EPTAM’s integrated MedTech manufacturing platform helps advance Class III cardiovascular device program from prototype through validated production.
NORTHFIELD, NH, UNITED STATES, July 28, 2026 /EINPresswire.com/ — EPTAM Precision Solutions announced the successful production launch and volume ramp of precision-manufactured components, sub-assemblies, and finished, packaged assemblies for a global MedTech leader. The program supports a device platform used in cardiovascular interventions and marks a significant expansion of EPTAM’s role as a contract manufacturing partner for Class III medical device programs.
The program drew on the breadth of EPTAM’s U.S. manufacturing network, integrating precision thermoplastic injection molding, laser engraving, ultrasonic welding, and final packaging and labeling through a single qualified EPTAM manufacturing platform. All work was performed within EPTAM’s ISO 13485:2016-certified quality system. EPTAM also provided engineering support throughout the program, including design-for-manufacturability guidance, ultrasonic weld joint verification, and quality inspection planning aligned with the regulatory requirements of a Class III device.
“At EPTAM, we understand the complexity of bringing a new product to market. Our New Product Introduction (NPI) process is designed to streamline the journey from concept to commercialization. This cardiovascular launch was supported by our systematic approach that ensured quality, efficiency, and innovation every step of the way,” said Mary Jo Sysko, VP Commercial Development, EPTAM Precision.
Scaling a Class III device program requires more than manufacturing capacity; it requires a partner that can support design maturity, maintain tight tolerances across complex geometries, and sustain quality through high-volume production. For this program, EPTAM navigated metal-on-metal mold shutoffs with no-scratch surface requirements, tight-tolerance molding across multiple components, and the engineering demands of developing and verifying a robust ultrasonic weld specification, translating a manufacturable design into a validated, scalable production process.
Production validations were completed in February 2026, with first shipments delivered in May 2026. The program is currently supporting U.S. market production. EPTAM’s involvement helped support improved manufacturability, scalable output, and a more consolidated supply model, strengthening the program’s long-term production foundation.
The scope of EPTAM’s role, spanning molding, laser processing, welding, and final packaging, enabled the global MedTech leader to consolidate critical manufacturing steps with EPTAM as a single-source manufacturing partner. This breadth, combined with EPTAM’s engineering support from early prototyping through validated production, provides a more resilient supply foundation as volume scales.
Across its U.S. manufacturing network, EPTAM continues to expand integrated capabilities in thermoplastic injection molding, liquid silicone rubber (LSR) molding, overmolding, precision machining of plastic and metal components, micromachining, laser cutting, and laser welding to support complex Class III programs designed for regulated scale-up.
Mary Jo Sysko
EPTAM Precision
+1 616-304-3843
msysko@eptam.com
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