Periodic Reporting for period 1 - Dynamic Molding (DM) (An innovative and versatile Additive Manufacturing Process: Dynamic Molding)
Reporting period: 2023-05-01 to 2024-04-30
The Dynamic Molding (DM) project is set within the rapidly evolving field of medical technology, where there is an increasing demand for precision, quality, and adherence to stringent regulatory standards. The primary objective of the DM project is to establish an advanced production environment that can manufacture a wide range of medical devices, from basic Class I devices to complex Class III implants. This project is motivated by the need to enhance patient outcomes through the production of high-quality, biocompatible medical devices that meet rigorous safety and efficacy standards.
The context of the project is defined by the challenges faced in the current medical device manufacturing landscape, which include ensuring biocompatibility, maintaining sterility, and achieving regulatory compliance. The DM project aims to address these challenges by leveraging cutting-edge technologies such as Dynamic Molding, which allows for the creation of ultra-realistic anatomical models and patient-specific devices. By integrating advanced environmental control systems, including HEPA filters and particle counters, the project seeks to maintain optimal production conditions that prevent contamination and preserve the integrity of medical devices.
The pathway to impact involves establishing a robust production line that complies with ISO 13485:2016 and the European Medical Device Regulation (MDR) 2017/745. The project envisions significant advancements in manufacturing processes, ultimately leading to better patient care and supporting the EU’s goals of improving healthcare quality and safety.
The context of the project is defined by the challenges faced in the current medical device manufacturing landscape, which include ensuring biocompatibility, maintaining sterility, and achieving regulatory compliance. The DM project aims to address these challenges by leveraging cutting-edge technologies such as Dynamic Molding, which allows for the creation of ultra-realistic anatomical models and patient-specific devices. By integrating advanced environmental control systems, including HEPA filters and particle counters, the project seeks to maintain optimal production conditions that prevent contamination and preserve the integrity of medical devices.
The pathway to impact involves establishing a robust production line that complies with ISO 13485:2016 and the European Medical Device Regulation (MDR) 2017/745. The project envisions significant advancements in manufacturing processes, ultimately leading to better patient care and supporting the EU’s goals of improving healthcare quality and safety.
The DM project has made substantial progress in several key areas:
• Validation of Raw Material Range for Medical Device Production: The project successfully validated a comprehensive range of raw materials used in the production of medical devices. This validation process included rigorous testing to ensure the materials meet the required standards for safety, durability, and compatibility. This step was critical in confirming the materials' suitability for use in manufacturing medical devices, ensuring they provide consistent quality and performance in medical applications.
• Validation of the Production Line Plan: A thorough validation of the plans for the entire production line was completed, ensuring all proposed components and processes are optimized for efficiency and quality. This involved extensive testing and fine-tuning of the production workflow to guarantee that every aspect of the manufacturing process is well-designed and will operate seamlessly once implemented. The validation ensured that the production line, when built, could consistently produce high-quality medical devices in an efficient and reliable manner. The actual production line has yet to be constructed, pending this validation of the plans.
• Reception of the v2 Deus Light Industrial Production Printer: The project successfully received and integrated the latest version of the Deus Light industrial production printer, version 2. This state-of-the-art printer plays a crucial role in the manufacturing process, offering advanced features and capabilities. The integration of this printer into the production line marks a significant upgrade, enabling higher precision, faster production speeds, and improved overall efficiency. The new printer enhances the project's ability to produce complex and high-quality medical devices on a larger scale.
• Certification ISO 13485 : The project achieved ISO 13485 certification for the production facility, confirming that the facility meets the stringent quality management system requirements for the manufacturing of Class I medical devices (both in-house and subcontracted) and the design of medical devices of all classes. This certification is a critical milestone, ensuring that the production processes adhere to international standards for medical device quality and safety.
• Validation of Biocompatibility: Extensive biocompatibility tests, including cytotoxicity, irritation, and skin sensitization studies, were conducted on Dynasoft25 parts. These tests confirmed that the materials used in manufacturing are safe for medical applications, meeting the requirements of ISO 10993 standards.
• Sterilization Processes: The project successfully validated sterilization methods using ethylene oxide and autoclaving for Dynasoft25 parts. These methods were shown to maintain the mechanical and visual properties of the parts, ensuring they remain effective and safe for use.
• Technological Innovations: The introduction of Dynamic Molding technology has enabled the creation of functional twins and patient-specific medical devices, enhancing surgical planning, training, and in vitro testing capabilities.
• Validation of Raw Material Range for Medical Device Production: The project successfully validated a comprehensive range of raw materials used in the production of medical devices. This validation process included rigorous testing to ensure the materials meet the required standards for safety, durability, and compatibility. This step was critical in confirming the materials' suitability for use in manufacturing medical devices, ensuring they provide consistent quality and performance in medical applications.
• Validation of the Production Line Plan: A thorough validation of the plans for the entire production line was completed, ensuring all proposed components and processes are optimized for efficiency and quality. This involved extensive testing and fine-tuning of the production workflow to guarantee that every aspect of the manufacturing process is well-designed and will operate seamlessly once implemented. The validation ensured that the production line, when built, could consistently produce high-quality medical devices in an efficient and reliable manner. The actual production line has yet to be constructed, pending this validation of the plans.
• Reception of the v2 Deus Light Industrial Production Printer: The project successfully received and integrated the latest version of the Deus Light industrial production printer, version 2. This state-of-the-art printer plays a crucial role in the manufacturing process, offering advanced features and capabilities. The integration of this printer into the production line marks a significant upgrade, enabling higher precision, faster production speeds, and improved overall efficiency. The new printer enhances the project's ability to produce complex and high-quality medical devices on a larger scale.
• Certification ISO 13485 : The project achieved ISO 13485 certification for the production facility, confirming that the facility meets the stringent quality management system requirements for the manufacturing of Class I medical devices (both in-house and subcontracted) and the design of medical devices of all classes. This certification is a critical milestone, ensuring that the production processes adhere to international standards for medical device quality and safety.
• Validation of Biocompatibility: Extensive biocompatibility tests, including cytotoxicity, irritation, and skin sensitization studies, were conducted on Dynasoft25 parts. These tests confirmed that the materials used in manufacturing are safe for medical applications, meeting the requirements of ISO 10993 standards.
• Sterilization Processes: The project successfully validated sterilization methods using ethylene oxide and autoclaving for Dynasoft25 parts. These methods were shown to maintain the mechanical and visual properties of the parts, ensuring they remain effective and safe for use.
• Technological Innovations: The introduction of Dynamic Molding technology has enabled the creation of functional twins and patient-specific medical devices, enhancing surgical planning, training, and in vitro testing capabilities.
The DM project has achieved several results that push the boundaries of current medical device manufacturing:
• Enhanced Precision and Customization: The Dynamic Molding process allows for the production of highly precise and customized medical devices, tailored to the specific needs of individual patients. This capability significantly improves the accuracy of surgical procedures and patient outcomes.
• Improved Biocompatibility and Sterility: The project’s rigorous testing and validation processes have ensured that the materials used are biocompatible and that the sterilization methods employed do not compromise the integrity of the devices. This enhances the overall safety and efficacy of the medical devices produced.
• Environmental Control and Contamination Prevention: By implementing advanced environmental control systems, the project has set new standards for maintaining clean and controlled production environments. This is crucial for preventing contamination and ensuring the consistent quality of medical devices.
• Scalability and Flexibility: The modular design of the production environment allows for scalability and flexibility, enabling the efficient production of a wide range of medical devices. This adaptability is essential for meeting diverse medical needs and responding to changes in demand.
• Enhanced Precision and Customization: The Dynamic Molding process allows for the production of highly precise and customized medical devices, tailored to the specific needs of individual patients. This capability significantly improves the accuracy of surgical procedures and patient outcomes.
• Improved Biocompatibility and Sterility: The project’s rigorous testing and validation processes have ensured that the materials used are biocompatible and that the sterilization methods employed do not compromise the integrity of the devices. This enhances the overall safety and efficacy of the medical devices produced.
• Environmental Control and Contamination Prevention: By implementing advanced environmental control systems, the project has set new standards for maintaining clean and controlled production environments. This is crucial for preventing contamination and ensuring the consistent quality of medical devices.
• Scalability and Flexibility: The modular design of the production environment allows for scalability and flexibility, enabling the efficient production of a wide range of medical devices. This adaptability is essential for meeting diverse medical needs and responding to changes in demand.