The Importance of Maintenance Performance in the Medical Devices Manufacturing Industry

The medical device manufacturing industry in the US is quite large. Manufacturers in this industry are in charge of medical devices and products that are needed to diagnose, monitor, and treat conditions; it’s a crucial industry, and for these manufacturers, performance is critical.

In 2020, the market size of the industry is $47.1 billion, which has grown on an average of 2.7% per year from 2015 to 2020. The demand for medical devices like ventilators and respirators has increased this year in response to the COVID-19 pandemic. But even before the pandemic, hospitals and medical facilities have demanded that medical device manufacturers become more efficient, cost-effective, secure, and innovative.

Good Manufacturing Practices are Essential

The medical device manufacturing industry faces many challenges: the integration of the Internet of Things and medical devices has introduced concerns about cybersecurity, and medical device manufacturers must meet rigorous regulations from the government. Most importantly, though, medical device manufacturers must ensure they are using Good Manufacturing Practices (GMP).

GMP must be followed at all times by medical device manufacturers, as lives depend on the devices that are produced. Much like in a pharmaceutical plant, the stakes are higher for this industry. Adherence to these practices ensures a level of safety and quality that is critical to medical devices. 

How Important is Maintenance Performance?

One aspect of medical device manufacturing that is critical is maintenance performance. Given the aggressive time-to-market that is required for medical devices, it is essential to identify the cause of potential equipment failures before they occur. 

While maintenance performance is important in any type of manufacturing, it is especially important in the manufacturing of medical devices. When the COVID-19 pandemic began to really spread across the US earlier this year, we all saw how quickly the demand for ventilators and respirators increased. In a study conducted in the earlier months of the pandemic, it was found that in all COVID-19 cases that required care in the intensive care unit, 50% required some form of mechanical ventilation.

Improper maintenance can lead to unexpected downtime in a manufacturing plant. The average manufacturer faces 800 hours of downtime every year. When the demand is so high for medical devices, manufacturers cannot afford downtime like this. 

One reason they can’t afford downtime is the urgency with which medical devices need to be manufactured, but it can also be expensive. For example, on average, an automotive manufacturer’s downtime can cost $22,000 per minute. So manufacturers may literally not be able to afford the downtime. 

How to Improve Maintenance Performance

So what is needed to prevent costly downtime and improve maintenance performance? Here are some suggestions:

• Track maintenance metrics – It’s impossible to improve anything if you don’t know where you are starting. Some good metrics to keep track of are Planned Maintenance Percentage (PPC), Overall Equipment Effectiveness (OEE), Preventive Maintenance Compliance (PMC), Mean Time Between Failure (MTBF), and Mean Time to Repair (MTTR). These metrics will help you to turn data into actionable information. You will get a better idea of how you need to improve your maintenance performance when you have a better understanding of what your performance is now.
   
• Use Predictive Maintenance – With a Predictive Maintenance technique, the condition of the equipment is evaluated in order to predict when maintenance should be performed. This type of strategy requires a comprehensive understanding of how and why asset failure occurs so the warning signs of potential problems can be identified. Predictive Maintenance allows for preemptive corrective actions, safety compliance, and increased asset life.
• Spend more time in training – Of all the unscheduled downtime manufacturers experience, operator error causes 18% of it. One study from the American Society for Training and Development (ASTD) showed that staff members who receive formal training can be up to 230 percent more productive than untrained colleagues working in the same role.