The Medical Device Innovation Consortium (MDIC) has been awarded $2.8 million in funding by the U.S. Food and Drug Administration (FDA) for the expansion of the Case for Quality and medical device cybersecurity programs.
Jeff Shuren, director of FDA’s Centre for Devices and Radiological Health (CDRH), said: “MDIC has been an essential partner for the Case for Quality since 2015. 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 modelling 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.”
The new CfQ effort will apply the systemic improvement focus of the quality maturity appraisal used by the CfQ VIP, product safety metrics, and incorporate regulatory compliance perspective using the ISO 13485 standard.
MDIC will study the adoption and use of advanced manufacturing practices in non-medical device industries and contrast against the use in medical device industry, identify barriers within the industry that prevent adoption, and to inform how adoption of these best practices can improve quality, performance, and compliance. It will be launching a boot camp series on cybersecurity threat modelling for medical devices; and the development of threat modelling best practices for device stakeholders.
Together, MDIC will help CDRH and industry determine if the success of the CfQ VIP for compliant manufacturers can also help non-compliant medical device manufacturers accelerate their returning to a compliant state of operation while implementing improvements that not only address compliance gaps but also promote higher product quality.
Additionally, MDIC’s work on cybersecurity threat modelling for medical devices aims to enable manufacturers to address system level risks, including risks related to the supply chain, design, production, and deployment.
Original Article: (https://www.med-technews.com/news/fda-awards-funding-for-expansion-of-medical-device-cybersecu/)