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Executive summary
Healthcare’s digital shift has given rise to the Internet of Medical Things (IoMT), where diagnostic and therapeutic devices exchange data in real-time across connected networks. Monitors, wearables, infusion pumps, imaging platforms, and implantables now support faster, more personalized treatment. The same connectivity also introduces cyber threats in healthcare that can disable medical devices and hospital networks, leading to delays, errors, and risks to patient care. Many hospitals operate tens of thousands of connected medical devices running outdated operating systems and insecure communication protocols. These devices operate on flat, unsegmented networks where a single compromised device can provide access to critical systems like electronic health records.
Healthcare cybersecurity costs average $10.93 million per breach compared to $4.88 million across other industries, according to IBM’s 2024 report. Forescout Technologies found that 89% of healthcare organizations use devices from the riskiest IoMT categories, with 32% of critical imaging systems carrying unpatched vulnerabilities. The FBI recorded 444 cyberattacks against healthcare organizations in 2024, making it the most targeted critical infrastructure sector. These numbers expose a troubling reality. While financial institutions require multi-factor authentication for routine transactions, life-critical medical devices often operate on unpatched software for years.
Three forces converge to create unprecedented risk for medical device manufacturing. Legacy devices with hardware limitations prevent modern security implementations while remaining in service for decades. FDA compliance requirements under Section 524B now mandate cybersecurity demonstrations across device lifecycles. Connected medical devices expand attack surfaces faster than security teams can manage, with single hospital beds supporting 10-15 networked devices. Together, these factors widen the cybersecurity maturity gap between healthcare technology and other critical infrastructure sectors, highlighting the urgent need for IoMT security solutions.
Companies addressing these cybersecurity challenges in medical device manufacturing gain decisive advantages in regulatory approvals, market positioning, and patient safety outcomes. Medical device manufacturers who treat cybersecurity as secondary to functionality risk operational disruptions, regulatory delays, and patient safety incidents that could define their market position for years. The solution requires adopting holistic approaches like Zero Trust architecture that verify every device and user continuously. Zero Trust models move beyond traditional perimeter-based security to protect today’s distributed healthcare environments.
The uncomfortable truth about medical device security
For years, medical device manufacturers placed cybersecurity behind patient safety and regulatory compliance. That order once seemed logical when devices functioned in isolation, but it has left behind what experts now call a dangerous “complacency gap” compared to other critical industries. Healthcare organizations demonstrate a notable security paradox. While administrative systems implement sophisticated IT security protocols, medical devices frequently operate with default configurations, unencrypted communications, and limited update mechanisms. The contrast stems from a long-standing focus on device functionality and patient safety at the expense of cybersecurity. Recent research reveals that while 52% of IoMT devices run Windows software, only 10% actively run anti-malware protection.
The gap is rooted in deep industry assumptions. Medical device companies have operated under the belief that their specialized protocols and closed systems provide inherent protection. Unlike financial services firms that assume every transaction could be under attack, medical device manufacturers have maintained faith in security through obscurity. Recent Congressional hearings have exposed growing concerns about this approach, particularly as attackers demonstrate increasing sophistication in targeting healthcare infrastructure.
Why attackers target healthcare infrastructure
Healthcare has become a prime target for cybercriminals because it offers both high financial returns and psychological leverage that few other industries present. Stolen medical records often sell for ten times more than credit card data on underground markets since health information is permanent and valuable throughout a patient’s lifetime. Extortion risk increases the appeal even further. Ransomware groups know that delays in treatment can carry life-or-death consequences, which makes hospitals more likely to pay quickly to regain access to critical systems. In many cases, the cost of downtime far exceeds the ransom itself. The problem is worsening, with more than 80 percent of healthcare providers worldwide reporting at least one successful breach in 2024, the highest rate among all sectors.
Medical devices present particularly attractive targets because they combine weak security controls with direct patient impact. Attackers exploit default configurations, unpatched vulnerabilities, and exposed remote access interfaces to steal data and manipulate treatment settings while harvesting clinical information. The University of New Brunswick documented successful attacks against 40 different IoMT devices using common wireless protocols, demonstrating that these threats are actively occurring in real healthcare environments.
The perfect storm of three converging forces
The legacy device hardware trap
Medical devices present a cybersecurity challenge that most industries don’t face, combining extreme longevity with fixed hardware capabilities. While consumer electronics get replaced every few years, medical devices routinely operate for 10-15 years or longer. An MRI machine installed in 2015 represents a multi-million-dollar investment that hospitals expect to amortize over many years.
Recent research shows just how exposed medical devices can be. Forescout found that nearly one in three DICOM workstations (Digital Imaging and Communications in Medicine) and imaging systems carry critical unpatched vulnerabilities. Pump controllers are not far behind, with over a quarter affected and one in five so exploitable that an attacker could act with ease. These are not hypothetical scenarios. The University of New Brunswick’s 2024 dataset recorded 18 different types of cyberattacks successfully launched against 40 IoMT devices using Wi-Fi, MQTT, and Bluetooth connections.
The root of the problem lies in the hardware limitations of legacy systems. Many older medical devices run on embedded processors with very limited memory and computing power. As a result, they cannot support modern security measures such as advanced encryption or real-time threat detection without compromising their primary medical functions. Healthcare IT teams are left with a difficult choice between continuing to operate vulnerable legacy devices that are essential for patient care or replacing equipment that still functions well in order to meet cybersecurity requirements.
Global regulatory convergence accelerates compliance pressure
The regulatory transformation extends far beyond US borders, creating a coordinated global shift toward mandatory cybersecurity standards. The FDA’s 2023 guidance requiring Software Bills of Materials and long-term patch management plans represents just the beginning of worldwide regulatory alignment. The UK’s Medicines and Healthcare Products Regulatory Agency has included cybersecurity-specific guidance for Software as a Medical Device in its 2025 regulatory roadmap, forming part of broader reforms targeting post-market surveillance and risk management frameworks. The EU Cyber Resilience Act introduces similar expectations across European markets. Manufacturers that do not build secure-by-design practices into their devices risk reputational harm and restrictions on market access. The legislation requires companies to demonstrate resilience throughout the entire operational life of a device, going well beyond the initial approval stage. Compliance strategies must now account for multiple regulatory frameworks while ensuring that security standards remain consistent across global markets.
These parallel regulatory developments signal a fundamental shift from voluntary cybersecurity guidelines to mandatory compliance requirements. The global nature of medical device markets means companies must meet the highest security standards to maintain market access across key regions. Companies that invest early in cybersecurity frameworks gain competitive advantages across multiple markets simultaneously.
Connectivity explodes beyond IT control
Connected medical devices are reshaping care delivery and expanding the scope of cybersecurity. A single hospital bed may now link 10 to 15 devices, including monitors, infusion pumps, ventilators, and imaging systems, all exchanging real-time patient data. The broader ecosystem creates attack surfaces that extend far outside the traditional IT perimeter. The risks are tangible. Weaknesses in Wi-Fi, Bluetooth, and internet protocols such as KRACK can expose patient data and interrupt critical clinical operations. Supply chain compromises through third-party software components further erode trust and are notoriously difficult to detect before deployment. Artificial intelligence introduces its own high-stakes vulnerabilities. AI-driven diagnostics depend on continuous data feeds, creating openings for model manipulation, data poisoning, and bias exploitation, threats that could directly affect clinical outcomes.
The shift to home healthcare pushes security even further outside organizational control. Wearables, remote monitoring tools, and home diagnostic devices often operate on unsecured consumer networks, yet still handle protected health information. For leaders, the key takeaway is that security strategy must extend beyond the data center to include the device, the algorithm, and the patient’s home, closing gaps before they turn into clinical, regulatory, or reputational crises.
The hidden costs of cybersecurity failures
Medical device cybersecurity incidents create cascading costs that extend well beyond direct breach expenses. Device configuration changes represent the most immediate threat to patient safety. Cybercriminals who gain access to connected medical devices can modify dosing parameters in insulin pumps, alter alarm thresholds in patient monitors, or disable critical safety features in life-support equipment.
Operational disruption extends throughout healthcare systems. Ransomware attacks that encrypt medical device data or disable network connectivity force hospitals to revert to manual processes, delay procedures, and sometimes transfer patients to other facilities. Since 2015, ransomware attacks on healthcare have surged by 300%, creating disruptions that directly impact patient care delivery and can result in life-threatening delays.
Patient data theft creates permanent vulnerabilities that extend throughout individuals’ lifetimes. Medical records contain detailed personal information that cybercriminals use for identity theft, insurance fraud, and targeted blackmail campaigns. Unlike credit card numbers that can be quickly replaced, medical information remains constant, creating lasting vulnerability for affected patients.
Medical device cybersecurity incidents are likely underreported. Research from the University of New Brunswick documenting successful attacks on 40 different IoMT devices indicates that actual incident rates are higher than publicly recognized. Limited visibility prevents manufacturers from learning from peers’ experiences and makes it harder to build accurate risk models or justify security investments.
Strategic priorities for medical device leaders
The cybersecurity choices made today will shape the safety, compliance, and competitiveness of tomorrow’s medical devices. One priority is assessing cybersecurity maturity across the full device portfolio to identify vulnerabilities and compliance gaps where targeted improvements can most effectively reduce risk. Another priority is establishing a clear strategy for legacy devices. Leaders need to decide which devices can be secured through network controls, which require immediate replacement, and which can be upgraded to meet current standards. Equally important is building cross-functional teams that embed cybersecurity into engineering, regulatory, clinical, and security processes throughout the product lifecycle.
Zero Trust architecture represents a major shift in security thinking. Traditional perimeter-based models treat devices inside the network as inherently trustworthy. Zero Trust, in contrast, requires continuous verification of every device and user. For legacy devices with limited built-in security, robust network-based controls are often necessary. Effective implementation must address the distributed nature of modern device ecosystems and maintain security boundaries across edge computing applications and home healthcare environments.
Quest Global’s proven methodology for medical device cybersecurity
With more than two decades of MedTech experience, Quest Global blends deep engineering expertise with globally recognized certifications such as ISO 13485, IEC 62304, ISO 14971, ISO 27001, IEC 60601-4-5, IEC 81001-5-1, and UL 2900-2-1. The foundation enables the delivery of secure, compliant, and high-performing medical devices. Our approach is built around four tightly integrated pillars. The process begins with a thorough gap analysis against FDA cybersecurity requirements, followed by a risk-based assessment that prioritizes vulnerabilities based on patient safety impact. From there, we focus on pragmatic control implementation, applying defense-in-depth strategies that work within the technical and operational constraints of medical devices. The process is completed with rigorous regulatory documentation, producing detailed threat models, software bills of materials, and post-market surveillance plans that streamline 510(k) approvals.
The approach has already shown measurable results. Quest Global applies AI-powered diagnostic engineering grounded in security-by-design principles and aligned with regulatory expectations. The team’s experience in medical device sustenance engineering enables legacy systems to be modernized with minimal hardware changes. In diagnostic imaging, Quest Global supports AI integration and prepares regulatory documentation, including elements essential for 510(k) submissions.
Security as a competitive advantage
Leading medical device companies prove that cybersecurity accelerates innovation rather than limiting it. Strong security foundations unlock advanced connectivity, AI integration, and cloud services that differentiate products in the market. Organizations with mature cybersecurity capabilities adopt new technologies faster, while healthcare facilities increasingly assess security capabilities during procurement decisions.
Cyber defense in healthcare is moving from reactive measures to proactive protection with the help of artificial intelligence. Machine learning models now monitor device telemetry, log data, and network behavior to detect anomalies in real time. For example, a pacemaker sending data outside expected hours can trigger an automated alert, while unusual dosing patterns from an insulin pump may point to tampering attempts. Achieving this level of vigilance depends on accurate, timestamped logs from every device. Without reliable data, AI tools risk overlooking critical warning signs or producing false alarms. Research is already shaping the next stage of protection. Confidential computing could allow implantable devices to accept cryptographically verified firmware updates without exposing source code to untrusted intermediaries. Work on quantum-resilient encryption also shows potential to secure sensitive implant data well into the future.
Resilience for tomorrow’s connected healthcare
Medical device cybersecurity decisions made today determine which companies will thrive in tomorrow’s connected healthcare ecosystem. Legacy vulnerabilities, global regulatory alignment, and expanding attack surfaces create competitive opportunities for proactive manufacturers. Companies that embed cybersecurity into engineering processes, regulatory strategies, and market positioning navigate FDA approvals more effectively, exceed customer expectations, and respond decisively to emerging threats. Manufacturers treating security as an afterthought face mounting risks, from patient safety incidents to market access restrictions across multiple regions.
Engineering leaders must integrate security into device design early in development cycles, while business leaders must recognize cybersecurity capabilities as essential market differentiators. Strong security foundations accelerate innovation by enabling safer deployment of AI integration, cloud connectivity, and advanced therapeutic capabilities. Medical device manufacturers who invest in security capabilities today position themselves to lead connected healthcare, delivering safer products, earning customer trust, and building competitive advantages that extend well past regulatory requirements.
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