BioMeTIOMaticBio-Medical Application of Incremental Forming: Towards industrial upscaling and medicalaccreditation

The goal of the project is to take the necessary steps to push custom incrementally formed titanium skull implants from proof of concept stage, resulting from the BioMeTIOm project, to clinical validation. This encompasses the design of the implant based on CT scans, the production process, the post processing of the implant including cleaning and sterilization and finally the implantation. On one hand an effort needs to be done to create an autonomous production workflow, leveraging algorithms and techniques explored in the BioMeTIOm project. This workflow will enable fast processing of varying skull geometries. The other major effort lies in ensuring conformity of the implant and production process with the newest European regulations on medical devices (EU 2017/745). A mechanical engineering profile will focus on the flexible sheet metal production workflow, while a medical profile is needed for CT and cleaning/sterilization protocols and the clinical trials (conform EU regulation 536/2014). Inputs on implant design and mechanical testing protocols will be given by the department of Biomechanical Engineering.

Keywords:Incremental Forming, Skull implant, Clinical trial, Patient specific, Titanium

Disciplines:Manufacturing process planning, Manufacturing systems, Neurosurgery