As the medical device industry embraces cloud-native technologies, security can no longer be treated as an afterthought. From mobile apps to cloud infrastructure, every layer plays a role in safeguarding patient data and ensuring device integrity. In our earlier posts, we explored the shift to...
Introduction Building on the cloud-native trend explored in Part 1 of this series, medical platforms are undergoing a foundational shift toward architectures that depend on cloud-connected companion apps as critical components. These apps are increasingly responsible for user interface, data transmission, and remote monitoring. Particularly in...
Introduction The medical device industry is experiencing a pivotal transformation. Cloud-native architecture is rapidly becoming the backbone of modern healthcare platforms, driven by widespread smartphone adoption, the rise of home-based care, and heightened demand for remote monitoring solutions. The COVID-19 pandemic accelerated these trends, highlighting the...
At Key Tech, we work on all manner of instruments that collect and analyze raw data for novel therapies, research, and diagnostic decisions. Over the past ten years, the amount of raw or unprocessed data associated with these instruments has grown tremendously. While having this...
To follow up on Lei Zong's post last week about threat assessments, a specific area of concern that is overlooked is related to vulnerabilities of Software of Unknown Provenance (SOUP) items. The FDA has been working to change that by requiring a more systematic approach...
During this challenging time, cybersecurity for medical instruments should be on the forefront of every device designer’s mind, particularly those life-saving devices such as ventilators. It is imperative to incorporate cybersecurity strategies into each step of the software development process, from architecture threat assessment to penetration...