In 2011, the FDA launched its Case for Quality. As part of that initiative, the FDA and members of the Medical Device Innovation Consortium (MDIC) met repeatedly to discuss and develop a strategic plan and define specific initiatives to move companies from a culture of compliance to a culture of quality. Compliance focuses on meeting regulatory requirements, whereas a culture of quality embodies the principle of continuous improvement and focuses on customer (providers and patients) needs. One of these initiatives has led to a Leadership Engagement Playbook that describes best practices.
Quality is integral to the entire organization. A survey among MDIC members taken during the initiative highlighted the importance of leadership, role definition, behaviors, and communications, and revealed where companies were falling short. The team then collected best practices and crafted a playbook that provides guidance in 10 key areas: Facilitate a Culture of Quality, Develop a Quality Strategy, Make Quality a Priority, Measure the Value of Quality, Be Proactive - Not Reactive, Clearly Define Quality at the Individual Level, Encourage Quality Behaviors, Use Quality Benchmarking, Use Quality Metrics, and Recognize and Reward Quality. The panel members will present the key principles embodied within the playbook as well as their personal experiences implementing quality programs in their organizations.

Leadership Engagement: Fostering a Culture of Quality

DIA Europe 2022

A global, member-driven non-profit organization mobilizing life sciences and healthcare. DIA fosters innovation to improve health and well-being worldwide. Professionals from 80 countries continue to engage with DIA through our unparalleled membership network, educational offerings, and professional development opportunities.