The VELYS robotic-assisted solution: a strategic technology evaluation informed through scoping review

Robot-assisted surgery (RAS) is increasingly utilized in arthroplasty, with emerging evidence suggesting potential benefits, however, the overall evidence base remains immature. Given the heterogeneity of available systems, device-specific evaluation is required. The VELYS Robotic-Assisted Solution (VRAS; Johnson & Johnson MedTech) is an imageless, semi-active robotic platform for knee arthroplasty. This study provides a structured strategic evaluation of VRAS aligned with the National Institute for Health and Care Excellence Early Value Assessment (EVA) and proposes a roadmap for future evidence generation. 16 relevant studies were identified in a systematic literature search, predominantly retrospective and lacking randomized controlled trials. Findings were synthesized using a strengths, weaknesses, opportunities, and threats framework, with subsequent analysis to inform strategic recommendations. Key strengths of VRAS include avoidance of pre-operative computed tomography imaging, integration with established implant systems, a relatively short learning curve, and early signals of improved short-term outcomes. Weaknesses center on the limited quality and maturity of the evidence base, absence of long-term outcome data, and system-specific design considerations such as lack of haptic feedback boundaries. Opportunities include reduced resource burden with imageless workflows and potential optimization of patient outcomes, while threats involve high capital costs, competition from more established RAS platforms, and the risk of unmet evidence requirements within defined timelines. Across EVA domains, evidence for patient-reported outcomes, cost-effectiveness, and long-term clinical benefit remains insufficient. High-quality, adequately powered studies, comprehensive health-economic analyses, and registry-linked longitudinal studies are essential to define the clinical and economic value of VRAS in light of the EVA.