A hardware-interlocked system for manufacturing a spinal fixation rod, comprising:
- a computing platform comprising one or more processors configured to calculate a stress state under physiologic loading conditions by executing a biomechanical simulation of a candidate spinal rod geometry, wherein the biomechanical simulation uses a digital twin model comprising distinct material property domains for cortical bone, cancellous bone, and intervertebral soft tissues derived from anatomical imaging data, wherein the computing platform is configured to determine whether the stress state satisfies a biomechanical stability criterion;
- wherein the computing platform is further configured to generate manufacturing instructions corresponding to the candidate spinal rod geometry in an encrypted format, the manufacturing instructions comprising G-code or vector coordinate data specifically formatted for a robotic rod-bending unit;
- wherein the computing platform is further configured to generate, within a Trusted Execution Environment (TEE) that is inaccessible to user-level software overrides, a decryption key only upon verifying that the stress state satisfies the biomechanical stability criterion, wherein the decryption key is derived from a cryptographic hash of a final validated stress tensor field;
- the robotic rod-bending unit comprising actuation motors;
- and
- hardware-interlocked control circuitry communicatively coupled to the computing platform and to the robotic rod-bending unit, the hardware-interlocked control circuitry comprising a hardware-interlocked execution module and a safety relay conforming to ISO 13849-1 Category 4, Performance Level e (PL e) standards;
- wherein the hardware-interlocked execution module is configured to:
- (a) receive the encrypted manufacturing instructions;
- (b) maintain a locked state, before receipt of the decryption key, by electrically de-energizing the safety relay so that the safety relay isolates a power supply from the actuation motors of the robotic rod-bending unit and physically prevents execution of the manufacturing instructions by the robotic rod-bending unit;
- (c) electronically suppress user input signals from a manufacturing actuation widget on a user interface while the hardware-interlocked execution module is in the locked state;
- and
- (d) transition from the locked state to an unlocked state only upon receipt of the decryption key, wherein the unlocked state allows execution of the manufacturing instructions by the robotic rod-bending unit.