Understanding Medical Devices Manufacturing: Key Insights

Various factors, such as heightened pricing pressures, stricter regulations, and operational inefficiencies, have transformed the Medical Devices industry landscape. By digitizing their operations, Medical Devices companies can create the momentum needed to achieve sustainable growth and profitability. Here is what you need to know about how digitization processes work.  

Importance Of Manufacturing To Medical Devices

Coming up with an innovative idea is just the beginning. Bringing that vision to life may be hard. That is where a good manufacturing partner is key. It starts with coming up with a reasonable timeframe and budget. Development can then begin. Manufacturers will help you source the ideal materials. They will come up with a way of mass-producing the product. Medical manufacturing technology needs to be advanced to provide a high-quality product. Once inspection and validation have been completed, large-scale production can begin. Even then, strict QMS MedTech standards need to be met.

This might sound like a lot of work. That is because it is. It can take months before a new medical product gets officially approved. That’s why a greater focus on technology like Manufacturing Execution Systems (MESs) and automation are key medical devices industry trends. Manufacturers who know how to leverage these tools can reduce the time it takes to start production.

Overcoming The Challenges Of Medical Equipment Manufacturing

Getting these products right is critical. If a manufacturer makes a mistake, they can cause real damage. That is why medical device regulatory compliance is strict. However, this can pose a few major hurdles for manufacturers. To avoid them, you need the right medical device manufacturing process. Here is how an  MES can help you out: 

• Bring products to market quicker. In the medical devices industry, speed is key. If you cannot get your products into the market faster, your competitors will take advantage. An MES lets you tap into the Internet of Things (IoT). With a large amount collected data, you can use machine learning to identify the root cause of your manufacturing problems. This helps you ramp up the production of new products or improve yields for existing items. 

• Assuring quality. Maintaining quality is one of the biggest regulatory challenges for medical device production. Currently, the cost of quality in the MedTech industry is rising. That is why our MES uses best-practice closed-loop NCR and CAPA processes. These allow you to identify problems and stop them from occurring again. The Statistical Process Control (SPC) automatically reacts to errors. This lets you respond quickly when issues occur. Manufacturers that use formulation processes can also spot errors quickly. Thanks to Weigh and Dispense and fully configurable sampling plans, you’ll know when something has gone wrong. An MES can also guide manufacturing operators, to help eliminate the chance of human error. 

• Ease of traceability and reporting. Manufacturing of medical equipment requires strict regulatory oversight. An MES makes this simple. Material traceability is available at the individual batch, lot, or unit level. This meets the stringent EU rules and complies with Unique Device Identifier (UDI) tracking. As a result, reporting and regulation is simplified. If something goes wrong, it will be easy to identify which items were affected. This makes recalls simple, reducing both time and costs.

• Improving efficiency and increasing profitability. An MES has some functionalities that can boost agility across the supply chain. You can create a digital twin, to get a real-time look at your shop floor. With material logistics, you can track the entire materials lifecycle, helping you plan the perfect time to make an order. IoT lets you connect seamlessly with any type of technology. You can use factory automation to create a complete automatic workflow that ensures you have the right materials, in the right place at the right time. Operators can be introduced to new processes with augmented reality. High-quality hands-on training experience, teaching best practices without any risk of damage to the equipment.

Accessing Next-Generation MES For The Medical Devices Industry

An MES offers advanced functionalities to enhance medical device manufacturing process. Implementing an MES can enable real-time visibility and comprehensive control across your global network of your medical devices manufacturing facilities.

Take Automated Validation To The Next Level

The FDA has strict quality control in medical device manufacturing. Validation is key. During the production of medical devices, validation and quality control must be ensured. This is one of the biggest roadblocks that manufacturers face when creating a new product. Having an MES, you can have end-to-end traceability. Even better, it can be done simultaneously with the implementation. This will help manufacturers get rid of the traditional validation process, by reducing the time it takes to validate from months to days. If you want more information, watch this video on automated validation.

Using Predictive Analysis To Your Advantage

 Understanding how to manufacture medical devices is just the beginning. Through predictive analysis, you can be on the lookout for continuous improvements. This innovative MES also allows you to gather data at every aspect of production. Using this resource, you can create informative feedback loops. This knowledge helps you spot potential problems and find ways to speed up production. Ongoing manufacturing monitoring also ensures that you will always have quality products.

How MES Benefits MedTech Manufacturing

Nowadays, getting access to medical manufacturing technology is relatively easy. Despite this, many manufacturers insist on taking a traditional approach. Some even rely on paper spreadsheets to track their performance. This simply is not acceptable anymore. Outdated systems can cause errors and they can also slow down the process of manufacturing medical equipment.

The solution is simple. Having an MES, which can be easily configured to suit any manufacturing business, can transform your manufacturing business:

• Error-proof management. Getting medical device regulatory compliance is one of the biggest challenges manufacturers face. An MES makes it easier. Compliance and documentation are built into the system. They meet and exceed the standards required for medical product manufacturers.

• Generate transformative insights. You can reduce costs in the medical device value chain by connecting equipment to the IoT. From there, you can get a clear idea of how your factory is operating. But that is not all. With an MES, you can leverage the power of AI. This lets you find areas of your factory that are underperforming. By continually optimizing your manufacturing approach, you can cut costs and boost productivity. This article has more information about how why MedTech companies are looking for cloud-based solutions.

• Avoiding risks. Mastering QMS MedTech is essential. It is imperative to prevent any oversight that could lead to a factory shutdown or costly product recalls, both of which could significantly damage the factory’s reputation. Despite the associated risks, some individuals still opt for manual risk management. An advanced MES provides data-driven insights to swiftly detect and address any anomalies. This empowers your employees to rectify issues and uphold operational integrity.

• Gaining a competitive advantage. Bringing a new medical device to the market is expensive. There are many ways that manufacturers have attempted to tackle this matter. This includes using a MedTech CDMO. By having an MES, you can have the tools needed to adapt quickly to the market and make it easier to pass through the validation process. Aside from that, you will also see a cost reduction in medical device prototyping.

• Connect your factory. Using medical manufacturing cloud services to create the IoT is a game-changer. The functionality you can unlock is unparalleled. At the basic end, you can gather data, letting you know how machines are performing or giving you ideas on how to optimize workflow. Besides, engineers can use the IoT to control machines. Due to the intuitive MES interface, engineers don’t even have to code. Just drag and drop the elements into the right place. This will give you complete control over your factory floor.  

• Get complete control over the assembly process. An MES is fully configurable. This lets you customize the assembly process to suit you, which may be helpful because you can keep track of defects, allowing you identify recurring problems.

• And many more. This is just scratching the surface. With an MES, you can take your medical device operations to another level.

Get Started Today

At Critical Manufacturing, we are proud to have helped digitize some of the largest manufacturers on the planet. This includes working with companies like: Ultradent, Jabil, Elektra, Braun, and Integer. With our revolutionary MES, we are confident that we can deliver amazing results for any medical device manufacturer.