Understanding the Case for Quality Program by the FDA

To promote better public health, the United States Food & Drug Administration has launched the Case for Quality program intended to raise production standards for medical devices. The initiative began in 2011 when the FDA discovered common risks in medical device manufacturing and the challenges involved in improving quality.

Research showed that manufacturers who focused on mitigating those risks enjoyed more productivity and fewer accidents than those who did not. The FDA concluded that investing in product quality generates worthwhile payoffs for all stakeholders over the long term.

New Priorities

The Case for Quality program follows in line with the FDA’s strategic priorities for the coming years:

• A dedication to employee success. Employees engaged in their work are more motivated and achieve better productivity. The FDA intends to foster communication between employees and manufacturers, improve work-life balance, and provide more opportunities to succeed in this regard.
• A new focus on simplicity. Medical issues are often complicated, but the FDA believes that simple solutions can still have an immense impact.
• An effort to foster collaborative medical communities. Stakeholders should work together to solve the community’s shared problems and raise public health standards for everyone.

Working with Stakeholders

The FDA will work with various stakeholders in the industry, including health care providers, patients, and investors for this initiative. The medical community can learn from the manufacturers that produce the highest-quality devices, and the FDA can adopt these best practices in its own regulations.

Utilizing Data

Case for Quality emphasizes the importance of a data-driven approach. The FDA will now analyze device quality and performance through empirical means, allowing stakeholders to focus their strategies toward better medical device quality.

Additionally, the FDA will continue to support its Library of Quality Practices, an essential resource for industry partners to collaborate on existing knowledge.

Benefiting Everyone

This program will not only reduce costs and increase profits for manufacturers, but a stronger focus on device quality also raises customer satisfaction and trust. Hospitals and patients will appreciate the smoother review process for new devices resulting in faster access for consumers.

The Case for Quality in Three Parts

• Quality and Outcome: The FDA’s new program will focus on not only device manufacturing but also how it affects the patient’s outcome. It aims to improve product design and manufacturing error detection.
• Data Transparency: The data regarding medical device quality, such as recall information and event reports, is available on open.fda.gov. Independent stakeholders can access, search, and analyze this information.
• Stakeholder Engagement: To expand on the collaborative nature of the program, the FDA continues its discussions with the Medical Device Innovation Consortium at public meetings.

Improve Your Quality Control and Patient Outcomes

Your organization needs to keep up with the Case for Quality program and other FDA developments. The Center for Professional Innovation and Education offers detailed training courses for pharmaceutical, biotech, and medical device companies.

Take advantage of our pharmaceutical training to update your company’s internal policies and staff knowledge. A few of our relevant quality control training courses include:

• Product Quality Reviews [Pharma/Biotech]
• Quality Assurance/Quality Control for Biologics and Biopharmaceuticals [Pharma/Biotech]
• Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries [Medical Device] [Pharma/Biotech]

Are you interested in attending one of these courses? Please call 1-610-648-7550 or visit Cfpie today!