Strategy and Solutions
The client is a seed-stage digital therapeutics company focused on cardiac and behavioral health monitoring. They aimed to launch an FDA-cleared CBT-based digital therapeutic application integrated with biofeedback systems. However, they lacked a scalable cloud platform, clinical validation framework, and regulatory-ready architecture. To accelerate product development and compliance, the company partnered with Zymr.
The client needed to build a regulated Software as a Medical Device (SaMD) platform combining cardiac monitoring with cognitive behavioral therapy (CBT). However, there was no existing infrastructure to support biofeedback-driven therapy or real-time patient monitoring.
Clinical validation was a major hurdle, as the platform required measurable outcomes and regulatory-grade data to support FDA submission. Without a structured approach, achieving compliance within timelines was difficult.
The absence of clinician-facing tools limited the ability to monitor patient progress and adjust therapy protocols. Additionally, lack of integration with EHR systems created data silos, impacting continuity of care.
The company needed a secure, scalable, and compliant cloud platform that could support therapy delivery, data capture, and regulatory workflows while ensuring a seamless patient and clinician experience.
Zymr enabled the client to successfully build and launch a connected cardiac monitoring and CBT platform with full regulatory compliance. The solution accelerated time-to-market while ensuring clinical effectiveness and scalability.
Zymr designed and implemented a cloud-native SaMD platform integrating cardiac monitoring, CBT protocols, and clinical workflows.
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