Hydromer, Inc., a company with over 40 years of experience in hydrophilic, thromboresistant and antimicrobial coating technologies, has announced its expansion into manufacturing and supplying UV coating, curing and testing equipment. This strategic move allows the company to offer medical device manufacturers a comprehensive end-to-end solution by integrating its proprietary coatings and liners 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 is particularly important for medical device companies navigating complex regulatory landscapes while trying to maintain production efficiency.
Hydromer's expanded equipment platform includes several key components designed to enhance manufacturing processes. The hydrophilic coating equipment delivers uniform coating application and UV curing with minimal manual intervention. The automated high-throughput coating system is a modular configuration comprised of load, dip coating and UV curing workstations that can be operated by a single operator, increasing production rates while reducing reliance on manual labor. Additionally, the company is offering friction testing equipment designed for lubricity tests with precise and repeatable measurements to support 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 from primarily providing coating solutions to offering complete manufacturing systems. This development could potentially reshape how medical device manufacturers approach coating processes, particularly for companies seeking streamlined production methods that maintain compliance with stringent medical industry standards. The announcement was made through a press release available on www.newmediawire.com.
For medical device manufacturers, this expansion offers potential benefits including reduced technical barriers, faster time to market, and improved manufacturing consistency. The integration of coatings and equipment from a single supplier could simplify supply chains and quality assurance processes, particularly important for companies operating in multiple international markets. As medical device regulations continue to evolve globally, having an integrated solution that addresses both coating performance and manufacturing processes may provide competitive advantages in an increasingly complex industry landscape.
