Tight quality control is mandatory for medical molding, but the relationship between a medical-device manufacturer and its preferred suppliers is equally important, according to a top parts buyer for Boston Scientific Corp.
Trust and transparency are important, said Alex Mastorakos, Boston Scientific's global sourcing director for plastics.
“The relationships have to be very close, just because of the nature of the products and level of disclosure we have with each other,” Mastorakos said. He cited the act of buying a car, where you walk out wondering if you really got a good deal. “I think the way you answer those questions is to have full disclosure, trust and deep transparency throughout the entire relationship. That's a critical element.”
Medical demands nothing less. “This is an area where you can see a 20-cent molded part essentially take down a product line or worse yet, potentially harm or kill a person,” he said.
Mastorakos spoke on a panel during the Plastics News Executive Forum in Tampa last month. The topic: Challenges and opportunities in the medical-devices market.
The other speaker was Gaet Tyranksi, director of a growing medical business unit at contract manufacturer Jabil Inc. The moderator was Brenan Riehl, president and CEO of medical molder GW Plastics Inc. of Bethel, Vt.
Medical, with its higher margins and growth prospects, looks attractive to plastics processors slogging it out in markets like automotive and consumer products. But cracking into medical is not easy.
Mastorakos and Tyranksi both said they prefer to deal with existing plastics suppliers that have already been qualified, rather than newcomers. “It's a very tight-knit group and the suppliers are pretty well-known in the industry,” Mastorakos said.
Mastorakos listed several core themes that Boston Scientific looks for in suppliers, including a common vision, trust, performance, people experienced in medical, and a proactive expertise in plastics.
“One of the things we look for is, is it somebody who's already in the medical space, or do they have enough critical mass in that space to truly understand what we're looking for,” he said. “These are people we have established relationships with, which many times it took years and years to develop.”
Tyranski said St. Petersburg, Fla.-based Jabil has built an $800 million medical business in just three years, as it expands beyond its roots as an electronics contract manufacturer. Jabil generated 2009 sales of $11.7 billion. The company runs about 700 injection presses worldwide — all of its processing is done in Asia — and also buys lots of plastic medical components from suppliers, he said.
“We're probably one of the largest companies that you've never heard of,” Tyranski said.
Jabil generates more than half of its medical sales from Asia and Latin America, focusing on the single-use device sector. Tyranski said customers in emerging markets want Jabil to bring in a complete supply chain right away, an “integrated product solution.” He said Jabil audits suppliers for factors such as cost, quality, delivery and service.
Financial stability is important. “You can't have your supplier go bankrupt and cause a crisis, because then you are going to be facing your customer and it's going to become your crisis,” Tyranski said.
Boston Scientific, based in Natick, Mass., is a global device giant with a portfolio of more than 13,000 products. So how does Boston Scientific determine its preferred supplier list?
Historically, Mastorakos said, companies used standard assessments to pick suppliers. But Boston Scientific has evolved into a company that uses a highly targeted and comprehensive process.
“It's very case-specific. It's custom. It's a cross-functional representation of what we're looking for,” Mastorakos said. Boston Scientific digs deep into the supplier's processes. Both the supplier and Boston Scientific need to have the right controls in place to ensure quality parts, and traceability, he said.
“What I've seen in over the past few years is [assessments are] evolving from a more classical, traditional ISO-type audit, into a much more part- and product- and risk-based assessment specific to the exact part that we're buying. It's not a one-size-fits-all approach,” Mastorakos said.
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