early stage of medical device manufacturing

Medical Device Assembly Automation: Crawl, Walk, Run (Manual, Semi, Fully)

North America remains the medical device industry’s largest market. On average, medical device manufacturers spend $700,000 on assembly technology a year (Assembly Magazine). Medical and pharmaceutical device manufacturers have to follow strict guidelines set by the FDA (Federal Drug Administration) to ensure devices are up to code. This, paired with the vast amount of medical devices there are, makes assembly logistics feel overwhelming and extremely complicated. Device size and quantity needed are also very diverse within the medical production field, requiring assemblers to be adaptable.  In this blog, we review the early stage of medical device manufacturing and how you can begin to crawl, walk and run with automation for medical devices. Wherever you are in the process, it’s important to understand what factors need to be considered in the early stage of medical device manufacturing.

Crawl (Manual Operation)

Ensuring that everyone can adhere to regulations, The FDA has established a three-class system to differentiate the rising class grades of increased need for safety control and different application processes.  In conjunction with these regulations, a medical device manufacturer can continue to grow its automation to safely meet the class requirements while also improving production efficiency.

In the early stages of medical device manufacturing, manufacturing is learning the ins and outs of the vastly complex world of medical device assembly. In this phase, you as the manufacturer have no automation set in place. Usually, you are producing niche items that take precise assembly and do not have large enough units needed to rationalize automation. When starting in this phase it’s important to understand the Class I general controls set by the FDA.  About 47 percent of medical devices are in Class I medical devices. Devices such as elastic bandages, examination gloves, electric toothbrushes, hospital beds, and handheld surgical instruments are all common Class I medical devices. If the need to grow becomes apparent, the OEM or contract manufacturer may want to consider semi-automated or automated production.

Walk (Semi-Automated)

Now that there is a set process for producing and assembling medical market products,  there is a potential to run past your capacity limit. Although you are aware that automation is the key to more efficient production, you don’t have the right product line yet for fully automated systems. This can occur when the assembly of a particular device would be too difficult for fully automated systems because it can not be economically fed or the volume of the part is not justifying full automation.  It’s also important to note that in this phase, you must adhere to the Class ll regulations set by the FDA. 

 Semi-automated automation is the perfect solution to this problem. By allowing parts of the process to be taken out of the operator’s hands and given to a system, you can run more efficiently. Examples of this could be part loading, testing or part unloading. Or it can also replace a great deal of labor, such as having manual checks at every station to allow for the automated conveyor to continue down the line. The key for semi-automated processes is to have the manual and automated processes make the most sense from an efficiency standpoint. Therefore, humans and machines can work together to reduce cycle time and improve efficiency, part quality and productivity. 

Run (Fully Automated)

Fully automated processes mean that the product is loaded into either a feed system or transferred from another system to one that will automatically load the part into the assembly process. Essentially, no humans are involved in the creation of the device, including testing, inspecting and unloading the product. In this scenario, you must also recognize that there is more involvement from a regulatory standpoint from Class lll of the FDA approval process. 

Fully automated systems are used for companies that are looking to increase the production of a product where automatic feeding and assembly are possible. It also is important to note that the volume requirements must also speak to the need for automation. Fully automated systems can have huge returns on investment when the process indeed validates it.

Need Help With Medical Assembly Automation?

Medical device assembly often brings up a vast array of questions and problems that seem difficult to navigate. At Automated Machine Systems, we have worked with many medical device manufacturers at every early stage of medical device manufacturing. Our 17-step process, engineering capabilities and expertise work together to create quality products time and time again. Choose AMS as a strategic partner in your growth in medical device manufacturing. 

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Automated Machine Systems, Inc. (AMS) increases the productivity of manufacturers by helping them design, build and implement their factory automation systems.