Process digitalization refers to the systematic process of planning, simulating, optimizing and managing the entire life cycle of product manufacturing processes using digital technology, software tools and knowledge-driven methods. It is a key bridge between product design and manufacturing. Modern manufacturing industries need to use digital means to improve the efficiency and quality of process design, shorten the design cycle, and accelerate the training of process technology talents, and ultimately achieve the transformation from experience-driven to knowledge-driven1,2. Today, we will start from the process links involved and talk about the importance of process digital design in the medical device packaging industry.

(1) Digital design of packaging structure and protection

Medical device packaging companies can use CAD and 3D modeling software to build a digital model of the packaging structure, and then combine it with the three-dimensional shape data of the medical device for precise adaptation design and simulation. For example, for the special-shaped structure of minimally invasive surgical instruments, the lining buffer structure is optimized through 3D modeling, and the vibration and impact loads during transportation are simulated using finite element analysis (FEA) to ensure that the packaging structure provides good protection for the device. This can reduce the number of physical prototype trials, thereby significantly shortening the design iteration cycle and reducing the cost of trial and error. In the future, it is also possible to build a cloud-based design collaboration platform, where medical device manufacturers and packaging suppliers can share 3D design models through the cloud platform, collaborate and optimize packaging solutions in real time, and greatly shorten the response time for design changes.

Through digital modeling, the sterile barrier system of medical devices can be designed, and the sealing performance and microbial barrier capacity of packaging materials can be simulated and analyzed to ensure that the packaging meets standards such as ISO 11607 after sterilization. Furthermore, simulation software can be used to simulate the material flow of thermoformed packaging, optimize the design of sealing lines, and avoid the risk of leakage after sterilization.

(2) Digital management of production process parameters

The company digitally enters the automated molding process parameters of blister packaging and hard blister packaging into the MES (Manufacturing Execution System), and can achieve rapid production changeovers for different products through parametric programming. The consistency of process parameters can be increased to more than 99%, reducing the scrap rate caused by manual machine adjustment.

Digital technology is used to optimize product printing and labeling processes. For example, the digital printing system can not only achieve high-precision printing of sterilization indicator labels and traceability QR codes on the packaging surface, but also monitor printing parameters such as ink volume and temperature in real time through the PLC (programmable logic controller) system.

(3) Digitalization of compliance and traceability systems

Medical device packaging companies convert the requirements of relevant regulations and standards such as FDA and ISO 13485 into digital checklists and embed them into the design process, so that engineers can automatically verify whether parameters such as material biocompatibility and sterilization compatibility meet the standards during the packaging design stage. Through digital technologies such as RFID and QR codes, information such as packaging design data, production process parameters, and sterilization records are integrated into the blockchain platform to achieve full life cycle traceability from design to clinical use.

References:
1. Implementation of intelligent scenarios for process digital design and interpretation of application models | Interpretation of "China's Intelligent Manufacturing Development Research Report - Intelligent Factory" in the "Intelligent Manufacturing Tour" series - World Intelligent Manufacturing Conference
2. Unveiling process digitalization: From concept to case, opening a new revolution in the manufacturing industry!