K-prosthesis
CYBERnano is a key member of the TBMED project in which the company is developing new statistical methods and tools to facilitate the implementation of Quality-by-Design services for SME in Medical Device Engineering: https://tbmed.eu/quality-by-design
TBMED aims to develop an Open Innovation Test Bed (OITB) for high risk medical devices that provides a single entry point to services along the whole value chain from preclinical development to clinical testing. The entire development will be based on a Quality-by-Design (QbD) concept.
TBMED aims to support med-tech companies in the development of high-risk medical devices by reducing their time-to-market for the European sector.
TBMED will help European SMEs to maintain their competitiveness and innovation capacity in the face of global competition, e.g. from larger providers. Its aim is to minimize time-to-market and efforts for reimbursement and make medical devices accessible to patients more easily.
CYBERnano through TBMED is collaborating with AJL Ophthalmic, a company dedicated to the manufacture of intraocular lenses and other medical devices in the field of ophthalmology. In 1998, the company started manufacturing intraocular lenses for the treatment of cataract and since then it has been working on developing innovative high-performance products to improve competitiveness and to be able to compete with multinationals. At present, the company’s R&D department is working in four research areas: Ophthalmology, Maxillofacial, Airway and Veterinary.
In the TBMED project, AJL is involved as industrial manufacturer and, together with Cidetec, case study developer of a new Keratoprosthesis. The design and production of the Keratoprosthesis will be optimized using QbD methodology to achieve controlled, reproducible and safe product according to ISO 13485. Pilot production will be used to validate pre-clinically the advanced Keratoprosthesis in rabbit so as to ensure efficacy and safety of the medical device.
