Capabilities

Capabilities for
Any Challenge

We blend manufacturing innovation with technical and engineering design expertise to offer a unique set of capabilities. From in-house product and mold development, contract manufacturing on state-of-the-art injection and blow molding machines, to high-speed automation and assembly, we’ve got you covered!

The Manufacturing Platforms and
Technical Resources You Need

We possess a unique set of mixed manufacturing platforms and a deep bench of technical resources to help you unlock growth!

Full-service Design and Development
  • Upstream project involvement with Ideation and Innovation
  • Product and Mold Design and Development including:
    • Design to Value (DTV)
    • Design for Manufacturability (DFM)
    • Design for Assembly (DFA)
  • Process Development and Technology Transfer
  • Creation of Samples for qualification
  • Small lot production for clinical trials and limited market launch
Proactive Program Management
  • Structured Project Management Stage Gate Process
  • Single Point of Contact & Accountability
  • Timely Communication to Key Stakeholders (includes Timelines, Milestones and Value/Cost considerations)
  • Breadth of Molding Knowledge
"Easy To Do Business With"
  • Dedicated account teams providing clear and proactive contact
  • Active partnership and service commitment
  • Reliable, proactive, agile and responsive work style that fulfills projects on time, to specification and without hassle to help you succeed.
Rigorous Regulatory Compliance
and Quality Control

Strict adherence to regulatory requirements

  • ISO 13485:2016 and ISO 9001:2015
  • FDA Registration at multiple sites
  • FDA Class I, Class II Medical Device & Component Manufacturer
  • FDA 21 CFR 820 cGMP (Current Good Manufacturing Practices)
  • FDA DMF (Drug Master File)
  • EU MDR 2017/ 745 Compliance
  • Always Audit Ready

Robust qualification and validation processes

Full-suite of metrology laboratory equipment including:

  • Zeiss CMM, O-Inspect, and Metrotom CT Scan
  • Zeiss Calypso
  • Keyence Vision Systems
  • Reverse engineering capabilities
  • IQ/OQ/PQ/TMV
  • Detailed feedback on the validation process
  • Process validation and design verification
Full Suite Manufacturing
  • Injection molding (1-96 cavities)
  • Multi-shot injection molding
  • Tight tolerance precision molding
  • Scientific injection molding
  • Injection blow molding
  • Injection stretch blow molding
  • Extrusion blow molding
  • Finished device assembly solutions ranging from fixture based manual assembly through fully automated, high speed assembly automation
  • Complete assembly capabilities
  • Transfer programs
  • Value added secondary operations
National Footprint and
Operational Excellence
  • 9 Manufacturing Facilities ensuring close ship-to locations and reduced transit time
  • Agile production capacities supporting lead times and industry leading OTIF delivery performance
  • Total supply chain management solutions (VMI, Consignment, Inventory Management Programs)
  • Management sponsored lean initiatives and culture of constant improvement

We don’t just fit the
mold, we make it.

We Engage…

early in the process, integrating our team with yours to provide front-end solutions from concept to commercialization.

We Execute…

with precision, using all of our resources to mitigate project risks and delays, and ensure your schedules are faithfully met.

We Elevate…

our solutions, consistently achieving more than was asked of us and always continuously improving to serve you better.

Ensuring the Highest
Levels of Quality Production

Registered ISO 13485:2016
Certified iso 9001:2015