Hydromer, Inc., a leader in hydrophilic, thromboresistant and antimicrobial coating technologies, announced its expansion into the manufacturing and global supply of UV coating, curing and testing equipment. This strategic move allows the company to provide medical device manufacturers with comprehensive, end-to-end solutions by integrating proprietary coatings with high-performance machinery.
The integrated platform enables manufacturers to correlate process parameters directly with performance outcomes, supporting compliance with ISO 13485 and FDA Quality System Regulations (21 CFR Part 820). This development addresses critical needs in medical device manufacturing where consistency, quality control, and regulatory compliance are paramount.
Hydromer's expanded equipment platform includes three key systems. The Hydrophilic Coating Equipment delivers uniform coating application and UV curing with minimal manual intervention. The Automated High-Throughput Coating System features a modular design with load, dip coating and UV curing workstations, operating with a single operator to increase production rates while reducing reliance on manual labor. The Friction Testing Equipment provides precise and repeatable measurements for lubricity tests, supporting performance evaluation and quality control.
"Hydromer has long been focused on coating performance and manufacturing consistency," said Michael Torti, CEO of Hydromer. "By manufacturing and supplying the equipment used to apply our industry-leading hydrophilic coatings, we eliminate technical barriers and help our clients reduce time to market while maintaining the highest standards of quality and regulatory confidence."
The expansion represents a significant shift in Hydromer's business model, moving beyond coating formulations to encompass the entire manufacturing ecosystem. This vertical integration allows the company to control more aspects of the coating application process, potentially leading to more consistent results for medical device manufacturers. The equipment manufacturing capability positions Hydromer as a more comprehensive solutions provider in the competitive medical device coatings market.
For medical device manufacturers, this development could translate to reduced implementation timelines, as they can now source both coatings and application equipment from a single provider. The integrated approach may also simplify validation processes and documentation requirements under regulatory frameworks. The availability of testing equipment alongside application systems creates a closed-loop quality assurance system that could enhance product reliability and manufacturing efficiency.
The global medical device coatings market continues to grow, driven by increasing demand for advanced medical devices and stricter regulatory requirements. Hydromer's expansion into equipment manufacturing positions the company to capture additional value in this expanding market while addressing manufacturers' needs for streamlined, compliant production processes. The company's decades of experience in coating technologies provides a foundation for this equipment expansion, potentially offering manufacturers greater confidence in system performance and reliability.
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