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In a previous issue, we asked materials suppliers to offer OEMs guidance on quality, safety and performance factors to consider in 2013. Supplier responses appeared in the December issue of BONEZONE. Since then, more suppliers have chimed in with opportunities and challenges that they expect OEMs to face in the months to come.
Participants:
Grant A. Niewinski, Forécreu Biométal
Larry Shrimp, CaP BioMaterials
D.L. Smith, Boston Centerless
What one question do you wish your orthopaedic device manufacturer customers would ask you about materials?
Grant A. Niewinski, U.S. Sales and Marketing Manager, Forécreu Biométal: What are your long-term pricing and supply/usage programs and how do they work?
Larry Shimp, President and CEO, CaP BioMaterials: Do your materials meet all of the ASTM, ISO and FDA requirements, and is your manufacturing facility easily available for audits?
D.L. Smith, Vice President, Sales and Business Development, Boston Centerless: What dimensional attributes should a Swiss screw machinist look for in the precision bar product that will optimize the productivity of Swiss machining operation?
What one thing should your orthopaedic device manufacturer customers know about materials for 2013?
Niewinski: Materials in 2013 are going to be more difficult to source in the short-term with the approval of the new medical tax. Medical grade titanium and medical grade SS, 17-4, 455, 465, 316LVM and titanium will be more difficult to source. Part of the reason is due to FDA only approving a handful of people to actually melt this material in steel mills, and the cost of this material is going to limit short-term buying for most companies.
Shimp: Bioceramics quality control is difficult, so it is important to find an experienced, qualified manufacturer that is willing and capable to meet custom specifications.
Smith: Low productivity and high finished part rejection rates can be overcome in your Swiss machining department with the use of a highly consistent precision ground bar.
What one significant challenge will materials suppliers face in 2013, of which OEMs should be aware?
Niewinski: The new medical tax and how it will effect short-term supply chains.
Shimp: There are very few qualified independent manufacturers of calcium phosphate bioceramic materials. It will be difficult to find one that has full manufacturing and testing capabilities, and is not competing with its customers.
Smith: Despite a lackluster business environment, lead times for certain critical alloys that were specifically designed for the medical device industry are likely to remain long, in some instances longer than six months. Partnering with suppliers that can mitigate these long lead times with VMI, Kanban and other such service offerings could be a good strategy for 2013 and beyond.
