How Industry 4.0 Impacts Medical Device Manufacturers

Alex D'Souza, Medical Tech Outlook | Wednesday, January 19, 2022

Industry 4.0 will help medical device manufacturers improve medical devices' manufacturing processes like syringes and stents. 

FREMONT, CA: In terms of product mix, throughput specifications, quality standards, and regulatory guidelines, medical device manufacturers face specific challenges. If a business makes cancer screening equipment, disposable devices like syringes, or implantable devices like stents, the manufacturing method must be error-free while providing high throughput.

Companies are investing in factory automation to meet these targets and achieve other benefits. Manufacturers of medical devices are automating individual assembly procedures and the entire manufacturing process, which includes monitoring, inspection, packaging, storage, and recovery.

The mere mention of automation usually conjures up images of factory floors loaded with robots and machinery. The "behind the scenes" tasks of data collection and processing are still part of automation's future.

The solution to achieving these objectives isn't necessarily increasing automation. It has to do with Industry 4.0's central concept of integrating automation and IT (information technology). Specifying production equipment planned with the automation-IT connection in mind is the best way to incorporate and capitalize on Industry 4.0 capabilities.

Industry 4.0 Drives Openness and Ease of Use

Machine interfaces are the foundation of data processing, but the success of Industry 4.0 is found in how the data is utilized for parts tracking, error reduction, and process stability. The Internet of Things gateway controller is at the core of Industry 4.0 technologies, enabling engineers to collect, broadcast, or use data to increase efficiency, minimize processing times, and meet regulatory requirements.

Data protection is a significant concern in the medical device industry. The more data that is accessible and the more ways that data is made available, the greater the potential for misuse. It's unavoidable because if a system has an IoT gateway, the chance of leaks or hacks increases automatically.

The most significant hurdle to full implementation and integration of Industry 4.0 concepts is security, so consumers and machine builders must be aware of the risks and how they can be alleviated or minimized. For safe remote access, cloud-based apps with certificate authentication and external industrial VPNs are preferred.

Products that were once considered commodities, like linear guides, ballscrews, and sensors, will become critical enablers of innovative functions like real-time monitoring, predictive and preventive maintenance, and part tracking as Industry 4.0 progresses on the manufacturing floor.