The SIGMA3D project, funded by the German Federal Ministry of Education and Research under grant 16SV8387, ran from 1 March 2020 to 31 August 2023. Its aim was to create a fully digital, web‑based value chain for orthopaedic aids that starts with patient data capture, proceeds through 3‑D design, virtual testing, and ends with production and user evaluation. The core innovation was an automated safety check that uses validated virtual load and function tests in real time, enabling future on‑demand 3‑D printing of patient‑specific orthoses.
Simq GmbH, an ISO 13485‑certified provider of patient‑specific simulation solutions, led the development of the simulation methodology and the virtual testing back‑end. The company integrated its cloud platform Simq VIT (formerly docq) into the workflow, adding modules for importing patient scans, generating finite‑element models, and running virtual load tests. A meta‑model of optimal prognosis (MOP) was constructed to predict mechanical performance and guide design optimisation. The FE simulation model was verified against the MOP and then transferred to a new product line, demonstrating the method’s generality. The workflow also includes secure data exchange with the cloud infrastructure and automated export of design files for downstream manufacturing.
A key technical milestone was the automation of hand‑orthosis (WHO) model generation. The system now accepts raw scan data, automatically constructs a 3‑D model, and subjects it to the virtual testing pipeline. Results from the virtual tests are fed back into Simq VIT, where orthopaedic technicians can review and refine the design. The project also employed an optical measurement system (GOM) to validate the deformation of hand orthoses in a physical test stand, providing empirical data to calibrate the simulation models.
The project’s schedule was organised into 12 quarters, with Simq contributing to digital process chain design, platform architecture, interface development, regulatory guidance, simulation methodology, FE verification, and the final implementation and usability testing of an orthosis. The validation phase of the simulation models required an additional six months, extending the project cost‑neutrally.
Collaboration involved eight partners: Simq GmbH, Mecuris GmbH (Munich), Antonius Koester GmbH & Co. KG (Meschede), Care Center Rhein‑Ruhr GmbH (Bochum), Sanitätshaus Gäher (Münster), FH Münster, Klinikum der Universität München, and the Technical University of Berlin’s Institute for Sociology. The VDI/VDE Innovation + Technik GmbH acted as project manager. Each partner contributed expertise in patient data acquisition, clinical validation, manufacturing, and academic research, ensuring that the digital chain covered all stages from capture to production.
In summary, SIGMA3D delivered a back‑end capable of automated virtual testing and optimisation of orthoses, a fully integrated workflow that links patient data to cloud‑based simulation and design refinement, and a validated meta‑model that predicts mechanical performance. The project’s interdisciplinary partnership and the involvement of a regulatory‑aware simulation platform position it as a pioneering step toward a fully digital orthopaedic supply chain.