Cloud native EDA tools & pre-optimized hardware platforms
Posted on 15 October 2021 by Celia Butler
Medical devices typically provide challenges in terms of developing and building scalable workflows for design and customization to individual patients. However, modern fabrication tools and software are making it easier for manufacturers to speed up, and even automate, large parts of their production process. One key area of growth involves the use of new technologies to create high-quality, customizable devices.
Over the last few years, we’ve greatly expanded the medical applications of Simpleware software, from adding FDA 510(k) and CE-marking certifications for Simpleware ScanIP Medical, to developing AI technology for speeding up common segmentation and landmarking tasks involving 3D image data.
We recently collaborated with Carbon and nTopology on a webinar to demonstrate a seamless design and fabrication workflow to create a patient-specific tibial surgical cutting guide, utilizing technologies such as 3D printing, design automation, and processing of anatomical scan data. So, how does this automated digital workflow come together?
The workflow begins with acquiring patient-specific image data in the form of MRI or CT scans and processing it in the Simpleware software platform. For this project, we used the Simpleware Knee CT tool, part of our Simpleware AS Ortho (Auto Segmenter for Orthopedics) module, which uses AI-based Machine Learning algorithms to power automatic segmentation. Compared to manual, tedious work by users on segmenting regions of interest, this approach employs a one-click solution to rapidly segment bones of the knee and identify common anatomical landmarks. The algorithms are also trained by experts and verified for clinical professionals, and are also available for ankle CT, knee MRI, and hip CT data to give a 20x to 50x faster rate of segmentation over manual operations.
In this case, we:
Automated tibia segmentation using Simpleware AS Ortho
The Simpleware bone geometries and anatomical landmarks were then used in nTopology software to design the patient-specific tibial cutting guide. nTopology provides a geometry design and management platform that utilizes implicit modeling technologies to generate unbreakable geometries and fast, reusable workflows. Although the software is applied to different industries, in the field of medical devices it provides many options for customizing designs to different requirements. The nTopology approach can also be easily adapted and scaled to different patient anatomies to speed up workflows.
When working with the Simpleware image data, nTopology:
Cutting guide design workflow in nTopology
Finally, the actual patient-specific tibial cutting guide was manufactured using the Carbon DLS™ process to ensure a robust final product.
To do so, Carbon:
3D printed cutting guide using a Carbon printer
The workflow from the image data processing in Simpleware software, via nTopology, to the 3D print in Carbon is very quick and flexible, with adjustments possible depending on the particular case and design requirements. In addition, as more data is added to the AI algorithm used for the Simpleware knee segmentation, the range of different features and pathologies can be expanded.
The success of this approach shows the potential of streamlining the process of going from image data to a print, offering benefits for medical device manufacturers and pre-surgical planning. In the future, the entire workflow could be housed within a dedicated 3D printing hub within a hospital, improving communication and making 3D printed models an even more valuable resource for patient care.
Watch a recording of Carbon, nTopology, and Synopsys presenting this workflow:
If you would like to know more, please contact us. Our technical specialists will be happy to show you Simpleware software and our Machine Learning-based solutions for any anatomy.