Developing potentially life-saving products requires unparalleled performance, security, and compliance. However, as medical technology continues to evolve, so does the complexity of managing the systems that power it. Hospitals and healthcare providers are facing pressure to deliver superior patient outcomes while complying with stringent regulatory standards. Furthermore, this must be done while reducing costs and managing complex IT infrastructure. That’s where medical device managed services can help. This blog explores how outsourcing the management of medical device systems can optimize performance, improve compliance, and enhance patient care.
Managed Services for Medical Devices: The SPK Approach
SPK and Associates brings more than two decades of experience supporting complex infrastructure and applications in regulated industries. Our team understands the unique needs of medical device manufacturers and healthcare organizations alike. From managing CAD and PLM systems used in device design to securing cloud pipelines and ensuring FDA readiness, we offer specialized support tailored to the healthcare device lifecycle management process.
Our managed services consulting approach covers:
- Application Management: Including CAD, PLM, and software development tools used in R&D and product lifecycle management. We monitor application health, optimize performance, and eliminate inefficiencies.
- Infrastructure Management: Whether in the cloud or on-premise, SPK manages the infrastructure powering medical devices, ensuring availability, performance, and scalability.
- Compliance and Risk Mitigation: We maintain alignment with regulatory standards like FDA 21 CFR Part 11, IEC 62304, ISO 14971, and HIPAA through security best practices, audit support, and change control processes.
- Real-Time Monitoring and Alerting: Through SPK’s proprietary Client Analytics Portal, we proactively identify and resolve issues before they impact operations or patient safety.
By managing the technical complexities behind medical devices, we enable our clients to focus on what matters most: improving healthcare outcomes.
Benefits of Outsourcing
Partnering with a specialized MSP like SPK ensures healthcare organizations are always one step ahead. Here’s how:
- Better Device Performance
Our dedicated infrastructure and application teams continuously monitor and optimize device systems. This not only prevents downtime but also improves reliability. For example, through proactive license and usage tracking, SPK helps clients reduce bloat and maximize engineering productivity.
- Compliance with Evolving Regulations
From FDA audits to cybersecurity mandates, compliance can’t be left to chance. SPK embeds risk mitigation into your workflows, implementing audit-friendly tools, version control, and traceability across the healthcare device lifecycle.
- Enhanced Patient Care
Reliable, compliant devices lead to better patient outcomes. By reducing device errors, accelerating product updates, and enabling secure innovation, SPK helps healthcare organizations deliver safer, more effective care.
- Cost Efficiency
Outsourcing eliminates the need to hire and retain specialized technical staff for every application or infrastructure component. SPK’s managed services optimize cloud usage, reduce licensing costs, and eliminate inefficiencies. In one case, a medical equipment supplier saved over 80% on a single software license after SPK used our Licenseminer tool to identify underused resources.
- Seamless Integration with Hospital IT
SPK’s strength lies in bridging the gap between engineering systems and IT operations. We work alongside internal IT departments to integrate CAD, PLM, QMS, and DevOps tools with broader hospital networks, ensuring compliance, performance, and visibility across departments.
Medical Device Managed Services in Action
The following examples display how SPK has successfully aided medical device manufacturers with our managed services.
Modernizing Hospital Infrastructure
A leading medical device manufacturer faced mounting pressure from hospitals struggling with outdated recording systems. Legacy storage couldn’t keep up with growing capacity, security, and access demands. SPK stepped in to support hospital IT teams directly, both on-site and remotely. Our engineers led the migration of case data from legacy infrastructure to new, high-capacity storage systems, without disrupting surgical workflows. The result: 90% of the hospital upgrades were completed ahead of schedule, with 21 successful projects delivered in 2024 alone. Hospitals reported zero rendering failures and faster export times. With modern authentication and secure sharing capabilities, surgeons can now distribute case data externally while remaining HIPAA compliant.
Enabling a Fortune 100 MedTech Sale to the DoD
A global medical device company sought to expand its commercial device sales to the U.S. Department of Defense (DoD). However, meeting DoD cybersecurity requirements required stripping functionality and implementing strict security controls. Without in-house resources to address these challenges, the client turned to SPK. We assigned a dedicated team to define the required cybersecurity controls and implement them on the device. This included installing and configuring necessary security tools, whitelisting software, encrypting disks, performing vulnerability scans, and ensuring successful Windows updates. Our team remediated key technical issues, resulting in an accelerated time-to-market, ensured security, and cost savings.
Why Use SPK for Medical Device Managed Services?
SPK and Associates isn’t your average managed services provider. We specialize in engineering and healthcare technology environments that demand both technical depth and regulatory rigor.
Here’s what sets us apart:
- 20+ years managing complex, regulated infrastructures
- Deep knowledge of FDA, ISO, IEC, and DoD compliance requirements
- End-to-end visibility with real-time analytics via SPK’s Client Analytics Portal
- Application-level expertise across CAD, PLM, QMS, and DevOps pipelines
- Seamless integration with existing IT systems and processes
- Proactive support from specialists who understand your business and your tools
We don’t just support your technology—we elevate it.
SPK for Healthcare Device Lifecycle Management
SPK and Associates empowers healthcare organizations to improve device performance, maintain continuous compliance, and deliver exceptional patient care, all while saving time and costs. If you’re ready to streamline operations, stay audit-ready, and make your devices work smarter, it’s time to partner with SPK. Let’s advance healthcare together. Contact us to explore our managed services for medical devices.
