Design, Development and Manufacture

If you are a medical device company wanting to enhance products with biomaterials or an academic wanting to translate your innovation through to clinical testing, we can support you with design, development and manufacture. We offer a series of modules tailored to your needs:

  • Feasibility studies
  • Method development: verification and validation
  • Quality and regulatory documentation
  • Pilot production of samples
  • Manufacture of clinical grade material

Our experience includes:

  • Development 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
  • 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

Contact us to discuss your project requirements