Contract Design and Development
The Electrospinning Company has a range of capabilities and expertise to support the development of electrospun membranes into medical device products or product components. We offer a range of services to translate ideas, product concepts and lab processes through to clinical testing and pilot production.
We offer a series of studies tailored to your needs supported by flexible business models:
- Concept plans: Turning an idea into a Target Product Profile including technical feasibility, regulatory and IP considerations, bearable pricing and risks.
- Feasibility studies: Evaluating whether we can create a scalable, reproducible process from a concept or lab scale process.
- Pre-design control studies to design freeze: research studies to achieve the desired target profile and optimise the process including packaging and sterilisation regimes. Make samples for in vitro and other testing.
- Design control Modules: Verification and Validation studies to establish the tolerances of the optimised process. Make samples for regulatory studies.
- Regulatory studies: Manage ISO 10993 biocompatibility studies with accredited third party suppliers and coordinate documentation. Generation of documents for Design History File.
- Pilot production: Product batches with Certificates of Conformance to the finalised product specifications.
Our experience includes:
- Development (proof of concept, pre-design control and design control studies)of the first electrospun material that is incorporated into an implantable medical device which has achieved US FDA 510K approval
- Fabrication of scaffolds for a corneal transplant Phase I clinical trial in India, including provision of support to The University of Sheffield and L.V.Prasad eye clinic in compiling the Clinical Investigator’s Brochure (regulatory document)
- Development of methods and fabrication of devices for pre-clinical trials in tendon repair for the University of Manchester
- Delivery of a feasibility study on the translation of a research to an industrial manufacturing process for the University of Freiburg
- Delivery of a feasibility study on cell support membranes for a biotech company