The Medical Device Innovation Consortium (MDIC) recently partnered with the MITRE Corporation, Adam Shostack, and the FDA to host a webinar regarding the soon to be released “Playbook for Threat Modeling Medical Devices.” The playbook was created during a series of bootcamps held by the team over the past year and the webinar provided a quick overview for the public. A playback of the webinar is available here.
The idea of creating a playbook came as a result of recognizing the lack of official methodologies for threat modeling in the increasingly complex ecosystems of the medical device industry. The writers drew from techniques and processes proven to strengthen cybersecurity and safety in a variety of other domains. The importance of bringing threat modeling into the design early cannot be emphasized enough. Though many companies can be reluctant to spend the time early on, it can keep development costs down in the long run by preventing re-work and recalls. Used in conjunction with other resources like AAMI TIR 57 (See our post on TIR57) and ISO 14971 (See our post on the ISO 14971 2019 update), a proper cybersecurity risk management strategy can be followed, that incorporates feedback mechanisms to reassess the maturity of the threat model throughout the product lifecycle.
The speakers did make a point of noting that the playbook was not created as a “how-to” guide or checklist. Rather, it was created as a resource to walk you through the process of creating your own threat model using examples which were designed to incorporate as many scenarios as possible.
The goal is to release the playbook sometime in February, 2022.