A newly developed platform has been designed for large-scale industrial manufacturing of reproducible and scalable fiber-based scaffolds for Class I, II and III medical devices. The launch of the MediSpin XL™ platform marks a global breakthrough in the controlled large-scale production of well-defined scaffolds for implants and membranes using fibers ranging from nanometer up to micrometer scale.
Applying specific polymers, the advanced equipment creates fiber-based medical device solutions that mimic the natural human extracellular matrix in nanometer and micrometer format for implants and membranes in the human body. Human cells recognize this artificial matrix (scaffold) as the body’s own facilitating the repair of the damaged tissue for heart valves, blood vessels, nerves, tendons, skin, and bone etc. This is in contrast to implants and membranes of traditional structures, which are seen as foreign and therefore can lead to scar tissue or rejection phenomena.
The MediSpin XL platform has been developed specifically for medtech industrial manufacturing of medical devices and ensures the firm control of the crucial parameters of the electrospinning process, leading to identical and consistent end products.
The electrospinning process is governed by a number of variables that are crucial for success in research and development, but certainly also for large-scale manufacturing of fiber-based medical device solutions. Crucial parameters in fiber diameter and structure, porosity, mesh thickness, and tensile strength are vital for the in vitro and in vivo functionality of products, but that were challenging to control in the past. In particular, changes in temperature and relative humidity between the seasons and during the day, could lead to inconsistencies within one batch as well as between batches.
The MediSpin XL platform resolved all this and is the result of IME’s pioneering research and more than a decade of medical electrospinning experience in manufacturing smaller scale R&D equipment. It is the first large-scale production platform that eliminates factors that might distort the electrospinning process, enabling an optimal process setup and stability, including climate control and online quality monitoring measurements, ensuring a consistent end product.
The equipment is built using state-of-the-art materials and process controls in compliance with tight regulatory requirements for medical products to minimize the chance of product contamination during the process. Downstream process steps such as cutting and blistering can be easily included in the system. And lastly, ultimate automation minimizes the need for operator intervention, which further adds to a reproducible process and minimization of product contamination during the process.
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