Lumitex Highlights MedTech Quality & Regulatory Excellence in “Beyond the Light” Podcast

Cleveland, OH — December __, 2025 — Lumitex, a global leader in medical lighting solutions, today announced the release of a new episode of its Beyond the Light podcast, offering a rare behind-the-scenes look at how the company embeds quality and regulatory excellence into every phase of medical device lighting development.

In this episode, Director of Marketing, Lindsay Jankovic, sits down with Kim Tetuan, Director of Regulatory Affairs and Quality, for a candid conversation about the real work required to meet—and exceed—FDA expectations while accelerating speed-to-market for OEM partners.

Quality in medtech is often discussed as a requirement, but at Lumitex, it is a culture, a philosophy, and a technical discipline.

Key Themes From the Episode

1. Quality Is Not a Phase — It’s a Design Input
   Kim explains how Lumitex bakes regulatory considerations into programs from day one. By treating FDA expectations as foundational—not procedural—the team reduces risk, improves reliability, and strengthens device performance long before validation.
2. How Experience Reduces Regulatory Delays
   With decades of experience across surgical lighting, HMI backlighting, and phototherapy components, Lumitex applies lessons learned to anticipate potential failure points, identify documentation gaps early, and streamline submission pathways.
3. Cutting-Edge Systems That Ensure Speed + Safety
   Kim highlights the internal systems that allow Lumitex to deliver faster without compromising quality, including:

• • Phase-gated quality checkpoints

• • Automated traceability

• • Integrated risk-management frameworks
    
    
  • Cross-functional design reviews with engineering, quality, and regulatory teams
    
    

Why This Matters for the Future of Medical Lighting

As surgical and diagnostic environments demand higher reliability and tighter tolerances, lighting components must meet increasingly rigorous safety, electrical, and photobiological standards. High-performance lighting is no longer a peripheral feature — it’s a critical component of clinical outcomes.

“Every lighting solution we produce ultimately affects patient care,” said Tetuan. “Quality and regulatory strategy aren’t obstacles; they are the engine behind innovation.”

🎧 Listen to the Full Episode

Podcast + transcript:  https://www.lumitex.com/press-insights-lumitex