Our hybrid-layered surgical navigation system for spine integrates optical trackers, imaging modalities, and sterile instrument interfaces into a modular platform. Systems integration consolidates hardware (trackers, computers), firmware for real-time navigation and planning, registration, and gap-assessment modules via a CI/CD-driven release process. Systems engineering establishes traceability from clinical requirements to design features and verification under ISO 13485, IEC 60601-1, and ASTM F2554. Calibration routines—including landmark, surface ensure sub-2 mm accuracy validated via phantom and cadaveric trials. Product management synchronizes VOC workshops, KOL engagements, TRL-based milestones, pilot deployments, and regulatory submissions to guarantee timely delivery.

Primary Themes:

• Hybrid optical + imaging fusion
• CI/CD‑released planning & registration modules
• Phantom + cadaver accuracy validation
• VOC workshops & pilot deployments

Our semi-autonomous robotic assistance system for spine surgery integrates with the navigation platform via quick-change interfaces and modular connectors. Systems integration aligns robotic kinematics, optical tracking, and control firmware within a layered architecture. Systems engineering defines safety interlocks, force/torque sensor thresholds, and haptic boundary limits, verified via cadaveric trials under ISO 13485 and IEC 60601-1. Hand-eye calibration routines and tool-tip pivot calibrations deliver repeatability. Product management drives VOC workshops, TRL-centric development sprints, pilot deployments, and CDSCO submissions, coordinating budgets, timelines, and infrastructure preparation. A CI/CD pipeline orchestrates releases across planning, control, and UI components.
 

Primary Themes:

• Robot–navigation integration
• Safety interlocks & fault detection
• Kinematic repeatability
• TRL‑centric sprints to CDSCO filing
   

Cadaveric Evaluation – M. S. Ramaiah Medical College, Bengaluru
FIRST CADAVER EVALUATION · NOV 2024

Our team and site surgeons completed the first cadaver study, focusing on pre-op CT planning and post-op CT verification.

1. Successful import of multi-level plans to navigation console
2. Robotic drilling achieved target vectors on first pass
3. Post-op CT shows screws centred within pedicles (Grade-A on visual review)
4. OR staff trained on quick-change docking & sterile workflows in < 10 min

Recent Cadaveric Evaluation – Saveetha Medical College, Chennai
22 pedicle screws placed · 95 % Grade-A accuracy

A cadaveric study was conducted at Saveetha Institute of Medical & Technical Sciences in February 2025, and the full Navigation + Robotic Assistance Workflow was exercised on thoracic and lumbar levels in live OR conditions:

1. Plan - Pre-op CT defines each pedicle trajectory; routes are exported to the navigation console.
2. Guide - Under optical tracking, the robot drills every path with repeatability.
3. Place - Screws are advanced over K-wires in live-guidance mode, yielding 21 Grade-A and 1 Grade-B placements.
4. Verify - A final C-arm check confirms Grade-A alignment while keeping exposure below three shots per level.