Research project SIGMA3D
At present, orthoses are still largely fabricated by hand or as catalogue goods. Individual fabrications are currently still combined with a high level of craftsmanship. With the introduction of MDR next year, the approval of these aids will also become more difficult. This inevitably leads to an immense amount of time and also pushes up costs.
In this respect, digitalisation in particular offers new opportunities for the medium-sized sector. The additive production of orthopaedic aids is becoming more and more common. However, a complete digital process chain from patient scan to additive manufacturing does not yet exist.
In order to counteract exactly this challenge, the three-year joint project "SIGMA3D – Simulationsgestützte Medizintechnikplattform zur individuellen 3D-Hilfsmittelversorgung" (engl.: Simulation-based medical technology platform for individual 3D aid supply).started in March 2020. The overall goal is to digitally map the entire digital process chain.
For the first time, a digital quality check is also to be carried out on the Mecuris Solution Platform by validated load and function tests in real time, providing valuable information for the product documentation required by MDR.
As project managers, we, the Mecuris team, work together with our project partners from industry, research, service providers and health insurance companies from the healthcare sector to advance the future of orthopaedic technology. Orthopaedic companies, regardless of their size, will in this way be able to individually model and digitally test web-based orthoses using patient-specific data.