Globally, automation has long been an important part of the medical device manufacturing industry. With industry 4.0 assisting in the development of new innovative technologies within this sector, including machine learning and artificial intelligence, the possibilities for automation are ever increasing.

According to a recently published report by Future Market Insights, the global market for portable medical devices is expected to grow at a CAGR of 10.7% during 2022-2032. Medical device manufacturing and production processes require a high degree of control. In order to ensure quality control, serialization plays a major role in maintaining complete control over the process from start to finish.

In the medical device industry, automation provides many benefits, including cleanliness, speed, and most importantly, control over production processes. The production process can be hampered in various ways, and as a result, the production cost will soar high. But with the increasing adoption of automation in this industry, manufacturers are striving to make their products more efficient. To maintain processes and ensure they comply with stringent procedures, the medical device industry relies on highly skilled staff as well as automation. As a result, machines that replace these operations also require this level of control.

In this article, I will discuss how the use of robots can be beneficial to reduce the production costs for medical device manufacturers, how case packaging is helping in increasing production, thus reducing costs, and lastly, how the use of AI can enhance the production process and help in reducing various errors.

Easing the Production Process with Robotics-Driven Automation

Robots are used in some niche applications of medical device manufacturing, however, in contrast to other industries, medical automation is much less prevalent. There is often a great deal of product specificity in automation systems. Dedicated production solutions can be expensive investments and may require significant expenditures when modifications are needed to accommodate changes in product design. When novel products are introduced, a completely new system is usually designed. As a result of commercial pressures, device manufacturers are turning to robotic-based automation systems to meet quality, consistency, and flexibility requirements.

Since robots can process diverse products through the same system and can be reconfigured for new products, production costs can be reduced and delivery flexibility improved. Because medical device manufacturers are facing increasing cost pressures and shorter product life cycles, such integrated automation is becoming increasingly compelling.

An example of this is NuTec Tooling Systems Inc.’s production of syringe coating machines for pharmaceutical companies. To provide an alternative to the more expensive glass syringes typically manufactured by its competitors, the client intended to mass-produce the plastic syringes along with a glass coating. To automate the production of syringes precisely and cost-effectively, NuTec installed four robots from Epson Cleanroom SCARA that were developed by Epson Robots. Every one of the four robots strategically placed within the machine was used to automatically manufacture syringes in a precise and cost-effective manner.

By using an automated process, 38 parts per minute are coated, the parts are put through a series of inspection stations, then the hypodermics are siliconized before the temporary caps are changed into final caps and the syringes are subjected to a final X-ray inspection. As the syringes are coated with their glass-like coating, robots handle them both before and after; in the final stages, they apply inner and outer covers and apply labels using laser markers.

As of November 2020, NuTec’s pharmaceutical customers were able to manufacture huge quantities of these glass coated syringes to be used in combating COVID-19 with the help of NuTec. Additionally, the farm was able to increase its production quantity and reduce its costs at the same time.

Optimizing the Production Procedure with Case Packaging

Another area where manufacturers can reduce production costs is the packaging. Medical device manufacturers need end-of-line secondary packaging systems that are reliable, cost-effective, and comply with FDA guidelines and stringent requirements—and case packaging is one such option to rely on.

Case packing machines and systems provide folding, packing, gluing, and taping of cardboard boxes for end-of-line packaging of medical devices. Robotic case packers or hard-automated case packers are typically selected based on the case style. Pick-and-place robots are most suitable for top-load applications, especially if they can load the entire case at once. For example, robotics is well suited to the handling of 12-packs of parenteral.

Brenton’s M2000 case packer would present a viable option for many medical device applications for hard-automation case packing. In addition to being able to produce 35 cases per minute, it is sufficient for higher production applications. In addition, it is the fastest small-footprint case packer available. As the compression time reaches a critical threshold, the process of gluing and sealing flaps starts imposing a top-speed limit. The average upstream process for medical device assembly, for example, is faster than 35 cases per minute. One of the most efficient machines in its class, the M2000, has a high output per unit footprint. Thus, the higher the output, the lower the production costs with ample profit in hand for manufacturers.

Another significant factor is flexibility. There is a significant increase in flexibility with robot-based solutions. The individual components of a robotic system can be placed in various locations to accommodate the available space. This is despite the fact that a robotic system might have more components and require more space.

Brenton’s RC1000 robotic case packing system, also available from Brenton, is a versatile system that can pack RSCs (Regular Slotted Cases), wraparounds, or trays. Designed to handle harsh, cold, and wet applications, this system runs 90,000 mean hours between failures and can be redeployed to accommodate a variety of sizes and package types. Therefore, such advances in the world of medical devices will not only reduce human labor but also decrease production costs and increase manufacturing flexibility.

Eradicating Errors with AI

Even carefully tested and designed medical devices can sometimes cause unintended consequences to patients. These factors can negatively affect the company’s manufacturing costs and result in losses. In contrast, AI makes it possible to predict these issues ahead of time and take appropriate steps to resolve them.

The use of artificial intelligence was recently used to retrieve gender-based data about failures. There was a problem with the database of FDA Manufacturer and User Facility Device Experience (MAUDE) when the researchers initially used it. Those public datasets contain 8 million reports about medical device malfunctions or incidents that put people at the smallest risk. MAUDE was not gender-diverse, but researchers thought it to be significant to note the differences between men’s and women’s reactions to medical devices.

As a result of a detailed review of the data available, it became evident that descriptions in the reports often had mentions of pronouns. In response to that realization, the researchers developed an AI algorithm to accurately identify the gender in over 340,000 reports of injuries and deaths related to medical devices. In addition, it revealed that 67% of the total numbers of patients were females, while 33% were males.

Researchers are now urging the FDA to take up serious steps to keep patients safe from the dangers of medical devices. As part of this process, the entire dataset of recorded incidents will be made public. In this way, providers, patients, and device manufacturers will be able to understand what and why it happened. In the case of medical device manufacturers, it could help them prevent future problems by shaping their decision-making based on the information. In this way, they will ensure ample profits by lowering their production costs and improving their production processes.

Hospitals could also save money by using AI applications. U.S. hospitals incur about 33% of their operational costs from supply chain costs. It may be found that some elements break down within the body more quickly than others when analyzing what causes medical devices to fail. It may be possible to reduce the number of surgeries along with medical implanted device replacements that a lot of patients are required to undergo in order to prevent various complications by addressing the particular problem.

Conclusion

Automation in the healthcare industry has long been a blessing in several ways. By utilizing robotic-driven procedures, the total production can be improved, thus cutting costs. Additionally, automation in packaging can improve the quality of packages as well as reduce packaging costs. Human errors can increase the cost of labor. But with the right automated procedures, even such extra costs can be reduced too.

The benefits of automation extend beyond the reduction of production costs per device. Making better products is more important than lowering prices. A device OEM can improve consistency, reduce waste, and respond more flexibly to market demands by designing with automation in mind and identifying supply chain partners with automation expertise.

Article source: MPO