The integration of machinery and software in medical device manufacturing revolutionised production processes, driving efficiency, precision and scalability. From robotic assembly systems to advanced inspection tools, automation technologies have transformed the way medical devices are manufactured, enabling manufacturers to achieve unparalleled levels of quality control and regulatory compliance.

David E. Williams, president at Health Business Group, a consulting firm that helps medical device companies develop and execute innovative business strategies, describes how the landscape of medical device manufacturing had changed in recent years: “Medical device manufacturing has shifted from manual processes and craftsmanship to a highly automated and digitised production environment.”

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.

“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.

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, thereby reducing human error and increasing product reliability. It also increases traceability and accountability, which is helpful for regulatory compliance and effective management of recalls. Automation also reduces contamination risks in sterile or implantable devices by minimising human contact.”

The future of manufacturing

As the industry continues to embrace automation, the future of medical device manufacturing holds immense promise for innovation and advancement. Emerging technologies such as artificial intelligence, machine learning, and additive manufacturing are poised to further revolutionise production processes, enabling manufacturers to push the boundaries of what is possible in terms of product design, customisation and performance.

We’re already beginning to see an increase in specific technologies and machinery that is improving the efficiency and precision of medical device manufacturing. Samproni describes a specific process that she has seen a rise in: “Driven by the high stakes of a patient’s well-being and the need for precise planning and forecasting, simulation plays a crucial role within medical device manufacturing to optimise processes.

“One such technique, discrete event simulation (DES), models the operation of a real-world system as a sequence of discrete events. The technology allows medical device manufacturers to safely and accurately model, simulate and analyse the necessary relevant assembly, testing and shipping processes. With DES in place, medical device manufacturers can design an efficient flow of people and materials and increase output.”

According to the Gitnux ‘Marketdata Report’, by 2025, half of manufacturing tasks will be automated. The report found too that automation related to Industry 4.0 is expected to have generated $267bn worldwide by 2025. These figures clearly indicate it is essential for the manufacturing industry not to underestimate the potential of automation.

So, what can we expect for the future of medical device manufacturing in terms of technology and automation, at a time when advances are being made faster than ever?

“Original equipment manufacturers (OEMs) are increasingly looking for opportunities for network optimisation, to improve manufacturing and supply chain management. By working with a manufacturing partner, OEMs can optimise revenues and reduce risk,” says Samproni.

As well as this we can expect to see a rise in the use of AI-powered algorithms to enhance quality control and ensure regulatory compliance by detecting defects and deviation in real time. Not only will this ensure that only the highest-quality products reach the market, but also allow us to identify patterns and trends to predict and prevent equipment failure or malfunctions, which will inevitably improve manufacturing workflows.

Overall, it’s clear the evolution of medical device manufacturing towards greater automation and software integration represents a transformative shift that offers unprecedented opportunities for efficiency, quality and innovation. By embracing advanced technologies and overcoming challenges, manufacturers can position themselves at the forefront of the industry, driving positive outcomes for patients and stakeholders alike.