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.
SILTISS, created in 2016, is a subsidiary of the SILAB group. SILTISS is dedicated to the development, production and marketing of biomaterials of natural origin that promote tissue regeneration processes. The first applications concern class III medical devices, as bone substitutes for the orthopaedic, dental and maxillofacial surgery. Other applications in the field of wound healing and regeneration are already in the development phase. SILTISS considers the introduction of an alternative to bone substitutes of animal origin as a real breakthrough and has developed a bone substitute from biopolymers: GlycoBone®. SILAB and SILTISS are linked as SILAB provides financial and Human Resources support as well as expertise in Quality Management, and other key resources to SILTISS.
INSERM’s Laboratory for Vascular Translational Science has developed a strong partnership with the SILAB group to produce the 3D scaffolds. Glycobone® is an osteoinductive and injectable ready-to-use polysaccharide-based scaffold combined with hydroxyapatite tailored for oral bone defect reconstruction. This class III medical device is under industrial co-development by INSERM/SILAB group and is expected to be introduced in clinical practice in the course of TBMED.
In addition to the use of GlycoBone® as a case study in TBMED, which includes the production of the medical device, the scaling-up and packaging and preparing the regulatory toxicology dossier, SILAB group will be involved as the sponsor of two clinical trials.