A key piece of managing medical device and diagnostic cybersecurity risks is the integration of threat modeling (TM). TM provides a blueprint to strengthen security through the total product lifecycle of the devices, thereby ensuring improved safety and effectiveness of medical products. Threat Modeling must be used to systematically identify, evaluate, and prioritize potential security threats and vulnerabilities to enhance overall risk management and defense strategy of medical devices.
In 2019, FDA awarded funding to MDIC to increase awareness on systematic approaches to TM that can enable manufacturers to effectively address system level risks. MDIC delivered multiple bootcamps on TM for medical device stakeholders. MDIC collaborated with over two dozen SMEs on threat modeling – both from MedTech and non-MedTech sector, led by Shostack & Associates, in developing the modules for bootcamps. The selected participants included both technical professionals working in the product development sector as well as regulatory professionals in the medical device public and private sectors.
In parallel to the bootcamps, MDIC and MITRE collaboratively developed the Playbook for Threat Modeling Medical Devices.
Intensive, hands-on sessions on threat modeling.
Learning about structured, systematic and comprehensive approach to threat modeling for engineering more secure systems from SMEs from public and private sector.
Networking opportunity with SMEs from MedTech and non-MedTech sectors to learn on cybersecurity best practices that can be incorporated into the medical device industry
To learn more about participating in a TM Bootcamp, please contact the MDIC Cybersecurity team at cybersecurity@mdic.org
Mitre
Mitre
MedSec
MedSec
FDA
Smith + Nephew
Abbott
BD
Roche
FDA
Abbott
Johnson and Johnson
Beckman Coulter
Apraciti
Medtronic
Boston Scientific
Shostack + Associates
FDA
Roche
Beckman Coulter
Kansas State University
Mitre
Motional
I am the Cavalry
Mitre