Thought Leadership
We don’t just operate in the regulatory space—we help shape it. As pioneers in cybersecurity for medical devices, our influence extends from the engineering bench to FDA guidance. These resources reflect the depth of our expertise and the leadership we bring to a rapidly evolving field.
Regulatory Science Meets Cyber Science; Why It’s So Much More than a Pen Test
Harbor Labs CEO Nick Yuran distinguishes cybersecurity from cyberscience, and explains why understanding the shared scientific disciplines of regulators and security professionals are important in achieving positive regulatory outcomes.
Harbor Labs Supports DOJ False Claims Act Litigation in Healthcare
Harbor Labs is proud to have supported the U.S. Department of Justice in its False Claims Act litigation against Kaiser...
The 2015 FDA Cybersecurity Alert That Shaped the Medical Device Industry
It could be reasonably argued that the medical device cybersecurity industry was born in August of 2015, when the FDA...
Dr. Mike Rushanan Teaches Groundbreaking Course on Medical Device Cybersecurity at Johns Hopkins University
The Internet of Things has long delivered on the promise of connecting everyday products such as smart thermostats,...
Compliance v. Completeness: Rethinking SBOMs Under FDA Premarket Cybersecurity Guidance
Harbor Labs Chief Scientist Dr. Mike Rushanan served as the Principal Investigator for the paper Compliance v....
Regulatory Science Meets Cyber Science; Why It’s So Much More than a Pen Test
Anyone who has had professional interaction with the FDA has encountered the term regulatory science. It is used...
SBOM Transparency v. Exposure: Evaluating Adversarial Risk in Healthcare
Harbor Labs Chief Scientist Dr. Mike Rushanan served as the Principal Investigator for the paper The SBOM Transparency...
Medical Device Manufacturer Must Do’s for Cybersecurity
At Harbor Labs, one of our most common services is reviewing the cybersecurity content of the premarket submissions of...
Medical Systems and Third-Party Smart Devices
It is an increasingly common practice in the medical device industry to integrate third-party smart devices such as...
DIY Diabetics and FDA Policy
This past week, I had the opportunity to brief policy analysts from the FDA on the growing Do-It-Yourself (DIY) trend in...