Medical Textiles Services
Innovative Medical Textile Services
J-Pac offers a one-stop source for sourcing and converting a broad range of medical textiles into finished devices. We offer sourcing of class VI textiles of various pore sizes, thicknesses, polymer types, and structure. Because most of our medical textiles are off-the-shelf and we have extensive in-house processing and packaging capabilities, we can provide rapid prototypes using the actual textiles required. Additionally, we manage the entire supply chain and packaging and sterilization requirements, providing you with a trusted single-source solution.
J-Pac’s medical textile services include:
- Sourcing medical grade, USP Class VI textiles including mesh, braids, knits, weaves, non-wovens, and absorbables
- Design support and rapid prototyping
- In-house converting processes for forming, shaping, particulate-free cutting, scouring, sewing, ultrasonic welding, heat welding, bonding and tipping
- Custom in-house tooling
- Cleanroom assembly
- Packaging design, validation, and sterilization
- Supply chain management
- 3D anatomical shape forming, unique geometries, and edge treatment techniques enable the precise placement of combination products with minimal tissue irritation
- Quality management, tracking, reporting, and validation are conducted at every stage of textile development, manufacturing, and packaging
- Solvent scouring to remove impurities from textiles
- Low humidity bio-absorbable processing performed in Class 7 cleanroom environments
- Sterilization services including ethylene oxide (EtO), gamma irradiation, vaporized hydrogen peroxide sterilization (VHP), autoclave, and more
Resorbable and non-resorbable polymers can be used to create medical textile devices that are custom-shaped to meet specific anatomical and biological requirements, as well as facilitate shape transformation in situ. Customization of an implant’s shape by the manufacturer can reduce surgical procedure time by minimizing or eliminating intraoperative adjustments, and can also provide surgical repairs with reductions in tension inherent with non-customized implants. The value of a pre-shaped medical textile implant has been most notably demonstrated in the area of hernia repair, but potential applications exist across general, cardiovascular, and orthopedic surgical applications.
Specialized textile engineering techniques enable J-Pac Medical to capitalize on the unique properties of different materials. Braiding, weaving, knitting, and non-woven textile manufacturing processes help to significantly enhance strength, texture, flexibility, and other performance characteristics for customized device requirements. For engineers, the possibilities for improved mechanical performance and anatomical accuracy are limitless, which ultimately benefit the patient.
Testing + Validation
J-Pac’s manufacturing technology allows biomedical textiles to be cut, formed, shaped, and assembled, often without the need for sewing. Textile assemblies are tested after manufacturing to ensure the mechanical properties of the materials have not been altered. Typically this involves destructive tests performed in our Quality Control lab. In most cases, our attachment joints of assembled textiles are stronger than the textiles themselves.
J-Pac validates all manufacturing processes that cannot be 100% tested. Our textile cutting, forming, shaping, and assembly processes are fully validated to the desired Process Capability Index (Cpk). Validated processes are revalidated upon certain manufacturing changes that may occur over time. We take a risk-based approach to evaluating critical parameters.
A textile-based implant is only completed when it is coupled with the proper methodology for placing the device in situ in the most minimally invasive manner possible. In meeting this objective, it is sometimes necessary to add attachments to what will be the final implant that will interface effectively with needed instrumentation. These attachments to the implant are removed post-implantation, but nonetheless are critical to an optimized implantation procedure. The same cutting, shaping, and forming capabilities that drive the manufacture of an anatomically correct textile implant can also support this critical instrument integration and needed deployment features that can minimize the invasiveness of any given implantation method.
One of the greatest benefits of medical textile devices is that they can be patient-specific and developed for specialized end-user needs. Devices can be made entirely of absorbable components or a combination of resorbable and non-resorbable parts. They can even be used for controlled delivery of drug or biological agents directly at the site of implantation.
J-Pac will help you select the right textile materials to maximize the performance of the finished device for its intended purpose.
We understand regulations inside and out and devote time and attention to assure timely delivery of the highest quality products. We customize our own equipment and have custom tooling on-site. We have far fewer equipment malfunctions and recalibration downtime, which saves you time and money.
Quality management and validation are essential components of our approach to the development, manufacturing, and packaging of medical textiles devices. Tracking and reporting are conducted at every stage of the process to provide assurance of the highest quality end product.
Sterilization services are conducted and validated in close collaboration with our trusted strategic partners to deliver market-ready products to customers. Sterilization methods include ethylene oxide (EtO), gamma irradiation, vaporized hydrogen peroxide sterilization (VHP), autoclave, and more.
Simplify your Supply Chain
en you work with J-Pac, you have an expert on your team. Reduce the number of vendors you need to locate, interview, hire, and manage. J-Pac can produce your custom two- or three-dimensional medical textile device, ensuring it is the highest quality, sterile, durable, and delivered complete with custom packaging that survives the stresses of shipping and Operating Room presentation.
J-Pac is your partner for proven Class II/III compliance and adherence to stringent quality and validation standards at every step of the supply chain.
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J-Pac Medical has the expertise and industry knowledge to be your go-to manufacturing partner.
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J-Pac is ready to simplify your supply chain by manufacturing and packaging your single-use medical devices.