Capabilities

When you’re creating a new medical device, you want assurance that your device is handled with care at every stage of production. That’s why we adhere to the highest level of quality standards throughout the manufacturing process. Our vertically integrated facility includes controlled environments, rigorous inspection protocols and highly experienced teams to help you produce devices that make a difference.

Click below to learn more about our standalone and integrated capabilities, including:

  • Design concepting
  • Development and prototyping through process validation
  • Manufacturing and assembly
  • Barcoding, packaging and labeling
  • Sterilization management

Questions? Contact us today to speak with one of our specialists.

Product Development

To help with all stages of your product development process, our offerings include:

  • Part design optimization and component consolidation
  • Design for Six Sigma, Design for Manufacturing and Design for Assembly
  • CAD/CAM/CAE
  • FMEA
  • Moldflow®/Moldcool analysis*

Our suite of integrated contract manufacturing services, enhanced by our SmartStack® and NeuroStack® technologies, provides a competitive advantage with customizable linear contact systems. Plus, our facility features controlled environments, ISO 7 (class 10,000) cleanrooms and cleanroom production cells with integrated vision systems capable of operating at ISO 5 (class 100) level.

*Moldflow® is a registered trademark of Autodesk® Inc.

Prototyping

Whether you need a few pieces or a few thousand, our highly specialized team can produce parts with near-production tolerances in as little as a few days. As part of our integrated services, we work closely with your design team to select the best polymers and metals to bring accuracy and consistency to your molded components. You can also rely on our expertise with hundreds of exotic materials, including high-temperature, implantable-grade and silicone.

Injection Molding

Our facility features more than 45 injection molding machines, ranging from 5- to 300-ton capacity, to precisely produce a variety of components, including micro, insert and overmolded pieces. In addition, our team has expertise working with a variety of engineered resins and we stock many of the most commonly used materials to keep turnaround times as fast as possible.

Liquid Silicone Molding

Your liquid silicone component will be molded in an ISO 7 (class 10,000) cleanroom, which has added capabilities for post-molding annealing, cleaning and insert molding. Our microprocessor-controlled, closed-loop systems provide fast cycle time and high output volume, along with optimal process control for tight tolerances and critical part features.

Micromolding

Our micromolding processes help you achieve extremely tight tolerances, manufacturing critical components that weigh less than 1 mg. Automated handling systems ensure these intricate components are manufactured, inspected and packaged accurately and consistently to reduce waste and produce clean finished results.

Precision Machining

Accuracy is a must-have when it comes to precision medical machining. As a medical device contract manufacturing leader known for accuracy and consistency, we’ve created hundreds of critical surgical and implantable devices. Industry leaders rely on our full-service precision medical machining, which is available as a standalone or integrated service. Specific capabilities include:

  • Multi-axis CNC machining
  • Wire EDM
  • Finishing operations
  • Precision cleaning and finishing
  • Machining of implantable-grade materials
Secondary Operations

We offer the following secondary operations  as part of our integrated services:

  • Medical welding (plastic and metal) – ultrasonic, laser, resistance
  • Bonding – UV, solvent, medical adhesive
  • Decorating – pad printing, hot stamping
  • Laser marking
  • Medical cleaning
Assembly & Packaging

To help you bring your medical products to market accurately and on schedule, we provide 24/7 assembly and packaging as part of our suite of integrated services. We have an impeccable track record of meeting project deadlines and maintain a 99%+ on-time delivery rate.

Our assembly and packaging capabilities include:

  • Extended supply chain management
  • Tray sealing
  • Leak testing
  • Label printing
  • Pouch sealing
  • Impulse sealing
  • Auto bagging with in-line printing
  • Barcode printing and verification
  • Sterilization management
  • Data analysis and reporting

 

Process Validation

Our team of specialists includes certified packaging professionals and quality engineers. Among other areas, they’re experienced in medical device process validation methodologies, Geometric Dimensioning and Tolerancing (GD&T) and scientific process development.

Get exactly the support you need – 24/7

– From a single manufacturing process to a complete solution

– Through continuity and reduced risk across each manufacturing phase

– In spec, on time and on budget

Our capabilities span medical device design, development and prototyping through validation, manufacturing, assembly, barcoding, packaging, labeling, sterilization management and delivery.

Our facility is vertically integrated, and includes controlled environments, cleanrooms and rigorous inspection processes. Plus, throughout the manufacturing process, we adhere to the highest level of quality standards, so you can rest assured at every stage.