As FDA struggles with the changes to the 510(k) process, it may be time for you to review your processes. Structural and organizational changes may have inadvertently knocked your process a bit out of whack, and you may not be getting the same level of information bubbling up to the top. In an interview with Tim Mohn, Sparta Systems’s resident medical device expert and former manager of worldwide quality systems at Johnson & Johnson, he shares some pearls of wisdom for ensuring that you glean the information you need to drive your next-generation product changes.
“FDA hasn’t landed exactly where they’re going to regarding the changes to the 510(k) process. And although you want to be prepared, in some ways there’s not much you can except to comply when it comes about,” says Mohn. “There are other things you can do in the interim that will truly prepare you for things that you can control that will put you in a better position regardless of how the 510(k) process comes out, and frankly will put your business in a better, more attractive situation.”
Tim Mohn, Sparta Systems
Mohn says that lots of companies are trying to centralize operations, break down organizational barriers, reduce from several business units to one. They are focusing on supply-chain changes, which makes sense because that’s one of the highest cost centers. He says the interesting thing, however, is that companies don’t seem to be spending a lot of time focusing on the supporting processes to make those changes really meaningful.
“As companies go from a product-centric way of working where, maybe facility A focuses on hips and facility B focuses on knee replacements, and as these companies look to streamline operations, they might put those two divisions together with one common organizational structure with shared processes. They often take the complaint-handling unit from the local site and shfit to global responsibilities across all product lines.”
Mohn explains that when companies are based out of a single facility around a product, especially in the device world, that big issues, whether from quality or nonconformances or complaint handling or R&D, are addressed in a collaborative environment.
“Clearly, the highest-risk issues rise to the top quickly,” he says. “However, when you go to this sort of ‘brave new world,’ all the people who are experts are no longer colocated. The people who are now evaluating complaints oftentimes aren’t the experts anymore because rather than supporting one product line, they’re supporting three or five or 20. So it’s more important than ever that your process bubbles the right things up to the top.
Mohn says that the more-compelling business angle is that device companies make their money by driving product changes for next-generation products primarily through nonconformances and complaints. “If you’re not escalating these things appropriately, regardless of where they’re identified in this new corporate environment, you might still be doing design changes but they won’t be the ones that matter and ultimately not driving your top-line growth.”
The 510(k) process is going to evolve in some way, shape, or form. But when it’s all said and done, everyone is going to be playing on an equal field. The companies that are going to get ahead, says Mohn, are the ones that are truly optimized in this new environment to be effective.
“I’m not just talking about dollars and cents or how much it costs them to run their business. I’m talking about their ability to drive design changes in a new organizational structure,” says Mohn. “The reality of it is, when you’re colocated with the other experts, together you evaluate the critical things and make sure they’re getting elevated. In this new world, you’re not going to be able to do that anymore. The inherent standardization between these different inputs to your design change process is going to be handled by people who might not even know each other or who are not experts in the product.”
Device companies are centralizing operations in these different process groups for logical reasons (fewer resources, ability to scale, and so on). But, says Mohn, companies are failing to focus on the inherent new requirements for the process.
“That’s the ‘aha’ moment for me,” says Mohn. “You need to look at what’s changing and what you need to do to maintain the same level of control. Before it was more reliant on people’s expertise whereas in this new world, there is more onus on process than what there was before. You need to understand how much more is your burden shifting from expertise of people to process expertise and documentation. I’d like to shine a light on it, and say, really, guys, is this going to be an issue in your environment? If it is, do something about it now before it impacts your design change effectiveness.”