Thirdwayv, a specialist in secure software for connected medical devices, and Medcrypt, a provider of medical device cyber-security and vulnerability management, have agreed to work together.

The agreement to advance cyber-security and interoperability standards across the connected medical device ecosystem was announced at last month’s Diabetes Technology Society Conference, in California.

The partnership seeks to address the increasing regulatory and operational demands for robust, life-cycle-spanning medical device cyber security. Together, Thirdwayv and Medcrypt will deliver integrations that help medical device manufacturers embed security earlier in development, maintain compliance throughout the device lifecycle, appropriately document cyber-security controls and traceability in regulatory submissions, and deploy secure over-the-air (OTA) software updates for connected devices.

Both companies bring complementary strengths to the partnership. Thirdwayv’s secure connectivity and cryptographic identity software development kits (SDKs) have been essential in the implementation of wireless cyber security, enabling smartphone control for hundreds of millions of US FDA-cleared, connected diabetes automated management systems.

Medcrypt’s platform empowers device manufacturers to identify, assess and mitigate vulnerabilities while streamlining compliance with evolving FDA and global regulatory requirements. With several Medcrypt experts serving as contributing authors of the Health Sector Coordinating Council’s Joint Security Plan (JSP), the company brings insight into how regulators expect cyber security to be implemented across the total lifecycle.

Medcrypt’s software and services span vulnerability management, cryptography, security programme assessments, and regulatory pre- and post-market services, helping manufacturers reduce security and business risk while aligning with best practices and standards. The company advances the industry’s cyber-security maturity through active participation in standards working groups.

“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 is a game changer,” said Mike Kijewski, CEO of Medcrypt (www.medcrypt.com). “Thirdwayv’s decade-long track record of providing comprehensive software and intellectual property 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.”

Jim Kamke, CEO of Thirdwayv (thirdwayv.com), added: “We are thrilled to be partnering with Medcrypt to create the most complete and compliant cyber security. As the global leader in healthcare cyber security, 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 two California-based companies will jointly deliver a validated security and compliance pathway for medical device manufacturers looking to accelerate time to market by de-risking cyber-security regulatory compliance in the FDA and other regulatory agencies throughout the world.