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Medical technology has revolutionized the healthcare industry, offering enhanced precision, efficiency, and improved patient outcomes. Manufacturing processes in medical devices involve several key steps, including design, prototyping, fabrication, assembly, testing, and quality control.
Let’s take a closer look at these processes:
The first step in manufacturing medical devices involves designing the components and systems that make up the device.
This includes mechanical design, electrical design, and software development.
CAD (Computer-Aided Design) software is often used to create 3D models of the device and its individual parts. By importing the Design CAD model into WizGen, assembly, disassembly, and rework manufacturing instructions are generated early in the process, ensuring that manufacturing procedures are continuously updated.
Once the design phase is complete, prototypes of the medical device are built to test and refine its functionality.
Prototyping often involves rapid techniques such as 3D printing, enabling quick iteration and modification of design concepts.
WizGen enhances manufacturing processes by incorporating engineering knowledge, including tools, materials, jigs, and ensuring completeness and accuracy at each stage.
This results in a comprehensive and validated engineering database, supporting production fault isolation and ongoing maintenance.
After the prototype is validated, the fabrication process begins.
This involves manufacturing the device’s components using various techniques and materials.
Different fabrication methods may be employed, such as CNC (Computer Numerical Control) machining, injection molding, laser cutting, or additive manufacturing (e.g., 3D printing), depending on the specific requirements of the device.
By uploading the production processes generated in WizGen to WizShield and applying atomic steps, the system ensures that each step matches its predicted results, improving manufacturing time and enhancing first-time yields (FTY).
Once the individual components are fabricated, they are assembled to create the complete medical device. This step involves integrating mechanical parts, electronic components, sensors, actuators, and any other necessary elements.
Assembly can be done either manually or through automated processes. WizShield tracks the assembly and testing of all components, ensuring that each step meets quality standards and providing QA approval for the final product.
Testing is a crucial step to ensure the functionality and safety of the medical device. Various types of tests are conducted, including performance testing, stress testing, and functional testing, to verify that the device operates as intended and meets the required performance and safety standards.
WizShield utilizes the test and fault isolation procedures generated by WizGen, ensuring the device’s functionality is thoroughly proven and validated.
Quality control procedures are integrated throughout the manufacturing process to maintain high standards in medical device production. This involves thorough inspection, verification, and validation of the device’s components and subsystems to ensure they meet the stringent requirements of the healthcare industry. Quality control measures include visual inspections, electrical and mechanical testing, biocompatibility assessments, and strict adherence to regulatory guidelines such as FDA or ISO standards to ensure safety, reliability, and compliance in medical applications.
Medical robots must comply with strict regulatory requirements, such as those set by the Food and Drug Administration (FDA) in the United States or similar authorities in other countries. Manufacturers must ensure their robots meet the necessary safety and performance standards, and documentation needs to be prepared for regulatory submission.
Integrating WizSuite into the design and manufacturing processes generates complete and validated manufacturing processes “WizGen” and complete test and QA reports of each manufacturing process “WizShield” reduces time to acknowledge the FDA this time to market is reduced dramatically.
Once the medical devices are manufactured and tested, they are packaged appropriately to ensure safe transportation and storage.
Depending on the intended use, some devices may require sterilization to maintain a sterile environment during surgical procedures.
WizGen generates detailed packing instructions, which are followed by WizShield once production and QA are complete. This ensures that the packing process is carried out consistently, while also automatically preparing the unpacking, assembly, and testing steps before the device is installed in the surgical room.
The manufacturing of medical devices is a highly complex process that requires meticulous attention to detail and adherence to stringent regulatory standards.
Each device must be designed and produced with precision, ensuring it meets specific safety, performance, and functional requirements.
This complexity is further compounded by the need to manage traceability, maintain sterile environments, and ensure biocompatibility for devices that come into direct contact with patients.
Every stage, from design and prototyping to production and post-market surveillance, requires careful planning, specialized knowledge, and a commitment to ensuring the highest standards of safety and efficacy.