Galen Data Company Research Report

Company Overview

Name and Mission

Galen Data is dedicated to supporting innovation in the Connected Health space by making medical device connectivity easy. They provide a turn-key, compliant platform for device-to-cloud connectivity and data analysis that is compliant with FDA, HIPAA, CE Mark standards.

Founded and Key People

• Founded by: No information is available

• CEO: Chris DuPont

• CTO: Abbas Dhilawala

• COO: Alex Condon

• CFO: Russell Naisbitt

• VP of IT Operations: Tim Sandberg

• Advisor: Elizabeth Hoff

Headquarters and Employees

• Headquartered in: 1331 Gemini Street, Suite 305, Houston, TX 77058

• Number of Employees: No information is available

• Revenue: No information is available

Company Highlights

Galen Data is known for:

• Medical device cloud connectivity and data analysis.

• Comprehensive regulatory compliance, ensuring solutions meet FDA, HIPAA, and CE Mark standards.

• A platform that helps medical device companies focus on innovation without the burden of compliance and data storage infrastructure.

Products

What Products They Offer

Galen Cloud Platform

High-Level Description of the Product

The Galen Cloud is a configurable, scalable, and easy-to-use platform that allows medical devices to centralize data and leverage cloud technologies. It is designed to support speed to market, regulatory compliance, scalability, ease of use, and 24/7 technical support.

Key Features of the Product

1. Speed to Market:

• Reduced development cost and time—on average 12x faster.

2. Responsiveness:

• Designed to provide a consistent experience on all devices.

3. Full Compliance:

• Full regulatory audit support and certifications such as FDA, CE, and Health Canada.

4. Reduced Regulatory Risk:

• Developed under ISO 13485 certified quality management system.

5. Scalability:

• Scalable, secure, and modern data storage capabilities.

6. Ease of Use:

• Intuitive and smooth user experience for both newcomers and experts.

7. Support:

• 24/7 access with a 99.9% uptime guarantee and comprehensive technical support.

8. Personalization:

• Highly customizable to meet unique client needs.

Recent Developments

New Products and Features

• Galen Data and B-Secur Partnership:

• In May 2024, Galen Data announced a partnership with B-Secur to enhance next-generation cardiac monitoring.

• HITRUST Recertification:

• In February 2024, Galen Data achieved HITRUST re-certification for the Galen Cloud Platform hosted on AWS.

Regulatory Updates

• FDA Guidance on Real World Data:

• In December 2023, the FDA issued new guidance on assessing real-world data registries for regulatory decision-making.

• FDA Guidance on Cybersecurity in Medical Devices:

• In September 2023, the FDA released final guidance on cybersecurity considerations in premarket submissions for medical devices.

Awards

• Best Software Solution Provider of the Year:

• In October 2023, Galen Data won the prestigious award at the Med-Tech World Conference in Malta.

Partnerships

• B-Secur:

• Partnership for advanced cardiac monitoring solutions.

• Cloud Platform Hosted on AWS:

• Galen Cloud is hosted on Amazon Web Services, leveraging AWS's scalability and security features.

Conclusion

This report provides an overview of Galen Data's offerings, leadership, recent achievements, and partnerships. Galen Data focuses on supporting medical device innovators with turnkey, compliant, and scalable cloud solutions, ensuring they can focus on innovation without the burdens of compliance and data management.