The Electrospinning Company manufactures the electrospun component at the core of Nurami Medical’s ArtiFascia® dural repair graft. This case study describes how TECL successfully scaled manufacturing using an advanced electrospinning platform, increasing production capacity while maintaining the quality, consistency and reproducibility required for a regulated medical device.
Challenge
The Electrospinning Company supplies electrospun sheets to Nurami Medical as a critical component of its ArtiFascia® dural repair graft.
Nurami achieved FDA 510(k) clearance and launched the product in the USA in 2024 and has been building traction across leading neurosurgical centres since. Increasing commercial demand created the challenge of scaling manufacturing capacity while maintaining the quality, consistency, and reproducibility required for a regulated medical device.
As the product had already achieved FDA clearance, the scale-up programme was completed while maintaining regulatory and quality requirements.
Although the electrospinning process had been successfully established and manufactured at modest scale for several years, larger production volumes required a carefully controlled scale-up strategy. Any increase in throughput needed to to maintain product quality and manufacturing consistency while supporting future commercial growth.
Solution
The Electrospinning Company led the scale-up programme, combining its electrospinning manufacturing expertise with an advanced electrospinning platform. A structured scale-up plan was developed with Nurami Medical, defining the manufacturing strategy required to increase production while maintaining the validated process and quality requirements of an FDA-regulated medical device.
The team then applied its expertise in electrospinning science, materials behaviour and quality requirements to optimise process conditions for large-scale production and execute the agreed manufacturing strategy. The scale-up programme was conducted in accordance with medical device quality requirements, with process changes evaluated through established quality management practices while maintaining product quality.
Structured manufacturing workflows and validated standard operating procedures formed a core part of the implementation plan, minimising operator variability and ensuring repeatable execution across teams as production capacity increased.
Drawing on lean manufacturing and Six Sigma principles, TECL implemented validated standard operating procedures and standardised production practices to deliver a manufacturing process capable of supporting ongoing production within the regulatory constraints of an FDA-cleared medical device. These structured workflows ensured consistent execution across operators and production campaigns while maintaining the traceability, process control and documentation required for commercial manufacture. Following implementation, the scaled manufacturing process was successfully validated, providing a robust and scalable manufacturing platform for continued commercial production.
“One of the most rewarding aspects of this project was seeing different areas of expertise come together to solve a complex manufacturing challenge. The Fluidnatek LE100 platform provided the process control we needed, while our team’s experience in electrospinning and regulated manufacturing allowed us to optimise and scale the process with confidence. Working closely with Nurami Medical throughout the project meant we could respond to challenges together and successfully deliver a manufacturing process ready to support commercial growth.” — Giulia Creed, Product Development Engineering Manager, The Electrospinning Company.
Results
By combining advanced electrospinning equipment, structured change management and manufacturing expertise, TECL successfully increased the production capacity while maintaining the validated manufacturing process and avoiding significant process changes requiring regulatory notification.
Key outcomes included:
• Maintained industry-standard process capability metrics through structured manufacturing workflows.
• Successfully implemented a controlled scale-up programme while maintaining product quality and manufacturing consistency.
• Maintained the quality, consistency and repeatability required for regulated medical device manufacture while increasing production capacity.
The Electrospinning Company has supported Nurami Medical in the development and manufacture of the electrospun component of the ArtiFascia® dural repair graft from the initial partnership in 2018, through clinical supply, FDA 510(k) clearance and commercial scale-up. Throughout the programme, the electrospinning platform has provided the manufacturing capability required to support each stage of product development and commercial growth.
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