Medtronic Quality/Regulatory Program Director Kathryn Merrill is a problem-solver’s problem solver.
Right now, the problem she wants to solve is the way device manufacturers approach corrective and preventative actions — CAPA, an abbreviation that can trigger an avalanche of documentation and headaches for medtech engineers.
For five years, Merrill’s been part of a Medical Device Innovation Consortium (MDIC) team developing a new approach to CAPA, stemming out of conversations across the medtech industry and beyond. The goal was to implement improvements in months instead of years and allow teams to be more proactive.
“I’ve been at Medtronic for 26 years and very often we’d say, ‘Hey, I think we’re making this more complicated than it needs to be,’” said Merrill, who is lead co-author of MDIC’s risk-based CAPA framework. “But when we were in face-to-faces with all these other industry members and we were talking about it, we all had the same pain points. We were all struggling with the same process.”
Common problems with CAPA
Those talks and an industrywide survey identified common difficulties. The most common and distressing were a lack of clarity on when to open a traditional CAPA, overlaps and duplication due to a lack of clarity about the relationship between CAPA and other systems, and a lack of planning for CAPA resource allocation.
“It’s difficult to know when a corrective action is required, when to escalate to a CAPA,” Merrill said. “[And] if everything is important, nothing is. So the system would get plugged with low-risk issues and it was hard to get things through that we really needed to.”
MDIC’s risk-based CAPA framework is now used by medtech industry leaders such as Medtronic, Edwards Lifesciences and Stryker, Merrill said — and the FDA is on board as well.
“The main premise is CAPA is not bad,” she explained. “We want to have all the elements of CAPA, but the intent is to right-size it based on risk so you put all your resources and focus a majority on those issues that have the biggest potential to impact the patient or the user. It’s very patient- or user-focused on those larger CAPA activities. But we still have improvement that has to happen that might not directly impact them, but will ultimately improve the business and therefore product quality down the field. So how do we get those through the system even though they’re lower risk items? And that’s where we’ve developed a risk-based approach to CAPA.”
How to get started
MDIC published the first CAPA framework white paper in 2019 and helped launch internal pilots at 19 locations across eight life science firms: Abbott, Alcon, Baxter, Celonova, Edwards, Illumina, Medtronic and Stryker.
After learning from those pilots, MDIC published an updated white paper in May to help other device makers join in. The group is now working on training modules, videos and workshops to get device manufacturers of all sizes started. Piloting the framework takes about three to six months for training and implementation.
“CAPA was intended to improve things. That was the overall intent of FDA,” Merrill said. “When we were all in the room, the energizing thing was that industry and FDA were both totally aligned with the idea that we have to improve faster and help our patients — that overall goal is what allowed us to get there.”