I put that questions to Tom Black, vice president, OEM and international divisions sales and marketing at B. Braun Medical Inc. Two of the biggest trends, Black explained, are increase demand for transparency from outsourcers and tighter change control. “In general, the [medical device] OEMs are now expecting their [outsourcing] partners to manage a lot more and to be a lot more transparent.”
This push is a reaction to the FDA's demand for increased information related to the supply chain. “In the majority of 483 warning letters, manufacturers are getting written up for supply chain issues—not necessarily for things on their own manufacturing floor," Black says. Trends such as these are "making [device] OEMs really pound on their outsourcing partners." The quality control systems used by outsourcers to the device industry are become ever more stringent, Black explained. "Now outsourcing partners must follow [medtech firms' quality control] systems to a tee," he explains.
"As for change control, it used to be, if something really major changed to the product or the specs, you just notified the OEM," Black says. "Now OEMs want to know about every little change. For instance, if you swap a core pin on a tool," he says. "Even if you change standard products on a tool. It’s no longer about a product just meeting spec." Whereas in the past, it was sufficient to simply notify OEMs about supply chain changes, OEMs now want to know about changes in advance. "Device OEMs want to know about what the change is and they want as most advanced warning as possible."
Data related to materials and change control have also become especially important, thanks to regulations such as REACH and RoHS. "We have to make sure that our suppliers are up to date with all of those material requirements," Black says.