Should you make it, or buy it?

AI-powered decision support for medical-device supply-chain analysts. Score any component against manufacturing capability and regulatory constraints. Batch your bill of materials. Export defensible analysis for procurement, quality, and regulatory affairs.

Analyze a component Upload a BOM
Make vs Buy

Medical Device Make vs Buy Analyzer

AI enabled tool for Supply Chain Analysts to leverage Manufacturing and Regulatory Data

Control every step of the supply chain — from raw materials and manufacturing to shipping and distribution — to maximize margins.
A vertical-integration principle attributed to Andrew Carnegie, late 1800s · paraphrased, not a direct quote
Bulk mode: upload Excel or CSV with columns: Manufacturer, Device, Volume
Batch Queue
Known Pricing Optional — populate any fields you already have
Device Characteristics Drives the Regulatory NRE estimate
The model pre-fills these from the device name when you run an analysis — you are the expert on your device, so confirm or correct them. They determine which 510(k) cost stages apply.
Patient-contactingTriggers biocompatibility (ISO 10993)
Provided sterileTriggers sterilization + shelf-life
Electrically poweredTriggers electrical safety + EMC
Contains softwareTriggers software V&V + cybersecurity
ImplantableEscalates biocompatibility scope
Small businessGross receipts ≤ $100M — reduced FDA fee

Enter device details above to begin

Or upload an Excel list for bulk analysis
Email RFQ to Supplier
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