If you’re looking to manufacture a life science, medical, or diagnostic product, there are many advantages to utilizing a custom automation cell. However, even industry veterans don’t fully understand the benefits of this approach. Here’s what you need to know. 

What Is a Custom Automation Cell? 

Custom automation cells are designed to optimize the manufacturing processes using robots and other tools. Each part of the manufacturing function becomes partially or fully automated, as well as customized to the producer’s needs. It’s the opposite of a one-size-fits-all solution. 

What Are the Benefits?

There are myriad advantages of using custom automation cells, such as:

• Shifting More Focus to R&D: Automation speeds up the production process and reduces the need for manual labor, allowing the employees to focus on other aspects, such as quality control and researching and prototyping new devices.  
• Higher-Quality Products: Manufacturing involves repetitive and precise tasks, which can lead to occasional errors by employees. Automation reduces mistakes and ensures that each item meets the highest standards every time.   
• Safer for Employees: Shifting some of the manufacturing processes to robots allows employees to avoid dangerous tasks, such as working with chemicals or operating sharp tools.  

Are There Regulatory or Compliance Issues Related to Custom Automation?

When you’re manufacturing a medical device, complying with government-mandated regulations is crucial to getting the product on the market.

Following all the necessary protocols will ensure the device is safe for patients. Additionally, you’ll be able to pass annual quality audits from the U.S. Food and Drug Administration (FDA), protecting your reputation and preventing fines.

While there are many potential compliance issues to watch for, there are certain areas that manufacturers are more likely to struggle with. For example, the FDA has rules around Corrective and Preventive Actions (CAPA), which require medical device producers to document their procedures and Quality Management System (QMS). It’s important to follow the regulations around CAPA from the beginning of the product development process. 

If you’re looking to produce a medical device, contact Pacific Integrated Manufacturing. Serving San Diego County, CA, the company provides a variety of production and automation concepts to meet each customer’s required volumes and specifications. Additionally, products can be manufactured in both dry and white room controlled spaces. Their modular systems also allow for different automation methods to be integrated into the production process. Call (619) 921-3464 to speak to a member of their team, or head to the website to learn more about their services.