Hydromer, Inc., a company with over 40 years of experience in hydrophilic, thromboresistant and antimicrobial coating technologies, has 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 a comprehensive, end-to-end solution that integrates proprietary coatings with high-performance machinery.
The importance of this expansion lies in its potential to streamline medical device manufacturing processes while ensuring compliance with critical regulatory standards. By offering both coatings and the equipment to apply them, Hydromer addresses a significant challenge in the medical device industry: maintaining consistent quality while reducing time to market. 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).
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 is a modular configuration comprised of load, dip coating and UV curing workstations designed to be operated by a single operator, increasing production rates while reducing reliance on manual labor. The Friction Testing Equipment provides precise and repeatable measurements for lubricity tests 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 implications of this announcement extend across the global medical device manufacturing industry. Medical device companies now have access to a single-source solution that combines advanced coating technologies with the machinery needed for their application. This integration could lead to more efficient production processes, reduced validation timelines, and improved product consistency. For patients, this development may translate to more reliable medical devices reaching the market faster while maintaining the high safety standards required in healthcare applications.
The expansion represents a significant shift in Hydromer's business model, transforming the company from primarily a coating solutions provider to a comprehensive manufacturing partner. This move positions Hydromer to capture additional value in the medical device supply chain while addressing pain points that manufacturers face when implementing advanced coating technologies. The company's decades of experience in coating development and its existing compliance with standards including ISO 9001:2015, ISO 13485, and Good Manufacturing Practice provide a foundation for this equipment manufacturing venture.
Medical device manufacturers operating in highly regulated environments stand to benefit most from this development, particularly those seeking to implement hydrophilic coatings while maintaining strict quality control and documentation requirements. The availability of integrated solutions could lower barriers to adopting advanced coating technologies, potentially expanding their use across a broader range of medical devices. View the original release on https://www.newmediawire.com.
