Manufacturing & Assembly – The Right Solution for Custom Injection Molding

Having an innovative plastic injection molding design for your medical or drug delivery device is a perfect start for your project. Making that design a reality is the next big challenge. We’ll take that challenge. Decades of manufacturing medical devices, drug delivery devices and primary pharmaceutical devices as a contract manufacturer has led to a wealth of experience that we will put to good use on your project. Here’s what you can expect from us as your contract manufacturing company:

  • Class 8 (100,000) Certified Clean Rooms
  • FDA-registered Medical Facilities
  • cGMP Compliant Medical Facilities
  • Complete In-House Tooling Services (USA & Abroad)
  • Clinical Run to Fully Automated Molding & Assembly
  • Manual Labor to High-speed Robotics
  • Complete Supply Chain Management
  • Conventional, Insert, and Multi-Shot Injection Molding
  • Statistical Process Control on all Molded Product
  • Automated and Semi-automated Packaging Equipment
  • Vision Inspection Systems
  • Sterile Barrier Package Design, Development, and Validation
  • Dedicated Form, Fill, and Seal Lines
  • Sterilization Consultation

We love working on and solving complex problems. Let us start working on your manufacturing and assembly challenges and we’ll develop a unique solution for your medical or drug delivery device designs. You’ll love the outcome when we’re finished.

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Manufacturing & Assembly – The Right Solution for Custom Injection Molding

You need to get your medical device or drug delivery device innovation off the drawing board and onto the production line. We’re the full service injection mold contract manufacturing company that can do it. Why? Decades of manufacturing and assembly within the medical device, drug delivery device, and primary pharmaceutical packaging markets has given us unsurpassed clinical and technical expertise with creating plastic injection molds. We can do it all.

Streamlining the Contract Manufacturing Process – Our Capabilities

Good manufacturing practices (GMP) drive our day to day operations with advanced process controls and systems. By utilizing our in-house close tolerance injection molding processes, real-time monitoring systems, and custom automation for manufacturing, assembly and packaging, we are able to ensure compliance to your stringent quality requirements, tight control to specifications, and part repeatability for high-volume and high-cavitation production for any plastic injection mold.

For low-volume medical manufacturing of injection molds, we utilize flexible work cells and quick changeover tooling so you get the same attention to quality and use of state-of-the-art technology as their high-volume counterparts. Whether low- or high-volume production, we utilize the same innovative thinking which streamlines the entire contract manufacturing process while improving customer satisfaction, lead time and your bottom line.

Manufacturing During Pilot Phases and Clinical Trials – Our Approach

Typically, developers of medical products view the pilot phases and clinical trials of a project as obstacles to “get past.” We see the pilot phases as opportunities for enhancing speed-to-market manufacturing and improving cost efficiencies in assembly. After all, how the end product will be manufactured, packaged, and assembled must be considered long before the first final medical device or drug delivery device ever goes into production. This will help avoid complications and delays that can ultimately doom your project.

Speed and efficiency during the manufacturing and assembly portion of your program’s pilot phases and clinical trials are critical to your success. When you partner with us, you benefit from our expertise in bringing new and innovative plastic injection mold technologies to market, every step of the way. You’ll receive guidance starting in project planning and prototyping, through product development, past clinical evaluations, beyond market launch, and into high-volume production. The goal is to get you to full commercialization with as few complications as possible.

You also have our commitment to the quality systems management of your program from concept to commercialization. This, of course, also applies to pilot phases and clinical trials. We help you achieve compliance with drug and device regulations, current Good Manufacturing Processes (cGMP) and Quality Management Systems (QMS).

Manufacturing Plastic Injection Molding – Our Capabilities

When you partner with us, you align with a world-class, award-winning contract manufacturer of medical device and drug delivery devices. This includes injection molding, insert molding, overmolding, and micromolding for prototypes, pre-production or production projects. You also have access to our multi-shot plastic injection molding capabilities, which allows for complex part production in one press, resulting in improved product design, performance and cost.

Packaging, Assembly and Other Services – Our Expertise

No doubt that we can handle any manufacturing need for your drug delivery or medical delivery device, from low-volume prototypes to high-volume production. In addition, we also have a comprehensive post-manufacturing service offering that includes packaging and assembly services, sterilization management, and fulfillment services. Together, they can help you streamline your supply chain, reduce costs, and shorten lead times in the manufacturing of your project. Available at multiple locations across the globe, here’s a look at what we offer:

  • Automated and Semi-automated Packaging Equipment
  • Manufacturing Vision Inspection Systems
  • Sterile Barrier Package Design, Development, and Validation
  • Dedicated Form, Fill, and Seal (FFS) Lines
  • Sterilization Manufacturing Consultation

Along with flexible assembly options:

  • Pre-validated Stock Solutions
  • Custom-designed Solutions
  • Tray, Bar, Pouch and Impulse Sealing
  • In-house Custom Label Printing
  • Barcode Printing and Verification

Design for Manufacturability (DFM) – Our Team

Medical device manufacturing is complex. Knowing this, we make sure that your medical device or drug delivery device design can be economically manufactured from the earliest stages of Design & Development and throughout the product life cycle. Our cross-functional teams of technical and R&D engineers, manufacturing engineers, quality engineers, and regulatory specialists have DFM in mind every step of the way. Whether you’re looking to transfer, scale, or drive down costs, our expertise in DFM can help you improve quality, eliminate waste, and reduce costs throughout the entire manufacturing process.

Manufacturing Transfers & Scalability – Our Adaptability

Need to move the manufacturing and assembly of your medical device or drug delivery device to one of our facilities? No problem. We have a dedicated manufacturing engineering team that focuses on manufacturing transfers, applying their expertise to minimize risk. Whether the transfer originates from your facility, a supplier’s facility, or our own product development area, we follow a disciplined process to ensure smooth and efficient transitions. Transfer your manufacturing to one of our facilities, and we’ll deliver your finished product—on time and on budget.

Ready to scale up the production of your medical or drug delivery device? We can do that. With multiple locations around the globe, we have the flexibility to handle a full range of manufacturing and assembly needs. Our ability to scale means you can partner with us as a single-source supplier, with no need to transfer to a new supplier when you’re ready to scale up production. Whether you need small runs or high-volume production, you can count on us to deliver a consistent level of quality and performance to reduce risk and provide added security.

Sterilization Management in Manufacturing – Our Process

Every device presents unique challenges to the sterilization process during manufacturing. We’ll work with you to identify the optimal sterilization method and contract sterilization provider for your product, leveraging our in-house sterilization experts and decades of medical device manufacturing experience. Our services include:

  • Performing sterilization validations
  • Writing protocols
  • Auditing sterilization suppliers

Full Contract Manufacturing for Medical or Drug Delivery Devices – Our Focus

Looking for turnkey contract manufacturing for your medical device or drug delivery device? Look no further. Coupled with industry leading lean manufacturing innovation and a dedication to the rigorous disciplines of quality assurance, we are your full service manufacturing and assembly partner that offers:

  • Clean room molding & assembly
  • Solvent & UV bonding
  • Thermal welding
  • Ultrasonic welding
  • Ultrasonic staking and insert placement
  • Vision inspection
  • Laser marking
  • Pad printing
  • Product testing
  • Product packaging and contract sterilization
  • Material management control
  • Shipping and logistics support

We thrive on solving complex problems and developing unique manufacturing solutions. Let us start working on your manufacturing challenges. You’ll love the outcome when we’re finished.