Exploring Medical Device Manufacturing Domain Threat Modeling Methodologies: User Perspectives on Security, Privacy and Safety

Threat Modeling is one of the key tools used to identify cyber threats and evaluate the risks of cyber threats against Modern Medical Devices (MMDs). However, there is no existing study that investigates how MMD manufacturers utilize and perceive existing threat modeling methodologies. To address this gap, we conducted a survey involving 81 participants from many MMD manufacturing companies. Our research aims to uncover potential challenges when repurposing threat modeling methodologies—originally conceptualized for IT systems—for MMDs. Our research questions focus on understanding: which threat modeling methodologies are used; the privacy, and safety concerns of threat modeling methodologies used; and how threat model methodologies identify such issues. The study revealed that STRIDE is the most used methodology in the MMD domain. The study also discovered that satisfaction with participants’ threat modeling methodologies was not significantly dependent on the effectiveness of the methodology in discovering privacy and safety issues. Privacy concerns are more likely ($61 \%$) to be a factor in participants’ satisfaction with their methodology as compared to safety $(\mathbf{4 6 \%}$). Through this study, we offer a fresh perspective on how threat modeling is perceived and applied in the MMD industry and yield insights into the perceived privacy and safety issues of MMDs.

I. Introduction

A significant number of people around the world rely on Modern Medical Devices (MMDs) to either improve their health conditions or to treat health-related issues. For example, a patient with unbearable back pain may have a spinal cord stimulation which is implanted into the epidural space while a patient with heart problems may have a pacemaker implanted surgically near the heart [1]. The healthcare sector transformation through the integration of cutting-edge technology is characterized by the swift adoption of intelligent devices that utilize various communication protocols such as Bluetooth Low Energy (BLE), and Zigbee [2], [3]. Considering the importance of MMDs to patients and healthcare providers, ensuring their security has recently become critical due to new MMDs that can remotely collect sensitive patient data to manage patients’ health [1].