Additive Manufacturing for Medical Devices
What Role Does Additive Manufacturing Play in the Medical Devices Sector?
Having reached a good level of maturity in the aerospace and automotive markets, additive manufacturing technology is now benefiting many applications in the medical devices sector.
Indeed, driven by the need for constant innovation and subject to strict regulatory requirements, the medical devices sector faces major industrial challenges. Whether used for joint and spinal conditions or for trauma care, medical devices now require greater customization to meet each patient’s unique characteristics, while still maintaining the need for responsiveness and constant availability.
In hospitals, 3D printing – or additive manufacturing – can be used in several ways:
– Produce prototypes of medical devices more quickly so they can be tested and then adjusted before final production.
– Practice on 3D-printed models ahead of surgical procedures, in order to improve patient care and reduce the length of operations.
– Produce custom prostheses or implants tailored to the patient’s metabolism, which are less expensive and more effective than traditional prostheses.
Although additive manufacturing represents a real revolution in the medical devices sector, with results that are more than encouraging, this process is not without risk and requires increased monitoring, particularly for prints intended to be integrated into the human body.
A Still-Recent Technique That Requires Regular Checks
The lack of standards and clinical feedback complicates the regulations surrounding these practices in the medical device sector. The multiple risks inherent in the design of parts produced by metal additive manufacturing must therefore be assessed and controlled in order to ensure the performance and safety of these devices.
Every stage of the powder lifecycle, from purchase to recycling, will require multiple regular checks to guarantee the quality of the parts produced. The characteristics commonly assessed are:
– the chemical composition of the powders, determined by ICP-AES and ICP-MS after mineralization and by elemental analyzers (C/S, N/O and H),
– particle size distribution, most often measured by laser diffraction,
– the true density by pycnometry, the bulk density, the tapped density by tapped volume measurement, the Hausner ratio,
– morphology, characterized by Scanning Electron Microscopy (SEM-FEG) and Optical Microscopy to assess particle morphology, sphericity, satelliting, …
– the metallurgical condition, characterized by metallographic examination, which can have a significant impact on the final mechanical properties of the parts.
With significant experience in implementing these characterization techniques and benefiting from genuine recognized expertise in this field, the FILAB laboratory supports medical device manufacturers with their metal powder control needs and expertise related to additive manufacturing activities.
The FILAB laboratory can carry out these analyses according to Safran Pr 6000 and Pr 7210.
- Reminder: what is additive manufacturing?
More commonly known as 3D printing, additive manufacturing refers to a production process that consists of adding material by stacking successive layers, starting from material powder (metal, plastic or composite). This technology stands in contrast to traditional manufacturing methods based on material removal (machining, etc.).
Offering unmatched design freedom, additive manufacturing makes it possible to create customized parts with high geometric precision and in relatively short lead times. In addition, production costs are reduced and product performance can be optimized (weight, size, design, etc.).
Additive manufacturing is commonly used in industry to pre-visualize a product through a prototype, produce small batches of industrial components, or customize products according to specific attributes.
Additive Manufacturing for Medical Devices: What Checks? What For?
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