Building a digital production chain for patient-specific medical devices

AM-Flow is part of a consortium developing a fully integrated digital production chain for patient-specific medical devices. From medical imaging and design to manufacturing, quality control and delivery, every step is digitally managed and reproducible.

A medical device that fits one patient precisely often takes many separate steps: imaging, design, production and quality control, carried out by different parties and partly by specialized manual work. That makes customization costly and hard to scale.

Together with Radboudumc, BAAT Medical, Oceanz & 3D Medical Models, we are working on a different approach: one connected digital workflow, where each step feeds the next and is traceable end to end.

  • Imaging and design (Radboudumc): turning medical images into a patient-specific design.
  • Regulatory compliance and validation (BAAT Medical): keeping the chain within the legal framework for medical devices.
  • Production (Oceanz and 3D Medical Models): 3D printing in an ISO 13485 certified production environment.
  • Quality control and traceability (AM-Flow): automated inspection of every individual component, and integration of that data into the digital workflow.

When every part is different, quality can’t depend on one-off manual checks. Automated inspection per component lets manufacturers monitor, verify and document key quality parameters consistently, and links each part to its digital record. That traceability supports compliance and makes the process repeatable as volumes grow.

3D printing lets devices be tailored to the individual patient without costly molds. Combined with a digital workflow, customization becomes repeatable and more scalable. The medical specialist stays the leading authority on clinical decisions. The chain’s job is to convert the design into a medical device reliably and traceably.

The goal is a step toward scalable, affordable, high-quality personalized healthcare, so that patient-specific devices can reach a broader group of patients.

Interested in the project or in automated quality control for additive manufacturing? 

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This project is co-funded by the European Union through EFRO Oost.
Consortium partners: Oceanz · Radboudumc · AM-Flow · BAAT Medical · 3D Medical Models

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