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Beyond Compliance to Performance—How CeloNova Differentiated Itself With MDDAP

Lynn Penn, President Performance and Methods Consulting, LLC
For the last three years, I have had the opportunity to help medical device company CeloNova BioSciences differentiate itself through ISACA’s CMMI Medical Device Discovery Appraisal Program (MDDAP).
CeloNova is a small medical device company located in San Diego (California, USA). The company has approximately 30 staff and produces a coronary stent called Cobra PzF. They also make a polymer that allows an individual to more easily adapt to foreign bodies (implanted medical devices) instead of rejecting them. The polymer currently works with Cobra and is being studied to see how it can work with other devices, such as prosthetics.
Because of its small size, CeloNova wasn’t as visible as it should have been for the incredible work it does. Its CEO was looking for new ways to differentiate or accredit the company. CeloNova is really in tune with doing the best of the best, and they knew MDDAP would help them add business value, while also increasing its recognition.
When a company first gets accepted into the program, we do an intake call with a checklist of questions to get to know them. Typically, the company’s only similar experience is with compliance audits, so the challenge is to help them see how this program is different.
Medical device companies are very used to compliance—they have to be. They’re regulated up one side and down the other—and thank goodness they are, since lives depend on them. But regulations are compliance-based, and when you base your processes on compliance requirements, you could be missing opportunities. You could also be missing risks.
In contrast, this program looks at how you’re doing things. We look at their strategies and how they’re doing business, and see if that works for how they want to be doing business now and how they want to do business in the future. The results we get have nothing to do with compliance—we uncover the opportunities to improve business performance and add value.
CeloNova was quick to acclimate to the method and see its value, and the company has been extremely proactive. Everyone on the team willingly went above and beyond, and even their board was closely involved. When we finished the first appraisal, the CEO told me that MDDAP’s focus on performance was such a refreshing difference from typical compliance audits that medical device companies are accustomed to.
You can read CeloNova’s full case study here for more details. Among the improvements they’ve seen is a 27 percent reduction in the complaint time cycle. CeloNova has now completed three appraisals. The performance report template has become a practical tool for them because it aligns the metrics with business objectives. It isn’t just an appraisal artifact—it is a working tool and living document to help them with continuous improvement.
According to CeloNova CEO Carl St. Bernard, “CeloNova’s investment in CMMI has enabled our start-up medical device company to deliver our cardiovascular innovations at or above the quality levels of larger, more established, medical device competitors. CMMI’s process challenges our Quality Management System assumptions while ensuring that we build an ‘end to end’ culture of quality throughout our organization.”
Having such a strong focus on performance and business goal alignment has helped CeloNova effectively weather COVID-19. They were able to quickly define appropriate metrics that worked for the new conditions and effectively adjusted operations. They have had no layoffs, despite temporarily reduced demand as patients avoided hospital visits during quarantine.
CeloNova was one of the first to participate in the MDDAP program. I’ve been involved with the CMMI model for a very long time, and it is discouraging when people are only after a number. That’s what I love about MDDAP—the program doesn’t require a number. The FDA has embraced this program and looks at it as a continuous performance improvement tool. Companies voluntarily come to the table for this program, which is wonderful. They are really doing it for the right reasons.
More information on how your medical device manufacturing company can improve its performance is here. If you’re not a medical device manufacturing company, but want to improve your processes, capabilities and performance, learn more about the CMMI V2.0 model here.