Mike Kerns

Mike Kerns is a Senior Design Engineer at Lumitex, where his first role was focused on the company’s line of phototherapy products. Today, Mike serves as the team lead for Lumitex’s R&D engineering group, striving to apply Lumitex’s light delivery expertise to new medical device applications.  

Recent Posts

Lumitex Advances Engineering-Driven Innovation to Support Complex Medical Device Lighting Applications

Posted by Mike Kerns

Cleveland, Ohio (February 20, 2025) — Lumitex, a trusted partner in medical lighting solutions, continues to strengthen its engineering-driven innovation culture to support the growing complexity of lighting applications across the medical device landscape.

As lighting plays an increasingly critical role in device usability, therapy delivery and clinical outcomes, Lumitex has built an environment where innovation is embedded into the development process, not treated as a downstream activity. Medical device lighting refers to illumination technologies integrated into medical equipment to support usability, safety and clinical performance across diagnostic, therapeutic, and surgical applications.

The company’s approach emphasizes early technical exploration, cross-functional collaboration and disciplined risk management to help customers move from concept to production with confidence.

At Lumitex, innovation is driven by how teams think and work together. The company intentionally creates an environment where engineers are encouraged to challenge assumptions, identify risks early and design lighting solutions that perform reliably in real clinical environments.

Engineering Culture Designed for Medical Device Lighting Innovation
Lumitex’s engineering model is intentionally structured to meet the demands of medical devices, where performance, reliability and compliance must coexist. These practices align with the expectations of regulated medical device development environments. Key elements include:

Psychological safety and technical curiosity, enabling open discussion of design tradeoffs and early identification of potential failure modes

Cross-functional collaboration, integrating optics, thermal management, materials, electrical design and human factors

Early-stage risk identification, reducing downstream delays during verification, validation and regulatory review

Continuous customer feedback loops, ensuring lighting solutions align with clinician needs and OEM system requirements

This foundation allows Lumitex to support a wide range of medical lighting applications — from capital equipment to wearable and in-cavity devices — where lighting is tightly integrated into overall system performance.

Guided by its mission to Improve Life with Light, Lumitex remains committed to advancing medical lighting solutions that enable safer procedures, more effective therapies and better patient outcomes.

FAQ 
What is psychological safety in medtech engineering?
A collaborative environment where team members can propose ideas, identify risks and explore alternatives without fear of criticism.

Why does collaboration matter for medical device lighting development?
Lighting interacts with optics, electronics, human factors, sterilization and regulatory requirements. Collaboration ensures solutions meet real clinical needs.

How does quality engineering support innovation?
Strong quality systems prevent late-stage failures, reduce regulatory delays and support faster iteration cycles.

Listen to the Full Episode
Podcast + transcript: https://www.lumitex.com/press-insights-lumitex

Success Stories
https://www.lumitex.com/success-stories-update

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

Posted by Mike Kerns

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

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