FTI Leads Industry/FDA Collaboration to Develop Leadership Engagement Playbook
Playbook to Improve Quality of Medical Devices
Most life sciences organizations exhibit a culture of compliance, rather than a culture of quality. The Playbook describes 10 best practices that enable transformation.
This Case for Quality program led to the creation of the Medical Device Innovation Consortium (MDIC) in late 2012, a public-private partnership with the sole objective of advancing regulatory science to benefit patients.
This organization brings together representatives from the FDA, National Institutes of Health, Centers for Medicare & Medicaid Services, the medical device industry, and patient organizations to collaborate and improve the development, manufacturing, and commercialization of higher quality and safer medical devices and also foster the innovation of new medical technologies.
Company culture is one element recognized by FDA and industry as vital to the success of any organization and core to its quality management program. The life sciences industry is highly regulated, manifesting itself as a “Culture of Compliance” within most organizations.
However, the problem with this culture is its focus on the laws and regulations themselves - which are intended to define minimum requirements. Consequently, organizations focus on “doing things right rather than doing the right things,” limiting themselves to addressing compliance requirements with the FDA as a primary focus and patients and providers.