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Supplier Roundtable: Materials Suppliers Prepare for 2013

What one significant challenge will materials suppliers face in 2013, of which OEMs should be aware?

Steve Smith, Edge International: Mill lead times, especially in an improving global economy. The orthopaedic device industry continues to grow and the future looks positive, but is still considerably smaller than the aerospace industry. We all have to be aware that the manufacturing mills for our industry are highly invested in the supply of raw materials to the aerospace industry, and demand from aerospace has a major impact on mill lead times. Specialist orthopaedic material distributors can help OEMs balance out fluctuating mill deliveries.

Fran Alder, Ensinger: OEMs are all driving for cost reductions while at the same time tying the suppliers’ hands by specifying only single sources for the required resins. The two are in conflict in that our suppliers, resin producers, have the single source position and consequently no competition, while the OEM is squeezing for cost reduction without offering options to the converter supplier. In our case, we extrude the resins into bar stock for machining.

Bob Wiedinmyer, EPTAM Plastics: Raw material pricing will continue to put upward pressure on finished part pricing.

Dr. John Devine, Invibio: Understanding the regional requirements and changes of regulatory will be the significant challenge that material suppliers face in 2013. 2012 was the year with highly publicized PIP implant failures. The implications from the PIP event are that this will change the regulatory landscape, for medical device companies and their suppliers, making material regulations and testing more stringent in Europe and the rest of world. Focus on materials from a quality and regulatory perspective along with risk, validation and supplier controls are key. Given that regulatory bodies cite that the biggest risks to the medical device companies are their suppliers, OEMs should be aware of these implications when reviewing suppliers.

Emerging geographies, such as Brazil, China, etc., each have their own regulatory processes and approvals that medical devices must meet, including specific requirements for the device material. The challenge for material suppliers is to understand these differences and the processes involved in meeting the demands of national regulatory bodies to ensure that this growth can be realized.

Cameron Crowley, Maverick Biosciences: Foreign currency fluctuation.

Shawn Shorrock, Solvay Specialty Polymers: The most significant challenge will be related to cost pressures and how that may not enable innovation in design and materials. As a raw material supplier for implantable devices, instrumentation and sterilization cases, it is important for us to educate our customers on how plastics can help them meet their cost targets but also enable innovative design.

Michael Kell, Total Plastics: Many of the top ten orthopaedic OEMs have either not made the necessary material specification changes or made inappropriate changes over the last few years that effect supply of plastic materials to them. Formats such as those followed by ASTM and ISO would serve many of these companies well into the future.

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