The FDA develops regulations that set the standards for medical device design as well as their production. Today, when it comes to medical products, there is the new paradigm. It’s not quality over compliance, more that regulatory compliance is now the baseline and not the goal.
The FDA refers to its new paradigm as the “focus on quality”. That phrase means that for the FDA and the stakeholders in medical device manufacturing a greater emphasis is on “critical-to-quality practices” that lead to higher quality outcomes. Not only does the FDA look for “critical-to-quality practices” undertaken by manufacturers on a day-to-day basis in the design and production of medical devices, they also look to incorporate such practices in agency operations.
Battery Critical-to-Quality Pilot. The FDA’s “Focus on Quality” efforts began with a pilot study of the manufacture of medical devices that use batteries. They began by establishing a framework for identifying specific operations, design components and quality controls. These factors have strong consequences for the quality and safety of implantable medical devices . The FDA then changed its inspection protocols to concentrate more on these factors. The participants in the pilot program will work with the FDA to review the outcomes and determine the effectiveness of this approach to manufacturing and to FDA review.
FDA Library of Quality Practices. The FDA maintains a library of best practices in quality control. Medical device manufacturers can use the library to identify tools that will help them update their protocols in design and manufacturing techniques. The library has contributions from both the FDA and industry partners which allows manufacturers to share in the knowledge of quality practices so that everyone works together in the effort to improve quality. The FDA library includes resources contributed by the American Society for Quality and Advanced Medical Technology Association (Advamed).
The Case for Data Transparency. The FDA receives data on device quality from various sources, such as inspection results, adverse events, warnings, and recall reports. The latest FDA proposal is to share this critical information by publishing the data in a format that stakeholders can access and research using various analytical tools. They will also be analyzing the data and publishing the results of the analyses for stakeholders to review.
Engaging the Stakeholders. The FDA understands that to make this increased quality focus work, the agency needs to work with stakeholders and get their feedback. This increased dialogue has resulted in a more collaborative approach to improved quality practices.
The greatest benefit of this new approach to quality inspections is the increased transparency for stakeholders. Companies have a clearer idea of what to expect when an inspector arrives on-site. Companies who follow the quality control measures suggested have a 20-30% decrease in quality related costs. That, in turn, translates to increased profits of 3-4%. It also makes the manufacturers more competitive against competitors who do not follow such practices.
It’s a win-win for FDA, too. The collaborative protocol helps move the FDA forward in its mandate to improve public health. It helps them identify the manufacturers who follow the protocol so that the agency can spend its limited inspection resources on those companies who have not yet complied with the quality protocols.
A cultural shift of this size demands the engagement of regulators, industry, providers, payers and patients. Driving quality organization-wide enables companies to be more productive. They suffer through fewer complaints and investigations. And with smaller quality units with lower quality-related costs they can outshine competitors.
In other words, investing in quality pays.
Firms with an established quality culture are able to avoid quality failures and shift the resulting freed resources to accelerate device design, innovation, and market introduction.