Dr. Shane Pak co-founded Ruthless Spine with co-inventor Karlton Spindle and specializes in Spine Surgery of the neck and back at Pacific Orthopaedic Associates in Alhambra, California. HCB News spoke with him about his company’s innovative spinal navigation device, which is bringing greater accuracy and efficiency to spinal surgeries, with global implications.

HCB News: What challenges do traditional spinal navigation systems pose in resource-constrained hospitals?
Dr. Shane Pak: Traditional spinal navigation systems (TSN), while technologically advanced, are often impractical for smaller or resource-limited hospitals. These systems typically require large, dedicated spaces for installation and storage. Many community hospitals struggle to accommodate such bulky equipment in already crowded surgical suites. The financial burden is even greater—complete navigation systems can exceed $3 million in initial capital investment not accounting for ongoing maintenance and personnel. Beyond the purchase price, maintaining these systems and keeping staff trained and certified represents a recurring expense that smaller institutions can rarely afford. This creates a critical access gap: the hospitals most in need of precision-guided surgery often cannot afford the tools to provide it.


HCB News: How do these systems contribute to poor clinical outcomes?
SP: TSN is an improvement from freehand navigation, but a large number of case reports show that it still has step errors despite – or because of – its technological sophistication. For TSN to work effectively, different machines must interact seamlessly with each other even when not necessarily manufactured by the same company, and surgeons and staff must be highly skilled at navigating their layers of complexity. Because TSN uses pre-operative imaging, the image on the screen may not correlate perfectly with the patient’s intraoperative anatomy. These combined factors can lead to misplaced spinal implants, which compromise mechanical function and cause direct trauma to nearby nerves, blood vessels, or organs. Results include serious complications such as chronic back pain, limited mobility, neurological damage, or even failed back surgery syndrome (FBSS). When surgical outcomes fall short, patients often require revision surgery—an emotionally and physically taxing process. Revision procedures are not only riskier but significantly more expensive, with estimates suggesting they can add more than $50,000 to a patient’s healthcare costs. Although not all revision surgeries stem from implant misplacement, inaccurate screw placement is a known contributor to these adverse outcomes.

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