ES3039356A1 - INFORMATION MANAGEMENT SYSTEM FOR TRACEABILITY IN THE DEVELOPMENT OF CUSTOMIZED MEDICAL DEVICES - Google Patents

Abstract

The present invention discloses an information management system for traceability in the development of medical devices, which allows storing all the information of the medical device, from the moment it is developed and implanted in the user. The system incorporates a platform (10) comprising: a first module, File (1) with the specific information of the device; a second module, Image Study (2) that allows the management and review of the imaging studies; a third module, Device Development (3) that compiles all the information necessary for the effective development of the device; a fourth module, Work Centers (4) that allows registering and managing the work centers that participate in the development of the device, a fifth module, Work Teams (5) that compiles the information of the work team; a sixth module, Device Ratings (6), that allows the assessment of the device after its development and use; a seventh module, Pathology Section (7) that allows the classification of the pathology; and an eighth module, Explore (8), that allows viewing and accessing the different files to generate the certificate of conformity of the device. (Machine-translation by Google Translate, not legally binding)

Description

DESCRIPTION

INFORMATION MANAGEMENT SYSTEM FOR TRACEABILITY IN THE DEVELOPMENT OF CUSTOMIZED MEDICAL DEVICES

OBJECT OF THE INVENTION

The present invention discloses an information management system for traceability in the development of medical devices. This system allows for the storage of all medical device information, from the moment it is requested until it is developed and implanted in the user. Through a platform, the system facilitates traceability management in the development of customized medical devices, ensuring compliance with current standards and anticipating future industry needs. The system also generates the device's certificate of conformity, the device's unique identifier (UDE), and a post-use review report.

TECHNICAL SECTOR

Medical applications. Medical device management platform. Medical device traceability.

BACKGROUND OF THE INVENTION

One of the biggest beneficiaries of the arrival of 3D printing manufacturing technologies has been the medical sector, as it allows the development of unique medical devices for each patient, thus achieving personalized medicine.

Medical devices, also known as implants, must be monitored over time, as they involve introducing an external element into the patient's body to replace something that is not functioning or to treat a disease. Being external, they must be custom-made to meet each individual's needs. The evolution of medical prostheses has been remarkable in recent years, such as ocular and auditory implants that have allowed people deprived of their senses to see and hear again. The integration of 3D printing into medical implants offers numerous benefits for both patients and the healthcare sector. These include the possibility of creating much more personalized designs, better tailored to patients' needs, facilitating the adaptation and function of the prostheses, and reducing costs and manufacturing time. 3D printing also makes it possible to create biomodels, which are replicas of patients' organs, providing a new dimension in obtaining information about the patient. So far, experimentation has been limited to bone regeneration, the creation of skin for diagnostic purposes, face transplants, and organs that could replace transplants in the future.

To comply with regulations, a label and certificate of conformity are generated, documenting the entire development process. The technology requires a system that allows for monitoring and archiving the device's traceability, ensuring that all relevant information remains accessible for at least 5 years for medical devices and for the device's lifetime in the case of implants. This enables the continuous renewal of the certificate of conformity for personalized medical devices in accordance with the Medical Device Regulation (MDR) and the ISO 13485 quality management system.

In the art, European patent EP2713929 discloses a traceability system for a surgical instrumentation system, said system consisting of a set of disposable instruments for attaching implants and at least one set of sterile implants, each of said sets comprising an identifier, the first of said sets comprising a unique identifier that allows the identification of the set comprising the unique identifier, the second set comprising at least one identifier on a transferable medium, the first set comprising a means for recording additional identifiers consisting of a card bearing an identifier that takes back the unique identifier, said card being contained within the first set, one of said additional identifiers being a code associated with a patient, taken when said set is used, at least one other additional identifier being the identifier on a transferable medium of the second set, said identifier on a transferable medium being provided to be transferred to said means for recording additional identifiers when the second set is used. Furthermore, the system comprises a database for recording information relating to the manufacture, packaging, and sterilization of all assemblies, the system comprising means for reconciling information from the recording medium of additional identifiers from the unique identifier associated with said medium.

The request does not allow managing information from the development of medical devices from the moment they are developed and implemented in the user through a platform (10) that allows storing all the information of the medical device, where traceability allows compliance not only with current standards, but also anticipating future needs.

The present invention discloses a system that facilitates traceability management in the development of personalized medical devices, ensuring compliance with current standards and anticipating future industry needs. The system generates the label, the device conformity certificate, the unique device identifier (UDE), and a tracking report detailing the patient's medical image reviews, segmentation, design, technical requirements, printing, sterilization, and post-use review processes.

DESCRIPTION OF THE DRAWINGS

To complement the description being made and in order to help a better understanding of the characteristics of the invention, according to a preferred example of its practical embodiment, a set of drawings is included as an integral part of said description, in which, for illustrative and non-limiting purposes, the following has been represented:

Figure 1 shows a block diagram of the system, which incorporates a platform (10) that includes a first module, the record (1), containing specific device information with its respective sections: Record Name (1a), Work Center (1b), Responsible Parties (1c), Patient Data (1d), Case Details (1e), Pathology (1f), Intervention Data (1g), and Specific Procedure (1h). A second module, the Imaging Study (2), allows the management and review of imaging studies necessary for the precise development of the device, with its respective sections: Association with Records (2a), Type of Studies (2b), Anatomical Relevance (2c), and Imaging Study Details (2d). A third module, Device Development (3), compiles all the information necessary for the effective development of the device, with its respective sections: Associated File (3a), Anatomical Region (3b), Application Details (3c), Medical Device Details (3d), and Three-Dimensional Biomodel of the Pathology (3e). A fourth module, Work Centers (4), allows for the registration and management of the work centers involved in the development, manufacturing, and management of the device, with its respective sections: General Work Center Information (4a), Work Center Managers (4b), Device Manufacturing Manager (4c), Regulatory Compliance Manager (4d), Alternate Technical Manager (4e), Engineering (4f), Data Management (4g), and Postal Address (4h). A fifth module, Work Teams (5), compiles information about the work team, including an advanced database for managing the users involved in the device development process, with its respective sections: User List (5a); Search Functionalities (5b), Detailed User Information (5c). A sixth module, Device Ratings (6), which allows for the evaluation and feedback of the device after its development and use, with its respective sections: Evaluation of Developed Medical Devices (6a), Regulatory Compliance (6b), and Challenges in Participation (6c). A seventh module, Pathologies Section (7), which allows for the classification of pathologies according to specific areas of interest and anatomical divisions, with its respective sections: Comprehensive Pathologies Database Section (7a), Menu Selection Facilitation (7b), and Areas of Interest and Divisions (7c). An eighth module, Explore (8), which allows for viewing and accessing the different records of each device and generating the device's compliance label, with its respective sections: Graphical Visualization of Records (8a), and Intuitiveness and Accessibility (8b).

PREFERRED EMBODIMENT OF THE INVENTION

The present invention discloses an information management system for the traceability of medical devices, such as tools or implants, for example, anatomical prostheses, medical tools, etc., developed using 3D printing. The system incorporates a platform (10) that allows for the storage of all information about the medical device, from the moment it is developed and implanted in the user. This traceability ensures compliance not only with current standards but also anticipates future needs. The system generates the label, the device conformity certificate, the UDE (Unique Device Identifier), and the post-use review follow-up report, as required by the European Medical Device Regulation (MDR) and the ISO 13485 Quality Management System (QMS).

Device information can be managed by a system that incorporates a platform (10) with different modules that can be assisted by a computer.

This management system enables the safekeeping of the device's traceability, ensuring that all relevant information remains accessible for at least 5 years for tools and for the entire lifespan of implants. This management allows for the generation of a certificate of conformity for customized medical devices in accordance with the MDR (Medical Device Regulation) and the QMS ISO 13485 quality management system.

The development of a custom medical device begins with a Computed Tomography (CT) scan of the patient, which captures detailed images of their anatomy. These images are then segmented to identify and isolate areas of interest, which is crucial for the precise design of the device. Next, the device is designed using specialized software to tailor it to the patient's specific needs. Once the design is complete, rigorous validation is performed to ensure the device meets all medical and technical requirements. With validation complete, the device is manufactured using 3D printing, a technology that enables rapid and precise production. After printing, the device is sterilized, preparing it for safe use in patients. As mentioned, to comply with regulations, a label and certificate of conformity are generated, documenting the entire development process. The device is then released for use.

The Traceability Management System for the development of personalized medical devices allows the storage of all medical device information from the moment it is developed and implanted in the user. This system incorporates a platform (10) comprising: a first module, File (1) with specific device information; a second module, Imaging Study (2) that allows the management and review of imaging studies necessary for the accurate development of the device; a third module, Device Development (3) that collects all the information necessary for the effective development of the device; a fourth module, Work Centers (4) that allows the registration and management of work centers that participate in the development, manufacture, and management of the device; a fifth module, Work Teams (5) that collects information on the work team, including an advanced database for managing users who participate in the device development process; and a sixth module, Device Ratings (6), which allows for the evaluation and feedback of the device after its development and use. a seventh module, Pathology Section (7) which allows the classification of pathology according to specific areas of interest and anatomical divisions; and an eighth module, Explore (8), which allows viewing and accessing the different records of each of the devices and generating the device conformity label.

The first module, file (1), comprises a first section, File Name (1a), which allows searching within the platform; a second section, Work Center (1b), which indicates the place where the development or implementation of the medical device was carried out; a third section, Responsible Parties (1c), which indicates the users assigned to each file; a fourth section, Patient Data (1d), where gender and date of birth are collected; a fifth section, Case Details (1e), where the anatomical area is specified, specifying the anatomical region involved; a sixth section, Pathology (1f), which allows the description of the medical condition to be treated; a seventh section, Intervention Data (1g), where the date on which the intervention will be carried out is included; and an eighth section, Specific Procedure (1h), in which it is specified what procedure(s) will be carried out in the intervention.

The second module, Image Study (2), comprises a first section, Association with Records (2a), which allows each image to be directly associated with a specific record; a second section, Variety of Studies (2b), which allows the inclusion of computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, radiographs, in addition to medical images used to design the device; a third section, Anatomical Relevance (2c), where the device intended for a particular anatomical region requires information from imaging studies of various regions; and a fourth section, Image Study Details (2d), which includes Image Study Name, Anonymization Check, which allows ensuring the quality of the images, and Field for Description, which allows specifying the parts of the images that are relevant and those that may require cleaning.

The third module, Device Development (3), comprises a first section, Associated File Information (3a), which identifies its link to a specific file; a second section, Anatomical Region (3b), which specifies the body region for which the device is being developed; a third section, Application Details (3c), which includes Sterilization Requirement, indicating whether the device needs to be sterilized before use, Application Name, which allows searching within the platform, and Description, which provides a summary of the application; a fourth section, Medical Device Details (3d), which includes Device Type, defining the medical device category, Device Class, and Custom Parameters, allowing the specification of technical details for the device, such as dimensions, materials, or specific functional requirements; and a fifth section, Three-Dimensional Biomodel of the Pathology (3e), which allows for the planning of a three-dimensional representation of the anatomy without the need to manufacture tools or implants. This representation can be digital, displayed on a screen, or 3D printed using either technology and material.

The fourth module, Work Center (4), comprises a first section, General Information of the Work Center (4a), which includes the Name of the Work Center, Type of Work Center, and Tax Identification Code (CIF); a second section, Persons Responsible for the Work Center (4b), which includes the Name of the Technical Manager, the Person Responsible for Monitoring the Device, and the Person Responsible for Imaging Studies of the Device; a third section, Person Responsible for Manufacturing the Device (4c); a fourth section, Person Responsible for Regulatory Compliance (4d); a fifth section, Alternate Technical Manager (4e); a sixth section, Engineering (4f) with the name of the person responsible for the design of the devices; a seventh section, Data Management (4g) for data validation and the Person Responsible for Sterilization; and an eighth section, Postal Address (4h), which facilitates the location and communication with the work center.

The fifth module, work teams (5) comprises a first section User List (5a); a second section, Search Functionalities (5b), which allows filtering users by name, surname, telephone, email, status, role, and group; and a third section Detailed User Information, (5c) which includes User Name and Surname, User Telephone, User Email, User Status, User Role, which includes the user's function or responsibility within the team, and Group, which allows grouping users into specific categories based on departments, specialties, or projects.

The sixth module, Device Ratings (6), comprises a first section, Evaluation of Developed Medical Devices (6a), which allows for ratings and comments on the efficacy, safety, and conformity of the device with clinical expectations and regulatory requirements; a second section, Regulatory Compliance (6b); and a third section, Challenges in Participation (6c).

The seventh module, Pathologies section (7), comprises a first section, Comprehensive Pathologies Database (7a), which includes a complete list of pathologies that can be treated or diagnosed with medical devices; a second section, Menu Selection Facilitation (7b); and a third section, Areas of Interest and Divisions (7c), which allows the classification of pathologies according to specific areas of interest and anatomical divisions.

The eighth module, Explore (8), comprises a first section, Graphical Visualization of Files Information (8a), which allows a visual representation of the files; and a second section, Intuitiveness and Accessibility (8b), which allows the instant understanding of the distribution and classification of the files.

The platform (10) allows a unique identifier for each file with its details

Each file includes a unique identifier code, detailing the pathology, the affected anatomical region, and other essential data such as the workplace, the surgeon who performed the procedure, and the date of the procedure. The individuals responsible for each stage of the process are clearly specified, including the technician responsible for printing, design, and sterilization, facilitating fluid communication and effective collaboration among the various project participants.

The platform (10) automates the sending of messages and notifications throughout the device development process, from the creation of new projects and image studies to the approval of designs and devices. This ensures that all stakeholders are informed about status changes and necessary validations in real time.

The platform (10) allows users to have immediate access to listings of imaging studies and medical devices, simplifying the review and tracking of each item within each record.

The platform (10) includes document printing capabilities that can generate a summary of all relevant information regarding the device's development. Once validated, this document can be downloaded by the hospital and, with the simple addition of patient data, becomes the medical device's certificate of conformity. This certificate is essential not only for complying with regulatory obligations but also for ensuring the traceability and quality of the developed device.

Claims (1)

1- Information management system for traceability in the development of personalized medical devices, which allows storing all the information of the medical device, from the moment it is developed and implanted in the user, characterized by the fact that the system incorporates a platform (10) comprising: a first module, File (1) with the specific information of the device; a second module, Image Study (2) which allows the management and review of the image studies necessary for the precise development of the device; a third module, Device Development (3) which collects all the information necessary for the effective development of the device; a fourth module, Work Centers (4) which allows registering and managing the work centers that participate in the development, manufacture and management of the device; a fifth module, Work Teams (5) which collects the information of the work team which includes an advanced database for the management of the users who participate within the process of development of the device; a sixth module, Device Ratings (6), which allows the evaluation and feedback of the device after its development and use; a seventh module, Pathology Section (7) which allows the classification of pathology according to specific areas of interest and anatomical divisions; and an eighth module, Explore (8), which allows viewing and accessing the different records of each of the devices and generating the device conformity certificate. 2- An information management system for traceability in the development of personalized medical devices according to claim 1, characterized in that the first module, File (1), comprises a first section, File Name (1a), which allows searching within the platform; a second section, Work Center (1b), which indicates the location where the development or implementation of the medical device was carried out; a third section, Responsible Parties (1c), which indicates the users assigned to each file; a fourth section, Patient Data (1d), where gender and date of birth are collected; a fifth section, Case Details (1e), where the anatomical area is specified, specifying the anatomical region involved; a sixth section, Pathology (1f), which allows the description of the medical condition to be treated; a seventh section, Intervention Data (1g), where the date on which the intervention will be performed is included; and an eighth section, Specific Procedure (1h), in which it is specified what procedure(s) will be carried out in the intervention. 3- An information management system for traceability in the development of personalized medical devices according to claim 1, characterized in that the second module, Image Study (2), comprises a first section, Association with Records (2a), which allows each image to be directly associated with a specific record; a second section, Variety of Studies (2b), which allows the inclusion of computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, radiographs, in addition to medical images used to design the device; a third section, Anatomical Relevance (2c), where the device intended for a particular anatomical region requires information from image studies of various regions; and a fourth section, Image Study Details (2d), which includes Image Study Name, Harmonization Verification, which allows ensuring the quality of the images, and a Description Field, which allows specifying the parts of the images that are relevant and those that may require cleaning. 4- An information management system for traceability in the development of personalized medical devices according to claim 1, characterized in that the third module, Device Development (3), comprises a first section, Associated File Information (3a), which allows its link to a specific file to be known; a second section, Anatomical Region (3b), where the body region for which the device is being developed is specified; a third section, Application Details (3c), which includes Sterilization Requirement, which indicates whether the device needs to be sterilized before use, Application Name, which allows searching within the platform, and Description, which provides a summary of the application; a fourth section, Medical Device Details (3d), which includes: Device Type, which defines the category of the medical device, Device Class, and Personalized Parameters, which allows specifying technical details for the device, such as dimensions, materials, or specific functional requirements; and a fifth section, Three-dimensional biomodel of the pathology (3e), which allows planning without manufacturing a tool or implant, a three-dimensional representation of the anatomy. 5- Information management system for traceability in the development of personalized medical devices according to claim 1, characterized in that the fourth module, Work Center (4), comprises a first section, General Information of the Work Center (4a), which includes the Name of the Work Center, Type of Work Center and Tax Identification Code (CIF); a second section, Persons Responsible for the Work Center (4b), which includes the Name of the Technical Manager, Person Responsible for Monitoring the Device, Person Responsible for Imaging Studies of the Device; a third section, Person Responsible for Manufacturing the Device (4c); a fourth section, Person Responsible for Regulatory Compliance (4d); a fifth section, Alternate Technical Manager (4e); a sixth section, Engineering (4f); a seventh section, Data Management (4g) for data validation and Person Responsible for Sterilization; and an eighth section, Postal Address (4h), which allows for facilitating the location and communication with the work center. 6- Information management system for traceability in the development of personalized medical devices according to claim 1, characterized in that the fifth module, Work Teams (5), comprises a first section, User List (5a); a second section, Search Functionalities (5b), which allows filtering users by name, surname, telephone, email, status, role, and group; and a third section, Detailed User Information (5c), which includes User Name and Surname, User Telephone, User Email, User Status, User Role, which includes the user's function or responsibility within the team, and Group, which allows grouping users into specific categories based on departments, specialties, or projects. 7- Information management system for traceability in the development of personalized medical devices according to claim 1 characterized in that the sixth module, Device Qualifications (6) comprises a first section, Evaluation of Developed Medical Devices (6a), which allows providing ratings and comments on the efficacy, safety, and conformity of the device with clinical expectations and regulatory requirements; a second section, Regulatory Compliance (6b); and a third section, Challenges in Participation (6c). 8- Information management system for traceability in the development of personalized medical devices according to claim 1, characterized in that the seventh module, Pathology Section (7), comprises a first section, Comprehensive Pathology Database (7a), which includes a complete list of pathologies that can be treated or diagnosed with medical devices; a second section, Menu Selection Facilitation (7b); and a third section, Areas of Interest and Divisions (7c), which allows the classification of pathologies according to specific areas of interest and anatomical divisions. 9- Information management system for traceability in the development of personalized medical devices according to claim 1 characterized in that the eighth module, Explore (8) comprises a first section, Graphical Visualization of Records information (8a), which allows a visual representation of the records; and a second section, Intuitiveness and Accessibility (8b) which allows the instant understanding of the distribution and classification of the records. 10- Information management system for traceability in the development of personalized medical devices according to claim 1 characterized in that the platform (10) includes document printing elements with the ability to generate a summary of all relevant information on the development of the device.