The US FDA Case for Quality (CfQ): What It Is and Why You Should Care
For decades, the medical device industry has largely viewed the US Quality System Regulation (QSR) as a regulatory speedbump on the path to market access. Despite the regulation’s name, product quality has typically taken a back seat to regulatory compliance for manufacturers.
That’s understandable, since FDA’s inspection-oriented approach has rigorously emphasized compliance with specific aspects of 21 CFR Part 820. In recent years, FDA has had an epiphany of sorts. FDA inspectors had been seeing a high volume of the same issues year after year and, after talking with numerous industry stakeholders, FDA concluded that the regulations simply were not sufficient on their own to ensure high product quality and patient safety. Thus began the FDA’s Case for Quality (CfQ) initiative.
Basically, what drove the program’s creation was the fact that FDA could plainly see that companies with an internal culture emphasizing quality throughout the organization had fewer compliance issues, fewer product complaints, fewer CAPAs, and better patient outcomes.
Changing the mindset of the medical device industry
The US FDA, in cooperation with industry and the Medical Device Innovation Consortium (MDIC), started the Case for Quality (CfQ) initiative in 2011. The MDIC is a nonprofit that works with FDA, CMS, and NIH to advance regulatory science for patient benefit. They are focused on creating “sustained predictive practices that advance medical device quality and safety.”
The CfQ is exactly what it sounds like: FDA’s new emphasis on encouraging companies to view the QSR as a tool for improving product quality and gaining all the tangible benefits that come with it.
Dr. Jeff Shuren, former Director of FDA’s CDRH, acknowledges that FDA often sees medical device companies that fully comply with the QSR but produce poor-quality products, while others don’t fully comply yet make great products. In other words, an internal company culture that focuses on product quality does not always correlate with a high degree of QSR compliance. With that in mind, the CfQ initiative emphasizes three things:
1. A focus on product quality
2. Enhanced data transparency
3. Stakeholder engagement
Creating a standardized set of quality data metrics and sharing it
Point #2 above is an important one. FDA, with the assistance of MDIC, has identified a lack of data transparency and lack of established quality metrics as tools that would help companies in the industry see how they stack up against one another. As such, FDA et al. are working to develop Product Quality Outcomes Analytics, a standardized means of capturing quality data using registries and patient-reported data. According to MDIC, the goal is to “Develop new tools and metrics…that improve product quality and patient experience.” An emphasis is being placed on several factors, including safety, efficacy, reliability, patient perspective, usability, compatibility, and availability.
Developing a maturity model that establishes a baseline and rewards high-performing companies
With metrics established and datasets made more accessible via the FDA website, FDA wants to identify manufacturers that consistently produce high-quality devices, so the agency can focus their inspection resources elsewhere. By developing a maturity model to assess “quality maturity” of a manufacturer, FDA will adjust their engagement activities and submission requirements based on this independent assessment of quality maturity. Translation: If you improve your product quality, you’ll feel less heat from FDA in years to come.
The medical device industry has been slow to embrace CfQ
To date, willingness to jump on the Case for Quality train has been slow. Why? From one cynical perspective, there is only one reason to do so: the bottom line. Think about it…businesses, as a general rule, are either growing or dying. In the highly innovative medical device space, growth is directly correlated with new product introductions, which are often equated with innovation. Product line extensions, new applications for existing technology, and expanded indications often drive new marketing appetite along with patient and physician adoption. Business focus becomes intent on feeding this appetite, resulting in organizational celebrations when new products launch, new patients get implanted, issues are minimal, and EPS exceeds market and investor expectations. Unfortunately, it creates a bifurcated scorecard culture of “Green is good, red is bad.” From a job security perspective, this challenges functional leaders within medical device organizations to put green lipstick on a red pig. You’ve seen it…green scorecards are celebrated in management reviews, whereas owners of “red” metrics are pushed out of the organization and replaced with new, often cheaper, and less talented resources who may not actually know what “green” is. R&D challenges Quality saying, “That’s not a complaint. That is user error.”
The elephant (not) in the room
What is missed, however, are the thousands of “invisible” patients left living with the technology that serviced them at the time they needed it, while manufacturers pursue their next appetite to satisfy. Application of funding to support and sustain the designs on the market are often short-changed, resulting in inadequate resources and focus being applied to the systems designed to ensure continued product performance excellence – that is, quality systems. In other words, the current paradigm supports business growth.
Setting aside the realities of business, where is the value in hopping aboard the CfQ train and shifting dollars from investor coffers to changing culture? The answer: Create a culture where transparency is celebrated. Create an environment where red is OK as long as there is a plan to get to green, and celebrate continuous improvement. Create an organization that looks forward to inviting FDA in to look at where they are on their maturity journey. Will it all be perfect when FDA walks in the door? Absolutely not, and this is as it should be. An organization that has a mature quality culture will have a lot of red elements on their scorecards. But they will be able to show not only that they have identified these red elements internally, but also that they are making progress to improve the organization. However, will the FDA investigator recognize this growth when he/she inspects? Herein lies the risk….
Have a good track record? Enroll in the MDDAP pilot program.
If your company has a “culture of quality” and a clean inspection record with FDA, consider enrolling in the Medical Device Discovery Appraisal Program (MDDAP). It is voluntary right now, but it will give you an insider view as to how FDA wants to approach regulation in the future. It also yields benefits to participants. One benefit is that you will go through an evaluation process, during which a team of appraisers will measure your company’s ability to deliver high-quality products. The results will then be given to you in heat map format so you can see how you stack up against other companies. You’ll also get the benefit of identifying key areas for improvement that can improve product quality. Perhaps most exciting (relatively) is that once you sign the Statement of Work associated with participation in the program, your company will be removed from FDA’s routine inspection list. Woo-hoo! After you complete the Discovery Appraisal, you’ll also take advantage of streamlined 30-day change notices, streamlined site change submissions, and streamlined PMA submissions.
Whether you’re considering the CfQ program or not, begin shifting your internal focus to a culture that celebrates transparency and continuous improvement, which starts at the top of the organization.
Performance-based auditing may be a start…
The benefits of the Case for Quality initiative are compelling, but as we noted it starts with an internal shift in mindset from compliance to performance. Get to know your processes and how they interact. Understand the critical decision points within your processes and measure them. Be engaged with how your processes are performing, celebrate best practices, and share them within the organization. If your processes are performing poorly, acknowledge this and seek help. Create a culture in which “red” is OK, as long as there is a path to “green” and progress is being made. Oriel STAT A MATRIX can help you take the next step toward moving your organization in that direction. Our team can provide consulting on best practices for making the transition to performance-based auditing and also perform on-site training for your team.