The agreement will focus on delivering integrated solutions to support device cybersecurity, interoperability, and regulatory compliance from development through deployment.
Thirdwayv, specializing in secure software solutions for connected medical devices, and Medcrypt, a provider of medical device cybersecurity and vulnerability management solutions, announced at the Diabetes Technology Society Conference, DTM 2025, the signing of an agreement to jointly advance cybersecurity and interoperability standards and solutions across the connected medical device ecosystem.
The partnership seeks to address the increasing regulatory and operational demands for robust, lifecycle-spanning medical device cybersecurity. Together, Thirdwayv and Medcrypt aim to deliver integrated solutions that help medical device manufacturers embed security earlier in development, maintain compliance throughout the device lifecycle, appropriately document cybersecurity controls and traceability in regulatory submissions, and deploy secure over-the-air software updates for connected devices.
“With the increasing need to connect mission-critical medical devices to the internet and directly to each other, having access to an existing, previously certified secure connectivity solution is a game changer,” says Mike Kijewski, CEO of Medcrypt, in a release. “Thirdwayv’s decade-long track record of providing comprehensive software and intellectual property solutions for hundreds of millions of smartphone-connected insulin pumps is truly impressive. We look forward to working with Thirdwayv to offer our customers an end-to-end compliant security solution.”
Jim Kamke, CEO of Thirdwayv, adds in a release, “We are thrilled to be partnering with Medcrypt to create the most complete and compliant cybersecurity solution. As the global leader in healthcare cybersecurity, Medcrypt’s expertise is critical to this collaboration and ensuring the future of medical device security. Together, we will help medical device manufacturers stay protected throughout the lifecycle of their devices.”
Under this partnership, the companies aim to jointly deliver a validated security and compliance pathway for medical device manufacturers looking to accelerate time to market by de-risking cybersecurity regulatory compliance in the US Food and Drug Administration and other regulatory agencies worldwide.
