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Pressures from material costs and Federal regulations are expected to increase in 2013. To ensure commercialized product quality, safety and performance, suppliers and OEMs will need to maintain vigilant communication and share industry awareness. Here, material suppliers offer guidance for OEMs’ consideration as they team up on solutions in the coming year.
Participants:
Steve Smith, Edge International
Fran Alder, Ensinger
Bob Wiedinmyer, Director of Sales, EPTAM Plastics
Dr. John Devine, Marketing & Technology Director, Invibio
Cameron Crowley, Maverick Biosciences
Shawn Shorrock, Global Market Manager – Healthcare, Solvay Specialty Polymers
Michael Kell, Total Plastics
What one question do you wish your orthopaedic device manufacturer customers would ask you, about materials?
Steve Smith, Edge International: Does the material that you are offering meet all of the specifications and in-house requirements as specified on the drawing? As a raw material distributor, we try to ensure that the material that we have in stock is suitable for as wide a range of specifications as possible, but all too frequently, the initial inquiry references the basic generic specification and only at the order stage are more restrictive requirements added, causing re-quotes and additional costs.
Fran Alder, Ensinger: What post-processing testing do you perform to characterize your materials for safety in the intended medical device, and what bio tests have you performed post-processing?
Bob Wiedinmyer, EPTAM Plastics: Is the specified material available in the shape needed for machining?
Dr. John Devine, Invibio: The one question that orthopaedic device manufacturers should ask about materials is, how can my choice of material address the cost concerns of our supply chain and the hospitals without compromise on device performance? The industry is challenged with reducing cost of goods to meet with the demands of hospitals. Unlike other industries, there is absolutely zero scope for compromise on quality, safety or performance. One opportunity to address this is partnering with the material supplier. Invibio introduced PEEK to the medical industry almost 15 years ago. We’ve developed and supported the material from quality and regulatory stand-points, and serve as technology specialists in understanding the methods involved in processing it. This allows orthopaedic device manufacturer customers to partner with Invibio and benefit in two ways that address the economic challenge: one, to provide guidance and support to realize new device innovations and two, through providing cost-effective access to alternative routes to manufacturing.
Cameron Crowley, Maverick Biosciences: How could we collaborate to bring down total material cost per device and generate mutual benefit?
Shawn Shorrock, Solvay Specialty Polymers: How can we improve quality and reduce costs using plastics?
Michael Kell, Total Plastics: Is it possible to work with a supplier who can cover all our medical grade plastic requirements, including supply chain management, technical assistance and excellent customer service?
What one thing should your orthopaedic device manufacturer customers know about materials, for 2013?
Steve Smith, Edge International: The importance of more accurate forecasting and a longer-term commitment by the OEMs to their subcontract suppliers. This enables the raw material suppliers, and especially the stocking distributors, to ensure the continuous and timely supply of material that meets all the specifications and requirements of the OEMs.
Bob Wiedinmyer, EPTAM Plastics: Ensure color codes are current with raw material manufacturer availability, and prints and specs are current to those codes.
Dr. John Devine, Invibio: PEEK-OPTIMA is often used as an alternative to metal. Manufacturers should know that PEEK-OPTIMA polymer is not one product, but is the base for a family of products. Each shares the principle benefits of natural PEEK-OPTIMA, but is designed to achieve performance of a specific feature when the device demands it. They can choose PEEK-OPTIMA® HA enhanced for superior bone on-growth (for example, in spinal fusion), PEEK-OPTIMA® Carbon fiber Reinforced high strength grade to deliver fatigue life in trauma devices, PEEK-OPTIMA® Image Contrast with tailored radiopacity, etc.
Cameron Crowley, Maverick Biosciences: There is more emerging market activity, so be aware of regulatory needs, to maximize your opportunity.
Shawn Shorrock, Solvay Specialty Polymers: Utilizing plastics can help you meet your challenging cost targets, in both implantable and non-implantable devices.
Michael Kell, Total Plastics: Material requirements, particularly from FDA, will become more stringent. Testing data, certifications, etc. will be a significant part of the product profile moving through 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.
