Originally Published MDDI June 2002

AUTOMATION

Many factors may prompt a device manufacturer to automate assembly or packaging processes—whether those operations are performed in-house or outsourced. Although increased production rates and decreased per-unit cost are common reasons for considering automation, there may be additional benefits in the areas of consistency, material waste reduction, and quality.

In a recent interview, Tom Opaloski, vice president of engineering at United Plastics Group (UPG; Westmont, IL) and Chuck Hoar, UPG's vice president of strategic business, medical, offered their perspectives on current trends in the application of automation technology.

How early in the design and development process should use of automated assembly or packaging be considered?

Opaloski: The earlier you get the design people together, the automation people together, the tooling people together, and the manufacturing people together in that process, the easier and the better the end results will be.

What are some of the key elements to consider during the device design process?

Opaloski: One of the most critical aspects when you're talking about automation is the handling of the parts or the product, and getting it from one operation to the next operation. You could be talking about one simple operation where something gets inserted or something gets done to a part, and then that's a finished product. Or you could have several stages, and then the final stage is where the product finally gets packaged in its airtight foil envelope and put into a box.

But one of the most critical factors is how you are going to move the product from one stage to the next stage to the next stage. In certain circumstances, with certain things, that's what prevents you from going to automation. Some things just can't be automated because you can't handle the product properly. But with the type of robotics that are available today, and the feeder bowl systems, and things like that, those situations are probably very few and far between.

Hoar: Where I think this makes a lot of sense for OEMs is as they consolidate some of these automated opportunities, it gives them more control over their final product quality. So [as automation suppliers] we're able, through consolidation, to give them a better cost baseline to work off of. On top of that, we'd be able to give them one viewpoint for their total product quality.

Is there such a thing as a stock automation system? Or are they always custom?

Opaloski: In the custom injection molding and tool design and building business, every job is custom. And if you determine that the manufacture of a particular device is going to be automated, that requires a very customized setup that is specifically related to the manufacture of that device.

The components, like the vision systems you use, can be stock items, but the automation system as a whole is quite customized for that particular product. Every application is custom.

One thing that is adaptable is the robotics on the molding machine. Those are fairly standardized among the different products. But once you get to the downstream automation, what the robot does with the product after it gets it out of the molding machine, that's where the very customized automation cells come into play.

Are there regulatory or compliance issues that are specific to the use of automated processes?

Opaloski: Getting a medical device through the approval process from beginning to end is a long process in itself. It starts with the design and continues on through the manufacturing.

Validating each one of those stages is part of the approval process. When you're dealing with automation, and that automation system is built for a particular product, and you're going through the validation of each one of those stages—whether its the design, the tooling, then into the manufacturing and the capability studies—you are basically validating that automation system with that specific application and that particular product.

So when it's all said and done, and you have approval, everything is validated and certified that it's ready to go.

Copyright ©2002 Medical Device & Diagnostic Industry