If you need to coat a medical device with a more complex geometric shape—one that does not allow for efficient coating using standard equipment—the Fluidnatek LE-500 BioDevice electrospinning system, featuring a robotic arm integrated into the chamber, may be the most suitable, effective, and efficient solution for your needs. The robotic arm can grasp the medical device or the spinning injector and generate the optimal movements and trajectories to apply an appropriate nanofiber coating to the part.

 

Advanced software tools that contribute towards the certification of a GMP or ISO process are included in the machine configuration.

Maximum process control, including of course our Environmental Control Unit (ECU) for precise temperature and humidity control in the chamber.

The Fluidnatek LE-500 BioDevice represents the culmination of this experience, providing a platform specifically engineered to deliver reproducible electrospun coatings on medical devices with particularly complex geometries by integrating a robot arm in the spinning chamber, enabling all degrees of freedom for movement of the spinning injector, while supporting scalable and validation-oriented manufacturing workflows.

Electrospinning for Complex 3D Medical Devices

Electrospinning on medical devices which have particularly complex geometries requires far more than a standard electrospinning platform. Implant geometry, surface topology, and coating requirements directly influence emitter positioning, collector movement, deposition uniformity, and process reproducibility.

The Fluidnatek LE-500 BioDevice was specifically developed for electrospun coating of medical devices, bioimplants, and other particularly complex three-dimensional components. With configurable deposition strategies, automated motion control, and robotic handling thanks to the collaborative robot arm (cobot) integrated in the spinning chamber, the platform enables precise and reproducible nanofiber coating of geometries that conventional electrospinning systems cannot efficiently process.

Validation-Oriented Manufacturing Workflows

Designed for regulated environments, the Fluidnatek LE-500 BioDevice incorporates advanced software tools that support process traceability, batch documentation, user access management, and validation-oriented workflows. Complete track record. Fluidnatek can also provide IQ/OQ documentation, on-site qualification services, and process development support, including Performance Qualification (PQ) when required.

Built to support robust manufacturing and validation strategies for medical device production.

Maximum Process Control and Reproducibility

Consistent electrospinning starts with precise process control. The Fluidnatek LE-500 BioDevice integrates Fluidnatek’s Environmental Control Unit (ECU) for accurate temperature and humidity regulation, together with advanced process monitoring and automation capabilities, as well as a design studied to the finest details to provide the tightest process control.

The result is improved coating reproducibility, tighter process control, and greater confidence when scaling from development to production.

Configurable Platform for Unique Medical Devices

Every medical device presents unique coating challenges. The Fluidnatek LE-500 BioDevice is designed as an open and configurable platform that can be adapted to specific product geometries, process requirements, and manufacturing objectives.

From custom fixturing and collector configurations to robotic integration in the spinning chamber and advanced process automation, Fluidnatek works with customers to develop the most effective electrospinning solution for their specific applications.

HEPA Filtration and Cleanroom-Compatible Materials

HEPA filtration is implemented in the Fluidnatek LE-500 BioDevice to maintain the required air cleanliness within the spinning chamber, generating an ultra-clean environment. Robust, solvent-cleanable materials are used throughout the chamber construction, supporting thorough cleaning between batches and the hygienic conditions required for ISO and GMP-compliant biomedical device manufacturing.

Climate-Controlled Electrospinning: Environmental Control Unit (ECU)

Achieving a stable process and consistent coating quality requires tight control of both temperature and humidity within the electrospinning chamber. As one of the first companies to develop climate control systems specifically for electrospinning machines, Bioinicia Fluidnatek has built extensive expertise in this area.

The Fluidnatek Environmental Control Unit (ECU) included with the Fluidnatek LE-500 BioDevice and specifically designed for an evaporative process such as electrospinning, is capable of heating, cooling, drying, and humidifying the environment in the spinning chamber. It communicates directly with the actively regulated exhaust system to maintain the optimum balance between process stability and operator safety throughout every coating run, generating a slight negative pressure in the chamber for safe operation.

Precise Solution Dosage for Medical Nanofiber Coatings

Control and precision in solution delivery are critical in medical device coating. The Fluidnatek LE-500 BioDevice is equipped with a high-accuracy, high-pressure syringe pump (2-channel or 4-channel pump) that delivers precise volumetric solution dosage, ensuring a consistent and stable coating process with batch sizes up to 240 mL or up to 480mL, respectively.

Dual-Material Deposition

An additional second solution feed is available on the Fluidnatek LE-500 BioDevice, enabling simultaneous deposition of two different materials on the same device, meaning two types of electrospun fibers simultaneously — for example, combining bioactivity and mechanical strength properties within a single nanofiber coating structure.

Rotating Collector Platform with Adaptable Collector Mount

Medical devices come in all shapes and sizes. The Fluidnatek LE-500 BioDevice features a rotating collector platform that adapts accordingly, allowing one-ended or two-ended mounting of a variety of diameters and non-symmetrical collectors, thus including cantilevered configuration mounting. This adaptability is essential for the controlled coating of complex 3D medical device geometries that cannot be addressed by standard electrospinning configurations.

Customized holder designs are available on the Fluidnatek LE-500 BioDevice platform, enabling the system to be configured to the specific geometry of each target device.

Automated Spinning Head Positioning for Complex 3D Geometries

In order to accommodate a variety of 3D shapes, the spinning head on the Fluidnatek LE-500 BioDevice can be moved along the Y-axis and in the Z-direction (emitter-collector distance) from the touch-screen control and integrated into an automated program. Alternatively, the spinning head can be held and moved by a collaborative robot arm (cobot) integrated in the spinning chamber, or the collector (e.g. medical device) can be handled and moved by the robot arm instead. This enables fiber deposition from different positions relative to the device surface — as appropriate for the specific geometry — without needing to open the chamber.

World’s First: Collaborative Robot (Cobot) Arm Integration

In collaboration with The Henry Royce Institute (University of Manchester, UK), Bioinicia Fluidnatek has developed the world’s first electrospinning machine with integration of a collaborative robot (cobot) arm, available for the Fluidnatek LE-500 BioDevice platform.

This unique feature offers an unparalleled ability to manipulate the collector (e.g. medical device) or the emitter in 3D space, enabling multi-step processing and variable deposition angle. This capability is essential for uniform coating of complex 3D geometries that require the emitter or collector to be repositioned overtime during the coating process without interrupting the run, in order to reach all areas where the electrospun fiber deposition should be made.

The robot type is determined case-by-case in consultation with the customer, enabling the system to be optimally configured for each specific device geometry and coating application.

Automated Batch-to-Batch Consistency

Product consistency is a critical requirement in medical device coating manufacturing. The Fluidnatek LE-500 BioDevice incorporates automated features designed to minimize rejection rates and help support batch meets the required quality and specifications.

Multi-Step Programming

The Fluidnatek LE-500 BioDevice includes multi-step programming functionality, enabling complex coating sequences to be programmed and automated from start to finish. This minimizes operator-dependent variability and human errors, and ensures consistent process execution across production runs and users.

GMP-Compliant Electrospinning: Validation and Qualification Support

Manufacture of medical device coatings requires validated processes and properly documented manufacturing runs. The Fluidnatek LE-500 BioDevice provides multi-user level access control, batch control functions, audit trail, and high-definition process data collection for accurate process monitoring and data-driven decisions, to support these requirements. This enables complete track record files.

Bioinicia Fluidnatek provides an IQ/OQ (Installation Qualification | Operational Qualification) documentation package and on-site qualification service. A full process development and Performance Qualification (PQ) service can be also available, delivering a platform pre-validated for your specific coating process and device geometry before installation.

Ready to Develop Your 3D Medical Device Coating Process?

The Fluidnatek team has direct experience in medical device coating development and production by electrospinning. Whether you are establishing your first electrospinning process for a new device geometry, or scaling an existing process to move to production, we can support you at every stage.

Talk to a Fluidnatek specialist about your device geometry, target coating specifications, and production volume requirements. We can help you with the most suitable electrospinning technology for coating your medical devices.