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In Medical Device Manufacturing, Small is Increasingly Beautiful

January 30, 2017

There’s big profit in small plastic medical parts, which is prompting leading medical molders to make big changes of their own.  How small are these parts?  Try tenths-of-a-millimeter small.  This is a quantum leap forward — or downward, if you will — for these plastic injection molders. And the medical devices that they are manufacturing are not only getting tinier, they’re getting sleeker and lighter as these device makers try to meet the needs of ever shrinking implantable products in new applications, such as drug delivery.

All of this wouldn’t have been possible without modern molding equipment which utilizes computer-operated equipment that is light-years ahead of the manual equipment used 25-30 years ago.  Today’s molding equipment provides more control and greater efficiency, which helps molders deliver higher consistency — a critical consideration when dealing with tiny medical devices that are oftentimes the difference between life and death for the patients who receive them.

But even with modern machinery, the tiny size of the molded parts increasingly required in medical devices and implantable products can present daunting manufacturing challenges. Depending on the device being manufactured, the molder may need to adjust or modify the equipment.  For example, spindles that power cutting tools have to rotate at higher RPMs.

However, it’s not just the manufacturing process itself that molders need to consider;  they also have to think about the environment the molded component will be exposed to when the medical device is in use. For example, if the plastic device is in direct contact with the body or bodily fluids will affect the choice of material used in its construction.  Furthermore, if the device is implantable, molders need to know if it will be a short-term or a long-term implant. Other factors include the temperature to which it will be exposed, chemical resistance, and any bending or stretching that use of the device would place on the molded component.

There is also the question of what other kinds of materials are in the final, fully-assembled device. Will a the plastic part have to bond with some other kind of metal or plastic?  The molder will also need to know how much “squeeze” is needed, a reference to the resilience needed for a good seal to occur.

Whenever possible, plastic injection molding companies prefer that medical device makers work with them early in the design cycle of a medical device.  However, many times OEMs hold their cards close to their vests for competitive reasons, complicating the challenge of making plastic parts which will suit their needs.

 

One thing is certain: molders will need to think “small” if they want to make it big in the medical device manufacturing realm.

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