The Medical Device Innovation Consortium (MDIC) has announced the release of its Leadership Engagement Playbook of best practices and tools to help leaders move their companies from a culture of compliance to a culture of quality. Created through the Case for Quality Collaborative Community (CfQcc), the playbook aims to help organizations tailor their approach to quality by providing resources to determine which concepts, processes, techniques, and practices to implement.
The Leadership Engagement Playbook describes 10 best practices for moving from a culture of compliance to a culture of quality and provides a framework for piloting best practices. Leaders can use the playbook to invest in a culture of quality, share their performance improvements, and shift out of a culture of compliance. This will increase the level of quality across the industry, enabling medical devices to provide more value for manufacturers, providers, and patients.
“We recognize that every company has a unique culture and set of challenges which is why it was critical for this playbook to offer a customizable set of solutions. We look forward to continued collaboration as organizations implement these practices and share their results to raise the level of quality across the entire medical device ecosystem,” said Pamela Goldberg, MDIC President and CEO.
By establishing a culture of quality, life sciences organizations can experience added benefits including: meeting FDA expectations, meeting the needs of customers, improving financial results, facilitating innovation, and achieving a competitive advantage.
“A culture of quality moves an organization away from the silos that make quality the responsibility of one person or group, as it is a shared responsibility,” said Francisco Vicenty, program manager for the Case for Quality (CfQ) within the Food and Drug Administration’s Office of Compliance, Center for Devices and Radiological Health (CDRH). “This principle is the intent of the quality system regulations, integrating all the people, processes, departments, and functions around how to deliver the best outcome with the aim of improving the quality and safety of the products. This playbook created by the CfQ Collaborative Community may be an additional resource companies can leverage to potentially improve safety, quality, and gain value.”
About the Medical Device Innovation Consortium
Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s mission is to promote public health through science and technology and to enhance trust and confidence among stakeholders. MDIC works in the pre-competitive space to facilitate the development of methods, tools, and approaches that enhance understanding and improve evaluation of product safety, quality, and effectiveness. Its initiatives aim to improve product safety and patient access to cutting-edge medical technology while reducing cost and time to market. For more information, visit https://www.mdic.org.
About the Case for Quality Collaborative Community
The Case for Quality Collaborative Community (CfQcc) offers a unique opportunity for medical device stakeholders to work together to enhance device quality and patient safety. This program allows the FDA to identify device manufacturers that consistently produce high-quality devices. This enables the Agency to allocate its resources to assist other manufacturers with increasing the level of quality in their devices. As the Convener of CfQcc, MDIC helps the FDA with recognizing and supporting practices that encourage consistent quality manufacturing. Participating stakeholders include medical device companies, healthcare providers, payer organizations, trade associations, and educational institutions. For more information, visit https://mdic.org/program/case-for-quality/.
