AdhFix - Light-cured composite plates for fixing complicated hand fractures
|Coordinator||Biomedical Bonding AB|
|Funding from Vinnova||SEK 3 000 000|
|Project duration||April 2022 - May 2024|
|Venture||Swelife and Medtech4Health - Collaborative Projects for Improved Health|
Purpose and goal
AdhFix is a pioneering implant for fracture fixation where the surgeon shapes and hardens a composite-based fixation plate at the fracture site. AdhFix´s properties enable implants adapted for each individual fracture, regardless of the shape or size of the bone or the complexity of the fracture. In this project, the product owner Biomedical Bonding collaborates with medtech specialists at RISE, hand surgeons from Stockholm South General Hospital and researchers at KTH to develop AdhFix from a research prototype to a medical device ready for clinical trials.
Expected results and effects
The project will generate the technical documentation and validate the processes necessary to initiate a first clinical study of AdhFix. The final design of AdhFix will be determined in terms of safety and usability and the first production units will be manufactured. Tests will be performed on the final product to establish the necessary documentation and verify AdhFix´s properties under validated conditions and justify the conduct of clinical studies.
Planned approach and implementation
The development of AdhFix will follow the stages set out in the EU Medical Device Regulation (MDR) to develop a safe and functional product. The general requirements for safety and performance will be ensured through the development and execution of verification and validation methods adapted to the innovative implant technology that AdhFix entails. The project will be carried out by technical, clinical and regulatory experts as well as experienced specialists in testing of medical devices.