Molding
Component Molding
Precision-molded components and assemblies for a wide range of medical devices across multiple markets.
Employing design for manufacturing (DFM) principles, we create effective, repeatable solutions for our customers using the latest technology. We closely monitor critical dimensions and track process controls. Our commitment to meeting rigorous medical industry standards ensures you receive reliable, high-quality component parts.
Technology & Equipment Summary
- 140+ molding presses
- Vertical and horizontal presses
- Press sizes from 20-450 tons
- Mold design, build and maintenance
- Class 7 and Class 8 controlled molding environments
- 135,000 sq. ft. manufacturing space
- Dedicated NPI/NPD teams and manufacturing equipment
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Insert Molding
We specialize in implementing unique strategies, consistent and repeatable loading and unloading methods, and tolerance analysis of over-molded components to maintain proper shut offs and shot-to-shot repeatability.
Capabilities
- Over-molding of metal components such as Platinum or Stainless Steel
- Over-molding 1st shot plastic components with a 2nd shot of the same or different plastic.
- Press sizes ranging from Micro (<0.001grams) to medium/large handles for shafts
- Vertical rotating tables to allow additional flexibilities for loading and unloading inserts
- Tight stack up tolerance controls (such as when leveraging machined components from other Cretex companies)
Applications
- Surgical instrument handles
- Headers for cardio and neuro devices
Micro Molding
We have the expertise to meet the unique challenges of extremely small tolerances coupled with process validations that come with molding microscopic medical parts.
Capabilities
- Tolerances XX to XX microns . . .
- Gate and ejection pin design . . .
- Miniature features XX to XX microns . . .
Applications
- Bone screws and implants
- Diagnostic implants
Micro-Insert Molding
With micro-insert molding, we can produce very small components with complex geometries, including threads, plunging/bulkheads and holes to meet exacting requirements.
Capabilities
- Parts as small as .050” / XXX microns
- Critical tolerances in the range of XX to XX microns
Applications
- Leads for Deep Brain Stimulation (DBS) devices
- Diagnostic implants
Silicone Molding
With micro-insert molding, we can produce very small components with complex geometries, including threads, plunging/bulkheads and holes to meet exacting requirements.
Capabilities
- 20 to 40 ton vertical with open capacity
- 100 ton Horizontal with open capacity
- 4 presses, with planned expansion up to 16 presses
- Individual components to fully integrated over-molded sub-assembly
- Semi-auto to fully automated cells
- Implantable and non-implantable LSR
- Traditional LSR over-molding with micro-molding capabilities
- Material range 20-90A durometers
Applications
- Seals for cardio and neurovascular devices
- Balloons
- Surgical jaws
- Leads for neurostimulation devices
Two-Shot Molding
Our two-shot technology gives you increased freedom in part design, so you’re not limited by assembly requirements. Two-shot molding improves quality and consistency by reducing misalignments that can result from traditional insert or over molding processes. It also eliminates the costs of additional operations, assembly and extra tool validation.
Capabilities
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Applications
- Grips on surgical tools and instruments
- Slitter blades
- Instrument handles
- Connectors
Device Assembly
Assembling medical devices efficiently and effectively.
We manufacture a wide range of devices including orthopaedic and surgical instruments, ophthalmic surgical interfaces, and critical header and lead subassemblies for cardiac rhythm management and neuromodulation devices. Our facilities observe strict GMP adherence and employ ISO 13485 quality management.
Our highly trained employees work in cleanrooms equipped with cutting-edge technology for manufacturing and assembly of sterile medical devices and components.
Capabilities
- FDA registered facilities clean room assembly in both Class 7 and Class 8 environments
- Manufacturing Process Failure Mode and Effect Analysis (PFMEA)
- Tensile, torque and leak (mechanical & electrical) testing
- Sterile device verification and validation (V&V) testing
- Epoxy/UV curing assembly
- Mechanical assembly
- Subassembly and finished device assembly
- Heat staking and ultrasonic welding
- Laser and resistance welding
- Pad printing and decorating
- Part pouching and sealing
- Complete kitting, packaging, and labeling
- Sterilization management
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Materials
Ensuring safety and effectiveness of medical devices through diligent material selection.
With extensive injection molding experience, we have developed advanced capabilities across a wide range of medical grade polymers. We employ applied understanding of material properties and molding characteristics coupled with the latest mold flow analytical tools to optimize tooling for reduced variability, maintained tolerances, extended tool life, and controlled costs. Our practical knowledge of how materials behave during the molding process is applied during the Design for Manufacturability (DFM) process, ensuring optimal outcomes in device design.
Among the thousands of resins we use are:
- ABS
- Acetal
- Acetal copolymers – Ultem® (PEI)
- Bionate II
- Crystal styrene
- GF Nylon
- HDPE
- LC
- PEEK
- Bioactive PEEK (Proprietary)
- Carbon-filled PEEK
- Commercial grade PEEK (450G / 150G) Short term exposure and suitable for molding process development
- PEEK Optima (LT1 / LT3) Long term Implant
- Glass-filled PEEK
- Nylon
- 101L Nylon
- Nylon 6/6
- Polycarbonate
- Polystyrene
- Polysulfone
- Polyurethanes (Implant Grade)
- Elasthane
- Tecothane
- Pellethane
- PP
- Radel
- Stanyl
- UHMWPE
