Frequently asked questions (FAQ)

Medical electrospinning is a unique process technology used to manufacture innovative medical products, particularly medical implants. It involves the electrostatic spinning of biocompatible polymers – both natural and synthetic into nanofibers or microfibers. These fibers possess a high surface-to-volume ratio and mimic the extracellular matrix of tissues, making them attractive biomaterials for various biomedical applications.

Fiber-based biomaterials produced by medical electrospinning act as scaffolds when implanted in the body. They support cell growth, proliferation, and differentiation. These scaffolds act as a three-dimensional framework for tissue regeneration and repair, instructing the body to heal itself. As such, electrospun biomaterials bring distinct advantages to a wide array of medical applications such as cardiovascular, general surgery and soft tissue reconstruction, advanced wound healing, orthopaedic sports medicine, drug delivery systems, and tissue engineering

The process of medical electrospinning involves several steps to create nanofibers or microfibers from biocompatible synthetic and natural polymers. Here is an overview of the typical process:

Polymer Solution Preparation: A biocompatible polymer or a blend of polymers is dissolved in a suitable solvent to form a homogeneous polymer solution. The choice of polymer and solvent depends on the desired properties of the fibers and their intended medical application. Drugs or other active ingredients may be added to the solution for drug-delivery systems.

Syringe or Spinneret Setup: The polymer solution is loaded into a syringe or a spinneret, which acts as the source of the polymer solution during the electrospinning process. VIVOLTA’s MediSpin^TM production systems include proprietary polymer supply modules that constantly maintain the desired polymer viscosity and homogeneity to ensure process stability and product consistency from the first product to the very last product of a batch, every batch.

Electrostatic Charging: The syringe or spinneret is connected to a high-voltage power supply.  As the polymer solution is ejected from the syringe or spinneret, it forms a droplet. The high voltage creates an electrostatic charge on the droplet, causing it to elongate into a conical shape known as the Taylor cone.

Fiber Formation: The repulsion between the charges on the surface of the droplet overcomes its surface tension, resulting in the formation of a fine jet of polymer solution from the tip of the Taylor cone and ejected polymer fiber. The fiber undergoes whipping and bending instabilities during flight, leading to the stretching and solidification of the polymer into ultrafine fibers.

Collection: The fibers are collected on a grounded collector, typically in the form of a rotating drum, a flat plate, or a rotating mandrel. As the fibers accumulate on the collector, they form a non-woven mesh structure composed of nano- or microfibers.

In-Line Quality Control: VIVOLTA has developed unique, proprietary technology to quantitatively and qualitatively assess the quality of the electrospun fibers and mesh in terms of fiber diameter, mesh thickness, and mesh homogeneity. These analytical systems are built in-line into our MediSpin^TM production systems, so that all products can be 100% verified, rather than relying on process validation which always adds costs and uncertainty.

Post-processing: After electrospinning, the fiber mesh may undergo additional treatments such as crosslinking, annealing, cutting, sterilization, or coating with bioactive agents to enhance its properties and functionality for specific medical applications. In addition to the electrospinning process, VIVOLTA specializes in automating post-processing steps such as laser cutting, particularly for large volume production processes.

The resulting nano- or microfiber mesh can be used as a three-dimensional scaffold or as a sub-component as a medical device, recapitulating the native extracellular matrix for optimal cell attachment, proliferation, and functional tissue restoration, or precise drug delivery in various medical applications.

Medical electrospinning is a specialized manufacturing process used for the production of nano- and microfiber-based materials using biocompatible, synthetic or natural polymers. The fiber-based materials produced by medical electrospinning can serve as instructive scaffolds for functional tissue restoration or carriers for active ingredients, in high-impact therapeutic areas such as:

Cardiovascular Implants: While many cardiovascular implants, like heart valves and stent grafts, comprise traditional textiles such as woven or knitted polyester, they routinely suffer from adverse biological response such as implant fibrosis and suboptimal endothelialization. Medical electrospinning can be used to produce non-woven meshes that better integrate with vascular tissue, reducing fibrotic encapsulation and greatly improving the formation of functional, vascularized tissue. Moreover, electrospun meshes can be applied to metallic stents and frames without the use of sutures, drastically reducing the manufacturing cost of these life-saving devices.

General Surgery and Soft Tissue Reconstruction: Electrospun meshes can be used as soft tissue repair meshes for hernia repair and breast reconstruction. The major advantage of electrospun materials in these applications is a more favorable biological response owing to lower fibrosis rates and more complete tissue integration. As a result, post-operative complications such as painful internal scar tissue formation, contracture, and implant failure can be avoided resulting in better clinical outcomes.

Orthopaedics & Sports Medicine: Innovative electrospun patches for ligament and tendon repair and reconstruction are now commercially available in the clinic. These products offer the surgeon and patient with more accelerated soft tissue repair, faster recovery, and more rapid return to sport or normal activity at pre-injury levels. Best of all, electrospun materials can be created without animal-derived tissue, meaning eliminated risk of animal-derived pathogens and more sustainable manufacturing.

Advanced wound healing: Electrospun nanofibers can be used to create advanced wound dressings with high porosity and surface area. These dressings facilitate wound healing by promoting cell migration and healthy tissue regeneration, while also providing a barrier against infection. Some examples of electrospun wound healing products are already commercially available in the clinic.

Drug Delivery Systems: Medical electrospinning is used to produce drug-loaded fibers, allowing for precisely controlled and sustained drug release at the site of injury or disease – not systemically. The large surface area and interconnected porosity of electrospun materials enhance their drug loading capacity, making them suitable for targeted and localized drug delivery across a variety of therapeutic applications.

Tissue Engineering: Medical electrospinning is notably used to create scaffolds that mimic the extracellular matrix of human tissue. These scaffolds act as a three-dimensional framework to support cell adhesion, proliferation, and differentiation, promoting functional tissue regeneration. They are particularly valuable in regenerating complex tissues such as bone, cartilage, skin, and blood vessels. Even without the addition of exogenous cells, electrospun scaffolds instruct the body’s own healing response, guiding the body to heal itself.

Overall, medical electrospinning plays a vital role in the development of a wide array of innovative medical products with the potential to revolutionize patient care by reducing complications and improving clinical outcomes.

Medical electrospinning offers several advantages that make it a valuable manufacturing technique in the field of medical implants, regenerative medicine, tissue engineering, and drug delivery. Some of the key advantages include:

Tunable Fiber Structure: Medical electrospinning produces fibers with diameters in the nanometer and micron range, mimicking the natural extracellular matrix of tissues. Using this process, fiber diameter is highly tunable based on the target design requirements. Electrospun materials possess high surface-to-volume ratio, enhancing cell adhesion, proliferation, and differentiation, as ideal scaffolds for tissue regeneration.

Tunable Porosity: In concert with fiber diameter, mesh porosity can be finely tuned using medical electrospinning to achieve the desired functional attributes of the material. Highly porous electrospun materials facilitate nutrient and oxygen transport, enabling better cell viability and tissue growth. High porosity also aids in the effective loading and release of drugs, growth factors, or bioactive molecules. Conversely, densely constructed electrospun meshes can be used to block cell infiltration, serving as barriers for different medical applications.

Customizable Mechanical Properties: The electrospinning process allows for precise control over the material composition, structure, and resulting mechanical properties of the scaffolds, ranging from highly elastomeric to relatively stiff. Different polymers, blends, additives, and post-process steps can be used to tailor the electrospun material’s mechanical properties for specific applications.

Biocompatibility: Electrospun fibers can be fabricated from both synthetic and natural materials with excellent clinical track records of biocompatibility and safety. As such, electrospun materials can reduce the risk of adverse reactions or toxicity.

Permanent or Resorbable: Medical electrospinning can be applied to a wide range of natural and synthetic polymers, both resorbable and non-resorbable, allowing for huge design space  in creating the ideal fiber-based material for different medical  applications

Controlled Drug Delivery: Electrospun fibers can encapsulate drugs or bioactive agents and offer controlled and sustained release. By carefully tuning the drug loading, fiber size, and porosity, the drug elution profile can be precisely controlled according to the needs of the therapy. VIVOLTA is also able to coaxially electrospin drug-loaded fibers to achieve elution characteristics that would otherwise be technically impossible.

Readily Integrated: Electrospun materials can be readily applied to other medical device components, like metallic stent frames and textiles, without sutures, greatly reducing the cost of manufacturing and unlocking new functionality. Vivolta’s manufactured electrospun components can be reliably integrated into our client’s supply chains thanks to our ISO13485 certification.

Scalability: At VIVOLTA, medical electrospinning processes can be scaled up for commercial production on our MediSpin^TM platform, making large-scale manufacturing of electrospun medical products possible.

Cost-effective: Compared to R&D electrospinning processes, VIVOLTA’s MediSpin^TM system allows for large-volume, cost-effective manufacturing of electrospun medical products based on its fully automated design and integrated quality control systems.

Innovative Research: Medical electrospinning continues to pave the way for innovative research in tissue engineering and regenerative medicine, enabling the development of advanced therapies and solutions for currently incurable medical conditions.

These advantages make medical electrospinning a valuable manufacturing technology with significant potential to revolutionize the medical and healthcare industries.

Electrospun medical materials offer numerous biological benefits, making them highly valuable for various biomedical applications. Some of the key biological benefits of electrospun medical materials include:

Biomimetic Architecture: Electrospun nano- and microfibers closely mimic the fibrous structure of the natural extracellular matrix (ECM) found in human tissues. This biomimetic architecture promotes cell adhesion, proliferation, and differentiation, facilitating tissue regeneration and repair processes.

Enhanced Cell & Tissue Response: The high surface area and porosity of electrospun materials allow for increased cell-material interactions, particularly cell adhesion, proliferation, and differentiation. Cells can attach, spread, and migrate more effectively on the scaffold, leading to improved cell viability and functional tissue formation. This is especially important for medical devices whose purpose is to restore damaged or diseased tissue.

Bioresorbable: Electrospun materials can be designed to be biodegradable, meaning they can be safely broken down and resorbed by the body over time. This property is crucial in the design of tissue scaffolds, because as the electrospun material gradually degrades it allows newly formed tissue to replace the implant and its function.

Anti-microbial: Bioresorbable electrospun materials can also be designed to incorporate antimicrobial agents, so that as the implant is safely resorbed, it also releases antimicrobial agents preventing acute or chronic infection. In this strategy, the localized, targeted use of antimicrobial agents, can greatly reduce the need for systemic administration of antibiotics, thereby counteracting side effects and antibiotic resistance.

Tissue Integration: Electrospun materials integrate seamlessly with the surrounding tissues, reducing the extent of chronic inflammation and adverse foreign body reactions. This integration fosters better tissue regeneration and long-term stability of the electrospun implant without deleterious scar tissue formation.

Controlled Drug Delivery: Electrospun fibers can be engineered to encapsulate drugs or growth factors, offering controlled and sustained release directly at the injury site. This feature enables targeted drug delivery, which is beneficial for localized treatments – particularly by improving their potency and reducing side effects.

Angiogenesis: Due to their high porosity and tunable pore size, electrospun materials promote angiogenesis, the formation of new blood vessels. Proper angiogenesis is essential for providing oxygen and nutrients to developing tissues, accelerating the healing process.

Modulation of Cell Behavior: Electrospun materials can be functionalized by incorporating bioactive molecules, such as peptides or growth factors. These functionalized materials can modulate cell behavior, guiding cellular activities like stem cell differentiation and tissue-specific functions.

Enabling Advanced Therapies: Electrospun materials provide an excellent platform for advanced stem cell-based therapies and tissue engineering. They can act as carriers and scaffolds for stem cells and provide the necessary cues for guiding stem cell differentiation into specific cell and tissue types.  Eventually, electrospun scaffolds incorporating growth factors and stem cells may be able to replace damaged or diseased organs.

Mechanical Properties: Electrospun scaffolds can be engineered to possess mechanical
properties that match those of the target tissue. For example, bone scaffolds can be designed to have high mechanical strength, while cardiac scaffolds can have elasticity similar to  heart tissue. Similar to specialized human tissues, electrospun materials can be engineered to be anisotropic – e.g. stiff in one direction and elastic in the other – offering a large design space for new medical implant design and development.

Non-immunogenic: VIVOLTA’s electrospun medical materials are non-immunogenic, meaning they do not trigger an immune response. This is due to their composition based on biocompatible synthetic and natural polymers that have a proven clinical track record of safety. This characteristic is crucial for implantable materials, as it reduces the likelihood of rejection by the body’s immune system.

These biological benefits highlight the tremendous potential of electrospun medical materials in regenerative medicine, tissue engineering, drug delivery, and various other biomedical  applications.

There are some notable examples of electrospun medical devices approved for clinical use in the US, Europe, and beyond. Typically, electrospun materials can be sterilized using the same methods as non-electrospun materials, namely: irradiation (Gamma, E-beam, X-ray), plasma, ethylene oxide gas, and others. For consultation on selecting a preferred sterilization method for your electrospun medical device, please contact us at bd@vivolta.com.

VIVOLTA has deep expertise electrospinning a wide variety of biocompatible polymers, both synthetic and natural, resorbable and non-resorbable. Small molecules, colloidal particles, and composites – comprising even metals and ceramics – can also be electrospun.

Please contact us at bd@vivolta.com to learn more.

The cost of an electrospinning system can vary depending on its complexity, specifications, process control, and throughput. Basic laboratory-scale electrospinning systems can range from a few thousand to tens of thousands of dollars based on the level of parameter control and consistency afforded by the equipment. These R&D scale systems are suitable for academic research and small-scale experimentation, but more basic systems may suffer from a lack of reproducibility and consistency between experiments.

It’s important to consider factors such as product requirements (e.g., mesh or tubular), material compatibility, and desired outcomes when selecting an R&D scale electrospinning system. Investing in a high-quality and versatile electrospinning system is crucial to achieving successful outcomes in medical applications and research. VIVOLTA offers best-in-class R&D scale electrospinning systems for academic use. Please contact us for more information.

While some industrial-grade electrospinning machines, intended for higher production capacity exist, few if any systems possess the internal automation and integrated quality control systems to make them suitable for the precise tolerances and homogeneity required for medical implants. This is why VIVOLTA has developed the MediSpin^TM system for scalable production of electrospun medical products at the quality, consistency, and volumes required by the medical industry.