Manufacturers in the medical industry face unique challenges in terms of product mix, throughput requirements, quality standards, and regulatory guidelines. Whether a company is developing imaging equipment, orthopedic implants, or diagnostics, the manufacturing process must be absolutely error free while delivering high throughput. Device companies are looking more and more to factory automation to ensure that they are addressing these disparate requirements.
The advent of Industry 4.0 and the Internet of Medical Things (IoMT) have also had an impact on manufacturing. Medical device and equipment manufacturers are finding that implementing automation not only improves throughput and quality but provides other benefits such as robustness, accuracy, and interoperability of the parts and systems. This article examines motor-integrated automation technology and cabinet-free technology holistically. It also explains how manufacturers can reduce costs and time in all project phases throughout the life of the production equipment.
Integrating Automation and Information Technology
The implementation of automation of not only individual processes but also entire factories is helping device manufacturers meet the strict quality requirements mandated by FDA and other government agencies. Medical device manufacturers are demanding automation of the complete manufacturing and handling value chain, including product testing, inspection, packaging, and storage and retrieval.
While the idea of automation typically leads one to think of manufacturing plant floors filled with robots and machinery, the future of automation is much more than that. Automation of the future incorporates background functions such as data collection and manipulation. For example, when FDA requires documentation of machine parameters and deviations on a part-by-part basis, automated data collection allows the manufacturing parameters to not only be collected and stored automatically, but to also be written to files tied to individual serial numbers, providing the required part-by-part verification.
Achieving this level of automation, however, is not simply a matter of installing more machines and robots. Rather, it requires embracing the core principle of Industry 4.0: combining automation and IT (information technology). Choosing vendors and products that are designed with the automation-IT connection in mind is key to successful integration of Industry 4.0 capabilities.
Industry 4.0: Openness and Ease of Use
The definition of Industry 4.0 was first introduced in 2011. Although explanations of Industry 4.0 vary, Germany Trade and Invest (GTIA) — the economic development agency of the Federal Republic of Germany — defines Industry 4.0 as: “A paradigm shift… made possible by technological advances which constitute a reversal of conventional production process logic. Simply put, this means that industrial production machinery no longer simply ‘processes’ the product, but that the product communicates with the machinery to tell it exactly what to do.”
“The next phase is the digitization of the manufacturing sector, driven by four disruptions: the astonishing rise in data volumes, computational power, and connectivity, especially new low-power wide-area networks; the emergence of analytics and business intelligence capabilities; new forms of human-machine interaction such as touch interfaces and augmented-reality systems; and improvements in transferring digital instructions to the physical world, such as advanced robotics and 3D printing.”
To build this connection between automation and IT, Bosch Rexroth has developed the Open Core Engineering platform, which combines software tools, functional toolkits, open standards, and Open Core Interface technology.1 Specifically, the Open Core Interface allows programmers and operators to use a familiar software platform — such as National Instruments’ LabVIEW, Java, or CATIA — to control the machine, eliminating the need to learn ladder logic or a Bosch Rexroth programming language. The Open Core Interface includes software development kits (SDKs) that can be used, for example, in Excel’s 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 PLC, handshaking with Bosch Rexroth programming software.
In smaller medical manufacturing operations, technicians often work directly with the automation systems, so it’s necessary for them to make changes to programs, test points, and other machine parameters specific to the sample being tested. The Open Core Interface allows the machine builder or end user to create an interface that provides the technicians with access to certain levels of machine control to customize or change the operation. Once the interface is created, a handheld tablet with Excel can be used to transfer the interface to a PLC. This is a simpler — and less expensive — option than using a full-blown, machine-grade human-machine interface (HMI). Portability, Wi-Fi connectivity, and Bluetooth are already built in.
The true benefit of Industry 4.0 is found in how that data is used — for part tracking, error reduction, or process stability — all of which play a critical role in the manufacture of medical devices and equipment. At the heart of Bosch Rexroth’s technology solutions for Industry 4.0 is the controller, or IoT gateway, which allows users to capture data and broadcast or use that data in a manner that helps them improve quality, reduce turnaround times, and meet regulatory requirements. Software such as ActiveCockpit processes and visualizes production data in real time, easily connecting with back-end manufacturing execution systems (MES) or enterprise resource planning (ERP) systems, allowing rapid diagnosis and optimization of machines and processes.
In another example, Open Core Engineering principles are applied to Bosch Rexroth’s EFC variable frequency drive, which incorporates networking capabilities that allow for remote control and monitoring. When used with the VarioFlow plus conveyor system, the user has easy access to the machine via wireless or Bluetooth connectivity. This access allows the operator take actions such as adjusting speeds, inspecting diagnostic codes, or viewing machine parameters — without ever opening an electrical enclosure or calling for engineering support. Similarly, maintenance personnel can be alerted to problems via email or text message and can receive diagnostic codes as needed without having to access the machine.
Of course, for the medical device industry, it is essential to ensure the security of data that is gathered, stored, and shared through IoT and Industry 4.0 applications. As more data is made available, it opens the door to more chances for it to be used inappropriately. Any time there is an IoT gateway on a machine, there is a risk of leaks or hacks. Machine builders need to understand these risks and how they can be mitigated or reduced when implementing Industry 4.0. Currently, Bosch Rexroth’s cloud-based apps use certificate authentication, and an external industrial VPN is recommended for secure remote access.
How to Get the Most Out of Industry 4.0
The scale of capital investment required for automation in medical device manufacturing, together with the critical nature of the products and processes, place heavy demands on suppliers for robustness, accuracy, and interoperability of the parts and systems used to implement automation and Industry 4.0. With an extensive range of automation products and integrated solutions — including linear motion components, Cartesian robots, conveyors, motors, controls, tightening tools, and RFID and sensor technologies — Bosch Rexroth can help manufacturers meet these requirements.
As Industry 4.0 and IoMT projects expand their reach across the medical manufacturing floor, products that were once seen as commodities — such as linear guides, ball screws, and sensors — are now key enablers of advanced functions, including real-time monitoring, predictive and preventive maintenance, and part tracking. For example, the XDK sensor box, a turnkey kit that provides instant IoT connectivity for devices or machines, combines traditional automation with advanced sensing technologies and provides critical integration.
Automation ensures a fully robust process that enables device manufacturers to meet regulatory requirements. Complete automation solutions require ease of use and interoperability. Providers such as Bosch Rexroth have designed products and systems that integrate automation and IT as a core principle, allowing customers to fully embrace and capitalize on the benefits that Industry 4.0 can provide.
This article was written by Richard Hansen, Sr. Automation Engineer, Mechatronics, Bosch Rexroth Corp., Charlotte, NC. For more information, visit here .
- Hibbard, S., “Open Core Engineering: New Freedom for Machine Automation Programming,” Medical Design Briefs, 7(4): 11a–12a, 2017.