Empowering Medical Device Innovation with Tytonyx and Super Protocol's Confidential AI Solution

Case Study Snapshot: Tytonyx & BEL

Brain Electrophysiology Laboratory (BEL) needed to streamline FDA clearance for its AI-driven medical devices while protecting trade secrets. Tytonyx's AI-Agent automated the audit process, and Super Protocol's confidential AI cloud (using NVIDIA GPU TEEs & Intel TDX) ensured IP protection. This reduced review times from weeks to hours and eliminated human error risks, accelerating time-to-market and safeguarding BEL's innovations.

The Challenge: FDA Compliance & IP Protection in Medical AI

Brain Electrophysiology Laboratory (BEL), a recipient of National Institute of Health grants, develops cutting-edge medical devices and AI software for Epilepsy and Sleep disorders diagnostics. Meeting the FDA’s guidelines for AI/ML products is a major challenge for medical device manufacturers, requiring them to engage 3rd party auditors for quality reviews. This introduces risks related to critical trade secret exposure and delayed product launches due to human-caused errors – which creates significant pressure on ROI for products with lengthy R&D cycles.

Client Situation: Submission for FDA Clearance

BEL faces key challenges, including:

Protecting proprietary know-how and minimizing trade secret risks.
Eliminating human mistakes during reviews to ensure clearance without multiple iterations.
Reducing review times and improving product economics without compromising quality or compliance.

Traditional Solution: Lengthy & Risky Audits

Standard audit processes involve application reviews by external agencies, often taking weeks to complete, and requiring multiple NDAs. None of this prevents errors in documentation or guarantees data security, given that external agencies provide human-based feedback and serve multiple competing clients. Mistakes, if discovered at FDA review, delay time-to-market for up to 120 days, and delay both patient access to critical care and capturing product revenue.

The AI-Driven Approach: Automation & Confidentiality

Tytonyx Automated AI-Agent Solution

Tytonyx, a US-based AI company, offers a cutting-edge AI-Agent that streamlines and accelerates the auditing process for FDA applications of medical devices. BEL adopted this automated AI solution to enhance its submission efficiency and reduce risks of human errors. However, the protection of proprietary data remained a critical challenge, as traditional Cloud-based hosting of the AI Agent still posed risks related to IP confidentiality.

Super Protocol IP Protection During AI-Auditing

To address the critical need for data confidentiality, Tytonyx partnered with Super Protocol, which provided a decentralized, trusted-by-design confidential AI cloud. Built on a zero-trust foundation, this architecture ensures that BEL’s proprietary know-how remains fully protected — inaccessible even to hardware, infrastructure, or audit software providers involved.

Business Impact: Accelerated Compliance & Secured Innovation

Business Impact from Confidential AI-Agent Processing on NVIDIA GPU TEE and Intel TDX

With the combined capabilities of Tytonyx’s automated AI-agent audits and Super Protocol’s secure infrastructure based on NVIDIA GPU TEEs and Intel TDX, BEL achieved the following:

IP Protection

Trade secret risks were eliminated, ensuring BEL’s competitive edge while accelerating product launches.

Faster Time-to-Market

BEL reduced compliance review times from 2-4 weeks to just 1-2 hours, while eliminating risks of human-caused iterations that can extend the process for up to 120 additional days.

Faster Patients access to care

Innovative medical devices reach patients significantly faster, reducing delays in delivering critical treatments.

These results not only expedite patient access to life-saving medical devices but also safeguard BEL’s innovation pipeline, ensuring the sustainability of its R&D investments.

Scaling within Medical Industry

As the collaboration between BEL, Tytonyx, and Super Protocol matures, medical device manufacturers will benefit from a fully confidential, secure environment for ongoing quality reviews, enabled by NVIDIA GPU TEE and Intel TDX. This revolutionary approach is expected to save months in development time per product while ensuring ultimate IP protection and regulatory compliance. For BEL and the broader medical device industry, this translates into faster patient care, earlier return on R&D costs, and long-term competitive differentiation.

Technical Deployment Details

Super Protocol is a confidential and self-sovereign AI cloud and marketplace that enables AI projects to collaborate and allows AI developers and data providers to process and monetize models and datasets — with full privacy, ownership, and control for everyone involved.

Its decentralized, programmatically orchestrated infrastructure enables confidential workloads to run across independently operated nodes, eliminating reliance on a single cloud provider. This architecture ensures security, scalability, and flexibility for AI development and deployment.

For this project, Super Protocol leveraged confidential computing infrastructure to run workloads across two independently operated and physically distributed locations:

Gcore colocation: hosting Exxact 2U servers, paired with NVIDIA H100 GPUs and 5th Gen Intel Xeon Scalable CPUs, operated by an independent TEE provider
Engage Stack cloud: equipped with a Lenovo SR680a HGX 8-GPU system, paired with NVIDIA H200 GPUs, 5th Gen Intel Xeon Scalable CPUs, and 4 NVSwitch modules.

All systems operated in confidential computing mode, using Intel TDX and GPU TEEs, and were deployed on Ubuntu OS — ensuring trusted, verifiable AI execution across a distributed, multi-provider environment. ensuring trusted and verifiable AI execution across a distributed, multi-provider environment.

All systems operated in confidential computing mode, using Intel TDX and GPU TEEs, ensuring trusted and verifiable AI execution across a distributed, multi-provider environment.

Blockchain infrastructure is crucial for enabling the algorithmic, trustless orchestration of the confidential computing network. Super chose opBNB Chain, a high-performance Layer 2 solution within the BNB Chain ecosystem, for its speed and enterprise-grade reliability, delivering high transaction volumes seamlessly for Super’s clients.