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Cheaper Doesn't Mean Better

Tooling is a strength of NPI/Medical, a medical device molding company based in Ansonia, Connecticut. “You need quality tooling to get quality parts,” says general manager Dave Kelly, pictured here.
Photo courtesy of NPI/Medical.

Rebecca Carnes
Design-2-Part Magazine

NPI/Medical knows that communication, quality, and protecting intellectual property is what its medical device customers want most — and they can’t get that overseas.

A past medical customer decided to go with a China source due to price and, as a result, their product never got off the ground. None of the parts for the product fit together because the dimensions were off and there were a lot of problems running the tools, resulting in short shots.

The medical company eventually called NPI/Medical back up and said they wanted the molds sent to their shop to do a complete review. NPI/Medical, which does in-house tooling, got the molds up and running to get them some initial product.

The medical device company had thought they were getting a class 101 mold from Asia, but that’s not what they got.

“They got soft-steeled tools instead,” said David Kelly, general manager at NPI/Medical. “They really had no contact or relationship with the overseas supplier and they’ll never do that again,” Kelly added, explaining that the customer is now a regular and loyal customer of NPI/Medical.

‘Relationships are Important’

For domestic medical device companies, new products and new developments are best designed and made in the United States, Kelly said, explaining that NPI/Medical’s tool makers are mold makers and the work is done in-house with communication driving the quality of the product.

The quality of NPI’s work is driven by the medical protocols and validations that are required.

“You need quality tooling to get quality parts,” Kelly said. NPI/Medical adheres to class 101 through 105 standards with two grade 7, class 10,000 clean rooms. Using a DynaClass® process, NPI/Medical offers single cavity molds designed and built in-house with medical validation. The company’s P2P process entails producing the single cavity molds to get product to the market faster.

“A lot of our customer base starts off with low volumes for several years until their product gets to market, and then they will invest in multi-cavity tools,” Kelly said.

NPI/Medical, a medical device molding company based in Ansonia, Conn., can handle the easiest part configurations to the most complex moldable geometries. The company works with customers to build a prototype mold of a “bridge tool” to use to get the product into market as fast as possible. If the product takes off down the road and higher volume is needed, then NPI/goes to a production class 101, multi-cavity tool which gives longer life and reduces part cost.

“We already have the electrodes built and the design proven out, so it’s a competitive advantage. If a customer comes to us and validates a particular mold and process that stays with us, then we can grow as needed with the part,” Kelly said.

‘No Fear of Pirated Ideas or Designs’

Intellectual property is a major consideration for medical device companies, who often seek NDAs to protect their ideas. But overseas suppliers often times steal designs, Kelly said.

“You have no idea where the design is going,” Kelly said. “And you have no way of managing something that is going on in a province of China when you’re sitting in Connecticut.”

Having a nearby valued partner with open communication and trust is something medical device companies should consider when choosing between domestic and overseas suppliers. The initial cost might be lower to go overseas, but down the road, the medical device company will likely face heavy costs due to poor quality, delayed time to market, and stolen ideas.

Customers who have gone overseas and since returned to NPI/Medical have told Kelly they “have issues with intellectual property and complained that the (overseas) sources they used did not comply with the rules of non-disclosure.”

Those medical device companies who choose an overseas supplier often find that when their product hits the market, copy-cat products were already out, and they wound up competing against their own design.

And fighting those that cheat can be costly.

“To make matters worse,” Kelly said. “travel expenses incurred to dispute the claims (stolen product designs) far outweighed the profits to be realized on the product.”

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