Our Services
From Concept to Commercial Manufacturing
From first feasibility study to commercial-scale manufacturing, The Electrospinning Company is the specialist electrospinning partner that medical device teams trust. We engineer for the end goal from the start: materials designed for manufacturability, processes built for scale, and quality systems that underpin regulatory readiness for submission when you need them.
A proven track record in regulated manufacturing
Components supplied for five FDA 510(k)-cleared devices and over a decade of continuous medical device manufacturing experience. We don't just develop electrospun materials, we manufacture them to the standards that regulated markets demand.
Over 100 feasibility projects delivered to date
Across orthopaedics, ophthalmology, soft tissue repair, cardiovascular and neurology. Breadth of cross-application experience means faster problem recognition, stronger material selection decisions, clearer path from feasibility to development.
Built for regulatory submission from day one
Our quality systems, validation protocols and manufacturing records are built to support regulatory submission, assembled as your programme progresses. We've supported client products through pathways including FDA 510(k), PMA and CE marking.
One specialist partner, from feasibility study to supply
The same specialist team, the same quality systems and the same institutional knowledge of your programme, from first feasibility study through to regulated commercial supply, backed by over a decade of proven manufacturing experience.
Managing The Full Product Lifecycle
Every product development journey is unique. Our five-stage process provides the structure, documentation and manufacturing discipline to take your programme from early concept through to regulated, repeatable production.
1┃Feasibility
- Rapid proof-of-concept electrospinning studies to determine project viability and development programme design.
- Risk identification leveraging 100+ projects of experienceÂ
2┃Product Development
- Design for manufacturability and cost from day oneÂ
- Iterative prototyping to optimise fibre and scaffold propertiesÂ
- Functional testing results and client feedback translated into clear specifications and design refinementsÂ
- Full design control documentation under ISO 13485Â
3┃Process Development
- Scale-up from lab to pilot to production scale, matched to your programme’s stage – pre-clinical, clinical or commercialÂ
- Process optimisation via design of experimentÂ
- Test method development and validation for CTQ requirements Â
- Production of clinical-grade material in ISO Class VII cleanroomsÂ
4┃Process Validation
- Equipment and process validation (IQ, OQ, PQ)Â
- ISO 13485 documentation ready for audits and submissionsÂ
- Comprehensive mechanical, chemical and sterility QC testing          Â
5┃Manufacturing
- Clinical-grade manufacturing in ISO Class VII cleanroomsÂ
- High-throughput production with multi-nozzle electrospinningÂ
- Statistical process control to ensure consistenc
- Global delivery with ISO-compliant quality assurance
Manufacturing at Scale: Built for Regulated Medical Device Production
Electrospun materials need to do more than perform in the laboratory and clinic. They need integrate with the device and support regulated commercial use and their manufacture needs to scale repeatedly The Electrospinning Company's manufacturing capability is the decisive advantage for programmes moving beyond feasibility.
Cleanroom facilities and production capability
All development and manufacturing takes place in ISO Class VII cleanroom environments, purpose-built for medical device production.
Designed for manufacture from day one
Our manufacturing experience includes a key component of the Artifascia® dura mater repair membrane - taken from feasibility through development, process scale-up, verification and validation, and into regulated manufacturing.
Supply chain discipline
We integrate with your product development programme quality, documentation and supply chain requirements, as a manufacturing partner, not just a process developer. We draw on a network of trusted suppliers of raw materials, equipment and parts engineering and GMP testing.
Manufacturing partnership in practice
We run structured manufacturing review meetings with our clients, providing visibility of production status, process performance and quality data when it matters most.
Scaled to match your programme's stage
We scale process and production volume to what your programme actually needs - pilot scale for pre-clinical and clinical trial supply, full production scale for commercial growth.
Quality Built Into the Process
Quality at The Electrospinning Company is proactive, data-led and grounded in continuous improvement, and built into every stage of development and manufacturing.
This lean mindset runs through manufacturing and quality operations alike, strengthening repeatability, improving efficiency and supporting cost control as your programme scales.
We use statistical process control and Lean Six Sigma methodology to monitor manufacturing performance and drive continuous improvement. Quality is built into the process.
ISO 13485 certified since 2015. All production in ISO Class VII cleanrooms.
Support regulatory submissions across FDA 510(k), PMA, CE marking and global pathways.
What we do
• Statistical process control
• Proactive trend monitoring
• Six Sigma continuous improvement
• IQ/OQ/PQ validation
• ISO 13485 certified since 2015
What it means for your programme
✔ Consistency and repeatability as you scaleÂ
✔ Issues identified before they become deviationsÂ
✔ Efficiency and cost control over timeÂ
✔ Audit-ready documentation from day oneÂ
✔ Regulatory confidence across FDA, CE and global pathwaysÂ