Combination Product Industry News & Guidance

Cybersecurity: Consider the Network, Not Just the Device

We wanted to share this Seattle Times article, “Why health care has become a top target for cybercriminals,” which does a good job of consolidating cybersecurity risk in the healthcare environment and why it has become a focus of our industry – including drug delivery device and combination product development.

It is not just patient records that are of concern, but also medical devices like X-ray and CT scanning machines. While they might not carry patient data directly, they can act as an entry point for attackers trying to break into an organization’s broader network. In a health care facility, there could be hundreds of internet-connected devices which require various types of security measures that, to date, have not always been prioritized. As we develop devices for combination products, we not only need to consider the cybersecurty of that device, but also the cybersecurity of the network within which it might be connected.

This is one reason why the FDA is focusing so much on cybersecurity, as have our Suttons Creek consultants. Although the broader health care ecosystem is not under control of the FDA, they have taken it upon themselves to ensure cybersecurity for those aspects over which they do have jurisdiction (medical devices).

If you feel like you need a conversation to understand the areas of cyber risk that you should be addressing within your own combination products, please reach out. We are happy to help ensure you are covering all of your cyber-bases.

AUTHOR

Jonathan Amaya-Hodges, Director, Technical Services, Suttons Creek, Inc. – Jonathan has over 16 years of multidisciplinary experience in regulated medical products (drugs, biologics, medical devices, and combination products) at multiple global companies. He has practical experience in Development/Engineering, Quality Assurance, and Regulatory Affairs for various types of combination products with a focus on drug delivery. Additional background includes digital health (including smart packaging/connected devices and software as a medical device, or SaMD) and in vitro diagnostics, along with clinical development (bridging) and lifecycle management for combination products. Jonathan engages with the global combination product community by speaking at conferences, lecturing in courses, serving key roles within prominent industry organizations, and interfacing with regulators on a variety of topics.