The Case for Quality
FDA launched the Case for Quality in 2011 to elevate the focus of all medical device stakeholders from baseline regulatory compliance to sustained, predictive practices that advance medical device quality and safety to achieve better patient outcomes.
A cultural shift of this magnitude demands the engagement of regulators, industry, providers, payers and patients. So in 2014, FDA enlisted the Medical Device Innovation Consortium (MDIC) to foster a new level of collaboration between the Agency and industry in a far-reaching Case for Quality movement.[youtube title=”” size=”h3″ transform=”none” link=”” style=”top” id=”5ne0cjCOwhs” height=”200″ border=””] [/youtube]
Today, the Case for Quality offers a unique forum for medical device stakeholders to work together to enhance device quality and patient safety. Participants in the Case for Quality include FDA and a growing number of medical device companies, healthcare providers and payer organizations, as well as trade associations and educational institutions.
In 2017, MDIC is focused on expanding on the Maturity Model pilot, completed in 2016. The Maturity Model team is working on addressing the barriers to assessment, enrollment and measurement (metrics) for the implementation of the Maturity Model as part of the CDRH third party voluntary program to be announced in December 2017. MDIC is also continuing work on the development of an analytics dashboard to use accessible quality data to inform a user-friendly dashboard make it possible to compare medical devices based on quality. Such a dashboard also makes it possible for medical device companies to compete based on the quality of their products.
Quality: An investment that pays
FDA established the Case for Quality following an in-depth review of device quality data and feedback from regulatory and industry stakeholders. The FDA’s analysis flagged manufacturing quality risks. It also showed that firms that manage those risks by driving quality organization-wide are more productive, with fewer complaints and investigations per batch, and often with smaller quality units with lower quality-related costs than their 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.
Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, affirmed the Case for Quality’s role in advancing solutions to ensure patient access to high quality medical devices and the FDA’s commitment to their shared goal to improve patient outcomes. Listen to Dr. Shuren at a 2015 Case for Quality Forum in Washington, D.C.
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