Product Tracking and Security Through Design Methodology in Additive Manufacturing

Product tracking and security through design methodology in additive manufacturing1 Specific AimsAdditive manufacturing (AM) is increasingly being used in the medical for applications as diverse as printingprosthesis 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 thedesired 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 3Dprinted plate for fixation in a patient?s jaw. This exciting new manufacturing method comes with newchallenges. All steps of the AM process chain, including the final printing step, are based on software programsand are exposed to cybersecurity threats. Stolen CAD files can be used to print parts of (a) exactly the samequality as the original component and make it difficult to separate originals from counterfeits or (b) exactly thesame geometry but with inferior materials, which may not have the same performance.Given the cybersecurity scenario that even themost protected federal government assets andcorporations have been breached recently, it islikely that the designs developed by biomedicalresearchers and companies are exposed to thesame risks. In the biomedical and medical fields,inferior components can pose significant risk tothe health and wellbeing of the patient. Thestolen CAD files can make their way to countrieswhere neither intellectual property protections (a) (b)are strong nor tracking of implants is possible. Figure 1. A mandibular reconstruction plate: (a) a CAD modelGiven such scenario, the present project is and (b) a manufactured plate applied to the locations whereaimed at developing tools to embed security jaw injuries, disorders, or mandibular deformities and fractures take place. Image courtesy: Dr. Paulo Coelho, NYUfeatures 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 methodologydeveloped by the PI Zeltmann and co-PI Gupta, which is now patent-pending and formed the basis forestablishing 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 invisibleto unsuspecting people. In the presence of such features, the component will print in high quality only under apre-determined set of conditions, while any other condition will result in a severely defective component thatwill be unsuitable for use. This design methodology is used in the present proposal to print identification codesin the genuine implants.Specific Aim #1An identification code will be embedded in the mandibular implant. A process will be developed so that theembedded code can be printed in the material only under certain file processing conditions for 3D printing. Allother processing conditions will ignore the presence of the code. This scheme will also help in identification ofgenuine products from counterfeits, which may have been printed from stolen files and possibly using inferiorquality materials. The code will be sliced into several sections and embedded in different layers of the materialby taking advantage of the layer by layer manufacturing process. Such possibilities are unique to additivemanufacturing 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 theproduct in any way. Tensile tests will be conducted on the specimens to determine the properties of the implantwith and without the embedded codes.Specific Aim #2A software utility will be developed that will take the STL files of the implant design as inputs and embed thesecurity 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 theimplant. The Phase I effort will demonstrate the utility developed in MATLAB. The utility will take into accountthe 3D printing technology used for that product and the processing parameter in order to develop the desiredembedding scheme.