AdhFix - Light-cured composite plates for fixing complicated hand fractures
| Reference number | |
| Coordinator | Biomedical Bonding AB |
| Funding from Vinnova | SEK 3 000 000 |
| Project duration | April 2022 - February 2025 |
| Status | Ongoing |
| Venture | Swelife and Medtech4Health - Collaborative Projects for Improved Health |
| Call | Swelife and Medtech4Health - Collaborative projects for better health autumn 2021 |
Important results from the project
The overall goal of BMB is to develop AdhFix into a "gold standard" for the treatment of complex fractures. To market and sell AdhFix in Europe, CE marking is required according to the MDR, which requires a QMS and ISO-13485 certification. Clinical studies are needed to demonstrate that the product meets the "intended use". The project has developed AdhFix from a prototype to a medical device ready for clinical testing and CE marking. The project has essentially met its set goals.
Expected long term effects
Introduction of a QMS and validated production of AdhFix will facilitate future product development. Processes developed can be applied to other products in the pipeline. In the longer term, networks and collaborations established can lead to more innovative solutions and improved treatments. Long-term effects include a smoother development process for new products, strengthened clinical collaborations and a potential expansion in both the human and veterinary markets.
Approach and implementation
The project was executed with a structured plan. The activities encompassed the development and validation of a quality management system (QMS), the production of AdhFix kits, and preparations for clinical trials. These tasks were followed by ongoing monitoring and adjustments as necessary. The activities proceeded as intended, with a few modifications due to external influences. Collaboration with project partners was effective and positively impacted the project´s implementation.