Kensey Nash offers comprehensive synthetic polymer capabilities, including product design and engineering, tool design, mold building, material and product testingclean room commercial manufacturing, sterilization services through a contracted sterilization provider, and packaging services.

We use many types of resorbable polymers either by themselves or in combination to achieve the desired properties for each particular product. Our process development is aided by the use of statistical “design of experiments” to establish effective processing parameters. We can also assist with process and sterilization validations, degradationstudies and selection of packaging materials best suited to meet specific polymer and product needs.

Capabilities
• Injection Molding
• Extrusion
• Compression Molding
• Insert Molding
• High Strength Reinforcing
• Low Volume, Low Temperature Processing
• Clean Room Machining
• Ultrasonic Processing

Materials
• Polylactides (PLA) *
• Polyglycolides (PGA) *
• Polycaprolactones (PCL) *
• Polycarbonates (e.g. TMC) *
• Polydioxanones (PDO) *
*and their co-polymers

Compounding
Frequently, standard off-the-shelf resorbable polymers do not provide the
desired properties for a specific medical device application. Whether the
material requirements are more osteoconductive, radiopaque, stronger,
or easier to visualize during implantation, compounding may be a good
option to achieve these features. Kensey Nash can custom blend various
fillers into resorbable polymers including:
• Ceramics
• Fibers
• Nanoparticles
• Dyes
• Other Resorbable Polymers

Support
As a full service provider, Kensey Nash is capable of meeting your Polymer manufacturing needs. From concept development to large-scale GMP manufacturing, we can help you get your product to market.

Assembly
• Loading Resorbable Parts into Delivery Systems / Tools
• Secondary Component Assembly

Design & Engineering
• Concept and Prototype Development
• Pro-E and FEA Capabilities

Clean Packaging
• Customized Tray Forming and Sealing
• Vacuum or Inert Gas Fill Sealed Packaging

Material and Device Characterization
• Full Biomechanical and Biochemical Analytical Lab
• Testing for Design Optimization, Product Development,
Regulatory Submissions, and Lot Release
• Accelerated and Real-time Shelf Life, Ship Shake,
and Complete Packaging Stability Studies

Tool and Machine Shop
• 10,000 sq. ft.
• 15 Full Time Machinists
• Mold and Die Fabrication
• Specialty Tooling and Test Fixturing