The medical device manufacturing industry has traditionally been driven by a compliance-focused mindset. Fortunately, that is changing, as device manufacturers increasingly recognize that compliance with regulations as an end goal vs. a starting point does not necessarily translate to device quality.
By helping medical device manufacturers better understand and sharpen their capabilities, ISACA’s Medical Device Discovery Appraisal Program (MDDAP) is advancing device quality and patient outcomes by driving toward a culture of continuous improvement.
George Zack, principal and co-founder at Two Harbors Consulting, LLC, puts it this way: when his 16-year-old son had just earned his driver’s license, he was compliant with meeting state requirements by passing the mandatory exam, but characterizing him as a quality driver at that moment would have been misleading. In his role as an MDDAP appraiser, Zack sees first-hand the difference between compliance and truly prioritizing quality, and how MDDAP puts medical device manufacturers on a path toward producing more reliable, often life-saving, devices for patients.
Capability Maturity Model Integration (CMMI) provides a framework of globally respected best practices that help organizations improve quality and efficiency. As Kim Kaplan, senior product manager for MDDAP at ISACA, recently said, “MDDAP is a tailored version of CMMI that enables medical device manufacturers to understand, measure and improve their capabilities to deliver high-quality products to patients.”
There is often a misconception that quality refers only to something being of the highest possible caliber – for example, many might equate a quality meal with going to a fancy restaurant. But availability, safety and efficacy are among the aspects that help make up quality, Zack said. To continue the restaurant analogy, going to a casual, no-frills diner around the corner can be a quality experience for a family looking to grab a quick meal. Organizations can turn those various components of quality into an important competitive advantage by earning the trust of customers and stakeholders.
In the medical device sector, MDDAP helps organizations with a strong compliance history focus on quality and improving performance in a way that makes sense for their business and customers. Organizations that enroll in MDDAP agree to have independent appraisers come to their site and leverage the CMMI model to evaluate the capabilities of how they are performing against selected practices, and then collect feedback on strengths and opportunities for improvement. Agreeing to proactively have light cast upon their organization’s practices when they are already fully compliant organizations speaks to a culture of continuous improvement from program participants, Zack said.
MDDAP appraisals allow device manufacturers to understand their gaps and prompt the needed conversations – whether within their site or collaborating with other stakeholders – to improve their performance. An overwhelming 95%+ of program participants report that the appraisal provided value to their organization, and 85%+ indicate the appraisal method provided a direct value to improving product quality.
“The way we approach MDDAP appraisals is, this is for you, this is not just for you to get a certificate, it’s for you to collect information on how your organization can be better,” Zack said. “Taken in that spirit, I’m not surprised at that those percentages because people see value in that approach.”
Organizational resilience and business continuity have become especially resonant with organizations in the COVID-19 era. The CMMI model utilized in MDDAP enables organizations to make sure their capabilities in those areas are sufficient for today’s volatile business environment.
“CMMI sets up processes to be more defined so organizations should be more resilient,” Zack said. “By assessing organizations against practice areas, we test if they have habitual, persistent and sustainable processes that will work not only when things are going well but in times of stress. That is true not just for medical device organizations but anyone assessing against CMMI practices.”
In the medical device sector, there often are disconnects between the design and manufacturing functions – both between sites and even within an organization’s own four walls. Zack said the handoff of processes between these groups is “ripe fruit for an appraisal team to examine the capabilities of these processes.”
Given the importance of medical device quality in patients’ lives, it’s important not to lose sight of what is at stake in organizations’ commitment to improving performance and device quality. Zack relayed an anecdote of patients who have pacemakers installed in their chest being brought as guests to one site so that the manufacturing lines workers could gain a true appreciation of how meaningful the quality of their work is to medical patients.
“That’s the beauty of this industry,” Zack said. “It’s very easy to think about it as manufacturing and compliance and business, but the true magic of this is that the people that we get to interact with are truly trying to impact the health and the enjoyability of people’s lives. And that’s pretty amazing.”
