IT Services Overview:

Partnership with DeGen Medical

Client Profile

DeGen Medical is a South Carolina-based medical device development company specializing in innovative spinal implants, augmented reality platforms (such as DeGen Medical XR™), and patient-specific solutions for complex spinal disorders. Headquartered in Florence, SC, DeGen Medical is a patient-centric organization focused on advancing spine surgery outcomes through cutting-edge technology and precision engineering.

Challenge

As a growing innovator in the medtech space, DeGen Medical required reliable, secure, and scalable IT infrastructure to support rapid product development, regulatory compliance (including HIPAA and FDA requirements), remote collaboration, and protection of sensitive intellectual property related to their proprietary implants and AI-driven tools.

Our Solution

Clark Data Services partnered with DeGen Medical to deliver comprehensive managed IT services tailored to the unique needs of a medical device firm. Key services provided included:

Managed IT Support and Helpdesk: 24/7 proactive monitoring, rapid issue resolution, and on-site/on-demand support to minimize downtime for engineering, R&D, and administrative teams.
Cloud Migration and Infrastructure: Seamless transition to secure cloud environments (e.g., Microsoft Azure or AWS with healthcare-compliant configurations) for improved scalability, data backup, and disaster recovery.
Cybersecurity and Compliance: Implementation of advanced endpoint protection, multi-factor authentication, encryption, vulnerability assessments, and ongoing compliance auditing to safeguard protected health information (PHI) and intellectual property.
FDA Software Lifecycle Compliance (SaMD/SDLC): Design, implementation, and ongoing management of validated IT systems and processes aligned with FDA 21 CFR Part 11, Part 820, and IEC 62304 requirements, including electronic records/signatures, risk management, change control, and computerized system validation (CSV/CSA).
Network and Infrastructure Optimization: Upgraded on-premises and hybrid network setups, including secure VPNs for remote access and high-performance Wi-Fi to support AR/VR development workflows.
Strategic IT Consulting: Guidance on emerging technologies, software integrations (e.g., CAD/3D printing tools, ERP systems), and scalable growth planning as DeGen expanded its product portfolio.

Results and Impact

Through this partnership, DeGen Medical achieved [e.g., 99.9% uptime, 40% reduction in IT-related incidents, enhanced data security posture, or faster time-to-market for new innovations]. Our proactive approach allowed their team to focus on core missions—developing life-changing spinal solutions—while we handled the technology backbone reliably and cost-effectively.

Clark Data Services is proud to support DeGen Medical's mission of redefining spine care and improving patient outcomes.