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Suppliers Speak to Economic and Regulatory Challenges in Global Expansion

Orthopaedic industry suppliers continue to expand globally as they seek to keep pace with customer demand and add customers in new geographic markets. Three suppliers convened at OMTEC® 2014 to discuss the challenges and opportunities they’ve faced from economic, regulatory and quality standpoints during overseas expansion, as well as the continual requirements that their medical device manufacturing partners ask them to meet.

The conversation focused largely on emerging and Asian markets, as all three suppliers have or are building facilities in Asian countries—Orchid Orthopedic Solutions broke ground in India in May; Paragon Medical opened its China facility in 2008 and Symmetry Medical chose Malaysia for its Asia-Pacific headquarters in 2007.

Andrew Miclot, Executive Vice President of MicroTechnologies, moderated the conversation that included Christopher Norbye, Executive Vice President Global Operations, Orchid Orthopedic Solutions; Greg Hall, Director of International Business Development, Paragon Medical and Thomas Barrett, Senior Vice President and Chief Commercial Officer OEM Solutions, Symmetry Medical.

andy-miclot-for-webAndrew Miclot: What challenges and opportunities—economic, regulatory and government-related—have you encountered in supplying to a global market?

 


Christopher-Norbye WEBChristopher Norbye: In terms of manufacturing set-up, the biggest challenge is finding the right people in the local regions. If you’ve got the right people, then things work out. For regulatory approvals, as purely a contract manufacturer, we must simply work with our customers and their approvals to supply products. Finally, you must set up your infrastructure so you have the same quality systems wherever you are, because you have to have one way of working with quality. That’s one of our biggest strengths.

Greg-Hall WEBGreg Hall:
On the regulatory side, and I agree with Chris here, for us there’s always a change control that we all have to live and work with every day and that presents its own challenges. For us, China was really new. We didn’t have anybody over there. We hired a consultant to help us navigate the waters. Just working with the local offices and local bureau of the province in which we were operating was definitely a challenge because we had to work with them to understand their requirements.

Three aspects that I’d categorize as challenges and opportunities would be logistics, finding good people and finding our own suppliers. First, logistics. We’re doing work with multinational companies in Europe and the U.S. and also in China, but now that you have this facility 7,000 miles away, whether you’re dealing with customers in Europe or the U.S., you have logistics. You have inputs coming in and outputs going out—whether that’s transportation, whether that’s file transfers.

Next, trying to find good people. When we started the company, if you asked how many employees had medical device experience, I would have said that it was a very small number, if any at all. The folks whom we’ve hired are willing to learn, but we had to teach them about medical devices, how to process medical devices, which ties into your quality systems. People are definitely one of the challenges.

Finally, and we still face this challenge today: suppliers. We’re very fortunate where we operate in the U.S., Europe and other countries that we have good tier II suppliers. When you go to China and start talking validations for heat treatment or whatever the case may be, they’re used to running automotive, in high volume. Now you’re talking about smaller lot sizes and different validation requirements. They look at you like, “Really? You want us to do those things for you?” We’re definitely better positioned and smarter now, but those are some of the early challenges that we faced.

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