Recently, the FDA announced new priorities for the Case for Quality (CfQ) initiative for medical devices. The priorities outline the FDA’s trajectory for the initiative originally introduced in 2011. FDA launched the CfQ Initiative in response to an in-depth analysis of device quality data and industry feedback to increase quality focus in medical device companies beyond just baseline compliance. The goal is to encourage manufacturers to truly focus on product and manufacturing metrics that drive patient safety. In the years since the CfQ began, FDA reports data trends have been static, warranting the need to identify “other ways to support quality beyond inspections and traditional regulatory approaches.” To that end, FDA has developed three priorities to address barriers to quality:
- Focus on Quality
FDA considers compliance with regulations to be a minimum level of activities needed to ensure product quality and patient safety. As a result FDA has shifted its “focus increasingly to characteristics and practices that, when present in day-to-day device design and production, correlate to higher-quality outcomes.” FDA is actively working with a variety of stakeholders, including industry, to define device specific indicators that “will result in a shared understanding of product features and manufacturing processes most important to patient safety.”
- Stakeholder engagement
FDA knows that stakeholder engagement and buy in is critical to a successful CfQ program acknowledging the “extraordinary impact that engagement and agreement among regulators, industry, patients, providers, and payers can have on device quality.”
- Data transparency
FDA has made efforts and advancements in making data supporting device quality related to recalls, adverse events, inspections, and agency actions more accessible and transparent through open.fda.gov
FDA believes ultimately the CfQ will:
- “Promote the practice and culture of quality within firms.”
- “Allow stakeholders to focus resources on activities with the greatest impact on assuring that patients and users receive high-quality devices.”
- “Promote quality and excellence in the medical device industry.”
Using CfQ manufacturers will have “fewer complaints and internal investigations per batch of devices manufactured, often house smaller quality staffs, and have lower quality-related costs”
Okay, this is where the “see I told you so” part comes in. If the medical device industry wants some insight to the types of metrics that may be in the FDA pipeline, industry needs to look no further than the FDA pharma draft guidance “Request for Quality Metrics”. In case you missed it, here is the blog post where I surmised the proposed guidance and its impact on the device industry: How FDA’s pharma guidance “Request for Quality Metrics” will impact medical device manufacturers.
What is most interesting in both the recommended metrics for pharma and the current focus of the CfQ, FDA makes it clear that company culture around quality and attitude toward best practices directly affects product quality and thus patient safety.
FDA has given industry fair warning that minimum compliance efforts are not enough to ensure patient safety. In turn can be deduced that a company whose culture focuses on the bare minimum, treating quality as a necessary evil rather than a business benefit, will not survive increased FDA expectations.
Further, FDA is making a point to seek input and feedback from industry in the development of these metrics. I encourage you to get involved in the process and speak now about appropriate and meaningful metrics or forever hold your peace with what FDA comes up with on their own.
When your company makes its cultural Case for Quality to the FDA, what will the verdict be?
Stay tuned for more commentary on quality metrics and company culture.