Bringing a new medical device from concept to commercial release demands disciplined execution, regulatory alignment, and a manufacturing partner who can support rapid, reliable scale-up. As products become more complex and time-to-market pressures continue to rise, OEMs need an NPI framework that integrates design for manufacturability, risk management, validation planning, and cross-functional coordination from day one.
At EPTAM Precision, our dedicated Medical Device NPI program—led by Mary Jo Sysko, VP of Commercial Development—guides OEMs through every stage of development with structure, speed, and transparency. This comprehensive white paper explores:
Proven NPI frameworks for reducing risk and accelerating development Cross-functional practices that strengthen quality and manufacturability Strategies for smoother design transfer and scalable production across facilities
With seven U.S.-based manufacturing sites and deep experience launching complex Class II and III devices, EPTAM provides the technical depth, program discipline, and quality systems OEMs rely on to bring innovative products to market with confidence.
Looking ahead to your next device launch? Contact us today to see how EPTAM can help you build a faster, more reliable path from concept to commercialization.
EPTAM Precision
2 Riverside Business Park, Northfield NH 03276
+1 866-740-4782