Let’s face it; cybersecurity is a major concern for all modern businesses. However, virtually every statistic shows that firms working in the healthcare and medical arenas must pay the greatest attention. After all, 92% of organizations in this field have experienced a breach over the past year with an average cost in damages of over $9 million.
Online technologies have evolved at a rapid pace over the past 30 years. They have transformed everything from productivity to customer care. In the healthcare arena, a host of medical devices are now connected to others via the cloud and/or IoT tech. Given the sensitive nature of patient data connected to the use of medical devices, manufacturers of these products must get cybersecurity under control.
There are many providers to choose from, but it’s vital that you select one that is focused on this industry. Here are five of the best.
The Top Five Cybersecurity Companies For Medical Device Manufacturers
#1. Blue Goat Cyber: Best Overall
Blue Goat Cyber is the premier cybersecurity company for medical device manufacturers. It delivers specialized, end-to-end cybersecurity for medical device manufacturers – combining deep technical expertise, regulatory intelligence, and real-world offensive security capabilities to ensure devices are secure, resilient, and trusted across global markets.
The company is trusted by many of the world’s leading medical device manufacturers including Vital Connect, Medivis, Angio Wave, and Prime Care Technologies. It also adheres to all major MedTech industry compliance standards like SO 14971, FDA Guidance, UL 2900, AAMI TIR57, NIST 800-115, IEC 62304, ISO 13485, AAMI TIR97, ISO 27001, IEC 81001-5-1, and IEC 62443-4-1.
Blue Goat Cyber can handle all of your medical device cybersecurity requirements throughout a medical device’s cycle. This covers everything from penetration testing and SPDF development to SBOMs, threat modeling, and eSTAR submission-ready documentation. Whether in the pre-market or post-market phases, their support gives medical device manufacturers full confidence and compliance.
At Blue Goat Cyber, a team of experienced professionals prioritizes patient safety while also showing that security enables innovation. Its proactive solutions are built to prevent future threats while ensuring that compliance is the starting point rather than the goal.
The company works side-by-side with medical device manufacturers, delivering truly tailored services that provide comprehensive protection and compliance. The first step to working with the cybersecurity specialist is to book a discovery call to determine IF and HOW they can help. For most manufacturers of medical devices, Blue Goat Cyber will be the perfect partner.
#2. MedCrypt
MedCrypt is another highly popular solution for manufacturers of medical devices, boasting a 100% track record for cybersecurity documentation approval. It works with both early-stage and enterprise-level MedTech companies to deliver an industry-specific approach that aligns with FDA pre-market and post-market cybersecurity guidance.
Its embedded security solutions for manufacturers in this field cover cryptography, monitoring, and threat-detection with real-time results. SBOM management, vulnerability detection, and behavioral anomaly monitoring all support the needs of the medical device industry. From preventing threats to implementing quick responses to known dangers, MedCrypt’s solutions are up to the task.
As a global cybersecurity expert for medical device manufacturers, MedCrypt doesn’t only help teams prepare for FDA approvals. Its services can be tailored to satisfy the demands of
EU MDR / IVDR, Health Canada, ISO 14971, ISO 13485, IEC 62304, ISO 27001, UL 2900, IMDRF / IMDRF Legacy, MDCG, TGA, IEC 81001-5-1, AAMI TIR57 / SW96, AAMI TIR97, IEEE 2621, HSCC MC2, HSCC JSP, or MDS2.
#3. Sternum
Sternum specializes in cybersecurity for connected medical and IoT devices, being particularly useful for securing devices with long lifecycles and minimal performance overheads. Like the two companies above, it prepares medical device manufacturers for compliance with both FDA cybersecurity requirements and global regulatory frameworks.
Dedicated cybersecurity systems offer real-time threat detection and autonomous attack prevention directly on devices. The company also provides code-level observability and runtime analytics. As a major organization in this field, Sternum already processes over 100 million device metrics daily to provide protection against nation state level attacks with an overhead cost of just 3%.
With Sternum, it is possible to detect and diagnose device-level or fleet-level anomalies. In addition to its embedded runtime prevention and real-time alerting, it now features advanced AI-powered threat detection for optimal protection. This makes it a fantastic choice for manufacturers of medical devices for domestic or worldwide deployment.
#4. MedSec
MedSec is another cybersecurity solution for medical device manufacturers that can guide you towards regulatory compliance for FDA, EU MDR, or global markets. As an industry leader, the firm has contributed heavily to improved healthcare cybersecurity standards in recent years. It remains one of the top firms dedicated exclusively to cybersecurity for medical devices and healthcare systems.
Medical device manufacturers can partner with MedSec throughout the development stages for threat modeling and secure architecture. The company is regarded for conducting deep-dive penetration testing, risk assessments, and secure design consulting. The results are guaranteed regulatory compliance and superior protection against threats when creating innovations for this sector.
The team empowers companies to help them navigate the evolving landscape of cybersecurity with confidence. This means overcoming complex challenges to ensure all devices remain secure, compliant, and resilient at all stages of their lifecycles. For MedTech manufacturers, this also means more time can be invested in the development of those innovations rather than the legal and logistical challenges of modern cybersecurity.
Clearwater Security for healthcare teams combines deep healthcare security and compliance expertise with MSSP capabilities, managed cloud services, consulting and assessments, and compliance software. This provides manufacturers of medical devices with a sophisticated solution to meet compliance requirements while also keeping devices and data protected.
Its managed service programs include the ClearAdvantage and ClearConfidence programs while dedicated risk assessment and consulting services are also available alongside cloud and hybrid cloud security and assistance. Solutions can be tailored to FDA, HHS, and international cybersecurity frameworks while purpose-built tools such as IRM|Pro are used for risk analysis and compliance tracking.
Staying on top of IPAA/HITECH compliance and medical device security assessments becomes far simpler, not least when securing complex device ecosystems used by hospital networks. MedTech companies serving these arenas can subsequently ensure strong protections for sensitive health data with the help of Clearwater’s experts.