Oracle), FDA MedWatch adverse event reporting, post-market surveillance analytics, IoT environmental monitoring for temperature-sensitive devices.
Want to see ImplantChain in action? We run guided walkthroughs tailored to your organisation — access to a live environment is provided on request.
Request a DemoPre-loaded with real devices from the FDA Global Unique Device Identification Database (GUDID)