SIGMA3D - Interdisciplinary research project for the digitalization of orthotics
At present, orthoses are still largely fabricated by hand or as catalogue goods. Individual fabrications are currently still combined with a high level of manual 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 an increase in 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.
engl.: Simulation-based medical technology platform for individual 3D aid supply
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 safety and performance tests providing valuable information for the product documentation required by MDR.
The digital process at a glance
As project managers, we, the Mecuris team, work together with our project partners from industry, research, service providers from the healthcare sector and health insurance companies 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.
Antonius Köster GmbH & Co Kg is a provider of design and development services. For 25 years the company has been dealing with the introduction of 3D CAD/CAM workflows in companies, especially in the medical and Orthopaedic technology.
SIMQ (former CADFEM Medical) has set itself the goal of making the added value of simulation benefit a "new" product: the human being. The company benefits from the extensive experience of more than 25 years of Finite Elemente Simulation and applies it in a new way.
As a successful traditional company of the Berufsgenossenschaft Rohstoffe und chemische Industrie BG RCI, the core competencies of Care Center Rhein-Ruhr have been in technical orthopaedics and orthopaedic shoe technology for over 100 years.
The Clinic for General, Accident and Reconstructive Surgery at the University Hospital of Munich (LMU) contributes expertise as a medical user. In the SIGMA3D project, The clinic is testing the practical suitability of the digital process chain and evaluating the procedures from a medical perspective.
Mecuris is a young medtech company that improves medical care by 3D-printed individual orthopaedic aids such as splints (orthoses) and artificial limbs (prostheses), e.g. through the project management of SIGMA3D.
The owner-managed medical supplies store Gäher has eight stores and 53 employees with a regional focus on the Münsterland region. For the project, the extensive previous knowledge in area of the lower leg orthosis (AFO) is relevant.
Associated project partners