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. Here’s what they said about lead times.
Bob Weston, Director of Strategic Business Planning, Ortho Development: 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 from what I’ve seen before.
In the Sessions:
Orthopaedics leads the medical device industry in number of recalls, with 578 total recalls identified 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%. (Download the presentation here.)
With the final ruling on UDI expected for release this summer, orthopaedic manufacturers are beginning to focus on compliance. Karen Conway, executive director of industry relations for GHX, told manufacturers they need to view the regulations as a strategy and not just a project. Conway provided the following questions for audience members to ask as they prepare for UDI: (Download the presentation here.)
- Where are covered products produced? Into which markets are they sold?
- Do you need to add printing capabilities to accommodate dynamic (production) data? If so, how will that impact space and layout on the production floor?
- Do you perform late-stage labeling in warehouses or with third party logistics providers? How will their operations be affected?
- How will you handle validation of new IT equipment and processes?
- Do you have kits or combo products? If so, you do label each of them late-stage and then combine?