Product tracking and security through design methodology in additive manufacturing

在添加剂制造中通过设计方法实现产品跟踪和安全 1个具体目标 添加剂制造(AM)正越来越多地应用于医疗领域，从印刷到各种应用 使用软材料和活组织的陶瓷和金属材料甚至器官的假体和植入物 (生物打印)。在AM中，处理计算机辅助设计(CAD)文件并将其发送到3D打印机以打印 与传统的聚合物或金属加工方法相比，可减少时间和成本。 图1a展示了下颌骨重建接骨板的设计实例，图1b展示了3D 固定在病人下巴上的印制板。这种令人兴奋的新制造方法伴随着新的 挑战。AM流程链的所有步骤，包括最后的打印步骤，都基于软件程序 并暴露在网络安全威胁之下。被盗的CAD文件可用于打印(A)完全相同的部分 质量作为原始组件，使其很难区分正品和假冒产品，或者(B) 几何形状相同，但材质较差，其性能可能不同。 考虑到网络安全情景，即使是 最受保护的联邦政府资产和 公司最近被入侵了，是这样的 很可能是由生物医学公司开发的设计 研究人员和公司暴露在 同样的风险。在生物医学和医学领域， 劣质组件可能会对 患者的健康和福祉。这个 被盗的CAD文件可能会流向各个国家 在既无知识产权保护(A)(B) 也不可能追踪到植入物。图1.下颌骨重建钢板：(A)CAD模型 在这种情况下，本项目是和(B)适用于下列地点的制造车牌 旨在开发工具，以嵌入安全下颌损伤，紊乱，或下颌畸形和 骨折就会发生。图片提供：纽约大学Paulo Coelho博士 CAD文件中的特征，以便零件 医学院。 从被盗的CAD文件中可以识别打印出来的文件。该项目基于一种新的设计方法 由Pi Zeltmann和合作者Pi Gupta开发，目前正在申请专利，并形成了 成立3DP安全公司，将其商业化。这种新的方法利用了这一层- AM流程的分层制造，并具有开发不可见的安全功能的潜力 对毫无戒心的人。在存在这些功能的情况下，组件将仅在 预先确定的一组条件，而任何其他条件将导致严重缺陷的组件， 将不适合使用。在本提案中使用这种设计方法来打印识别码 在真正的植入物中。 具体目标#1 一个识别码将被嵌入到下颌种植体中。将开发一种流程，以便 只有在3D打印的特定文件处理条件下，才能在材料中打印嵌入的代码。全 其他处理条件将忽略该代码的存在。这项计划还将有助于识别 来自假冒产品的正品，可能是从被盗的文件中打印出来的，可能使用的是劣质产品 优质材料。代码将被分成几个部分，并嵌入到不同的材料层中 通过利用逐层制造工艺的优势。这种可能性是添加剂所特有的 其他传统的制造方法，如铸造和锻造，都不存在。 将进行机械测试，以确保嵌入的代码不会影响 任何形式的产品。将对标本进行拉伸测试，以确定植入物的性能 无论有没有嵌入代码。 具体目标2 将开发一个软件实用程序，将种植体设计的STL文件作为输入，并将 里面有安全码。该实用程序将首先生成所需的跟踪代码，将该代码分成几个部分， 然后将其嵌入到STL文件中，以使代码的每个片段打印在 植入。第一阶段的工作将演示在MATLAB中开发的实用程序。该实用程序将考虑到 用于该产品的3D打印技术和工艺参数，以开发所需的 嵌入方案。

Product tracking and security through design methodology in additive manufacturing 1 Specific Aims Additive manufacturing (AM) is increasingly being used in the medical for applications as diverse as printing prosthesis and implants of ceramic and metallic materials and even organs using soft materials and live tissue (bioprinting). In AM, a computer aided design (CAD) file is processed and sent to a 3D printer to print the desired shape, which reduces time and cost compared to the traditional polymer or metal working methods. Figure 1a presents an example of a mandibular reconstruction plate design and Figure 1b shows the 3D printed plate for fixation in a patient’s jaw. This exciting new manufacturing method comes with new challenges. All steps of the AM process chain, including the final printing step, are based on software programs and are exposed to cybersecurity threats. Stolen CAD files can be used to print parts of (a) exactly the same quality as the original component and make it difficult to separate originals from counterfeits or (b) exactly the same geometry but with inferior materials, which may not have the same performance. Given the cybersecurity scenario that even the most protected federal government assets and corporations have been breached recently, it is likely that the designs developed by biomedical researchers and companies are exposed to the same risks. In the biomedical and medical fields, inferior components can pose significant risk to the health and wellbeing of the patient. The stolen CAD files can make their way to countries where neither intellectual property protections (a) (b) are strong nor tracking of implants is possible. Figure 1. A mandibular reconstruction plate: (a) a CAD model Given such scenario, the present project is and (b) a manufactured plate applied to the locations where aimed at developing tools to embed security jaw injuries, disorders, or mandibular deformities and fractures take place. Image courtesy: Dr. Paulo Coelho, NYU features in the CAD files so that the parts School of Medicine. printed from the stolen CAD files can be identified. The project is based on a new design methodology developed by the PI Zeltmann and co-PI Gupta, which is now patent-pending and formed the basis for establishing 3DP Security, Inc. for its commercialization. This new methodology takes advantage of the layer- by-layer manufacturing of AM processes and has potential for developing security features that will be invisible to unsuspecting people. In the presence of such features, the component will print in high quality only under a pre-determined set of conditions, while any other condition will result in a severely defective component that will be unsuitable for use. This design methodology is used in the present proposal to print identification codes in the genuine implants. Specific Aim #1 An identification code will be embedded in the mandibular implant. A process will be developed so that the embedded code can be printed in the material only under certain file processing conditions for 3D printing. All other processing conditions will ignore the presence of the code. This scheme will also help in identification of genuine products from counterfeits, which may have been printed from stolen files and possibly using inferior quality materials. The code will be sliced into several sections and embedded in different layers of the material by taking advantage of the layer by layer manufacturing process. Such possibilities are unique to additive manufacturing and do not exist in other traditional manufacturing methods such as casting and forging. Mechanical tests will be conducted to ensure that the embedded code does not compromise the quality of the product in any way. Tensile tests will be conducted on the specimens to determine the properties of the implant with and without the embedded codes. Specific Aim #2 A software utility will be developed that will take the STL files of the implant design as inputs and embed the security code in them. This utility will first generate a desired tracking code, slice this code into several parts, and then embed it in the STL file in such a way that each slice of the code prints in a different layer in the implant. The Phase I effort will demonstrate the utility developed in MATLAB. The utility will take into account the 3D printing technology used for that product and the processing parameter in order to develop the desired embedding scheme.