Selected Success Stories
How is a medical device approved? A medical device is an article
An exciting new technology trend that could revolutionize healthcare is the “digital
With growing cross-linking in the digital healthcare sector and the possibilities of medical
In vivo, in vitro, in silico – Medicine is changing and with
With the introduction of the new Medical Device Regulation (MDR), the approval of orthopedic aids will also become more difficult. For the first time, a digital process chain is to be established that will enable preventive quality assurance of individualized prostheses and orthoses by validating a virtual load test of a 3D-printed prosthetic foot.
“With Simq’s support and expertise, we can pioneer this at Mecuris. Incorporating simulation-based quality assurance into the digital creation of personalized orthopedic devices can add real value for patients.“
Mecuris combines a variety of 3D technologies in an intuitive solution platform, enabling orthopedic technology to step into the digital age. Mecuris is supported by Simq in setting up the internal simulation of patient-specific designed products.
The project “Validated simulation of a 3D-printed prosthetic foot” brings together experts from the fields of biomechanics, orthopaedic technology, 3D printing, certification, validation and simulation.
Together we check whether the calculation of the strains of the real and virtual test yield the same results. This is a crucial step in validating the simulation. The project makes it possible to digitally test patient-specific designed orthopedic products before they are 3D printed and made available to patients in the shortest possible time.
In cooperation with a physician or orthopedic technician, patient-specific parameters are determined and automatically integrated into CAD models via the Mecuris Solution platform. The medical products are manufactured in certified 3D printing centers and checked by experts before they are used.
In cooperation with Simq GmbH, an initial finite element analysis of the Mecuris “NexStep” prosthetic foot was already developed in 2016 with the boundary conditions of the static test of the test standard DIN EN ISO 10328.
This standard describes the prerequisite of the mechanical stability of prostheses of the lower extremities and represents a prerequisite for the sale of the Mecuris prosthetic foot.
Mecuris is supported by Simq in setting up the internal simulation of patient-specific designed products. The current focus is on improving the material models and parameters to correctly represent the load behavior of the prosthetic foot. From the first comparisons of real and virtual strains in the “validated simulation” project, potential improvements could already be identified and iterations planned. An initial challenge has already been mastered on the basis of the tests: The fundamental suitability of strain gauges for the feasibility of the process of measurement validation of numerical simulation methods for additively manufactured medical devices was demonstrated. In order to find suitable measures that further increase the accuracy between real and virtual deformation and thus the safety of the medical device and finally the patient, Simq is available as a central partner in the project.
Paper by Prof. Dr. Dr. Max Mustemann zu MühlhausenWritten title of the paper, can also be a little longer
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