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Predictive Maintenance as a Quality Strategy in Medical Device Manufacturing

To get that quality, manufacturers must confirm their equipment can function at peak performance throughout production.

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By: Micah Statler

Director of Industrial Technologies at Advanced Technology Services

Photo: Justlight/stock.adobe.com

For medical device manufacturers, quality is more than a marketing campaign or a vision statement. Efficacy and integrity are vital requirements of production, often depending on the equipment producing each component. To get that quality, manufacturers must confirm their equipment can function at peak performance throughout production. By implementing predictive maintenance technology into their processes, manufacturers can gain a variety of benefits.

Benefits of Integrating Predictive Maintenance in Manufacturing

Manufacturing often runs on tight margins for costs and production. Given the high risk and precision needed for medical device manufacturing, excessive downtime to maintain or repair equipment can literally make or break a business. The use of predictive maintenance can provide these benefits.

Less Downtime

Delaying production until a piece of equipment becomes available can create complications that increase costs and even jeopardize customer relationships. The intricate nature of medical device manufacturing often means that businesses only have one piece of equipment that can perform a particular task. Predictive maintenance can reduce downtime, which increases production and gets necessary devices to users faster.

Fewer Repairs

Shutting down production to attend to faulty equipment is a source of wasted time and money, but it is also a hassle that medical device manufacturers should seek to avoid. Manufacturers relying on lean teams may not be able to dedicate the work hours needed to complete repairs. Incorporating predictive maintenance ensures that the equipment is consistently ready for use, which decreases the likelihood of unexpected system failures and expensive repairs.

Longer Lifespan for Equipment

With equipment that can cost hundreds of thousands of dollars or more, ensuring a longer lifespan is a chief advantage of predictive maintenance. Minor flaws in a system can grow over time, especially if they are not found and addressed promptly. Creating a system that prioritizes predictive maintenance and industrial maintenance training helps to confirm the ideal function of the equipment, providing the right environment for maximum lifespan.

Increased Quality

For manufacturers of medical devices, the quality of the product is paramount. In some cases, lives may depend on it. Production of each component requires a high degree of care and oversight, but even minor flaws can be missed by human testing teams. Implementing a robust plan for maintenance based on predictive analytics can reduce production flaws, leading to a higher-quality product that continues to meet user specifications.

Lower Costs

Manufacturers have to navigate hard-to-predict pricing related to supply chain, labor and other factors, highlighting the importance of lowering other costs. Investing funds into proper maintenance often costs much less than paying for increased production times and repairs due to unanticipated maintenance needs or system failures. Organizations looking to reduce their operating margins can increase their financial efficiency by staying ahead of equipment needs.

Higher Production Efficiency

Manufacturing teams often look for ways to increase efficiency as a way to keep operating costs down and remain competitive in a global market. Keeping equipment in good working order and using data to fine-tune it decreases unexpected downtime. Manufacturers can streamline their production processes to maximize the use of limited equipment without extending production timelines or increasing operating costs.

Stronger Compliance

Medical devices carry strict regulatory requirements to ensure that each device meets performance objectives and minimizes risks to the user. Even a slight fault in a handful of devices can trigger a recall of hundreds or thousands, which can harm a manufacturer’s reputation and bottom line. By ensuring that the equipment maintains ideal operation, manufacturing teams can increase device integrity and regulatory compliance.

Technology for the Modern Medical Device Manufacturer

In order to achieve these benefits, manufacturers of medical devices usually have to integrate the latest technology into the design and production processes. These tools in particular have the potential to increase efficiency, reduce waste, and minimize problems for manufacturers.

Data Analytics

Manufacturing teams do not have to rely on their own experience with the company’s equipment to gain practical information about usage and maintenance needs when data analytics can provide so much more. Data analytics relies on the use of large amounts of data from similar operating conditions. Professionals can use AI to process the data and turn it into useful insights about operating patterns, maintenance needs, and early signs of equipment failure. These insights can provide the basis for strategic changes to improve output without increasing risk.

Internet of Things

Traditionally, understanding how manufacturing equipment functions relied on human observation and testing. Today, the Internet of Things is rapidly streamlining this process by integrating smart technology into existing equipment, providing sensors, Wi-Fi capability and other features. These sensors deliver real-time data on the operability of each tool, device or system. When paired with an AI system, this setup enables continuous monitoring and immediate alerts when performance starts to slip.

AI

Integrating AI into smart medical device manufacturing enhances a data-driven approach by serving as an additional layer of oversight—working alongside human expertise rather than replacing it. Artificial intelligence can provide real-time monitoring to alert administrators to problems and ensure security during testing and maintenance. By analyzing historical data, AI can also assist in developing maintenance schedules that reduce downtime, minimize repairs, and help prevent manufacturing defects.

Conclusion

Finding the right production strategy for medical devices may require the integration of predictive maintenance. By incorporating smart technology in production, manufacturers can make data-driven decisions about their maintenance requirements. Adoption of these tools can improve efficiency and the quality of each device.


Sources (for further reading)


Micah Statler is director of Industrial Technologies at Advanced Technology Services and is responsible for the strategy, execution, and delivery of technology-driven maintenance solutions. Statler is a graduate of Bradley University, where he received his Bachelor of Science in Management and Leadership.

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