The Medical Device Innovation Consortium said this week that it won nearly $3 million in funding from the FDA for the expansion of its case for quality and medical device cybersecurity programs.
MDIC plans to put the $2.8 million award toward medical device manufacturing sites with quality system issues or ones that have been out of compliance with quality system regulations, while it also expands proposed work on threat modeling for cybersecurity in medical devices to help manufacturers identify system-level risks.
The consortium said it also plans to launch a cybersecurity threat modeling boot camp. Its goal is to strengthen security by identifying weaknesses and threats to products, product lines or in a supply chain that might cause harm to patients.
Additionally, MDIC intends to study the adoption and use of advanced manufacturing in non-medical device industries to compare it with the medical device industry. This practice sets out to find barriers within the industry and inform manufacturers of ways to improve quality, performance and compliance.
MDIC expects to assist the FDA’s Center for Devices and Radiological Health in determining the success of these programs with compliant manufacturers to see if they can help non-compliant medical device manufacturers return to a state of compliance and improve the quality of their products, according to a news release.
“MDIC has been an essential partner for the case for cuality since 2015,” CDRH director Dr. Jeff Shuren said in prepared remarks. “The expansion of this program will enable us to further collaborate with MDIC to enhance the success of CfQ VIP while promoting high-quality devices and increasing patient safety. Further, we are encouraged that the work being done by MDIC on cybersecurity threat modeling could ultimately help medical device manufacturers strengthen their cybersecurity efforts, leading to safer, more resilient medical devices that improve patient lives. We remain committed to our MDIC partnership and identifying opportunities like these to enhance our work together.”