Brain-computer interface commercialization.

BACKGROUND: Brain-computer interfaces (BCIs) have emerged as powerful tools to restore neurological function lost due to injury or degeneration. Despite scientific advancements, successful commercialization remains challenging. This article analyzes two rehabilitative BCIs—the Argus II retinal prosthesis by Second Sight and the ARC-IM spinal cord stimulation system by Onward Medical—as case studies to highlight critical factors influencing their commercialization outcomes. MAIN TEXT: The Argus II, initially heralded as groundbreaking, restored partial vision to patients blinded by retinitis pigmentosa through direct retinal stimulation. Despite clinical success and initial regulatory approvals leveraging reduced barriers via humanitarian device exemptions, it struggled commercially due to an insufficient patient population, prohibitive manufacturing costs, and high procedural and postoperative rehabilitation costs. Physician adoption barriers, driven by the unfamiliar surgical procedure and reimbursement challenges, further limited its scalability, ultimately leading to market withdrawal. Conversely, Onward Medical adopted a phased commercialization approach with its ARC systems targeting spinal cord injuries. Initially releasing the non-invasive ARC-EX device, Onward built clinical traction and provider relationships, strategically fostering familiarity to minimize early risk and regulatory burden. Leveraging established spinal cord stimulation technology widely familiar to physicians, Onward positioned its invasive ARC-IM system more favorably for broader adoption. Despite remaining challenges, such as surgical complexity, postoperative rehabilitation infrastructure, and cost, this methodical strategy may significantly mitigate commercial and clinical barriers. CONCLUSION: Comparative analysis of Argus II and ARC-IM underscores that thoughtful commercialization strategies emphasizing phased product introduction, leveraging predicate technologies, and aligning closely with established clinical practices are essential to translating BCI technologies from scientific milestones into sustainable clinical solutions.