What You Should Know:
– At the Diabetes Technology Society Conference (DTM 2025), Thirdwayv Inc. and Medcrypt Inc. announced a strategic 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 security.
End-to-End Compliant Security Solution
The alliance brings together complementary strengths to deliver integrated solutions that help medical device manufacturers (MDMs) manage security from design through deployment.
- Thirdwayv’s Expertise: Thirdwayv provides secure connectivity and cryptographic identity Software Development Kits (SDKs). The company has a decade-long track record of providing comprehensive software for hundreds of millions of FDA-cleared, connected diabetes automated management systems. Thirdwayv was also an instrumental steering committee member of the IEEE 2621 standard (which originated from DTSec) for wireless digital diabetes device security recognized by the FDA.
- Medcrypt’s Expertise: Medcrypt offers a platform to help MDMs identify, assess, and mitigate vulnerabilities while streamlining compliance with evolving FDA and global regulatory requirements. Medcrypt experts have contributed to key industry frameworks, including the Health Sector Coordinating Council’s Joint Security Plan v2 (JSP2) and the IEEE 2621 Standards Series.
Mike Kijewski, CEO of Medcrypt, praised the partnership: “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.”
Accelerating Compliance & Time to Market
Together, Thirdwayv and Medcrypt will deliver integrated solutions designed to accelerate compliance and reduce business risk. The joint effort focuses on four critical areas:
- Early Security Integration: Embedding security earlier in the device development process.
- Lifecycle Compliance: Maintaining continuous compliance throughout the entire device lifecycle.
- Regulatory Submissions: Appropriately documenting cybersecurity controls and traceability in regulatory submissions.
- Secure Deployment: Confidently deploying secure over-the-air (OTA) software updates for connected devices.
The core value proposition is the joint delivery of a validated security and compliance pathway for MDMs looking to accelerate time to market by de-risking cybersecurity regulatory compliance with the FDA and other global agencies.
