Intelligent manufacturing solutions for electronic medical devices

In order to ensure the stability and reliability of medical devices, the State Council of the People's Republic of China issued Order No. 276 that medical device production must meet strict production conditions. Major medical equipment manufacturers comply with national regulations and have developed a complete set of production, testing, and after-sales processes to ensure the qualified quality of medical devices.

In people's eyes, medical devices are relatively "mysterious", accompanied by impressions such as "sterile", "precision", and "expensive". With the rapid development of industrial automation, the production model of medical devices is also facing innovation and reform. In order to plan a stable and efficient production solution, Zhiyuan Electronics cooperated with a well-known medical and health electronic product company in Tianjin to complete the innovation of a new production process.

After investigation, it was found that most medical device manufacturers now follow the traditional process for equipment production and after-sales, using the processes of firmware burning, patch mounting, and functional testing for production. The process is shown in Figure 1.

Figure 1 Traditional process of production and after-sales of medical devices

In the traditional process, product function testing before leaving the factory and equipment upgrade and maintenance require the equipment to be returned to the factory for repair and inspection. For medium and large equipment, this will greatly increase the maintenance cost of the product. If it is an upgrade and maintenance for urgent customers (such as hospitals), it will directly affect normal work use, which will inevitably bring great inconvenience.

In order to solve the problem of strong regional requirements for factory repairs and functional testing, ZLG Zhiyuan Electronics worked closely with a well-known medical and health electronic product company in Tianjin to propose a practical improvement plan to transform the traditional production and maintenance processes. The transformed process is shown in Figure 2:

Figure 2 Improvement of traditional process

The improved process integrates firmware production and functional testing into one, planning a new type of production and testing equipment, which can produce, upgrade, repair and test equipment anytime and anywhere. Users only need to deploy the equipment to various outlets that need to be covered to solve problems such as upgrades and repairs. This process is more convenient and efficient, and will reduce the problem of end users returning for repairs due to failures affecting normal use.

In Figure 2, the disruptive innovation lies in the link of "online firmware burning and functional test integrated equipment", which uses Zhiyuan Electronics' intelligent programming solution - P800isp mass production online programmer. It mainly programs the product firmware online, and cooperates with the functional test components related to medical equipment to test the product in real time, which can more conveniently and quickly discover and solve problems.

P800isp has a wealth of interfaces to meet various remote connection needs. It also has powerful automatic control and intelligent management functions. This is why it is valued by integrated equipment.

Remote connection function

P800isp is equipped with network control interfaces and complete API call interfaces, which can perfectly realize device and system integration.

Automation control function

In the medical equipment production line, the automatic power-on and power-off detection function of P800isp is used to automatically perform online programming operations after detecting that the production equipment is in stable contact. The barcode gun in the integrated device is used during programming to automatically scan the one-dimensional code label on the surface of the production equipment, and automatically burn the SN and MAC address of the equipment into the corresponding area of ​​the chip, reducing the production control process and greatly reducing the production error rate.

Intelligent management function

The production details of medical equipment need to be recorded in the server in the form of reports for maintenance, inspection, and audit. After programming is completed, P800isp will provide the programming log in the form of reports to the server for storage, which is convenient for later error tracking and location. P800isp will also provide the programming yield rate for the manufacturer to check, locate and solve the bottleneck of the production process, and find the production failure point.

Cross-regional functionality

Since medical devices are used all over the world and need to be deployed across regions, in order to solve the upgrade and maintenance of medical device products, a programmer equipped with a network communication interface can be used. Medical device manufacturers can remotely upgrade the equipment and deploy and upgrade the firmware engineering. Remote operation and control through the network greatly facilitates communication and problem solving between the headquarters and the after-sales service department.

The era of Industry 4.0 has arrived, and "Made in China" is rapidly transforming into "Smart Manufacturing in China". How to quickly improve production efficiency is a problem that major companies need to solve urgently. ZLG Zhiyuan Electronics has been committed to providing users with the most reliable programming solutions to help "Smart Manufacturing in China"!