Case Study: A Case for Automation in Medical Device Assembly

Automation Fast-Tracks Assembly for Medical Device Manufacturer 

Challenge

A Cincinnati-based medical device manufacturer of minimally invasive wearable injectors was in a bind: The company’s senior manufacturing engineer needed a process for joining three small metal tube spikes to the plastic device. The joining technique had to be repeatable and efficient, and it required verification at every step in the manufacturing process.

Solution

The team at AMS reviewed the manufacturer’s challenge and method of assembly. At that point, the manufacturer was performing this process by hand. Various tedious activities were required to complete the proper assembly. In addition, because the device had to meet strict FDA regulations, the manufacturing process called for certain validation measures. 

AMS brainstormed a variety of solutions to address the customer’s problem. Ultimately, AMS designed and built three machines to automate the process by dispensing a precise amount of glue into a well, then drying that adhesive with UV light curing. 

These operator-assisted machines replace the need for time-consuming manual assembly tasks. The machines perform the glue assembly of the spikes automatically while decreasing the time it takes for the adhesive to dry and the assembly to be complete. 

Additionally, the machines are capable of automatically detecting the part presence in the machine before pneumatically moving the glue dispensers into place. From there, the machines apply the proper amount of adhesive, and a camera vision system verifies that the glue has fully wicked around the base of the spike. After the glue application process is complete and verified, a fixture slides the part into a UV curing system where an additional vision sensor inspects for presence of the adhesive. Once this process is successfully completed, the machine returns the part to the operator. During the process, the machines collect part data and send results to the customer’s ERP system for further validation. 

Medical Device Assembly Results

The new automated process has fast-tracked manufacturing for the company. The end result was an integrated system that dramatically reduces cycle times, increases efficiency and repeatability, and ensures all validation requirements are met during the manufacturing and assembly process.