The Challenge
A medical device manufacturer built a Medical Device Hub (MDH) to serve as a central connection point for a wide range of devices developed by different teams, each using varying technology stacks. To support secure growth and maintain regulatory compliance, the platform had to:
- Authenticate devices from diverse teams without overwhelming the registration process.
- Verify public keys securely to ensure only authorized devices could connect.
- Manage certificates centrally, including updates and revocations.
- Support in-field reprovisioning without disrupting clinical workflows.
- Scale securely, maintaining visibility and control across an expanding device ecosystem.
The Solution: Medcrypt’s Guardian
Medcrypt’s Guardian Platform delivered the tools needed to build a secure and scalable MDH:
- Simplified device registration and authentication, minimizing operational overhead for diverse device teams.
- Public key verification to ensure trusted communication and establish a robust Root of Trust.
- Cloud-based certificate management, enabling secure issuance, renewal, and revocation across lifecycles.
- Secure in-field reprovisioning, allowing updates without physical intervention.
- Scalable key management architecture to support growth and maintain security posture.
The Impact
Guardian enabled the manufacturer to implement a secure, compliant, and scalable foundation for device connectivity - future-proofing the platform and enhancing both security and clinical efficiency.
- Simplified onboarding and authentication for new devices.
- Established consistent security through a unified Root of Trust.
- Enabled continuous compliance via secure provisioning and certificate lifecycle management.
- Supported centralized control of growing device fleets.
- Met FDA cybersecurity expectations without rework or delay.