As additive manufacturing (AM) makes strides towards volume production in the medical device industry, challenges around additive materials need to be addressed to allow for a smoother transition towards reliable mass production. Barriers include powder quality, powder reusability, powder handling, and inventory management.
The U.S. Food and Drug Administration (FDA) permits the reuse of powders in AM for medical devices with a technical guidance document outlining methods to use throughout the reuse process. The guidance also recommends monitoring chemical composition, oxygen, and moisture levels in the powder to be reused, although exactly how to monitor these characteristics is not detailed. Further, documented evidence or a strong rationale is also required to establish that reused powders will not have any adverse impact on the printed implants. Manufacturers intent on reusing powder need to establish the traceability of the powders used and reused to produce any specific medical device.
Currently, powder is delivered in plastic bottles packed under an inert gas atmosphere, which are then manually emptied into printing equipment. One drawback of this process is inefficiency in operators unpacking, emptying, and dispensing material from the plastic bottles into the hopper. There is also the potential for contamination of the powder when exposed to the atmosphere, and poor control over moisture and impurity gases, such as oxygen, can affect powder flowability. Last but not least are worker and facility safety when working with metal powders. Further, 17 kg of plastic waste is generated for every 450 kg of powder. These various manual steps also offer no digital connection for automated traceability throughout the complete process chain.
Beyond the traceability required to meet FDA requirements, increasing the quality, lifespan, and efficacy of powders used in AM will improve the economics and expedite the shift towards volume production of AM implants in the orthopedic industry. Paramount to this is the need to have a well-established mechanism for powder handling and reuse because stricter quality control of raw material is essential to produce implants that go inside the human body. It is, therefore, necessary to have an effective powder management solution that addresses all the concerns of material handling while optimizing the production process—from powder to part and cycling back to powder reuse.
PowderLife from Carpenter Additive aims to address the challenges of large-volume powder handling and efficient powder reuse. It is specifically designed to be machine agnostic so users are not reliant on machine OEM equipment and can standardize powder management operations to drive down costs, increase production efficiencies, and promote vertical integration in their supply chain. Developed with advanced AM users in mind, the closed-AM ecosystem encompasses hardware and software certified to the latest safety standards to accelerate additive adoption while offering digital tracking of key variables to reduce risk and increase safety.
Large industrial hoppers of medical-grade stainless steel are designed and certified to safely transport bulk powder from the vendor to the production site. An IoT sensor can monitor oxygen, temperature, and humidity, letting the user know when the powder is safe to use—mitigating the risk of contamination, exposure, and environmental waste. Hopper blending equipment and integration into third-party systems enable a closed-loop ecosystem to ensure material quality for build reproducibility.
Governing the entire AM process is a software platform designed to capture the digital thread and fulfill FDA guidance to provide documentation for powder reuse, offering traceability and inventory management. Carpenter Additive’s software can be coupled with current business systems through available application programmer interfaces (APIs) to avoid unnecessary duplication and mitigate the risk of human error. The software’s ability to capture, store, organize, and analyze chemical, characteristic, and mechanical test data enable intelligent decision making and improved economic results. It takes away the “best guess” process for powder reuse limits and unlocks the potential for further data-driven continuous improvement activities.
Process inefficiencies, material quality, contamination, environmental waste, operator exposure, traceability, and inventory management are all barriers to the industrialization of additive manufacturing. The combination of hardware and software integration across AM platforms using big data, machine learning, and the digital thread will further increase the adoption of production-scale 3D printing. The result must be an easy-to-access, comprehensive digital thread containing information on the materials’ process-structure-property relationships. Solutions such as PowderLife provide manufacturers with performance and quality assurance for their additive parts, together with the traceability required to meet FDA guidance.
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