Leading Personalized Prosthetic Arm Manufacturer

A startup manufacturing personalized, 3D-printed prosthetic arms faced compounding complexity as it scaled. Because every device is custom-built for an individual patient — tailored to their unique anatomy and specifications — no two builds follow the same sequence. Assembly technicians had to rely heavily on senior staff knowledge to navigate each order, creating a fragile, person-dependent process. In a Class I medical device environment, this also meant generating up to 20 pages of paper-based device history records (DHR) per unit to satisfy FDA traceability requirements. With assembly times running 3–5 days per arm and documentation overhead consuming additional capacity, the company's growth trajectory was constrained by operational throughput rather than demand.

The manufacturer deployed Tulip's no-code manufacturing platform to digitize its assembly workflow end-to-end. At the core were digital work instructions that pull each patient's custom build specification directly into the technician's interface — presenting interactive checklists and visual aids tailored to that order's components and revision level. IoT-connected sensors and device integrations enabled real-time data capture at each assembly step, feeding ALCOA+-compliant records directly into an electronic device history record (eDHR), eliminating the paper-based process entirely. Beyond assembly, the operations team used Tulip to replace their existing ERP with custom apps and Tables for BOM management and inventory tracking, then integrated the platform with their CRM (FreshSales) via Tulip Connectors to enable bidirectional order status communication — all built by an operations manager with no prior coding experience using Tulip's no-code editor.

Assembly time dropped from 3–5 days to 1–2 days per prosthetic arm, a roughly 50% reduction achieved without adding assembly headcount. The paper-based DHR process — previously up to 20 pages per device — was fully eliminated in favor of automated digital records.

• Assembly throughput: ~50% faster per unit, directly expanding capacity
• Documentation: 20-page paper DHR replaced with automated eDHR meeting ALCOA+ compliance standards
• Systems consolidation: ERP replaced by Tulip-native BOM and inventory management; CRM integrated for real-time order status visibility
• Error reduction: Interactive checklists and patient-specific digital guidance reduced the risk of costly mis-builds on custom, non-interchangeable components

• Patient-specific data must drive the workflow, not just inform it. Pulling custom build specs directly into work instructions at the point of assembly is what made the throughput gain possible.
• eDHR compliance is a forcing function, not a constraint. For Class I (and higher) medical devices, digitizing documentation from day one removes a major scaling bottleneck.
• Platform flexibility matters more than feature depth at this stage. A no-code tool that an operations manager could extend and modify in real time was more valuable than a rigid best-in-class ERP.
• System consolidation reduces fragmentation risk. Replacing disconnected CRM, ERP, and file-sharing workflows with a single connected platform improved both operational and customer-facing visibility.