Collaborative Development: Partnering with OEMs for Seamless Product Launches
- TN Plastics
- Nov 19
- 4 min read
In the competitive world of medical device manufacturing, the difference between market success and failure often comes down to one critical factor: the strength of your manufacturing partnership. At TN-plastics, we don't just manufacture components—we become an extension of our clients' teams, bringing decades of expertise, global resources, and unwavering commitment to collaborative development that ensures seamless product launches.
The Evolution of OEM Partnerships in Medical Device Manufacturing
The medical device industry has undergone a fundamental transformation in how OEMs approach manufacturing partnerships. Traditional transactional relationships have given way to strategic collaborations where manufacturers become integral partners in innovation, regulatory navigation, and commercial success.
Today's leading OEMs recognize that the right contract manufacturing partner brings far more than production capacity:
Deep technical expertise in design optimization and manufacturability
Regulatory compliance knowledge supporting faster approvals
Supply chain resilience minimizing development risks
Quality management systems ensuring consistent performance
Scalability supporting growth from prototype to high-volume production
TN-plastics is recognized as the highest quality among top medical OEMs and serves as a top supplier to multiple diagnostic suppliers, delivering comprehensive value through collaborative partnerships that accelerate innovation.
TN-plastics Collaborative Development Framework
Our approach to OEM partnerships is built on a foundation of transparency, shared accountability, and mutual success. We engage early, contribute proactively, and remain committed throughout the entire product lifecycle.
Early Engagement: The Foundation of Successful Launches
The most successful medical device launches begin with manufacturer engagement during concept development. Our team brings critical manufacturing insights that shape product design for optimal performance and producibility:
Design for Manufacturability (DFM) analysis identifying potential production challenges
Material selection guidance ensuring biocompatibility and processability
Tooling strategy development optimizing investment and timeline
Regulatory pathway consultation leveraging FDA registration experience
Cost optimization recommendations balancing performance and economics
Integrated Team Approach: One Team, One Goal
True collaboration requires breaking down organizational barriers. Our partnership model creates integrated project teams combining client and TN-plastics resources:
Dedicated project managers coordinating across organizations
Engineering teams collaborating on design optimization and validation
Quality personnel aligning on specifications and testing protocols
Regulatory specialists ensuring compliance throughout development
Operations teams planning production scale-up and supply chain readiness
Value-Added Engineering Services: Beyond Manufacturing
Our partnerships extend far beyond mold-making and production. TN-plastics provides comprehensive engineering services that add significant value throughout the development process.
Design Optimization and Problem-Solving
Our engineering team actively contributes to design excellence:
CAD modeling and simulation for flow analysis and cooling optimization
Tolerance analysis ensuring dimensional requirements are achievable
Assembly design input facilitating efficient downstream processes
Alternative material evaluation offering performance or cost advantages
Failure mode analysis identifying and mitigating potential quality risks
Regulatory and Quality Documentation Support
Our ISO 13485:2016 certification and FDA registration provide partners with comprehensive quality and regulatory support:
Design History File (DHF) documentation support
Complete validation services through IQ/OQ/PQ protocols
Material biocompatibility documentation and lot traceability
Quality agreement development defining responsibilities and standards
Audit readiness and regulatory inspection support
Validated Partnership Success: Real Results from Real Collaborations
Our track record of successful OEM partnerships speaks through documented achievements across multiple industries and applications.
Documented Success Metrics
TN-plastics has delivered measurable value to OEM partners:
Over 100 billion parts shipped throughout company history
Decades of partnership with the world's top medical OEMs
Production capacity ranging from 1 million to 50 million injection molded pieces annually
Plastic ball production capability up to 500 million pieces annually
FDA-registered facility with ISO 9001, ISO 13485, and ISO 14001 certifications
Class 6-8 compliant cleanroom capabilities for contamination-sensitive applications
Proven Application Expertise
TN-plastics supports OEM partners across diverse medical and diagnostic applications:
Point-of-care device specialists in diabetes, cardiology, blood filtration and management
Amino assay and PCR testing component manufacturing
Medical beads for diagnostic assays with specialized surface finishes
Precision plastic tubes, dishes, cartridges, and disposables for medical use
Robotics components enabling 20% weight reduction and 1.3x faster speeds
Eco-friendly plastic alternatives replacing steel in dispenser applications
Customer-Validated Partnership Benefits
Our OEM partners have validated the following benefits through their experiences with TN-plastics:
High quality with low downtime through in-house mold design capabilities
Reliable supply enabling consistent production schedules
Second-source manufacturing through global network reducing carbon footprint and transportation costs
Comprehensive validation services supporting regulatory submissions
Automation design and implementation improving efficiency and consistency
Global Partnership Advantages: Local Support, Global Capabilities
As part of the Tsubaki Nakashima global network with 20 plants across 10 countries, TN-plastics offers unique advantages that single-facility contract manufacturers cannot match.
Strategic Geographic Presence
Our facilities in Michigan (USA) and Mirandola, Italy provide:
Local production and support for North American and European markets
Reduced logistics costs and lead times compared to offshore alternatives
Proximity to major medical device innovation hubs and OEM headquarters
Regulatory familiarity with FDA (USA) and MDR (Europe) requirements
Cultural alignment and time-zone compatibility facilitating collaboration
Building Long-Term Partnership Value
The most successful OEM partnerships evolve and deepen over time. TN-plastics is committed to growing alongside our partners, supporting their success through multiple product generations and market expansions.
Continuous Improvement and Innovation
We invest continuously in capabilities that benefit our partners:
Advanced manufacturing technology and automation reducing costs
Process optimization initiatives improving quality and efficiency
Material science expertise enabling performance improvements
Regulatory intelligence supporting faster approvals
Sustainability initiatives including eco-friendly plastic alternatives
Why Choose TN-plastics as Your OEM Development Partner
Our collaborative approach delivers measurable advantages for medical device OEMs:
Over 100 years of manufacturing experience with proven excellence
Recognition as highest quality supplier among top medical OEMs
FDA-registered facilities with ISO 13485:2016, ISO 9001, and ISO 14001 certifications
Global Tsubaki Nakashima network providing supply chain security and technical support
Comprehensive capabilities from design support through high-volume production
Documented track record with over 100 billion parts shipped
Flexible capacity supporting projects from 1 million to 50 million pieces annually
At TN-plastics, collaboration isn't just a buzzword—it's how we work every day. From initial concept through commercial launch and beyond, we partner with OEMs to overcome challenges, accelerate timelines, and achieve market success. When your medical device innovation demands a manufacturing partner who will truly invest in your success, trust TN-plastics to deliver collaborative excellence backed by over a century of manufacturing expertise and proven results.
