Contract Manufacturing

Without exceptional contract manufacturing, any innovative medical device or drug delivery device/combination product never really makes it off the drawing board. It takes the right combination of experience and innovative thinking to efficiently launch your finished device. We start with the end in mind through our process development and assembly planning.

Our expertise ranges from single-use consumable devices to full electromechanical systems, covering both medical devices and drug delivery/combination devices including certified API handling. Whether your complex assembly requires human hands or fully automated machinery our onshore or offshore facilities can handle it to accelerate your device commercialization timelines.

Complex Assembly &
Final Packaging

Customized start to finish devices

Plastic
Injection Molding

From prototype to production

Clinical &
Pilot Builds

1’s, 10’s, 100’s, 1000’s

Design for
Manufacturability

Innovative and viable device solutions

Manufacturing
Transfers & Scalability

Making the right moves to reduce risk

Sterilization
Management

From manufacturing floor to distribution center

Complex Assembly & Final Packaging

Customized start to finish devices

You need to get your medical device or drug delivery device/combination product innovation off the drawing board and onto the production line. We’re the full-service contract manufacturing company that can do it. Current good manufacturing practices (cGMP) drive our day to day operations with advanced process controls and systems.

Here’s what you can expect from us as your contract manufacturing partner:

  • Independent Accredited Lab Certified Clean Rooms meeting ISO 14644 Class 8
  • 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/Automation
  • 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

From low-volume prototypes to high-volume production, we’ll handle assembly, packaging, and manage sterilization for your device. Whether it’s assembling electronic subassemblies into integrated systems, building a complex drug delivery combination product or kitting various components into a sterile procedural tray, we’ve got you covered. Together, we can streamline and simplify your supply chain, reduce costs, and shorten lead times in the contract manufacturing of your project.

We love working on and solving complex problems. Allow us to start working on your contract manufacturing challenges and we’ll develop a unique solution for your medical device or drug delivery device/combination product designs.

Plastic Injection Molding

From prototype to production

Our in-house technology allows us to build and run injection molds for medical devices and drug delivery devices like no one else. We design, build and run our plastic injection molds for optimal cycle time and the largest process window possible. From single cavity, pre-production, fast development injection molds to high cavitation, engineered hot runner and two-shot injection mold systems, we can build them and make the parts you need for your finished device. Our team of certified injection mold makers, tool engineers, scientific molding experts, and program managers work closely with you, balancing the complexity of your project with budgets and timelines and employing ISO certified processes along the way.

Our global teams and facilities allow us to meet your programs goals

Clinical & Pilot Builds

1’s, 10’s, 100’s, 1000’s

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 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 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.

Design for Manufacturability

Innovative and viable device solutions

Medical device and drug delivery device contract manufacturing is complex. Knowing this, we make sure that your device design can be economically and efficiently manufactured from the earliest stages of Design & Development and throughout the entire 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 create, transfer, scale, or drive down costs, our expertise in DFM can help you improve quality, eliminate waste, and reduce costs throughout the entire contract manufacturing process.

Manufacturing Transfers & Scalability

Making the right moves to reduce risk

Need to move the manufacturing location 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 device or drug delivery device? We can do that. With multiple locations around the globe, we have the flexibility to handle a full range of contract manufacturing needs. Our ability to efficiently scale means you can partner with us as a single-source supplier from the very beginning, with no need to transfer anywhere else when you’re ready to scale up production. Whether you need a clinical build, small runs or high-volume production, you can count on us to deliver a consistent level of service, quality and performance to reduce risk your overall risk.

Sterilization Management in Manufacturing

From manufacturing floor to distribution center

Every device presents unique challenges to the sterilization process during contract 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 and combination product contract manufacturing experience. Our services include:

  • Performing sterilization validations
  • Writing protocols
  • Auditing sterilization suppliers
  • Dosimetric release