Laboratory analysis and characterization as part of additive manufacturing

Additive manufacturing of Medical Devices

What role does additive manufacturing play in the field of Medical Devices ?

Having undergone advances in the aeronautics and automobile industries, additive manufacturing technology is now used in very many applications in the field of Medical Devices.

Subject to continuous innovation and more and more stringent regulations, the field of Medical Devices regularly faces major industrial challenges. Whether they are used for articular and spinal pathologies or for traumas, Medical Devices today need to be tailored to fit the needs of each individual patient while maintaining a need for responsiveness and constant availability.

In a hospital setting, 3D printing – or additive manufacturing – can have many uses :

– Rapidly producing prototype Medical Devices which can be tested and adjusted before going into real production

– Training on 3D printed models before surgical operations to improve the care given to patients and to reduce the time needed to perform surgery

– Production of custom prosthetics or implants adapted to a patient’s metabolism at a lower cost and with better performance compared to traditional prosthetics

Even though additive manufacturing has the potential to be revolutionary for the field of Medical Devices, showing encouraging results, this procedure is not without risk and must closely monitored, especially if the device is intended to be integrated into a patient’s body.

A relatively new technique needing regular monitoring

The lack of standards and of solid clinical data make regulations surround the use of this technique in the field of Medical Devices extremely complicated. The various inherent risks of the designing process of metallic parts made though additive manufacturing must be assessed and properly handled in order to ensure the performance and safety of these devices.

 

Each step of a powder’s lifecycle, from purchase to recycling, requires multiple, regular inspections to ensure the quality of metallic parts being produced. These characteristics are generally :

– Chemical composition, determined using ICP-AES or ISP-MS following mineralization and using elemental analyzers (C, H, O, N, S)

– Granulometry usually measured with a Laser Granulometer

–  True density by pycnometry, bulk density, packed density using a volumometer, Hausner ratio

– Morphology measured using Scanning electron Microscopy (FESEM) and Optical Microscopy

– The characterization of microstructure, that impact mechanical properties

With extensive experience in implementing these characterization techniques and relying on its know-how and expertise in this field, FILAB laboratory can assist Medical Device manufacturers by inspecting their metallic powders and providing other services relating to additive manufacturing.

Reminder : what is additive manufacturing ?

Commonly known as 3D printing, additive manufacturing is a process consisting piling up successive layers of material made from powdered material (metallic, plastic or composite). This technique is the opposite of traditional manufacturing methods which consist of removing material (machining…).

Providing unbeatable freedom during the designing process, additive manufacturing makes it possible to produce custom made parts with high geometric precision in relatively short timeframes. Furthermore, production costs are reduced and product performance and be optimized (weight, size, design esthetics…).

Additive manufacturing is regularly used in industrial settings to get a preview of what a part will look like by producing prototypes, to produce small amounts of specific parts or to customize existing parts by changing specific attributes.

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