a SMART Knee isn’t just an implant — it’s a cyber-physical system of systems. Only a digital thread can hold together its hardware, software, requirements, and tests with the rigor that patient safety demands
Presentation

Digital Threads for a SMART Knee System: Advancing Orthopedic Innovation Through Connected Data and Intelligence

April 9, 2025

Manas Bajaj

Intercax

Kristina Carroll

Studio SE, Ltd.

A SMART Knee System is a digitally enhanced orthopedic solution designed to improve knee joint performance, often used in knee replacement surgery, rehabilitation, or performance monitoring. It is a cyber-physical system-of-systems including hardware, software, data, communication, and apps that need to be developed and managed using collaborative and integrated digital engineering best practices. This presentation will showcase a practical example of a SMART Knee architectural model using SysML in Cameo and its integration with hardware models (CAD/PLM), software modules (SCM/ALM), project tasks, requirements, simulations, and verification models, all configuration-managed in different enterprise tools. This presentation will cover approaches for leveraging the SMART Knee digital thread for system-of-system analyses, data traceability, regulatory and security compliance, data integrity, and incident tracking, all of which are key aspects for healthcare systems and medical devices.

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