Category: Case study

Tissue Bank – Allograft

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The Challenge

A Tissue Bank approached J-Pac Medical to provide a customized sieve/filter fabricated from medical grade textile mesh to be utilized in a specific tissue demineralization process

Current practice required engineers to fabricate a commercial mesh as needed to enable the particular process step.

The company wished to implement a quality improvement by upgrading to a medical grade mesh, and also to redesign and validate a process to provide the needed sieve/filter.

Our Solutions

J-Pac Medical identified an appropriate mesh alternative for the company, and also suggested specific fabrication methods that enabled the redesign and implementation of an improved sieve/filter.

This component is provided in a double barrier pouch put-up, and is terminally sterilized via Eto by J-Pac Medical.

The Results

The company improved tissue quality and regulatory compliance by ensuring medical grade processing, biocompatibility, and lot traceability.

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Medical Device Packaging Design Optimization

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The Challenge

A Cardiovascular Device Company came to J-Pac Medical with a request to establish a medical device contract packaging capability in the United States for an existing packaging flow had been established in Europe, as was the package design.

Our Solutions

As part of the overall transfer, J-Pac proposed a package design and validation to reduce the overall footprint, as well as downgauge all packaging materials.

The Results

In addition to reducing the overall footprint and down-gauging packaging materials, our redesigned package also enabled a 40% increase in Eto Sterilization throughput. Freight gains were also realized. J-Pac also provided medical device cleanroom assembly as part of its medical device outsourcing services.

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3D Printed Functional Medical Device Transfer Case

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The Challenge

An early-stage medical device company required a prototype of a unique instrument procedure case that involved unique seals and hinges that would experience high mechanical forces.

Our Solutions

J-Pac created a 3D printed, working prototype that allowed the functionality of the device to be operated and tested under real-world conditions. The prototype included gaskets and small hinges with the actual pins to be incorporated to match the exact design.

The Results

The rapid prototyping of functional parts identified areas in the medical device transfer case that needed design modification. The high material strength of the 3D printed materials also allowed the printer to produce manufacturing-ready fixtures used for process development.

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