Performance

The main testing approach was structured into four key evaluations:

1. Baseline Risk Assessment – Established the thermal hazards posed by an unprotected light cord.

2. Prototype Performance Testing – Measured LightLok’s effectiveness in temperature reduction and preventing burns.

3. Material Validation – Evaluated the thermal, mechanical, and biocompatibility properties of the chosen materials.

4. Manufacturing Feasibility – Assessed the effectiveness of 3D-printed prototypes and their transition to final production materials.

Next, LightLok’s ability to mitigate these thermal hazards was tested. The unit was attached to the light cord, and a series of controlled measurements were taken:

• Temperature Readings:

  • Each test began at full power and brightness

  • Placed the light cord and LightLok perpendicularly to the surgical drape. 

  • Using an accurate meat thermometer, the external temperature of the LightLok lens cap and sheath was measured over 10 minutes of continuous illumination in 30 second intervals (Fig. 15 & 16). 

  • The LightLok’s lens cap maintained a surface temperature of 47.5°C, a dramatic reduction from the original 262°C (Fig. 17).

• Material Interaction Testing:

  • The protected light cord tip was placed in direct contact with a surgical drape for ten minutes.

  • No visible scorching or ignition was observed, confirming the device’s effectiveness in preventing burns and thermal transfer.

Impact of LightLok

• Quality of Life - By preventing burns from fiber optic light cables, LightLok enhances patient safety and ensures that surgical staff can focus on the procedure without unnecessary distractions. The reduced risk of intraoperative injuries contributes to a more efficient workflow, leading to improved patient outcomes. Additionally, mitigating burn risks increases overall trust in healthcare systems, reassuring patients that all possible safety measures are in place during their procedures.

• Safety & Health - One of the most critical aspects of LightLok is its ability to reduce the likelihood of burn injuries, which have historically been a hazard in surgeries involving fiber optic light cables. By providing a physical barrier and diffusing heat effectively, it minimizes unintended thermal contact with both patients and staff. This directly enhances surgical safety, ensuring that procedures can be performed with fewer complications. Furthermore, preventing burns reduces the risk of secondary infections or prolonged recovery times, ultimately improving patient health and post-operative experiences.

• Reliability - Surgeons and operating room staff must often balance multiple responsibilities, and relying on manual vigilance to prevent light cord burns is not always feasible. LightLok provides a dependable solution that reduces human error and guarantees a consistent level of protection. This reliability translates to a lower likelihood of medical negligence claims, improving overall hospital efficiency and patient trust.

• Economic: Hospitals frequently face lawsuits and additional administrative burdens due to preventable surgical injuries. LightLok offers a highly cost-effective preventative measure, significantly reducing legal expenses and insurance liabilities. One of the biggest advantages of LightLok is its exceptionally low production cost, making it an affordable yet highly effective solution for burn prevention in surgical environments.

During the initial development phase, the Minimum Viable Product (MVP) cost approximately $12 per unit due to prototyping constraints, smaller-scale production, and higher material costs. However, through strategic material selection, optimized manufacturing techniques, and bulk production, the cost was successfully reduced to just $4.30 per unit, making LightLok significantly cheaper without compromising quality or performance.

The breakdown of the manufacturing cost per unit in bulk production is as follows:

• Fused Silica 12mm Diameter Lens – $1.00

• Spring Mechanism – $0.30

• Medical-Grade Polycarbonate – $3.00

With this drastic cost reduction, hospitals can implement LightLok at scale without financial concerns, ensuring widespread adoption for enhanced surgical safety. Given its ability to prevent costly malpractice claims, reduce patient burn-related complications, and lower post-surgical care expenses, the return on investment is substantial.

At only $4.30 per unit, LightLok is an incredibly affordable, life-saving solution that hospitals can adopt without hesitation. This low-cost, single-use design ensures that surgical teams can prioritize patient safety without adding financial burden to medical institutions.