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Polymers And Medical Device Manufacturing

The changing technology trends in medical polymers and its processing techniques contribute immensely towards the development, growth and innovations not only for Medical Device Industry but for the new polymeric materials. This is possible with close interaction between medical polymer manufacturers and device manufacturers. This is a great contributing factor for addressing unmet needs in medical device manufacturing.

The medical device market is booming with innovation. Medical Device industry needs to stay on top of emerging trends by successfully blending new materials into device developments. This is applicable not only for new products but also to improvements in existing designs.

At the same time, the emerging polymer technologies for Medical applications must always be seen in combination with changing and evolving regulatory boundaries.

Emerging Trends In Medical Polymer Materials & Processing

The following are few of the examples of important medical device made with the help of developments in medical polymers & their processing.

PEEK For non-metal lumbar cage in Japan

FDA cleared the first foot-and-ankle implant made from Invibio Biomaterial Solutions’ PEEK-Optima HA Enhanced polymer comes word that Solvay’s Zeniva PEEK was selected by medical device OEM KiSCO Co. (Kobe, Japan) for the first non-metal lumbar cage for vertical interbody fusion madein Japan. The advanced spinal cage is commercially available only in Japan, where that country’s Pharmaceuticals and Medical Devices Agency (PMDA) approved the implantable medical device for production.

It is said that the materials was selected because of its performance properties, including fatigue resistance and a modulus similar to bone. The company The wanted an implantable medical material that could facilitate post-operative diagnosis. PEEK is an alternative to titanium, which is typically used in this application, because its radio transparency allows for easy visualization in medical X-ray and MRI imaging.

The primary function of a spinal cage is to maintain the proper intervertebral angle and height until spinal fusion occurs. However, spinal cages also need to accelerate bone fusion and support adjustments during surgery. The company’s spinal cages allow surgeons to use a screw-and-spacer mechanism to make these necessary adjustments.

During clinical trials, the material enabled the spinal cage to maintain structural stability even when screws were used to expand the spacers.

The materials supplier’s ability to provide quality data for biological evaluation and its responsiveness facilitated the regulatoryprocess, allowing device manufacturer to secure approval from PMDA in a short period of time, said the company.

New Grade Of Silicone Elastomer For Microfluidic And Implantable Medical Device Applications

Materials innovator Gelest Inc. (Morrisville, PA) has introduced ExSil 50, a softer grade of an ultra-high elongation material that has been formulated to meet the requirements of soft-tissue implants or extracorporeal device applications.

The ExSil class of elastomers have unprecedented elongation greater than 5000% and shape recovery behavior, according to Gelest. They also have self-sealing and tear-resistance properties. The materials are available in an industrial grade, GelestExSil 100, as well as soft-tissue compatible ExSil 50.

Polyarylamide Resin For Single-Use Bone-Fixation Device

In developing a more robust, single-use bone-fixation system than currently available devices, medtech startup Reign Medical (Tulsa, OK) went on the hunt for a biocompatible material with exceptional stiffness properties. A polyarylamide (PARA) resin from Solvay (Alpharetta, GA) stood out and is used to mold several components of the medical device soon to be on the market.

The Clench compression staple system comprises a disposable sterile surgical tool set for fixating hand and foot bone fragments and performing related procedures. A patented threaded hub allows surgeons to incrementally expand the implant for proper insertion while retaining the mechanical properties of the nitinol staples for continuous compression across the fusion site after implantation. Reign Medical specified Solvay’s 50% glass-fiber-reinforced grade, for the device’s implant sizer, drill guide and each part of the implant delivery instrument, including its handle, the saddle on which the staple sits and the threaded compressor that forces the staples fully open, said Solvay in a press release.

A high-stiffness material was required for this application because of the mechanical strain that the components experience. Offering metal-like strength, rigidity and dimensional stability, the biocompatible polymer has to provide an exceptional surface finish .Gamma-stabilized colors are optimized for sterilization.

Importance Of Compounding In Medical Device Sector

Catheters used for vascular and other critical care applications need polymeric tubing requiring high precision, close tolerances and high level of functionality. This is particularly used for minimally invasive surgical techniques.

Along with the above mentioned properties, it is also necessary important to consider manufacturing process required to manufacture the medical device.

The inside diameter of the catheter is required to be very smooth to allow the guide wire to slide.

For catheter balloon manufacturing, it is important that the extruded tubing is amorphous prior to the balloon forming process.

In order to arrive at the right grade of compounded material, the device manufacturer has to work with the material supplier to meet not only the processing / manufacturing requirements but also the regulatory needs.

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