Thirdwayv Inc. and Medcrypt Inc. have signed 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, life-cycle-spanning medical device cybersecurity. Together, Thirdwayv and Medcrypt will 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 confidently deploy secure over-the-air (OTA) software updates for connected devices. 

“We are thrilled to be partnering with Medcrypt to create the most complete and compliant cybersecurity solution,” Thirdwayv CEO Jim Kamke said. “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.”

Both companies bring complementary strengths to the partnership. Thirdwayv’s secure connectivity and cryptographic identity Software Development Kits (SDKs) have been essential in implementing wireless cybersecurity, enabling smartphone control for hundreds of millions of U.S. Food and Drug Administration (FDA)—cleared, connected diabetes automated management systems. Moreover, Thirdwayv was an instrumental steering committee member of the IEEE 2621 standard, which originated from the Diabetes Technology Cybersecurity Standard (DTSec), for the wireless digital diabetes device security that is recognized by the FDA. Thirdwayv helped define the global benchmark for safe, continuously connected insulin delivery systems that meet or exceed the IEEE 2621 standards.

Building on this foundation, 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 deep insight into how regulators expect cybersecurity to be implemented across the total lifecycle, according to the company.

Medcrypt’s software and services span vulnerability management, cryptography, security program assessments, and regulatory pre- and post-market services, helping manufacturers reduce both security and business risk while aligning with industry best practices and standards. The company further advances the industry’s cybersecurity maturity through active participation in standards working groups, contributing to key frameworks like the HSCC “Joint Security Plan v2” (JSP2) and the IEEE 2621 Standards Series for Wireless Diabetes Device and Systems.

“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,” Medcrypt CEO Mike Kijewski stated. “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.”

Under this partnership, the companies will 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 FDA and other regulatory agencies throughout the world.

Based in Irvine, Calif., Thirdwayv enables secure, scalable wireless IoT solutions for healthcare, FDA-regulated medical devices, financial services, and critical infrastructure through multi-layered security software solutions. Their technology is proven in automated insulin delivery systems and other high-risk connected devices.

Medcrypt is helping healthcare technology companies ensure medical devices are secure by design. The firm provides cybersecurity products and strategic management consulting to expedite the go-to-market process of medical device manufacturers’ new connected technologies. Founded in 2016 by healthcare cybersecurity experts, Medcrypt is positioned to be the security catalyst for medical device manufacturers to design secure, FDA-approved technologies.