The pilot program will use the CMMI appraisal process to provide FDA regulators with data and insights into a manufacturing facility’s capabilities, quality process and performance. Device manufacturers, including those with MDIC membership, that become successful pilot program and appraisal participants would gain FDA regulatory benefits in an industry-wide effort to enhance device performance and improve time to market.
The FDA program, within its Center for Devices and Radiological Health (CDRH), has involved MDIC, CMMI Institute and healthcare industry leadership, and is a response to the growing need for actionable, unifying regulatory approaches focused on improved outcomes for patients using medical devices. A few of the companies participating in the development of the program include Boston Scientific Corp., Johnson and Johnson, Deloitte, Stryker Corp. and Innovize.
“MDIC offers a unique forum for medical device stakeholders to advance medical device quality and safety to achieve better patient outcomes,” said Bill Murray, president and CEO of MDIC. “In order to assess companies for this pilot program, we needed a tool to define manufacturers’ maturity—which prompted the inclusion of CMMI’s appraisal process.” CMMI Institute provides the tools and support for organizations to benchmark their capabilities and build maturity by comparing their operations to best practices and identifying performance gaps. CMMI appraisals, used in multiple industries and governments globally, provide a foundation for organizations to weigh risks and opportunities for continuous process improvement. The goal of this pilot is for the FDA to have greater confidence in firms that demonstrate high-quality systems in order to allow the agency to focus its limited resources on less mature firms.”
“We are honored to partner with MDIC and the medical device industry to drive improved patient outcomes. CMMI Institute has a history of elevating the reliability and performance of appraised organizations and industries,” stated Kirk Botula, CEO of CMMI Institute.
The pilot is open to all companies in the medical device industry that market in the United States. Organizations can learn more and/or register to participate in the pilot.
At the FDA, CDRH is seeking comment on the program.
Public comments will close Oct. 18. Once the pilot program is complete with public commentary, official program registration is slated to begin in December.
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. The organization works in the pre-competitive space to facilitate development of methods, tools, and approaches that enhance understanding and improve evaluation of product safety, quality, and effectiveness. Its initiatives improve product safety and patient access to cutting-edge medical technology while reducing cost and time to market.
A subsidiary of ISACA Enterprises, CMMI Institute helps advance best practices in people, process, and technology. The Institute provides the tools and support for organizations to benchmark their capabilities and build maturity by comparing their operations to best practices and identifying performance gaps. For over 25 years, thousands of high-performing organizations in a variety of industries, including aerospace, finance, healthcare, software, defense, transportation, and telecommunications, have earned a CMMI maturity level rating and proved they are capable business partners and suppliers.