WO2019212409A1

WO2019212409A1 - System and method for management of an additive manufacturing process

Info

Publication number: WO2019212409A1
Application number: PCT/SG2019/050238
Authority: WO
Inventors: Hwee Tian William NG; Uei PUA; Sze Wei Matthew YEO; Boon Keong Louis ANG
Original assignee: Tan Tock Seng Hospital Pte. Ltd.; National Healthcare Group Pte Ltd
Priority date: 2018-04-30
Filing date: 2019-04-30
Publication date: 2019-11-07
Also published as: SG11202004983QA; SG10201803630XA

Abstract

A system for management of an additive manufacturing process including a user interface device arranged to perform at least one of the following actions in relation to a three dimensional product:- receive a request to print the three dimensional product; display at least one intermediate product associated with the three dimensional product; and receive a data file associated with the three dimensional product; an encryption module configured to anonymize the request; and a database arranged in data communication with the user interface device to store any data file relating to the three dimensional product classified based on a plurality of categories, is disclosed.

Description

SYSTEM AND METHOD FOR MANAGEMENT OF AN ADDITIVE

MANUFACTURING PROCESS

TECHNICAL FIELD

[0001] The present invention relates to a system for management of an additive manufacturing process. The system may be applied to a variety of applications such as fast prototyping of medical devices.

BACKGROUND

[0002] The following discussion of the background to the invention is intended to facilitate understanding of the present invention. However, it should be appreciated that the discussion is not an acknowledgment or admission that any of the material referred to was published, known or a part of the common general knowledge in any jurisdiction as at the priority date of the application.

[0003] Personalized medicine, customized according to individual patient’s profile, is gaining traction. Increasingly there is an awareness and support for the use of additive manufacturing for personalized medicine, in particular for the manufacturing of customized implants and devices for individual patients in order to achieve better fit for patients, which can enhance the recovery process. [0004] An example of a customized manufacturing process is an additive manufacturing process. The additive manufacturing process may be adopted for clinical implementations, trials and research. The generated or manufactured three dimensional (3D) devices/objects/implements may include implants such as prosthetics, orthotics, training models, surgical implants etc. Such implants have led to improved quality in medical education, better customization for individuals, reduction in operative time and blood loss (in some cases). [0005] Currently, the process to produce or manufacture a 3D device is subjective and somewhat manual. A user (client) such as a healthcare professional will need to generate a request or work order for a 3D manufacturing job based on their patient’s needs. Data such as radiology data and images are attached to emails or saved into electronic computer readable media such as the ubiquitous compact disk (CD) or Universal Serial Bus (USB) drive. The email or computer readable media are then sent to an additive manufacturing company. The additive manufacturing company then converts the data into one or more formats for 3D printing. Subsequent approvals and/or verifications are typically communicated via emails or other electronic means between the additive manufacturing companies with the client. This process is heavily dependent on the diligence of the various personnel involved to anonymize the data for example and in checking and verifying the generated product.

[0006] In addition, there is no way to trace whether the correct file/format are sent between the various parties (client and service provider). Further, there is no standard IT security system, and a lack of regulatory standard(s) to identify errors in part to determine liability between different parties, and lack of transparency to assess the capability and competency of the additive manufacturing companies.

[0007] The actual workflow for additive manufacturing may involve complicated steps which include retrieving data from images such as Computed Tomography (CT) scans and Magnetic Resonance Imaging (MRI) scans in Digital Imaging and Communications in Medicine (DICOM) format. The retrieved data in DICOM format needs to be further converted in a file format suitable for 3D printing such as an SLA file. Further processing such as surface extraction, 3D model post-processing needs to be carried out before the model is segmented to get the area of interest. This may involve one or more generations of surface models. A final 3D model is generated based on the segmented model before the file is ready for printing or prototyping. This can be time consuming. [0008] It is appreciable that many of the steps in the workflow will require user intervention. In addition, there is no guidance of next steps and the correct implementation of workflow is dependent on the knowledge of individual user and/or additive manufacturers. [0009] In light of the above, there exists a need to simplify the existing workflow so that the process can be more user efficient.

[0010] It is an object to ameliorate at least one of the disadvantages or meet the need at least in part. SUMMARY OF THE INVENTION

[0011] A technical solution is to provide an encrypted system for facilitating the management of customized manufacturing, such as an additive manufacturing product life cycle. The encrypted system supports the entire additive printing process, allows a systematic management of the additive manufacturing product life cycle, and provides an integrated all in one solution that reduces complicated steps and processes for users.

[0012] The management of the whole additive manufacturing process may include, but is not limited to, 3D modelling and support design, data conversion and transmission, checking, preparation and building of components using various additive manufacturing process, post processing of additive manufacturing parts, approval of additive manufacturing parts and the approval and qualification of additive manufacturing providers.

[0013] In accordance with an aspect of the invention there is a system for management of an additive manufacturing process including a user interface device arranged to perform at least one of the following actions in relation to a three dimensional product:- receive a request to print the three dimensional product; display at least one intermediate product associated with the three dimensional product; and receive a data file associated with the three dimensional product; an encryption module configured to anonymize the request; and a database arranged in data communication with the user interface device to store any data file relating to the three dimensional product classified based on a plurality of categories.

[0014] In some embodiments, the plurality of categories include a category wherein the three dimensional product is used for research purpose only.

[0015] In some embodiments, the plurality of categories include a category wherein the three dimensional product is suitable for use in clinical setting.

[0016] In some embodiments, the data file associated with the three dimensional product includes information related to regulatory approval, usage by institutions, and a workflow guide.

[0017] In some embodiments, the user interface device is a mobile computer device.

[0018] In some embodiments, the encryption module is configured to anonymize the request in a reversible or irreversible manner. [0019] In some embodiments, the encryption module is configured to anonymize the request based on at least one of data perturbation and data generalization performed on the request.

[0020] In some embodiments, the encryption module is configured to anonymize the request based on a pseudonymization mechanism. [0021] In some embodiments, the database includes a distributed ledger.

The distributed ledger may be a blockchain.

[0022] In accordance with another aspect of the invention there is a non- transitory computer readable medium containing executable software instructions thereon wherein when executed on a computer device performs a method of managing an additive manufacturing workflow including the steps of:- (a.) receiving at least one source data file associated with an additive manufacturing work product; (b.) anonymizing the source file to remove sensitive information; (c.) converting the source file to an intermediate file; and (d.) storing the intermediate file in a database based on a plurality of categories.

[0023] In accordance with another aspect of the invention there is a method for management of an additive manufacturing process including the steps of: (a.) receiving at a user interface device, at least one source data file associated with an additive manufacturing work product; (b.) anonymizing by an encryption module the source file to remove sensitive information; (c.) converting the source file to an intermediate file; and (d.) storing the intermediate file in a database based on a plurality of categories.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [0025] Fig. 1 shows a system block diagram of an embodiment of the invention;

[0026] Figs. 2 to 4 shows a particular arrangements of an additive manufacturing ecosystem in accordance with various embodiments;

[0027] Fig. 5 illustrates a particular embodiment of a structure of encrypted system;

[0028] Fig. 6a to Fig. 6d illustrates various components of the library database;

[0029] Fig. 7 is a display of an intermediate product associated with an end product which has been approved by one or more regulatory authorities; Fig. 8 is a display of an intermediate product provided by various service providers, each of which has been assessed by clients; and

[0030] Fig. 9 shows another embodiment of an additive manufacturing ecosystem according with some embodiments.

DETAILED DESCRIPTION

[0031] Particular embodiments of the present invention will now be described with reference to the accompanying drawings. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the present invention. Additionally, unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one or ordinary skill in the art to which the present invention belongs. Where possible, the same reference numerals are used throughout the figures for clarity and consistency.

[0032] Throughout the specification, the term‘additive manufacturing’ refers to a process of joining two or more objects from three-dimensional model data to create an intermediate or end product that is customized in form and shape in three dimensions.

[0033] Throughout the specification, the term‘intermediate product’ or‘end product’ may include, but is not limited to, generated 3D CAD models or printed products for prosthetics, orthotics, pre-surgical models, training models, surgical equipment, implant, for research and clinical use.

[0034] Throughout the specification, the term‘user’ and‘users’ may include end user(s), client(s), service provider(s) and intermediaries service provider(s), where applicable.

[0035] According to an aspect of the invention there is a system for management of an additive manufacturing process including a user interface device arranged to perform at least one of the following in relation to a three dimensional product:- to receive a request to manufacture the three dimensional product; to provide at least one intermediate product associated with the three dimensional product; and to receive a data file associated with the three dimensional product.

[0036] Fig. 1 shows the block diagram of the various components forming the system, which will be elaborated with reference to Figs 5 to 8.

[0037] The system includes an encryption module configured to anonymize the request; and a database arranged in data communication with the user interface device to categorize data relating to the three-dimensional product based on a plurality of fields, tags or labels. The database further includes at least one interface for a service provider to upload an electronic file associated with the at least one intermediate product or end product. In some embodiments, the encryption may include an end-to-end encryption method.

[0038] In some embodiments, the request includes secured electronic requests. Examples of such electronic requests include short messaging service (SMS) messages, multimedia messaging service (MMS) messages, push notifications.

[0039] Fig. 2 shows an embodiment of the invention where the system 100 is deployed to connect various groups of users to manage and facilitate one or more additive manufacturing processes. The system 100 comprises a platform 120 having requisite interfaces to connect various types of users. In the ecosystem shown in Fig. 2, at least three groups of users are connectable via the interfaces to the platform 120. Each user may connect to the platform 120 via a user interface device. The user interface device can include mobile devices having computing capabilities such as mobile phones and/or tablet PC. The ubiquitous PC and laptop may also be utilized as user interface devices. The user interface devices may be arranged in signal or data communication with the platform 120 via direct wired interface or remote wireless interface, utilizing wired or wireless networks such as cable networks, fiber-optic networks, wireless Wi-Fi networks, near-field communication protocols/networks etc.

[0040] Fig. 2 illustrates three different types of users, i.e. healthcare professionals 130, one or more intermediary companies such as a software company 140, and one or more additive manufacturing companies 150.

[0041] The healthcare professionals 130 include, but are not limited to doctors, nurses and allied health professionals (such as physiotherapist, occupational therapist, prosthetist, orthotist and podiatrist).

[0042] The one or more software companies 140 include organizations functioning as intermediaries to convert data or files provided by the client such as a healthcare professional 130 into a data or file format that is suitable for the 3D manufacturers to process efficiently. For example, one or more software companies 140 may be operable to manipulate and convert 3D scan data or radiology files provided by the healthcare professional 130 into a 3D computer-aided design (CAD) file or data formats. In addition, the software company 140 may provide advanced 3D CAD modelling as a value-add service, and/or repair and further process of CAD models, which may be provided by the healthcare professional. In summary, the software companies may generate the 3D CAD drawings based on the raw data provided by the healthcare professional 130, and/or modify/repair the data provided by the healthcare professional 130. In some embodiments, the software companies may use known software to manipulate 3D scans or radiology files. The software companies may also use the manipulated file to do pre-surgical planning or visualization. The converted 3D CAD model files may thus be regarded as intermediate products.

[0043] The one of more additive manufacturers 150 are operable to translate the intermediate products such as manipulated files/ CAD models generated by the software companies 140 or directly by the healthcare professional 130 into an additive manufacturing product. The printing process and technique used by AM companies may include liquid-based additive manufacturing system (such as, but not limited to stereolithographic apparatus, polyjet, Multi-Jet Printing and 3D bioprinting), Solid-based additive manufacturing system (such as, but not limited to fused deposition modelling, selective deposition lamination, laminated object manufacturing, electron bean additive manufacturing and ultrasonic additive manufacturing) and powder- based additive manufacturing system (such as, but not limited to selective laser sintering, selective laser melting, colorjet printing and electron beam melting.

[0044] Fig. 3 illustrates another embodiment where the service providers 250 function both as intermediaries to convert data or files provided by the healthcare professionals 130, and additive manufacturing services. Such an arrangement negates the need for intermediaries, as the service providers have software manipulation and additive manufacturing capabilities. These service providers manipulate and convert 3D scan data or radiology files into 3D CAD models, provide advanced 3D CAD modelling services, repair and process of CAD models. These service providers may directly make use of the manipulated CAD models to do additive manufacturing services, subject to approval of the healthcare professionals 130.

[0045] Fig. 4 illustrates another embodiment where the users, intermediaries and additive manufacturers are integrated as a power user 350. This is likely the configuration for implementation in medical institutions such as hospitals or academic medical centres that possess in-house software processing capabilities and 3D printers. The users will have a use case and users may process files on their own or work with their in-house service providers to do software manipulation. After they process the files, they will send the files to their in-house 3D printers for printing.

[0046] It is appreciable that central to the various configuration and embodiments is the platform 120. Figs. 5 to 8 show various components of the platform 120 to function as a manager to facilitate customized or additive manufacturing process in a trustworthy and reliable manner, hence reducing the occurrence of errors and reducing the learning curves of healthcare professionals 130.

[0047] In the various configurations depicted in Figs 1 to 4, the platform 120 comprises an encrypted system 1000, a library database 1200, a quality management system 1400, and an artificial intelligence module 1600. It is contemplated that the various components 1000, 1200, 1400 and/or 1600 may be combined in various ways to achieve desired results.

[0048] Fig. 5 shows an embodiment of the encrypted system 1000. The encrypted storage/ transfer system can be implemented as a single or distributed server configuration, which can include single computer or a network of computers. In addition, the encrypted system 1000 may be directly or remotely connectable to one or more user interface devices. Part of whole of the encrypted system 1000 may be implemented remotely such as a cloud- based system. The encrypted system 1000 provides the necessary interface to allow file manipulation for authorized users. File manipulation can include functions such as read, write, upload, download, save, copy, delete etc.

[0049] The encrypted system 1000 comprises memory units having computer programs installed thereon to execute at least the following functionalities: - a. user login, b. data anonymization, c. secure file transfer and d. logging of data transfer. Each of the function may be implemented on a same data storage unit of a computer or may be across different computers, or between different data storage units such as hard disks on the same computer. The computer program for data anonymization comprise executable source codes that when executed is operable to remove any sensitive information, such as confidential information associated with patient identity. Such confidential information includes but not limited to personal identify number such as national registration identity card number (NRIC), name, date of birth, sex, height, weight and age. In other words, the data anonymization module operates to at least de-personalize each request and consequently each data file associated with each of the three dimensional product. It is appreciable that the anonymization can be performed in a reversible or irreversible manner.

[0050] In some embodiments, the anonymization can include methods of data perturbation and/or data generalization. In some embodiments, methods of pseudonymization to replace personally identifiable information with one or more artificial identifiers may be used.

[0051] The encrypted system 1000 provides user interfaces for registration by users. Prior to registration it is appreciable that there may be pre registration process where intended or preferred users may be invited to participate as part of the ecosystem 100. In the pre-registration process the users may be provided with verification codes (time-limited or otherwise) for utilization at registration. Upon registration the user will have to perform necessary procedures to verify their identity, provide verification codes if any to generate a user login name and password. Once registered, an electronic account will be generated for each user with the encrypted system 1000 specifying the type of user (i.e. client, intermediary, manufacturers, or others) and the user access controls. At a minimum level of security, all registered users will have to login with a username and password. In some embodiments, additional layers of security such as a two-factor authentication (also known as 2FA) or two-step verification can be deployed to enhance the security system.

[0052] In order to provide secure data transfer, such as uploading/downloading data files onto the platform 120, secured file transfer protocol (SFTP) and/or a cryptographic network protocol such as secure shell (SSFI) file transfer protocol can be used to support full security and authentication functionality of SSFI. Advantageously, SFTP utilized with SSFI protects data against various types of security attack, and protects the integrity of the data using encryption and cryptographic hash functions, and authenticates both the server and the user.

[0053] The data logging features enables monitoring of all file activities (For example file creation, access, write operations, rename and deletion). Any file activity is logged and associated with the registered user account for example via a link to a database entry. Data logging enforces the platform security policies by allowing users to get notification when files are uploaded. It provides file history by allowing administrators to see what users do to the files. It also tracks and provide history of how various files are used. Files can be monitored to prevent unauthorized access and use. The feature of data logging also provides traceability.

[0054] Fig. 6a shows an embodiment of the library database 1200. The library database 1200 can be implemented as a separate memory block within the same computer or network of computers as the encrypted system 1000, or may be separate and independent but arranged in data communication with the encrypted system 1000. The library database 1200 may be managed by a database management software such as SQL server manager.

[0055] The library database 1200 performs at least the following functions: - a. file structuring, b. type of products, c. add/remove part, d. management of documents, and e. search for specific parts/products.

[0056] In relation to file structuring, it is appreciable the database file structuring system will be used to control how data is stored and retrieved. A possible embodiment of the file structuring system includes the use of separating whether a file is used for research only or can be directly utilized for clinical use. Each file may also be associated with one or more users depending on the progress at which the file is at. For example, a file, which is uploaded by a healthcare professional 130 onto the platform 120 (with the necessary anonymization performed) may not be assigned to any service provider. In such cases the file will only be associated with the healthcare professional 130. Such an association also provides for a way to track the progress of a file and provides feedback in terms of turnaround and timeliness. In summary, the library database facilitates the organization of data and provides associations and relationship mapping of each file to its intended user(s). [0057] In some embodiments, based on the file structure and classification the standard library catalogue system comprises data files of parts approved for clinical use (Fig. 6b) and parts used for research use only (Fig. 6c). Such catalogue system may be generated and categorized over time. The data files may include 3D scan data or radiology files, 3D CAD models, advanced 3D CAD modelling services, repair and process of CAD models etc.

[0058] Under each group (research or clinical use), all additive manufactured products can be further divided into type of products or product categories such as, for example, prosthetics, orthotics, surgical and implants. In the ‘research use only’ product catalogue, users can find information related to a specific part but can only use such item on a research/ clinical trial application. Users have to accept a specific terms and conditions and may be asked to make a legal declaration before they are allowed to access the specific parts which is used for research purpose only. Users can also choose to register their interest to participate in any clinical trials when available.

[0059] The ‘approve-for-clinical-use’ product catalogue allows all users to use and 3D print these parts as standard clinical practice. When any healthcare professional 130 selects at each individual product, an interface displaying basic information will be retrieved for the healthcare professional’s 130 perusal. Such information may include any regulatory which has approved the part for clinical use, any healthcare institution(s) that is using the part for research and/or clinical use etc. The interface may provide links for a user to access the necessary document(s) showing approval by a regulatory body or any publication(s) associated with the parts.

[0060] In some embodiments, an automated guided workflow will guide various users through a step by step process from start (file processing) to end (printing of additive manufacturing part).

[0061] For example, the automated guided workflow provides a system to guide healthcare professionals from the start to end through a step-by-step guide as shown in Fig. 6d. As a start, the healthcare professionals can search the library and/or product catalogue for an available product (step s602). The healthcare professional can then select the product and create a job request. The online automated system will guide the healthcare professional to provide data in the form of a 3D scan or radiology files such as CT, MRI files (step s604). The healthcare professional will then upload the file and the system will automatically remove all confidential patient information before the file is uploaded onto the encrypted storage (step s606). Information will be sent to qualified additive manufacturers or companies to provide one or more quotations (step s608). Upon receiving the quotations, the healthcare professionals 130 will be prompted through an interface to select the additive manufacturer (step s610) and then issue a work order (step s612). Once a work order is issued, the additive manufacturers will do pre-processing of the data (step s614) and upload data onto encrypted server for approval (step s616). The healthcare professional requestor will do a check (step s618) and give an approval to start fabrication if he is satisfied (step s620). Otherwise he would communicate the dissatisfaction to the additive manufacturer and request for one or more revisions (not shown). The additive manufacturer will next print the part (step s622) and perform the required quality checks on the printed product/part (step s624). The printed product and required documents will then be sent to healthcare professionals (step s626). The healthcare professional received the part (step s628) and performs a final check (step s630). The printed part will then be issued or used on/for patients (step s632). In some embodiments, every step s602 to s632 of the workflow can be captured by the back-end encryption system 1000 to ensure traceability.

[0062] In relation to the add/remove operations, the additive manufacturing companies or software intermediaries will be able to add or remove a specific part subject to the approval of the system administrator. When an additive manufacturing company submits a part for approval, they will have to attach and submit the approval documents in a prescribed or predetermined format, such as a portable document format (pdf).

[0063] Where there are multiple entries and files in the library/database 1200, the part search feature allows users to search through the library and database. As information are neatly organized into fields including but not limited to part number, product name, category, description, price and clinical specialty, users can search for relevant information with relative ease. Depending on the database deployed, the library/database may include text search engines operable to store information in a single index and can find words in any field. More high-end databases can store field information, so searches can also be limited to a specific field.

[0064] The library database 1200 can be optimized to search for exact keywords and/or key phrases. Full text search engines can be configured to index keywords and store them so that searches can be performed efficiently and quickly. The search function will also have a mechanism for dividing up the search results and providing navigation from the first page to following pages (and back).

[0065] The quality management system (QMS) 1400 comprises modules and systems to document and track processes and procedures for achieving and monitoring of quality policies and objectives. The QMS 1400 is particularly useful because in additive manufacturing there is a lack of international standard and requirements. As such, the platform 120 allows proper definition and tracking of additive manufacturing quality system.

[0066] The QMS 1400 provides for two key benefits. It ensures that additive manufacturing companies and the parts they manufacture comply with regulatory standards (For example, a part can receive regulatory approval from a few standards bodies such as Underwriters laboratory/ SPRING or regulatory bodies such as Health Sciences Authority (FISA)/ Food and Drug Administration (FDA). It also instills confidence in users who intend to use the parts (Parts that comply with standards are usually more robust). This allows better scalability which can potentially lead to more customers, more sales and repeat business.

[0067] The regulatory approval system provides auditing and approving documents from various regulatory and auditing agencies (see Fig. 7). A service provider or intermediary such as an additive manufacturing company or software company can submit their product for approval/ audit upon receiving sufficient clinical data/ trial subjects. A product under the‘research use only’ product catalogue can be prescribed to patient at the institution own risk. Healthcare professionals 130 can be matched to additive manufacturing companies 150 based on their specific product requirements and categories. Rating or reviews can be given to companies according to ranking matrix such as quality, price and lead-time. Each healthcare professionals will be allowed to do a review for each company after they have completed a work order (see Fig. 8).

[0068] The artificial intelligence module 1600 can be implemented as a separate memory block within the same computer or network of computers as the encrypted system 1000, the database 1200, and/or the QMS 1400, or may be separate and independent but arranged in data communication with the encrypted system 1000, the database 1200, and the QMS 1400.

[0069] The artificial intelligence module 1600 includes an artificial intelligence/ machine learning algorithm installed thereon to provide‘learning capabilities’ to various aspects of the platform 120 so that the system could perform learning over time based on data collected. Various examples of the machine learning algorithm may include neural networks, support vector machines, expert rule based system, or combinations of the aforementioned configured to "learn" and improve on the matching system, for example matching users to the suitable additive manufacturing companies based on capabilities of the additive manufacturing companies and the qualitative analysis data received through surveys or reviews as shown in Fig. 8. In some embodiments, the learning may be performed through generation of a training set populated using data obtained based on various users and behavioral studies done on selected healthcare professionals 130 in their choice of selection an additive manufacturer. [0070] Fig. 9 shows another embodiment of the system for managing an additive manufacturing process implemented on a cloud-based environment. Computer resources within the cloud-based environment may be used to fulfil one or more functions and may be functionally distributed over multiple locations. One or more edge servers may be utilized.

[0071] Fig. 9 includes a payment module 920. The payment module 920 can include an e-commerce payment system that facilitates electronic payment for transactions on the platform. The payment module 920 may be configured to accept various payment modes. The payment modes can include credit/debit card payment, electronic credits payment such as alipay™, paypal™, and/or crypto-currency or tokens.

[0072] Fig. 9 includes a visualization module 940. The visualization module 940 can include a dedicated software interface, which can be implemented as a software application (colloquially known as an app) capable of being downloaded onto a user device. The user device may include a mobile phone, a tablet PC, general personal computers or laptop computer having user interface to allow one or more users to view the intermediate product such as three-dimensional images via the user interface. The intermediate product may be further manipulated by the user via the visualization module described below.

[0073] In some embodiments, the dedicated software application may reside on one or more off-site computers or remote servers, such as in remote cloud-based software system. It is to be appreciable that one or more portions of the dedicated software application may reside in different devices or servers.

[0074] Information from CT/ MRI scans (in the file format including Digital Imaging and Communications in Medicine - DICOMS), 3D scanned objects (such as STP file format, IGES file format) may be viewed by a clinician who can then visualize the 3D objects via an integrated software/ app that can project the 2D images into 3D images. The visualization module 920 may also allow users to rotate, pan, and perform various 2D cross-sections of the 3D part. The visualization module may also allow users to highlight (mark-up) various parts and provide annotation via text.

[0075] In the embodiment shown in Fig. 9, source file(s) such as radiology files may reside in a secure (encrypted) database also known as a‘Health- Cloud’. The encrypted database may be a hospital or health institution database. Any source file(s) retrieved will be anonymised before it is sent out into an external database, which can be a cloud network and may or may not be encrypted. Anonymised data can be traced back to the health-cloud via special encrypted key.

[0076] The radiology source file (in dicom format) can be processed by the software company who cleans up the data and do necessary segmentation. These segmented files are then converted into stl format (stereolithography CAD file format) which include information of the 3D printed parts including support materials). The stl files may then be given to the addictive manufacturing companies for printing.

[0077] For 3D files created by clinicians (which can be in the form of stump, head scan) to make Ankle foot orthosis (AFO) or cranial helmets, the 3D file in various file formats (e.g. stp, iges file format) may be scanned using a 3D scanner. The 3D scanner can be handheld or standalone. The 3D file may be anonymised using a software before it is sent to the public cloud. The anonymised data can be traced back to the patients via a special encrypted key. Once the software company retrieves a data file to build/print the 3D part, the file is then converted into stl file format. The converted file may include information for parts, inclusive of support, for printing.

[0078] The system may further utilize the following machine learning approaches, for example decision tree learning, association rule learning, deep learning and inductive logic programming etc.

[0079] According to another aspect of the invention there is a non-transitory computer readable medium containing executable software instructions thereon wherein when executed performs a method of managing an additive manufacturing workflow including the steps of (a.) receiving at least one source data file associated with an additive manufacturing work product; (b.) anonymizing the source file to remove sensitive information; (c.) converting the source file to an intermediate file; and (d.) storing the intermediate file in a database based on a plurality of categories.

[0080] According to another aspect of the invention there is a method of managing an additive manufacturing workflow including the steps of (a.) receiving at a user interface device, at least one source data file associated with an additive manufacturing work product; (b.) anonymizing by an encryption module the source file to remove sensitive information; (c.) converting the source file to an intermediate file, such as for example a 3D CAD file; and (d.) storing the intermediate file in a database based on a plurality of categories.

[0081] Although the disclosure is described in the context of using additive manufacturing, it is to be appreciated that various manufacturing methods or processes may be utilized to supplement, combine, or replace the addictive manufacturing process. For example, die-casting, machining and some other secondary manufacturing processes may be used. The secondary manufacturing processes may include one or more of the following: - Molding, machining, joining, shearing and forming.

[0082] Examples of devices/objects/implements formed using a combination of addictive manufacturing such as 3D printing may include prosthetics, which can be an assembly formed of 3D printed, machining and casting parts).

[0083] Heart stents which require higher degree of precision and accuracy may not be formed of addictive manufacturing. Other devices or implements such as scoliosis brace may be formed using vacuum forming process. [0084] It will be apparent that various other modifications and adaptations of the invention will be apparent to the person skilled in the art after reading the foregoing disclosure without departing from the spirit and scope of the invention. For example, it is contemplated that at least a portion of database library 1200 may be provided to the user interface device for offline access. It is further contemplated that

[0085] In the various embodiments, the database(s) or library configured to store data file(s) may be implemented in the form of a distributed ledger. The distributed ledger may be decentralized or centralized. In some embodiments, the database(s) or library may be implemented as a private blockchain. In some embodiments, the private blockchain may be a centralized blockchain.

[0086] It is intended that all such modifications and adaptations come within the scope of the appended claims.

[0087] Further, it is to be appreciated that features from various embodiment(s), may be combined to form one or more additional embodiments.

Claims

1. A system for management of an additive manufacturing process including a user interface device arranged to perform at least one of the following actions in relation to a three dimensional product:- receive a request to print the three dimensional product;

display at least one intermediate product associated with the three dimensional product; and

receive a data file associated with the three dimensional product;

an encryption module configured to anonymize the request; and a database arranged in data communication with the user interface device to store any data file relating to the three dimensional product classified based on a plurality of categories.

2. The system of claim 1 , wherein the plurality of categories include a category wherein the three dimensional product is used for research purpose only.

3. The system of claim 2, wherein the plurality of categories include a category wherein the three dimensional product is suitable for use in clinical setting.

4. The system of any one of the preceding claims, wherein the data file associated with the three dimensional product includes information related to regulatory approval, usage by institutions, and a workflow guide.

5. The system of any one of the preceding claims, wherein the user interface device is a mobile computer device.

6. The system of any one of the preceding claims, wherein the encryption module is configured to anonymize the request in a reversible or irreversible manner.

7. The system according to any one of the preceding claims, wherein the encryption module is configured to anonymize the request based on at least one of data perturbation and data generalization performed on the request.

8. The system according to claim 1 , wherein the encryption module is configured to anonymize the request based on a pseudonymization mechanism.

9. The system according to claim 1 , wherein the database includes a distributed ledger.

10. The system according to claim 9, wherein the distributed ledger includes a blockchain.

1 1. A non-transitory computer readable medium containing executable software instructions thereon wherein when executed on a computer device performs a method of managing an additive manufacturing process including the steps of: -

(a.) receiving at least one source data file associated with an additive manufacturing work product; (b.) anonymizing the source file to remove sensitive information;

(c.) converting the source file to an intermediate file; and

(d.) storing the intermediate file in a database based on a plurality of categories.

12. The non-transitory computer readable medium of claim 9, wherein the step of anonymizing the request includes anonymizing the request in a reversible or irreversible manner.

13. The non-transitory computer readable medium of claim 1 1 or 12, wherein the step of anonymizing the source file is based on at least one of data perturbation and data generalization performed on the request.

14. The non-transitory computer readable medium of any one of claims 1 1 to

13, wherein the step of anonymizing the source file includes a pseudonymization mechanism.

15. A method for management of an additive manufacturing process including the steps of: -

(a.) receiving at a user interface device, at least one source data file associated with an additive manufacturing work product;

(b.) anonymizing by an encryption module the source file to remove sensitive information; (c.) converting the source file to an intermediate file; and