As medical technology evolves, it brings new opportunities—and new legal considerations. A recent advancement in glaucoma management, the Belkin DirectSLT (DSLT) system, exemplifies how innovation can reshape both clinical practice and regulatory landscapes. This article provides a focused look at the Belkin DSLT system compared to traditional Selective Laser Trabeculoplasty (SLT), highlighting legal implications relevant to attorneys in healthcare, product liability, and regulatory compliance fields.
Traditional SLT treatments involve manual application of laser pulses through a gonioscopy lens placed on the patient’s cornea. Physicians must apply anesthetic eye drops, insert an eyelid speculum, and manually target the trabecular meshwork—the eye’s fluid drainage system. This procedure requires a high level of skill, with treatment times typically lasting 8 to 12 minutes per eye. Manufacturers of traditional SLT systems are required to demonstrate adherence to rigorous safety protocols, including mandatory use of accessories like speculums, under FDA-cleared usage guidelines.
In contrast, the Belkin DSLT system automates the process, using advanced eye-tracking to deliver 120 laser pulses directly through the cornea, without the need for a gonioscopy lens or manual aiming. The entire laser application phase takes just 1 to 2 seconds, with total procedural time under two minutes per eye. Importantly, the use of an eyelid speculum is optional, reflecting the non-contact, automated nature of the system.
From a legal perspective, several points merit attention:
1. Regulatory Compliance: Traditional SLT systems required FDA 510(k) clearance for a specific set of procedural steps and accessory use. DSLT systems, while still subject to FDA review, challenge traditional procedural assumptions, requiring new validation pathways. Traditional SLT systems can potentially apply existing technology to the limbal and perilimbal areas under the umbrella of off-label use. The manufacturers of conventional SLT systems will likely submit applications for FDA(k) clearance to overcome the designation of off-label use when their lasers are applied to the trabecular meshwork via an exterior approach. In the meantime, misbranding or off-label use risks exist if procedural variations are not clearly documented.
2. Product Liability: The shift to non-contact treatment reduces some procedural risks (e.g., corneal abrasion from a gonio lens) but introduces new ones (e.g., reliance on automated eye tracking). Attorneys advising manufacturers or medical institutions must consider how informed consent forms, risk disclosures, and device training materials should adapt to reflect these changing profiles.
3. Standard of Care Implications: If DSLT becomes more widely adopted, questions will arise about whether traditional SLT or DSLT represents the “standard of care” for particular patient groups. An argument may be made that both forms of treatment have equivalent efficacy and safety profiles. Early adopters must ensure that patient selection criteria, operator training, and documentation practices align with evolving clinical evidence to mitigate malpractice exposure.
4. Intellectual Property and Competition: The Belkin system’s departure from manual techniques may trigger IP disputes over novel targeting algorithms for alignment, safety features, or delivery mechanisms, requiring close monitoring of patent filings and competitive claims.
5. Accessibility and Medical Equity: DSLT’s simplicity opens access to broader practitioner pools, including general ophthalmologists in underserved regions. However, lower training thresholds may raise concerns about appropriate credentialing and liability for adverse outcomes. A great advantage is that the Belkin systems can potentially be used by trained technicians. In an age that needs greater access of glaucoma care to an increasing senior population, trained and certified technicians may be considered to provide DLST at lower cost. The safety and efficacy of the Belkin DSLT system warrants consideration as a technician-operable device.
In conclusion, the Belkin DirectSLT system illustrates how innovations in medical devices can reshape not only clinical workflows but also legal landscapes. Attorneys advising clients in healthcare innovation must stay attuned to shifts in regulatory compliance, liability exposure, and standards of care that accompany such transformative technologies.
As glaucoma affects millions worldwide, technologies like DSLT promise to improve access and outcomes—but they also demand a careful recalibration of legal frameworks to match the new realities of modern medicine.