In the fast-evolving medical device landscape, the ability to bring innovative products to market quickly and compliantly is essential. For Original Equipment Manufacturers (OEMs), selecting a contract manufacturing partner with a disciplined, proven New Product Introduction (NPI) framework can mean the difference between a successful launch and costly delays. At EPTAM Precision, with eight advanced U.S.-based facilities, our NPI program, led by Mary Jo Sysko, VP of Commercial Development, enables seamless transitions from concept to commercialization.
This white paper outlines the best practices in NPI for contract manufacturers and the OEMs they support, and details how EPTAM’s structured, cross-functional approach reduces risk, accelerates development, and ensures market readiness.
The Importance of an NPI Framework in MedTech
In an industry governed by stringent regulations and fast-paced innovation, a strong NPI framework ensures that medical devices are safe, effective, and brought to market efficiently. With FDA regulations (21 CFR Part 820), ISO 13485:2016 compliance, and increasing scrutiny over traceability and validation, OEMs must adopt a methodical approach to development.
Additionally, product complexity is rising. Devices are smaller, more interconnected, and often combine mechanical, electrical, and software elements. Meanwhile, market pressures demand shorter product life cycles. A robust NPI program mitigates regulatory, design, and production risks early—reducing costs, ensuring design intent, and accelerating time to market.
For OEMs, the right contract manufacturer becomes an extension of their development team, embedding compliance and manufacturability into every step.
EPTAM’s NPI Center of Excellence
Led by Mary Jo Sysko, EPTAM’s VP of Commercial Development, the NPI Center of Excellence brings deep industry insight and rigorous execution across our eight manufacturing sites. The team’s mission is to streamline the path from innovation to production with discipline, transparency, and speed
The Center of Excellence employs a hub-and-spoke model—centralized NPI leadership with site-specific execution teams. Weekly program reviews, standardized phase gate checkpoints, and real-time reporting tools ensure that every project stays aligned.
Key strengths include:
- Cross-functional expertise in engineering, quality, supply chain, and automation.
- Integrated quality planning and early design input.
- Strong customer onboarding protocols.
- Experience across hundreds of complex, highly regulated device launches.
EPTAM’s 5-Phase NPI Methodology
At each phase, progression is formally reviewed by a cross-functional Decision Gate Committee to ensure alignment with business goals, compliance, and project performance.
1. Kickoff & Chartering
Initiate program based on customer award. Define scope, assign project leadership, and establish baseline assumptions and risk factors. Create a formal project charter.
- Conduct internal handoff between Business Development and Project Management.
- Define customer requirements, part numbers, forecasts, and assumptions.
- Assign cross-functional team roles and responsibilities.
- Establish initial project goals, risk profile, and communication plan.
- Launch project in EPTAM’s centralized program management system.
- Hold formal Decision Gate review to authorize full project start.
2. Planning
Align cross-functional teams on resource plans, facility needs, tooling, materials, and project milestones. Develop risk registers and communication plans. Prepare for validation and early builds.
- Define capital equipment and facility requirements.
- Integrate project into site capacity planning.
- Align on supplier readiness and initiate sourcing activities.
- Initiate Design for Manufacturability (DFM) reviews.
- Develop quality, staffing, and material readiness plans.
- Build a resource-loaded timeline with risk-based countermeasures.
- Establish baseline KPIs and identify scope changes if applicable.
3. Development
Execute process planning, layout design, PFMEA, and validation protocols. Install equipment, develop manufacturing and inspection documents, and prepare for process qualification.
- Finalize process flow diagrams, inspection plans, and work instructions.
- Procure and install equipment, tooling, and fixtures.
- Create component specifications and metrology requirements.
- Perform incoming material qualifications and safety assessments.
- Draft validation protocols (IQ, OQ, PQ) and align with customer input.
- Begin staff training and internal documentation reviews.
- Monitor and update project risks, scope, and timeline as needed.
4. Validation
Complete installation (IQ), operational (OQ), and performance qualifications (PQ). Finalize training, documentation, and regulatory readiness. Deliver first articles for customer review.
- Complete final calibration, equipment qualification, and validation reports.
- Execute First Article Inspection (FAI) and document regulatory compliance.
- Finalize Device Master Record, traceability plans, and QA release processes.
- Conduct hiring and training for the production team.
- Ensure material traceability and system alignment for production launch.
- Confirm customer acceptance of validation builds and readiness for go-live.
5. Launch & Handoff
Transition ownership from project to operations. Track key performance metrics, close out risks, and document lessons learned. Validate supply continuity and long-term sustainment.
- Transfer process ownership to operations and quality control teams.
- Confirm alignment on supply chain, manufacturing, and regulatory readiness.
- Monitor post-launch metrics including scrap, yield, and throughput.
- Complete close-out of project risks and open actions.
- Document lessons learned for continuous improvement.
- Finalize long-term quality and commercial agreements as needed.
Capabilities and Technologies That Enable NPI Success
EPTAM’s technical breadth enables seamless scalability and faster time-to-market for complex devices.
These include:
- Plastics Machining: Expertise in high-performance medical polymers like PEEK, PPSU, and UHMWPE for implantables and surgical components.
- Metal Machining: Precision CNC machining of titanium, cobalt-chrome, and stainless alloys for implants, spinal fixation, housings, and surgical instruments.
- Liquid Silicone Rubber (LSR): ISO Class 7 cleanroom molding with advanced overmolding for drug delivery and diagnostics.
- Laser Processing: High-precision cutting, drilling, welding, and marking for guidewires, hypotubes, and delivery systems.
- Micro-Machining: Micron-level precision for MIS, RAS, and structural heart devices, enabling complex geometries and consistent performance.
- Automation Integration: Custom automation strategies that improve consistency, reduce cycle times, and enable lights-out manufacturing where applicable.
- Secondary Operations: Cell-based, lean manufacturing supported by cleaning, color anodization, passivation, and both sterile and non-sterile packaging.
- Rapid Prototyping: Quick-turn development capabilities for iterative product refinement and faster design feedback loops.
- Material Selection Expertise: Guidance on balancing biocompatibility, performance, regulatory compliance, and cost to ensure optimal material choices.
- Full-Scale Manufacturing Support: Infrastructure, staffing, and quality systems that support smooth ramp-up from pilot to full-rate production.
- Post-Launch Technical Support: Infrastructure, staffing, and quality systems that enable smooth, reliable ramp-up from pilot builds to full-scale production.
Industries We Serve
EPTAM supports top-tier OEMs across a range of high-growth medical sectors, offering precision manufacturing, regulatory alignment, and scalable production from prototype through commercialization. Our domain expertise allows us to serve as both a manufacturing partner and technical problem-solver throughout the product lifecycle.
Our expertise spans:
- Orthopedic Spine & Trauma: Components for joint replacement systems, fixation hardware, spinal spacers, and bone plates made from titanium, stainless steel, and PEEK, including trauma implants such as humeral and radius plates and screws.
- Interventional & Structural Heart: Ultra-precise components for catheter-based cardiovascular procedures, including vascular, congenital, and structural heart devices, supporting valve delivery platforms and structural heart implants.
- Robotic-Assisted Surgery: End effectors, actuation elements, and miniature assemblies enabling precise, sensor-integrated surgical tools, with validated, scalable manufacturing.
- Minimally Invasive Surgery (MIS): Tight-tolerance laparoscopic and endoscopic tools, including graspers, cutters, electro-cautery, vessel sealers, and implants, with support for disposable and reusable devices.
- Molecular Diagnostics & Life Sciences: Plastic and metal components for test cartridges, assay plates, micro-fluidics, and diagnostic components for biopharma, R&D, and point-of-care testing.
- Biopharmaceutical Delivery Systems: Enclosures, pump housings, and combination device components manufactured in cleanroom settings, maintaining biocompatibility and dimensional integrity.
- Implantable Devices: High-precision machining and molding of implantable-grade polymers and metals for spine, sports medicine, and cardiovascular use, with sterile processing protocols.
Best Practices for OEMs Working with Contract Manufacturers
Successful New Product Introduction (NPI) programs depend on more than technical execution—they require active, aligned collaboration between OEMs and contract manufacturing partners. To keep launches on track and compliant, consider these strategies:
- Engage Early: Involve your manufacturing partner during the design feasibility phase to enable DFM input, tooling planning, and early identification of regulatory or material risks.
- Define Scope Clearly: Set clear expectations around deliverables, tolerances, volumes, and timelines to reduce change orders, delays, and confusion.
- Maintain Documentation Discipline: Use revision-controlled CAD files, BOMs, specifications, and test protocols to support traceability, compliance, and design transfer.
- Use Structured Communication: Establish regular project reviews, dashboards, and issue-tracking tools to keep teams synchronized and resolve blockers quickly.
- Foster Agility with Accountability: Partner with organizations that can iterate quickly while maintaining rigorous controls and documentation.
- Prioritize Risk Management: Run joint PFMEA sessions and create aligned control plans to address potential failure modes early.
- Process Validation: Use comprehensive validation support (IQ/OQ/PQ, PPAP, Gauge R&R, SPC) to ensure stable, compliant, repeatable manufacturing.
- Leverage Digital Systems: Implement eQMS, MES, and ERP tools for real-time visibility and streamlined compliance across facilities.
By building the right foundation of communication, planning, and shared accountability, OEMs can accelerate NPI timelines, control risk, and increase their likelihood of a smooth and successful product launch. Choosing a manufacturing partner who actively enables these best practices can make all the difference.
Case Studies and Outcomes
Each outcome shows what’s possible when NPI is driven by speed, precision, and purpose. From surgical platforms to implants and drug delivery, EPTAM helps OEMs launch with confidence.
- Micro-Machining – Inner Body Spacer
A customer had completed an Alpha launch with a supplier unable to support their production ramp. EPTAM partnered early to identify manufacturing improvements, stabilize the process, and accelerate time to market while ensuring scalable volume capability.
→ Outcome: Accelerated design transfer and full production volumes achieved ahead of schedule. - Metal Machining – Trauma Implantable
An orthopedic OEM engaged EPTAM to advance the design and development of a trauma implant. Through iterative technical development, engineering samples, and targeted DFM feedback, EPTAM supported the customer through design maturation and design freeze.
→ Outcome: Customer completed a successful commercial launch while meeting performance goals and beating target pricing. - Liquid Silicone Rubber – Treatment for Calcified Arterial Disease
EPTAM partnered with the OEM early in the development phase of their ultrasonic pressure-wave system for fracturing calcified plaque. The customer needed to reduce cycle time and scrap, and their legacy glued assembly limited throughput and consistency. EPTAM identified and validated an overmolding solution that simplified production 10% and improved reliability.
→ Outcome: 4× reduction in cycle time and significantly reduced scrap, enabling a stronger, more scalable production process. - Liquid Silicone Rubber – Blood Transfer device
A customer faced high scrap rates and inconsistent quality from an overseas supplier. EPTAM collaborated with their engineering team to provide DFM recommendations and transitioned the design to injection molding, improving manufacturability and long-term stability.
→ Outcome: Product now exceeds quality expectations with negligible scrap and dependable, scalable capacity. - Precision Molding – Surgical Evacuation System
To support a late-stage development effort, EPTAM coordinated multiple capabilities across several facilities and delivered design samples for test builds. Feedback from these builds informed mold-design refinements that improved processing efficiency and achieved aggressive cost targets.
→ Outcome: Successful product launch, with automated operations helping the customer meet an aggressive launch schedule while beating pricing goals.
A Smarter Path from Concept to Commercialization
To lead in today’s medical device market, OEMs must treat New Product Introduction (NPI) as a strategic discipline. NPI excellence integrates design for manufacturability, regulatory alignment, rapid iteration, and cross-functional execution while accelerating speed to market without compromising quality.
EPTAM Precision delivers this level of execution through a dedicated NPI team, led by Mary Jo Sysko, providing agility, discipline, and accountability from early concept through full-scale production. With U.S.-based manufacturing sites, deep domain expertise, and proven success with complex Class II and III devices, EPTAM serves as a strategic partner for bringing innovations to life.
© EPTAM Precision 12/09/2025
Acknowledgments
This white paper was co-authored by Jim Hofer, Operations Support, and Mary Jo Sysko, Vice President of Commercial Development at EPTAM Precision. The Commercial, Engineering, and Product Management teams contributed expertise across research, development, and regulatory activities.
| Certifications (At the time of publishing December, 2025) |
| ISO:13485:2016 Certified |
| ISO 9001:2015 Certified |
| FDA #3005144609 Registered |
| 21 CFR 820 Compliant |
| CAGE Code: 1TYA1 |
| ITAR, DDT Registered |
| FDA #3011302692 (West/Metals) |