MedTech

FDA-Approved Nerve Simulation Therapy: A MedTech Startup’s Success Story

Client is an innovative healthcare technology startup dedicated to improving the lives of patients suffering from chronic Overactive Bladder (OAB) conditions. Zimetrics engineered Edge to Cloud ecosystem for class II medical device leveraging AWS native architecture.

Challenges

  • Reengineer data & app platform for scalability, reliability, security, & compliance.​
  • Support clinical trials for OAB & Urge Incontinence.​
  • Implement digital workflow from prescription to patient payment.​

Solutions

  • Secure & Scalable Application Delivery
    • Amazon CloudFront + AWS WAF for global distribution and security.
    • Elastic Load Balancing + Amazon EC2 (NGINX) for highly available application hosting.
  • Application & Data Management
    • Amazon ECS for containerized workloads.
    • Amazon RDS for relational data management.
    • Amazon ElastiCache for optimized performance with caching.
  • Monitoring & Analytics
    • Amazon CloudWatch for centralized metrics and alerting.
    • Amazon OpenSearch Service for log analytics and real-time troubleshooting.
  • Advanced Capabilities
    • Complex patient data calculations and analytics for decision support.
    • Developed clinician and patient apps for seamless engagement.
    • Implemented AWS API Gateway & serverless APIs for secure access and automated report generation.
    • Set up environments, data pipelines, and telemetry integration.
    • QA for app compatibility & secure boot to meet FDA compliance.
  • Governance & Program Management
    • Conducted detailed architecture reviews & redesign for resilience.
    • Applied mature program management practices for visibility and control.
  • Tech Stack:
    • Global content delivery & security: AWS CloudFront, AWS API Gateway, AWS WAF
    • Monitoring: AWS OpenSearch, AWS CloudWatch, AWS CloudTrail

Impacts

  • Rapid time to market.
  • <6 weeks to meet FDA compliance
  • 100% FDA Compliance, QMS and SaMD​
  • Delivered a secure, scalable, and highly available AWS-native system.
  • Enabled real-time and historical insights for clinicians and patients.
  • Improved decision-making with advanced analytics and tailored dashboards.
  • Achieved FDA compliance through secure architecture and rigorous QA.
  • Enhanced system reliability and performance with caching, search, and database optimization.
  • Established a future-ready foundation for continued innovation and scalability.

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