Manufacturing technology
“The concerns are being addressed through the adoption of industry standards, system integration, and the development of robust cybersecurity measure, without compromising safety, security and ethical standards,” says Williams.
Emerging tech such as AI and machine learning are poised to further revolutionise production processes.
With technology advancing at a rapid rate and being slowly integrated into all manufacturing fields, it’s no surprise that the medical device industry is eager to evolve in this aspect. “The evolution started with computer-aided design (CAD), then added computer-aided manufacturing (CAM), robotics, and digital factories under Industry 4.0. This integration has enabled predictive maintenance and flexible production, along with 3D printing for personalised medicine,” says Williams.
Automated assembly lines, once a novelty, have become commonplace in medical device manufacturing facilities around the world. These sophisticated systems are designed to perform a wide range of tasks, from precision machining and assembly to packaging and sterilisation, with minimal human intervention. Williams continues: “Automation displaces some workers, but provides opportunities for a new, higher-skilled roles. Automation has transformed human labour from manual, repetitive tasks to analytical and strategic roles. Workers oversee automated processes and solve problems. This requires workers with skills in robotics, software programming, and data analysis.”
Advantages and disadvantages While the benefits of automation are vast, in a world with increasing job insecurity and high rates of redundancy, it’s difficult not to fear the rise of automation.
“Challenges include technical complexity, cybersecurity, rising regulatory standards, and ethical concerns such as data privacy and algorithmic bias,” explains Williams. However, recent years have seen increased effort to address these issues, by introducing various processes to safeguard companies.
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As such, the manufacturing industry is entering the era of Industry 4.0. Jennifer Samproni, chief technology officer at the Health Solutions division of product manufacturer Flex, explains how the adoption of Industry 4.0 principles has affected the development and production of medical devices in particular: “Industry 4.0 technologies such as AI-powered digital twins allow customers to visualise simulated workflows using virtual reality technology. “Modelling and optimising production in a virtual world helps manufacturers to produce medical devices at scale with efficiency, agility and speed, while also reducing risk and cost. These types of technologies have driven forward the advancement of medical devices and enabled manufacturers to keep up with increased demand,” says Samproni. However, the adoption of these technologies requires overcoming various challenges and obstacles. Manufacturers need to continue to invest in talent development, regulatory compliance, and cybersecurity to ensure the seamless integration and operation of automated systems. Since the development of Industry 4.0, policymakers have put in place specific regulatory considerations that manufacturers need to adhere to when implementing automated processes in medical device production. Samproni explains further: “In the United States, the Class II medical device designation refers to those devices with a moderate to high risk to the patient and or user. More than 40% of medical devices fall under this category and require the utmost reliability, as any mistakes or issues in the design or manufacturing process could put patients at risk.” But developing these regulations isn’t as simple as it may sound. “Establishing compliant manufacturing processes for medical devices can take years due to the stringent performance, reliability, and safety specifications involved,” says Samproni. “Any modification to those processes requires revalidation, documentation and resubmission to regulatory committees – a time-consuming and costly process that can cause delays. Balancing all of these consideration and priorities, it can be challenging for medical device manufacturers to streamline processes for greater agility and resilience while still meeting all regulatory requirements.” But, of course, automation has just as many advantages as it does disadvantages, as Williams explains: “Automation enables precision manufacturing and stringent quality control,
Medical Device Developments /
www.nsmedicaldevices.com
asharkyu/
Shutterstock.com
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