Company insight
Build the safest route to 3D-printed medical devices
Lithoz specialises in the development and production of additive manufacturing machines and materials for the 3D printing of high-performance ceramics and bone replacement materials.
ecent developments in additive manufacturing have enabled a whole new spectrum of applications in the field of medical devices. This includes new materials, complex shapes, patient-specific devices for perfect fits, and reduced time and costs in the operating theatre. However, increasingly stricter regulatory frameworks surrounding this field often discourage potential developers from implementing such manufacturing methods despite their huge potential. This article will discuss the cornerstones necessary for the safe and reliable design and manufacture of medical devices via additive manufacturing.
R Device design
The safety of the device itself, as well as the establishment of a manufacturing process that is capable of delivering safe devices, starts with the device design. In this specific context, design does not refer to the geometry or look alone but to the complete specification of the medical device.
all other requirements being derived from this starting step. When it comes to additive manufacturing, possible applications include the production of patient-specific or serial medical devices. The selection of the device material naturally has a major impact on its mechanical properties and is of major concern for the device’s functional safety. Another very important factor is the biocompatibility of the material, especially when planning applications involving high-performance ceramics or producing implants using bioresorbable ceramics as such applications are very demanding in these regards.
“The first step in developing medical devices is defining the intended use, with all other requirements being derived from this starting step.”
Before even starting with the design of the actual device, an appropriate risk management system has to be established. Risk management relates not only to the device design, but also to the entire life cycle of the device – therefore, it also involves the later manufacturing and quality assurance processes. Any decisions taken during the device’s life cycle must be risk-based.
The first step in developing medical devices is defining the intended use, with
64 Calcium phosphate-based ceramics,
such as -tri calcium phosphate or hydroxyapatite, can be used for applications where biodegradation, bioactivity and osteoconduction are required. In such cases, the highest level of biocompatibility is mandatory and the manufacturer of the medical device is responsible for delivering proof of the device’s biocompatiblity. Such information also counts as substantial input for the risk management and the device design history file.
Before starting the medical device design, it is important to establish a risk management system.
The entire design process must be properly documented according to the applicable regulations. As previously mentioned, third-party documentation to the design file must be contributed – in particular, by the manufacturer of the raw material and equipment being used during the process.
Manufacturing process The raw materials used in additive manufacturing are essential for ensuring a reliable manufacturing process, with the process potentially requiring special purity grades or materials conforming to specific standards. In such cases, it is advisable to request a certificate of conformity from the material manufacturer, which may include a declaration that the material has been manufactured according to appropriate procedures, as well as more specific analytical data such as chemical analysis, viscosity and refractive indexes among other values. To ensure traceability, this information is provided by the material manufacturer at least on the material batch base.
Since additive manufacturing processes are influenced by environmental conditions
Medical Device Developments /
www.nsmedicaldevices.com
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