SBE Medical

admin162025-09-10 22:34:12

Company Overview

SBE Medical Inc. is a veteran-owned small business headquartered in Comstock Park, Michigan. Founded in 2019, the company specializes in medical device specification development and contract manufacturing. With over 30 years of industry experience, SBE Medical adheres to ISO 13485:2016 standards and collaborates with healthcare professionals to transform innovative ideas into market-ready products. Its mission is to enhance patient outcomes through value-driven manufacturing and lifecycle support for medical devices.

Core Business & Key Technologies

SBE Medical focuses on medical device specification development and contract manufacturing. Its flagship product is the Tibbe™ External Urinary Device (EUD), designed to address the unmet needs of female patients. The Tibbe™ EUD features advanced design, user-friendly operation, and quality assurance, reducing the risk of catheter-associated urinary tract infections (CAUTIs). It provides a better fit, broader coverage, enhanced flexibility and comfort, reduced emotional distress, and ease of removal, while offering convenience for nurses and medical staff. Its advanced adhesive technology extends USAbility over days, unlike traditional options that leak, require suction, or restrict mobility.

Market Position & Flagship Products

The Tibbe™ EUD is a pioneering product in female urinary healthcare. Approximately 15–25% of hospitalized patients and 5–10% of nursing home residents use indwelling catheters, with females representing the majority. The Tibbe™ EUD provides a comfortable, clean, external alternative, helping minimize CAUTI risk and improve patient outcomes.

Recent Developments

In September 2025, SBE Medical partnered with Medbio to finalize the Tibbe™ EUD design and prepare it for commercialization. Medbio assisted with molding, assembly, packaging, and cost reduction, enabling a U.S.-based supply chain and mass production readiness.

Quality Commitment

SBE Medical follows a rigorous Quality Management System to ensure compliance with regulatory standards. Processes include document control, risk management, supplier evaluation, and product realization, guaranteeing high quality and patient safety.

Applications

The Tibbe™ EUD is suitable for hospitals, clinics, and home care environments. It offers patients convenience, ease of use, and a dignified alternative to traditional catheters.

Leadership Team

The company is led by CEO Dan Byers, alongside Nicholas Borgdorff. The team brings extensive experience in medical device manufacturing and development.