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Medical device manufacturers face unique challenges in terms of product mix, throughput requirements, quality standards and regulatory guidelines. Whether a company is producing diagnostic equipment for cancer screening, disposable devices such as syringes, or implantable devices such as stents, the manufacturing process must be absolutely error-free while delivering high throughput. To achieve these goals and realize other benefits, companies are investing in factory automation. Medical device manufacturers automating not just individual assembly processes, but the entire manufacturing process, including testing, inspection, packaging, storage and retrieval.

Just mentioning automation typically triggers visions of plant floors filled with robots and machinery. However, the future of automation also applies to the “behind the scenes” functions of data collection and analysis. For example, the FDA requires documentation of machine parameters and deviations on a part-by-part basis. Software can collect and store that data automatically. It can also link that information to individual serial numbers, meeting the requirement for part-by-part verification.

The key to achieving these goals, however, is not simply a matter of adopting more automation. It lies with the core principle of Industry 4.0—combining automation and IT (information technology). The best way to integrate and capitalize on Industry 4.0 capabilities is to specify production equipment that is designed with the automation-IT connection in mind.


Industry 4.0 Drives Openness and Ease of Use

To make this connection between automation and IT, Bosch Rexroth has developed an Open Core Engineering machine control platform, which combines software tools, functional tool kits and open standards that allow programmers and operators to use more familiar software platforms rather than having to learn ladder logic or a specific programming language. The Open Core Interface includes software development kits that can be used in Excel’s Visual Basics for Applications (VBA) to create a user interface for controlling a motion axis. Then the axis can be run directly from Excel, or the program can be pushed from Excel to a programmable logic controller (PLC), handshaking with Bosch Rexroth programming software.

In smaller medical laboratories, where technicians work directly with the automation systems, it’s often necessary for technicians to make changes to programs, test points and other machine parameters specific to the sample being tested. The Open Core platform allows the machine builder or end user to create an interface that provides technicians with access to certain levels of machine control to customize or change the operation. Once the interface is created, a simple handheld tablet with Excel can be used to transfer it to a PLC. This is a simpler and less expensive option than using a machine-grade HMI. In addition, portability, Wi-Fi connectivity and Bluetooth are already built-in.

Machine interfaces are also the root of data collection, but the true benefit of Industry 4.0 is found in how that data is used for parts tracking, error reduction and process stability. The IoT gateway controller is at the heart of technologies for Industry 4.0, allowing engineers to capture, broadcast or use data to help improve quality, reduce turnaround times and meet regulatory requirements. Software such as Bosch Rexroth’s ActiveCockpit can serve as an interactive communication platform that processes and visualizes production data in real time, easily connecting with back-end MES or ERP systems, allowing rapid diagnosis and optimization of machines and processes.

In another example, Bosch Rexroth’s EFC variable frequency drive incorporates networking capabilities that allow for remote control and monitoring. When combined with the Rexroth VarioFlow plus flexible conveyor, engineers have easy access to the machine via wireless or Bluetooth connectivity. This allows the operator to adjust speeds, inspect diagnostic codes, and view machine parameters without ever opening an electrical enclosure or summoning the engineering department for support. Similarly, maintenance personnel can get alerts via email or text message and receive diagnostic codes without traveling to the machine and connecting to it.

Of course, data security is a significant concern in medical device manufacturing. The more data that’s available—and the more ways in which it’s made available—the more opportunities there are for inappropriate use. It’s unavoidable, Any time there is an IoT gateway on a machine, there is risk of leaks or hacks. Security is the biggest hurdle to full adoption and integration of Industry 4.0 principles, so users and machine builders need to understand the risks and how they can be mitigated or reduced. Cloud-based apps with certificate authentication and external industrial VPNs are recommended for secure remote access.

As Industry 4.0 expands across the manufacturing floor, products that were once seen as commodities—such as linear guides, ballscrews and sensors—will become key enablers of advanced functions, including real-time monitoring, predictive and preventive maintenance, and part tracking.