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Suppliers Speak to Economic and Regulatory Challenges in Global Expansion

Tom-Barrett WEBThomas Barrett: It’s interesting that we’ve all gone to different international locations in terms of a lower-cost alternative. From a manufacturing perspective, it seems like we’ve all had very similar challenges, and it goes back to the infrastructure that you have in place there. We take for granted our facilities here in the U.S. Some of our main facilities in Warsaw have been there for 35 years. Now all of a sudden you’re in a completely new time zone, new part of the world, and you’re doing things for the first time. It goes back to people. It goes back to training. It goes back to that technical learning curve. How do you bring them up to that learning curve? How do they understand the different requirements on validation and quality? All of these things are different when you have a new workforce that you’re basically pulling off the street and training. People are definitely a challenge in new sites. The other aspects talked about both from a quality and a regulatory perspective—a lot of these people have not done medical. We were fortunate in some cases where we are able to hire folks with medical backgrounds, which helped on both fronts. The last thing is the time zone challenge. We’re sleeping; they’re working, it affects logistics. If you want to support those facilities from the U.S., you have people on the phone from nine at night until one in the morning reporting those projects. You need to think about these things when you enter these new markets. How are you going to support those facilities? What are some alternatives; how can you do it differently to get them answers? If you want responses, you can wait days between an email and a phone call. It’s a challenge for us to remain responsive to our customers and at the same time execute and get the answers we need to do the quality job right the first time. We’ve all seen challenges in starting new facilities.

Miclot: Switching gears. There are so many acronyms: ISO, IEC, REACH, conflict minerals. What quality requirements are your customers increasingly asking you to meet?

Hall: Interesting question. I don’t know if there are any different requirements as far as multinational companies, but we’re seeing a lot of those requirements. We’re seeing more supply agreements and agreements in which they’re incorporating the conflict minerals and REACH. Whether we’re doing work in the U.S. or offshore in China, those requirements don’t necessarily change. One point I will make is that we’re working with the local companies in China that may not be multinational companies. We’re not seeing those requirements now; there are fewer requirements. However, give them time. Ten years from now, five years from now, as they start to increase their approval process to get products registered, you will see those requirements.

Norbye: I agree with everything Greg said. I don’t think it’s necessarily a bad thing, either. I’ve spent all my life in medical. I come from a big company background. These things were implemented in those businesses years ago. In the end, it’s getting the infrastructure up to manage and handle these requirements. For us to be competitive in the changing world, the Western-managed companies, we’re just dipping our toes in the emerging markets; we need to keep driving this forward because that’s one way we can excel. Keep on driving together with our customers.

VideoCallout WEBBarrett: From a quality perspective, we’ve seen a lot of requirements ratcheted up in terms of process validations and controls. Clearly, that’s an area of expertise, particularly around special processes and the types of validations, which our customers are now expecting of us. When we consider using a supplier, we need to hold them to those same standards because OUR customers expect us to fulfill those quality requirements.


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