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Voice of Industry

Voices from OMTEC 2013

Orthopaedic device manufacturers, suppliers and industry experts met in Chicago at OMTEC 2013, the 9th Annual Orthopaedic Manufacturing & Technology Exhibition and Conference, to discuss how to mitigate regulatory, manufacturing and supply chain challenges. Here are a few of the conversations you may have missed.
 
 
In the Panels:
A panel discussion on procurement and sourcing touched on how OEMs are handling supplier consolidation, outsourcing and new regulations. Steve Maguire, General Manager, Orchid Design, moderated the conversation and asked the OEMs how they’re working with suppliers. Here’s what they said about lead times. 
 
Bob Weston, Director of Strategic Business Planning, Ortho Development Corp.: We’re seeing extended lead times, even from our tried and true suppliers. We think that the larger OEMs are undergoing a lot of product launches that are impacting lead times in the industry. There used to be a cycle; I’d tell our engineers, “We want to have the supplier building the parts in August when the larger companies decide to decrease their forecast.” Right now, there’s some disappointment on our side on missed dates. What we’d like to see is some flex time at the supplier level to give us that wiggle room that we need moving forward.
 
Thomas Solowczuk, Director, Global Sourcing, Alphatec Spine: We’re increasingly creating strategic supply agreements with our suppliers, putting VMI programs in place, allowing the supplier to build ahead. We’ve been able to adapt to some of the changes in lead time and demand. A supplier can respond much faster if we’re able to give them six or nine months of requirements. If they’re able to bank some of that inventory for us, it can cut lead times down from 8-10 to 1-2 weeks, potentially.
 
Howard Levy, Chief Procurement Officer, Worldwide Operations, Biomet: I think it depends on the business that you’re actually supplying. One of our trauma suppliers told me any new order we place is a 20-week lead time. Some of my instrument suppliers are showing me a map, or are forward-planning our business and suddenly there is a cliff of no return that they’ve experienced, regarding volume. It depends on your OEMs, who you’re supplying to, what particular products you have; are you part of a new launch, or do you have stable business? It’s an interesting dynamic; one that’s different than I’ve seen before. 
 
 
In the Sessions:
Orthopaedics leads the medical device industry in number of recalls, with 578 total recalls between 2007 and 2011. Matthew Krueger, Chief, Orthopedic and Physical Medicine Devices Branch, Office of Compliance, Center for Devices and Radiological Health at FDA, presented data compiled by the agency.
 
FDA sorted the data into four categories (mislabeled, specification, sterilization, fracture), which were created based on prevalence and areas in which it foresees being able to address concerns. The percentage of each recall issued from 2007-2011 includes: mislabeled, 24%; specification, 19%; sterilization, 7%; fracture, 9%; other, 41%.
 
 
On the Floor:
OMTEC speaker Rob Packard walked the hall with notebook in hand, jotting down questions he received from attendees. Here’s one: Where will FDA be in five years?
 
Mr. Packard’s Answer: I don’t expect to see the 510(k) process go away, but FDA has good reasons for disliking it. Therefore, FDA will continue to rigorously screen and reject as many applications on technicalities as they can. Second, FDA will continue to promote the De Novo process, because it allows them to establish a new special controls document for verification and validation testing that will be required—instead of accepting what was accepted for past submissions. FDA will also increasingly require clinical trials for 510(k) devices. The trend has grown gradually, and ten to 15% of submissions now include clinical trial data. I’d like to see a 100% web-based solution to submissions, but I don’t believe FDA can change that fast. Ten years might not even be enough.