Applying specific polymers, IME’s 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.
Judith Heikoop, managing director of IME Medical Electrospinning, said: “The global launch of our state of the art production platform is testimony to our strong belief in the strategic goal of becoming the leading developer and producer of the most advanced electrospinning equipment for both large-scale production and R&D purpose, and broadens our trusted partnership worldwide in co-developing electrospun medical devices, which are seen as true game changers in the medtech industry.”
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 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 research and more than a decade of medical electrospinning experience in manufacturing smaller scale R&D equipment. MediSpin XL is the first large-scale production platform that eliminates all the important factors that might distort the electrospinning process, enabling an optimal process set-up and stability, including climate control and on-line quality monitoring measurements, ensuring a consistent end-product.
The MediSpin XL 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. Down-stream 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.
Ramon Solberg, founder and managing director of IME Medical Electrospinning, said: “This technology enables the large-scale manufacturing of reproducible and scalable fiber-based scaffolds, the wonderful pieces of art that will substantially transform the medical device market for a wide variety of medical applications and thus revolutionize regenerative medicine.”
With the introduction of the MediSpin XL platform, IME has further strengthened its global standard for the joint development and production of scalable and reproducible nanometer and micrometer scaffolds. To this respect the company recently commissioned its brand new high-end GLP Laboratory and set of ISO 7 cleanrooms. With these, IME is now able to not only develop and manufacture its top-end proprietary electrospinning equipment, but to also produce the actual scaffolds for the intended medical implants for their customers. The cleanroom facilities enable the production of Class I, II and III medical devices.
For over 10 years, IME Medical Electrospinning has developed and implemented electrospinning processes and equipment for the manufacturing of medical devices for (regenerative) medicine. Electrospinning is a flexible process for producing extremely thin fibers and structures that have excellent properties to help regenerate human tissue. IME Medical Electrospinning has developed a set of innovations in electrospinning technology for the reproducible and scalable production of electrospun material under tightly controlled conditions required for the MedTech market. Customers and scientific partners include the MedTech industry, scientists and health institutions. Shareholders in the company are Dutch economic development company De Brabantse Ontwikkelings Maatschappij (BOM) and informal investor network TIIN Capital (TIIN).