Are Medical Plastics ‘China-Proof’? For How Long?

27. December 2013

Custom injection molders often tell me that one of the advantages of the medical market is that it is relatively “China-proof”—that is, that it is so highly regulated that medical OEMs feel more confident that they can audit FDA compliance of suppliers closer to home. To the extent that this may be true, one has to wonder how long it may remain a “safe harbor” for custom plastics processors.

I heard the very same argument amount medical plastics and China recently from Dale Evans, president of EVCO Plastics, a custom molder based in DeForest, Wis., that is profiled in our January 2014 “On-Site” feature. He noted that regulatory issues were a factor making medical molding a particular strength for EVCO’s domestic molding operations (the company also has plants in Mexico and China). But EVCO is hedging its bets. During the same conversation, Evans revealed that EVCO is just now qualifying a medical clean room for its Shenzhen, China, plant to Class 100,000, the same as at EVCO MED in DeForest, Wis. EVCO also is planning to move one medical molding and assembly cell from DeForest to Shenzhen and plans to seek ISO 13485 medical quality certification for Shenzhen, as is already the case for EVCO MED.

One example does not a trend make—but it does make me wonder about how secure medical plastics will remain from overseas competition.

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