Designing a silicone medical device requires the knowledge of the many different silicone compounds and manufacturing processes available to meet the quality, cost, and timing considerations that are so critical. Let TechneMed assist in shaping your concepts by helping you understand the numerous design, engineering and production possibilities offered by silicone. By working with you during the early design and development cycle, we may enable you to realize substantial time and cost savings.

Our Offerings include:
Material Expertise | Engineering and Design |
Prototyping | Manufacturing | Assembly | Quality Control |


Material Expertise
The right silicone material and manufacturing process is crucial to your end product. Because we specialize in medical device silicone fabrication, our engineers are able to evaluate your design specifications and help you choose the optimum silicone material and processes to meet your products requirements.

Our expertise extends to virtually any silicone, from ultra-soft to the hardest versions. We maintain strong relationships with all the large and small manufacturers of medical silicone materials.

Engineering and Design
TechneMed's team will help you devise or refine your concepts for products as well as design the custom tools needed to produce them.

Our R&D engineers employ sophisticated CAD technology to design concepts, parts, and tools that meet our customers' performance requirements.

Prototyping
TechneMed accelerates the prototype process using advanced CAD Systems, which provide complete dimensional data in a visual format. These systems feature a 2D System, and 3D software programs to display graphic representations of the part.

Prototype times may be reduced by as much as 75% using our Quick Response Process and proprietary tooling.

TechneMed's Quick Response prototype system uses CAD technology in designing molds and components. Quick response is based in part on TechneMed's ability to mold Liquid Silicone Rubber in small quantities, thus allowing TechneMed to quickly produce prototypes at a minimum cost. These prototypes are made under the same quality traceability standards that control our high volume production. They are produced using the same material specified for full production allowing evaluation of the part in its final form. All the design, raw material, drawing, and tooling changes in the prototype process are documented under QSR guidelines. TechneMed provides customers with this information.

Manufacturing
Our QSR plant is equipped for small, medium, and large volume runs. Manufacturing capabilities range from:

Extrusion

  • single lumen to 30 lumens or more
  • profiles
  • sizes .005" through 1.75" ID/OD
Molding
  • low through high volume liquid injection molding (LIM)
  • transfer and compression molding
Assembly
  • complete device assembly
  • wash/packaging

Assembly Capabilities
We maintain a HEPA filtered environment for assembly, and our complete assembly operation adheres to the strictest customer, industry and QSR standards. We engineer a range of custom fixtures for assembly operations such as slitting, marking, trimming, and bundling. TechneMed's skilled personnel are able to assemble your intricate finished assemblies.


Quality Control
At TechneMed, besides meeting or exceeding government and industry standards, we develop specific test parameters and quality standards to meet customer requirements. This practice assures consistency and ensures that your product is manufactured in full compliance to all of your companies quality standards.

Our quality control procedures are audited by many customer and supported by an array of inspection equipment including electronic inspection systems, laser micrometers, digital scales, optical comparators, toolmakers' microscopes, binocular and video microscopes, material testing equipment, digital and dial calipers, and specialty gauges.

It is our practice to test incoming raw materials and perform continuous inspection control on the products we manufacture. Thus, we are able to assure consistent component quality and the traceability of process and raw materials.

Raw Materials Testing - Using a Tensile tester, TechneMed tests each lot of incoming materials for tensile strength, elongation, modulus, and tear resistance when specified. Durometer is measured using a Shore Hydraulic Instrument.

The benefits of raw materials testing include greater quality assurance, increased ability to design test parameters around customer specifications, and material lot history collection and analysis.

In-process Inspection - When specified, TechneMed performs 100% inspection using video or binocular microscopes. Due to the compressive nature of silicone rubber, thin walls, radii, undercuts, and hole diameters are most accurately measured using non-contact equipment.

TechneMed uses the non-contact Optical Measurement Inspection System to accurately measure, analyze, and record product dimensions. TechneMed emphasizes the accuracy, speed, and efficiency of the inspection process.

End Product Testing - In addition to raw materials and in-process testing, TechneMed performs customer specified end product testing such as break strengths and pressure testing. Other product tests include leak, electrical continuity, and balloon concentricity testing.