Medical Textiles

How Pre-Validated Medical Device Packaging Complies with ISO Standards

Biomedical Textile Devices

J-Pac is a leading manufacturer of biomedical textile devices, many of which must adhere to stringent anatomical geometries. We manufacture implantable-class textile based devices in four Class 7 clean rooms which contain customized equipment allowing 3D shaping without altering the base geometry and strength of the textile material.

Our textile products are often combined with other sterile devices in custom, ready-to-use sterile procedure kits that are designed and manufactured in-house on our thermoforming equipment. All our manufacturing processes are validated. Our capabilities also include custom fabricated mesh bags and filters for tissue bank allograft processing. These mesh bags and filters are manufactured and sterilized to the highest quality standards to improve cleanliness and adhere to FDA guidelines.

Our Unique Capabilities

J-Pac has developed unique manufacturing processes that allow customers to achieve anatomically correct shaped textiles with particulate-free, smooth edges that prevent irritation of the surrounding tissue.

Our processes include 3D forming, welding, sewing, and bonding an array of textile materials without altering the base properties of the raw material. In fact, we are able to increase the strength of the material at the joints and increase stability in many cases.

  • Anatomically correct formed textiles
  • Particulate free
  • Smooth edges to prevent tissue irritation
  • Processing to prevent suture pull-out
  • Bio-absorbable processing

Case Study: Implant Textiles

The Challenge

A Medical Device company with a broad presence in the soft tissue repair surgical segment came to J-Pac with a challenge to manufacture a 3-Dimensional shaped, multi-component textile implant.

The company had prototyped the product, but had failed to find a suitable manufacturer after a global search.

Our Solution

J-Pac Medical provided the tooling, equipment and validated processes to pressure form and assemble the textile implant, as well as provide it with a custom edge treatment designed to enhance tissue passage and reduce particulate.

The implant was provided to the customer in a tray/lid primary package put-up, also manufactured by J-Pac Medical.

The Results

The company achieved first to market status with an innovative design that became the leading mesh technology in the market.

Medical Textiles Mesh

Call Our Engineers Now

603.692.9955

info@j-pacmedical.com