By Shawn M. Schmitt
Communications Specialist, Enzyme
When Becky Fitzgerald strolled onto the production floor of a MedTech company participating in a pilot program aimed at improving the maturity of the firm’s manufacturing organization, she was immediately concerned. The overall building was not well lit, machines used in manufacturing were dirty, and the floor was cluttered with unused equipment – among other issues.
“It’s not a place where I’d want to work,” said Fitzgerald, Principal and Co-Founder of Minnesota-based Two Harbors Consulting, who conducted most of the appraisals under the now-concluded voluntary Accelerate Sustainable Capability (ASC) pilot, of which this particular problematic manufacturer was a part. The US Food and Drug Administration (FDA) and the Medical Device Innovation Consortium (MDIC) announced in July 2020 that it would aim for an ASC pilot that would include 10 facilities. (In the end, only seven companies participated.)
Fitzgerald’s reaction to the cluttered, grimy plant was to be expected. After all, ASC had been built with companies with less-than-stellar compliance records in mind, including the issuance of FDA-483 inspectional observation forms and warning letters from the agency.
The FDA said in announcing the pilot in 2020 that the goal was to provide enrolled companies with “insight that may help them improve product quality and safety, reach compliance quickly, structure their systems for continuous improvement, and identify metrics that will allow FDA to monitor product safety throughout the pilot process.”
ASC was modeled after the FDA’s popular Case for Quality Voluntary Improvement Program. CFQ VIP – also run jointly by the FDA and the MDIC – aims to boost product, manufacturing and process quality at device firms by appraising the companies against an industry-modified version of the Capability Maturity Model Integration (CMMI) framework. The most notable difference between CFQ VIP and ASC is that only manufacturers with clean compliance records can take part in the VIP program. In other words, having regulatory problems was an asset for a firm that played in the ASC pilot.
Late last year the MDIC released a pilot study report wherein ASC was described as a rousing success. “Success criteria for the study included progress toward compliance, improvement in quality management system and business process maturity, and the ability to address compliance observations/violations,” the report explained. “The ASC pilot study successfully demonstrated positive progress in improving organizations’ quality system and business process maturity with participating manufacturers successfully resolving their open advisory actions following a post-pilot re-inspection by FDA.”
After appraising the aforementioned manufacturer with the dim, dirty manufacturing floor, Fitzgerald came back to the same facility a year later and found that the ASC-enrolled firm made changes from top to bottom.
“They went through and evaluated all of their equipment assets on the floor,” Fitzgerald told Enzyme in an interview. “What they discovered when they went through all of their assets is that a bunch of equipment wasn’t operating well or wasn’t being used anymore or was a product that was at its end of life, a legacy piece of equipment. By cleansing their assets on the floor, they removed a few hundred pieces of equipment from their manufacturing floor. That had an enormous impact, just opening the floor up.”
She continued: “While doing that, the company noticed that there was nowhere for their employees to put their sack lunches and coats and other personal items. So they built an area for the employees to put their belongings. It was a real positive impact. And as they were moving equipment, they redid the floors. They painted all the walls. They painted the ceilings. They replaced the lighting – and all of this happened because the company was in the ASC pilot. As a result, the workers – the people – were visibly happier.
“So, do you think that had an impact on quality?” Fitzgerald added. “My reflection would be, how could it not?”
ASC’s Future is Murky, While VIP is ‘Entrenched’ at FDA, MDIC
Paul Sumner, the Case for Quality Program Director for the MDIC, told Enzyme that he couldn’t be happier with the results from the pilot program, noting that it “marks an important step forward in our mission to support safer, more effective medical devices for patients.”
“The ASC pilot gave manufacturers practical, hands-on support through action plans, quarterly checkpoints, and expertise from experienced CMMI appraisers and the opportunity to engage with FDA representatives,” he said. “This pilot demonstrated results – participants reported strengthened quality management systems and faster resolution of compliance issues. By making these improvements, manufacturers not only enhanced their own operational efficiencies but also contributed to safer outcomes for the patients who rely on their devices.”
Sumner added that the ASC pilot offered a pathway for companies ready to move beyond immediate compliance needs toward a commitment to continuous quality improvement. “Together, the ASC pilot and the VIP program create a comprehensive support system that helps manufacturers advance patient safety and quality at every stage. The MDIC is proud to support these initiatives.”
Nevertheless, despite an apparent successful conclusion of the pilot, the future of the ASC program is, for now, a big question mark. “I find it interesting that there is not a ‘next steps’ section in the MDIC’s white paper,” consultant Fitzgerald said. “So the $10M question is, what happens now?”
But Fitzgerald said ASC should have future life because “I think the good actors have reaped financial benefit, business benefit, from participating in the ASC pilot program. So I think they will likely continue because they’re getting value above and beyond cost. Whenever you have ROI, or return on investment, you’re going to have participation.”
Meanwhile, the VIP program, which Fitzgerald says is “pretty entrenched” in industry and the FDA, will soldier on. Sites have already been enrolled for VIP appraisals in 2025 and there has been a “steady stream of interest” on the part of other manufacturers.
“The FDA kind of expected a big flood of interest for VIP, but instead, the stream has been steady,” she said. “The FDA is for now able to support the volume of sites wanting to be in the program, and the program manager has to be able to support the volume of sites that want to be involved. So I’m excited that VIP is continuing and I sure hope that ASC has a future because it plays an important role. We’ll have to wait and see.”
