Orcanos and C2A Security: Aligning Supply Chain Security with Faster Time-to-Market in Healthcare

In the highly regulated world of healthcare, medical device manufacturers (MDMs) are under constant pressure to launch innovative products that can improve patient care. However, they face two significant challenges—balancing a fast time-to-market with robust supply chain security. With cyber threats on the rise and compliance standards tightening, the need for a comprehensive solution that addresses both speed and security has never been more critical.

Orcanos understands the unique hurdles MDMs face. By partnering with C2A Security, a leading provider of cyber protection for connected devices, Orcanos offers an integrated approach that not only accelerates product development but also ensures the highest levels of security and regulatory compliance.

Navigating the New Healthcare Landscape: Security at Every Step

MDMs today aren’t just building innovative devices; they’re building secure lifelines. Cyberattacks on medical devices can be catastrophic, exposing patient data and disrupting life-saving treatments. A recent study revealed that over 14,000 medical devices, including those in the U.S., are vulnerable to cyber threats. As technology in the healthcare sector becomes more advanced, the attack surface grows—making robust security non-negotiable.

But security isn’t just about protecting devices from external threats; it’s about compliance with a growing web of regulations. From the new FDA guidelines to the European Cyber Resilience Act, MDMs must adhere to strict standards to protect patient data and prevent device vulnerabilities.

This is where Orcanos steps in—providing MDMs with a comprehensive platform that integrates security and compliance into every stage of the product lifecycle.

Orcanos: Your Compliance and Risk Management Partner

Unlike traditional tools that treat compliance and security as afterthoughts, Orcanos weaves them into the fabric of the entire development process. Whether you’re in the early design phase or managing post-market updates, Orcanos ensures that your medical device complies with stringent regulatory requirements while maintaining a secure supply chain.

Automating Compliance: With Orcanos, manual, error-prone compliance processes are a thing of the past. Our platform automates regulatory workflows, helping MDMs meet FDA, HIPAA, and other critical guidelines efficiently. This ensures that your device moves through development faster while staying compliant.

Real-Time Risk and CAPA Management: Orcanos’ powerful Corrective and Preventive Action (CAPA) system enables MDMs to identify risks and vulnerabilities early in the software development lifecycle. By resolving issues as they arise, you minimize delays and ensure that your product remains secure and compliant throughout development.

Supply Chain Security: The healthcare industry increasingly relies on third-party components in medical devices. Orcanos’ Software Bill of Materials (SBOM) tracking ensures that all third-party libraries are accounted for, helping to identify potential security threats and mitigate them before they impact your product. This proactive approach to supply chain security is essential in preventing vulnerabilities from cascading through your product lifecycle.

Healthcare Cyber Threats Are Evolving—So Must Your Security

The healthcare industry has become a prime target for cybercriminals. With increasing interconnectivity between devices, hackers can exploit vulnerabilities to gain access to sensitive information, disrupt medical procedures, or even cause harm. MITRE’s recent report on the top software weaknesses highlights critical areas that MDMs must address to secure their devices:

• CWE-400 (Uncontrolled Resource Consumption): This issue, now more prevalent than ever, allows attackers to consume system resources, potentially leading to crashes or denial-of-service attacks. Orcanos helps manufacturers manage resource allocation securely, preventing unauthorized access and ensuring smooth operations.
  
  
• CWE-200 (Exposure of Sensitive Information): In healthcare, data breaches can be devastating. This vulnerability involves the exposure of critical patient data, network details, and product code. Orcanos helps mitigate this risk by encrypting data, implementing least-privilege access protocols, and regularly auditing data flows.
  
  

Partnering with C2A Security enhances this by adding cutting-edge, context-driven cybersecurity solutions that protect every layer of your product.

Accelerating Development Without Sacrificing Security

Speed is crucial for MDMs—healthcare innovations need to reach patients quickly. However, rushing products to market without fully securing them can lead to costly recalls, lawsuits, and loss of trust. Orcanos helps manufacturers move quickly without cutting corners on security.

• Built-In Security: Orcanos’ platform enables product teams to integrate security measures into every phase of the SDLC. Whether it's encrypting data with AES-256 or securing communications with TLS, these protections are part of your process from the beginning, not added as an afterthought.
  
  
• Seamless Collaboration Across Teams: One of the biggest challenges in balancing time-to-market with security is ensuring that everyone—from developers to compliance officers—is on the same page. Orcanos fosters collaboration by providing a unified platform where all stakeholders can track compliance, manage risks, and ensure that security protocols are followed from start to finish.
  
  
• Efficient Product Disposal: Even after a device has reached the end of its lifecycle, security remains important. Orcanos ensures that MDMs can securely decommission devices, disabling cloud access and safely managing any sensitive data stored on the device.
  
  

Orcanos: Enabling Fast, Secure, and Compliant Medical Device Development

At Orcanos, we believe that MDMs shouldn’t have to choose between speed and security. With our integrated quality management and compliance platform, manufacturers can bring devices to market faster while ensuring that they meet the highest standards of security and regulatory compliance.

By automating compliance tasks, offering real-time risk management, and providing comprehensive supply chain oversight, Orcanos empowers MDMs to streamline development without sacrificing security.

Together with C2A Security, Orcanos helps MDMs stay ahead of cyber threats and regulatory requirements, ensuring that devices are not only innovative but also safe and compliant.

Take control of your medical device development with Orcanos. Learn more about how our solutions can help you navigate the complexities of healthcare regulations while protecting your supply chain.

Get your product brochure today and discover how Orcanos can accelerate your journey to market while keeping your devices secure.

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