Without exceptional contract manufacturing, an idea for a medical device 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.
Customized start to finish devices
From prototype to production
1’s, 10’s, 100’s, 1000’s
Complex Assembly & Final Packaging
From low-volume prototypes to high-volume production, we can 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. 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.
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
Plastic Injection Molding
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
We see the pilot phases as opportunities for enhancing speed-to-market manufacturing and improving cost efficiencies in assembly. Manufacturing, packaging and assembly 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. 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
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 design for manufacturability process includes improving quality, eliminating waste, and reducing costs throughout the manufacturing process. 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.
Manufacturing Transfers & Scalability
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. 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.
Sterilization Management in Manufacturing
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.