Medical Device Cybersecurity Is Now a Procurement Gate: 2026 Hospital Buying Data

The Shift from Compliance Checkbox to Deal-Breaker

Medical device cybersecurity has crossed a threshold that many manufacturers have not fully internalized: it is no longer a regulatory compliance exercise. It is a procurement gate.

RunSafe Security's 2026 Medical Device Cybersecurity Index, released on April 29, 2026, provides the data to quantify what the industry has been sensing. Based on a survey of 551 healthcare professionals involved in device purchasing decisions across the United States, the United Kingdom, and Germany, the report reveals that cybersecurity now determines whether a device is approved or rejected — not whether it passes regulatory review, but whether it wins a purchase order.

The numbers are stark:

• 56% of healthcare organizations have rejected a medical device due to cybersecurity concerns, up from 46% in 2025
• 84% include cybersecurity requirements in their vendor RFPs, with 43% specifying detailed security requirements
• 35% of purchasing decision-makers will not consider a device that does not come with a Software Bill of Materials (SBOM)
• 79% report that FDA cybersecurity guidance and EU MDR requirements have meaningfully influenced their procurement processes

For medical device manufacturers, this means that even if a device clears the FDA's cybersecurity review and earns CE marking under MDR, it can still be locked out of more than half the market if it does not meet hospital procurement standards.

The 2026 Data in Detail

Device Rejection Rates Are Accelerating

The share of organizations that have declined to purchase a device on cybersecurity grounds jumped from 46% in 2025 to 56% in 2026 — a ten-percentage-point increase in a single year. The most common rejection grounds include:

• Known vulnerabilities with no patching plan
• Lack of secure software update mechanisms
• Weak or absent authentication controls
• No Software Bill of Materials
• No post-market patching commitment

The rate of rejection is now high enough that a manufacturer without a mature cybersecurity program is effectively disqualified from more than half of its potential customer base.

SBOMs Have Become a Hard Requirement

The Software Bill of Materials has moved from emerging best practice to near-universal expectation in just two years. The 2026 data shows:

SBOM Metric	2025	2026
Rate SBOM as "important" or "essential"	78%	81%
Will not consider device without SBOM	—	35%
SBOM strongly influences purchasing	—	46%
Unfamiliar with SBOM	—	4.4%

The 35% hard requirement figure is the most significant: more than a third of healthcare purchasers will not even evaluate a device that lacks an SBOM. Only 1.5% of respondents say SBOMs are not currently important.

For context, the FDA's cybersecurity guidance (updated February 2026) requires SBOMs for cyber devices under Section 524B(b)(3) of the FD&C Act, making failure to provide an SBOM a prohibited act. The RunSafe data shows that the market has moved even faster than regulation: hospitals are demanding SBOMs not just because the FDA requires them, but because they need them operationally for vulnerability management.

Regulatory Influence on Procurement Is Growing

Nearly 79% of respondents report that FDA cybersecurity guidance or EU MDR requirements have meaningfully influenced their procurement processes, up from 73% in 2025. This cross-regulatory influence is notable because it means manufacturers must satisfy both US and EU cybersecurity expectations to compete globally.

The EU Cyber Resilience Act vulnerability reporting requirements become effective September 11, 2026, and will impose additional obligations on connected devices placed on the EU market. Manufacturers that have not aligned their vulnerability disclosure programs with both FDA and EU requirements face compliance gaps in one or both markets.

Cyberattacks Are Increasing and Causing Greater Patient Harm

The defensive improvements in procurement are not keeping pace with the threat landscape:

• 24% of organizations reported cyberattacks or exploited vulnerabilities involving medical devices in 2026, up from 22% in 2025
• 80% of those attacked reported moderate or significant disruption to patient care, up from 75% in 2025
• Operational disruptions include delayed imaging, postponed procedures, and interruptions in critical care delivery

A separate Halcyon/Health-ISAC study cited in the report found that in-hospital mortality increased by 33% during ransomware incidents. The patient safety implications of medical device cybersecurity failures are no longer theoretical — they are measurable.

Legacy Devices: The Gap Procurement Cannot Close

Despite stricter procurement standards, hospitals remain burdened by legacy devices:

• 28% of organizations operate devices past the manufacturer's end-of-support date
• 44% acknowledge running devices with known, unpatched vulnerabilities
• A significant portion of these devices operate in the most critical care settings: emergency departments, ICUs, and operating rooms

This legacy device problem is driving the rapid adoption of runtime protection — technology that defends devices against attacks even when patches cannot be applied. In 2025, 36% of organizations actively sought devices with runtime protection capabilities. In 2026, 82% report having deployed or actively piloting runtime protection.

AI-Enabled Devices Introduce New Risks

57% of surveyed organizations now use AI-enabled or AI-assisted medical technologies. Of those, 80% express at least moderate concern about the cybersecurity risks these devices introduce.

The concern is well-founded. AI-enabled devices typically have larger software stacks, more third-party dependencies, and more complex supply chains than traditional medical devices. The FDA's February 2026 cybersecurity guidance update specifically addresses the intersection of AI and cybersecurity, requiring manufacturers to document AI-specific threat vectors in their cybersecurity risk assessments.

What Medical Device Manufacturers Must Do

1. Produce Machine-Readable SBOMs for Every Device

This is no longer optional. With 35% of buyers refusing to consider a device without an SBOM, and the FDA treating SBOM absence as a prohibited act for cyber devices, manufacturers that cannot generate accurate SBOMs are losing deals and risking enforcement action.

SBOMs should be:

• Machine-readable (SPDX or CycloneDX format) to integrate with hospital vulnerability management tools
• Comprehensive, covering all software components including open-source dependencies
• Current, updated with every software release, security patch, or material dependency change
• Accompanied by a declared Security Fixes Support Level that tells purchasers how long the manufacturer commits to providing security updates

2. Embed Cybersecurity Requirements in Product Development

The survey shows that buyers are looking for specific capabilities:

• 62% require secure software update mechanisms
• 61% require secure authentication and access controls
• 48% require third-party security testing or certification
• 37% require runtime or exploit protection technologies
• 36% require a vendor vulnerability disclosure program
• 25% require post-market patching commitments

These requirements should be treated as product specifications, not afterthoughts. Building them into the design input phase of development is far more efficient than retrofitting them post-market.

3. Establish a Coordinated Vulnerability Disclosure Program

The FDA's cybersecurity guidance requires manufacturers to maintain a vulnerability disclosure policy and a process for coordinated disclosure. The RunSafe data shows that 36% of buyers specifically look for this. A PSIRT (Product Security Incident Response Team) with a published vulnerability disclosure policy is now a competitive differentiator.

4. Prepare for Runtime Protection Expectations

With 82% of organizations deploying or piloting runtime protection, manufacturers should consider whether their devices can integrate with these technologies. This may involve ensuring that runtime protection agents can be installed without interfering with device safety functions, or building runtime protection capabilities directly into the device software.

5. Document Cybersecurity in Premarket Submissions Thoroughly

The FDA's February 2026 cybersecurity guidance update (superseding the June 2025 version) requires detailed cybersecurity documentation in premarket submissions for cyber devices. This includes:

• A complete SBOM
• A cybersecurity risk assessment addressing the device's intended use environment
• A plan for post-market vulnerability monitoring and remediation
• An architectural view of how the device's cybersecurity controls interact

Submissions that lack these elements face Additional Information requests that delay clearance timelines.

6. Address the Legacy Device Portfolio

For devices already on the market, manufacturers should:

• Assess which devices are approaching or past end-of-support
• Develop migration paths for customers running vulnerable legacy devices
• Consider providing runtime protection options for devices that cannot be patched
• Publish clear end-of-support timelines so hospitals can plan replacements

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The Business Case for Cybersecurity Investment

The RunSafe data provides a clear business case: 79% of respondents said they would pay a premium for devices with advanced cybersecurity features, with nearly half (49%) willing to pay 5% or more above standard pricing. In a market where device differentiation is often narrow and price competition is intense, cybersecurity maturity is emerging as a margin-preserving advantage.

Conversely, the cost of cybersecurity failure is escalating:

• 40% of organizations reported that security incidents affected their trust in specific vendors
• 7% have stopped purchasing from specific vendors entirely
• 23% report heightened caution in vendor evaluation going forward

A single cybersecurity incident can damage a manufacturer's reputation with its customer base for years. In a market where 56% of buyers are already rejecting devices on security grounds, the margin for error is thin.

How This Connects to Regulatory Requirements

The procurement trends documented by RunSafe are reinforced — and in many cases driven — by regulatory requirements on both sides of the Atlantic:

United States:

• FDA cybersecurity guidance (February 2026): Requires SBOMs, vulnerability disclosure, and cybersecurity risk assessment for cyber devices
• QMSR (effective February 2, 2026): Incorporates ISO 13485 by reference, requiring cybersecurity controls as part of the quality management system
• Section 524B of the FD&C Act: Makes SBOM provision a statutory requirement for cyber devices, with failure to comply treated as a prohibited act

European Union:

• EU MDR: Requires cybersecurity risk management for connected devices as part of the general safety and performance requirements (Annex I)
• EU Cyber Resilience Act: Vulnerability reporting requirements effective September 11, 2026, with full compliance required by 2027
• EU AI Act: High-risk AI systems (including AI-enabled medical devices) must demonstrate robustness, accuracy, and cybersecurity under Article 15

The convergence of regulatory requirements and procurement expectations means that cybersecurity investment pays off twice: once in regulatory compliance and again in market access.

Key Takeaways

• 56% of healthcare organizations rejected a medical device due to cybersecurity concerns in 2026, up from 46% in 2025
• 35% of buyers will not consider a device without an SBOM — this is now a hard market requirement
• 84% of organizations include cybersecurity in RFPs, and 79% say regulatory guidance has shaped their procurement
• 24% of organizations experienced cyberattacks on medical devices, with 80% reporting patient care disruptions
• Cybersecurity is no longer a compliance checkbox — it is a competitive differentiator and a revenue gate
• Manufacturers must invest in SBOM generation, vulnerability disclosure programs, secure development practices, and runtime protection compatibility
• 79% of buyers will pay a premium for devices with advanced cybersecurity, making security investment a margin strategy, not just a cost center