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Build a Resource Plan to Support Integrated IT and Biomedical Device Management

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  • Rising device complexity and volume: Health IT leaders must now support 10 times more devices – including biomedical, IoT, and imaging systems – without standardized processes or resourcing models.
  • Lack of staffing benchmarks for integrated device support: Hospitals are struggling to allocate the right mix of IT security, Biomed, and clinical informatics roles due to the absence of industry benchmarks for device management staffing.
  • Operational inefficiencies from poor device integration: Disconnected systems and unclear accountability across IT and Biomed lead to clinician frustration, security gaps, and workflow delays that threaten patient safety.

Our Advice

Critical Insight

  • No standard framework for tracking and securing devices: Many healthcare organizations rely on manual spreadsheets and point systems to manage device inventory making it difficult to ensure security across thousands of connected devices.
  • Skills and coverage gaps in staffing models: As device ecosystems grow, healthcare leaders face gaps in 24/7 support coverage, cross-trained teams, and cybersecurity readiness especially in remote or high-risk areas.
  • Unclear accountability between IT and biomed: Without clear roles, responsibilities, and shared governance, device management becomes fragmented, increasing risk and reducing organizational resilience.

The real risk in healthcare device management isn’t just the rise in connected devices, it’s the lack of a unified, data-driven resource plan to support them. As IT inherits responsibility for everything with an IP address, healthcare systems must proactively align staffing, governance, and support models across IT and Biomed to manage risk, scale operations, and protect care delivery.

Impact and Result

  • Review the current trends and models for biomedical device management, resource planning, and regulatory requirements.
  • Identify key organizational pain points through stakeholder interviews, define clear objectives and KPIs, and validate the biomedical and IT device inventory to establish an accurate baseline.
  • Evaluate asset lifecycle processes, staffing capabilities, and vendor solution gaps to uncover inefficiencies and identify improvement opportunities through a gap analysis.
  • Define a risk-based, integrated support model; build a scalable staffing and training plan; and develop a detailed implementation roadmap with milestones and communication strategies.

Build a Resource Plan to Support Integrated IT and Biomedical Device Management Research & Tools

1. Build a Resource Plan to Support Integrated IT and Biomedical Device Management Deck – A phased guide to building an integrated support model, scalable staffing strategy, and executable roadmap grounded in best practices.

Design an integrated IT and Biomed device management model by aligning stakeholders, assessing current capabilities, and defining a scalable, risk-based staffing and governance approach.

2. Biomed-IT Device Management Resource Planning Tool – A structured workbook to help determine your integrated biomedical and IT device management resource plan.

Build and forecast an integrated IT–Biomed staffing model by mapping device inventory to roles, estimating capacity, and projecting future resource needs and costs.


Build a Resource Plan to Support Integrated IT and Biomedical Device Management

Secure your expanding digital estate.

Analyst perspective

Align IT and Biomed to secure the expanding edge of care.

Sharon Auma-Ebanyat

The future of healthcare hinges on a quiet transformation: the convergence of clinical technology management and digital infrastructure. As every infusion pump, monitor, and imaging device becomes a networked endpoint, the line between IT and biomedical device teams has blurred. Yet most hospitals still operate with fragmented ownership – leaving critical gaps in security, support coverage, and governance.

What’s needed isn’t just more staff – it’s a unified operating model that reflects the shared accountability required in modern care environments. Biomedical and IT teams must evolve from parallel functions to an integrated capability – jointly responsible for lifecycle management, cybersecurity, compliance, and clinical uptime.

This research challenges the traditional model and proposes a future-ready approach rooted in cross-functional alignment. It empowers leaders to scale their support models, address the device explosion, and harden the expanding edge of care – where technology and patient safety intersect.

Sharon Auma-Ebanyat

Research Director, Healthcare Industry
Info-Tech Research Group

Build a Resource Plan to Support Integrated IT and Biomedical Device Management

Secure your expanding digital estate.

EXECUTIVE BRIEF

Executive summary

Your Challenge

Rising device complexity and volume
Health IT leaders must now support 10 times more devices – including biomedical, IoT, and imaging systems – without standardized processes or resourcing models.

Lack of staffing benchmarks for integrated device support
Hospitals are struggling to allocate the right mix of IT security, biomed, and clinical informatics roles due to the absence of industry benchmarks for device management staffing.

Operational inefficiencies from poor device integration
Disconnected systems and unclear accountability across IT and Biomed lead to clinician frustration, security gaps, and workflow delays that threaten patient safety.

Common Obstacles

No standard framework for tracking and securing devices
Many healthcare organizations rely on manual spreadsheets and point systems to manage device inventory making it difficult to ensure security across thousands of connected devices.

Skills and coverage gaps in staffing models
As device ecosystems grow, healthcare leaders face gaps in 24/7 support coverage, cross-trained teams, and cybersecurity readiness especially in remote or high-risk areas.

Unclear accountability between IT and Biomed
Without clear roles, responsibilities, and shared governance, device management becomes fragmented, increasing risk and reducing organizational resilience.

Info-Tech’s Approach

Review the current trends and models for biomedical device management, resource planning, challenges, and regulatory requirements.

Identify key organizational pain points through stakeholder interviews, define clear objectives and KPIs, and validate the biomedical and IT device inventory to establish an accurate baseline.

Evaluate asset lifecycle processes, staffing capabilities, and vendor solution gaps to uncover inefficiencies and identify improvement opportunities through a gap analysis.

Define a risk-based, integrated support model; build a scalable staffing and training plan; and develop a detailed implementation roadmap with milestones and communication strategies.

Info-Tech Insight

The real risk in healthcare device management isn’t just the rise in connected devices; it’s the lack of a unified, data-driven resource plan to support them. As IT inherits responsibility for everything with an IP address, healthcare systems must proactively align staffing, governance, and support models across IT and Biomed to manage risk, scale operations, and protect care delivery.

Healthcare CIOs are overseeing more devices due to cyberthreats

With rising device complexity and volume health IT leaders must now support 10x more devices, including biomedical, IoT, and imaging systems, without standardized processes or resourcing models.

  • Device growth is outpacing support structures: US hospitals now manage 10-15 network-connected devices per bed, creating a support burden that legacy IT/biomed support models aren’t designed to handle (The HIPAA Journal, 2024; Armis 2025).
  • Siloed departments widen oversight gaps: Biomedical, imaging, and IT/OT teams manage devices independently, resulting in fragmented security and inconsistent device support practices.
  • Hospitals lack benchmark staffing models for hybrid device support: No industry standard or guidance exists on how many biomedical equipment technicians, clinical engineers, cybersecurity engineers, or IT roles are needed per bed or per device, leading to wide variation in resource allocation making planning difficult.
  • Ad hoc staffing models risk gaps in device security: Without defined staffing structures or cross-functional roles, hospitals rely on informal coordination between Biomed and IT, increasing the risk of accountability breakdowns.
  • Device integration burdens staff under fragmented systems: In a US survey, 83% of nurses reported alarm fatigue, and 55% witnessed critical alarms go unchecked, highlighting operational strain from poorly integrated device systems (BMJ, 2023).

Healthcare CIOs face mounting barriers to secure device management

Lack of governance, staffing gaps, and unclear accountability hinder safe, scalable oversight of biomedical and IoT systems

No Standard Framework for Tracking & Securing Devices

  • Many hospitals still lack a unified system to track IoT/medical devices. They still rely on ad hoc methods such as spreadsheets, leading to blind spots in what devices are online. Industry experts warn that siloed, piecemeal tracking creates risky blind spots in device visibility and security coverage.

Skills and Coverage Gaps in Staffing Models

  • Healthcare organizations continue to struggle to recruit cybersecurity talent specific to device-level risk, undermining 24/7 support and cross-functional coverage for device management.

Unclear Accountability Between IT and Biomed

  • The rise of network-connected medical devices has blurred the traditional boundaries between IT departments and clinical engineering (biomed) teams. Many hospitals are now grappling with confusion over who owns tasks like device cybersecurity, integration, and maintenance. Undermining workflow efficiency and exposing the organization to safety risks.

Barriers to secure device management

84%
Of US and UK hospital leaders identified asset tracking as a priority, yet a majority still rely on manual spreadsheets or basic point systems

Source: Zebra Technologies Vision Study, 2024

70%
of health systems are recruiting for medical device security roles, yet 80% report difficulty finding qualified candidates

Source: The Global Healthcare Cybersecurity Study, Claroty, 2023

51%
of health systems incorporate medical devices into their cybersecurity planning, reflecting a lack of shared IT–Biomed governance

Source: The HIPAA Journal, 2025

Healthcare talent gaps threaten device security and operations

Healthcare systems are facing critical staffing gaps in clinical engineering, biomedical equipment technicians (BMETs), cybersecurity, and health IT roles.

Clinical engineers

Over 55% of clinical engineers describe their workload as “heavy” or “excessive,” with 40% of clinical engineers aged 55 or older and nearing retirement, creating leadership and skills succession risks (GE Healthcare, 2024).

Biomedical equipment technicians (BMETs)

With ~7,300 annual openings for medical equipment repairers (BMETs), the US Bureau of Labor Statistics projects 18% job growth between 2023 and 2033, while there are only ~400 BMET graduates from BMET programs per year, indicating a major talent gap in healthcare (Business Insider, 2025).

Health IT staff

39% of hospital CIOs identify retaining and budgeting for qualified IT staff as their top operational challenge for 2025, highlighting widespread constraints in securing enough tech resources to support initiatives (Stoltenberg Consulting, 2025).

Cybersecurity professionals

14% of healthcare organizations have fully staffed cybersecurity teams, while 30% report being severely understaffed, creating critical gaps in medical device security and incident response readiness (Healthsectorcouncil, 2025).

Emerging regulations complicate the creation of an IT–Biomed strategy (US)

Regulation Name

Summary of Key Requirements/Changes (2023–2025)

Applicable Area

Effective Date/Timeline

FDA – Medical Device Cybersecurity Requirements (FD&C Act §524B & Guidance)

  • As of March 29, 2023, new “cyber devices” must include cybersecurity plans and Software Bill of Materials (SBOMs) in FDA submissions.
  • FDA finalized guidance (September 2023; updated in 2025) requiring secure-by-design principles and post-market vulnerability response.
  • Submissions missing cybersecurity documentation may be rejected, underscoring the mandate’s role in lifecycle security management.
Cybersecurity (devices) Law effective March 29, 2023; FDA guidance finalized September 2023 with ongoing updates and enforcement refinement.

HIPAA – Privacy & Security Rule Updates (Proposed 2024)

  • Proposed rule (December 2024) would mandate currently “addressable” safeguards like encryption, MFA, and annual risk assessments.
  • Entities must document policies and ePHI flows, conduct audits, and implement new controls (e.g. vulnerability scans every six months).
  • If finalized in 2025, compliance will require updated inventories, access controls, and internal audits.
"Privacy & Security (health data)" Notice of Proposed Rulemaking published December 2024; final rule timeline pending (current Security Rule remains in effect).

Emerging regulations complicate the creation of an IT–Biomed strategy (UK)

Regulation Name

Summary of Key Requirements/Changes (2023–2025)

Applicable Area

Effective Date/Timeline

MHRA – Post-Market Surveillance Regulations (UK MDR 2002, as amended 2025)

  • Effective June 16, 2025, manufacturers must proactively collect device performance data and report serious incidents in 15 days.
  • Applies to all CE or UKCA marked devices in Great Britain; mandates Periodic Safety Update Reports (PSURs) for high-risk devices.
  • Strengthens manufacturer responsibility and aligns with international post-market surveillance standards.
  • CIOs should ensure that their device suppliers are compliant with the UK’s enhanced post-market monitoring and incident reporting obligations.

Post-market Surveillance & Safety

Effective June 16, 2025 (applicable to devices placed on GB market from that date). Further UK regulatory updates (covering device approvals, UKCA marking, etc.) are expected in phases through 2025–2026, but the PMS requirements are already in force.

NHS England – Data Security & Protection Toolkit (DSPT)

  • The DSPT is a required self-assessment for all UK organizations handling NHS patient data, measuring performance against 10 data security standards, including access controls, cybersecurity, staff training, and incident response.
  • NHS trusts and their partners must meet updated annual requirements – e.g. Version 6.0 (2023–24) was due by June 30, 2024 – demonstrating adherence to evolving NHS and National Data Guardian standards.
  • The DSPT integrates guidance from the National Cyber Security Centre and complies with UK GDPR and Cyber Essentials, ensuring medical devices and IT systems are securely managed and patient data is protected.

Cybersecurity & Data Privacy

Recurring annual requirement; e.g. 2023–24 Toolkit due by June 30, 2024 (Version 7.0 for 2024–25 due by June 30, 2025).

Emerging regulations complicate the creation of an IT–Biomed strategy (Australia)

Regulation Name

Summary of Key Requirements/Changes (2023–2025)

Applicable Area

Effective Date/Timeline

TGA – Medical Device Unique Device Identification (UDI) System

  • As of July 2024, high-risk medical devices must include UDI codes in labels and submit to the AusUDID database.
  • Implementation staged by class: Class III and IIb in 2025, lower-risk classes by 2026–2027.
  • Improves traceability, recall efficiency, and aligns with global UDI standards.
  • Hospital CIOs should update asset management and procurement processes to record UDIs, as this will facilitate inventory control, maintenance, and incident response (and may be required for electronic health records and supply chain systems).

Device Identification & Traceability

UDI law effective 2024; Stages from 2025 (Class III/IIb by Jul 2025; others by 2026–27)

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About Info-Tech

Info-Tech Research Group is the world’s fastest-growing information technology research and advisory company, proudly serving over 30,000 IT professionals.

We produce unbiased and highly relevant research to help CIOs and IT leaders make strategic, timely, and well-informed decisions. We partner closely with IT teams to provide everything they need, from actionable tools to analyst guidance, ensuring they deliver measurable results for their organizations.

What Is a Blueprint?

A blueprint is designed to be a roadmap, containing a methodology and the tools and templates you need to solve your IT problems.

Each blueprint can be accompanied by a Guided Implementation that provides you access to our world-class analysts to help you get through the project.

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Get the help you need in this 3-phase advisory process. You'll receive 8 touchpoints with our researchers, all included in your membership.

Guided Implementation 1: Clarify drivers and scope
  • Call 1: Scope objectives and identify key challenges.
  • Call 2: Validate current inventory baseline.

Guided Implementation 2: Define business capabilities
  • Call 1: Assess staffing and asset lifecycle practices.
  • Call 2: Conduct capability and gap analysis.
  • Call 3: Design future-state support model.
  • Call 4: Build staffing and certification blueprint.

Guided Implementation 3: Identify assessment criteria and assess solutions
  • Call 1: Develop roadmap and change plan.
  • Call 2: Finalize implementation toolkit and next steps.

Author

Sharon Auma-Ebanyat

Contributors

  • Anonymous, CIO, Hospital in South Africa
  • Anonymous, CIO, Hospital on the West coast of the US
  • Anonymous, CIO, Hospital on the East coast of the US
  • Anonymous, CIO, Hospital in Midwest US
  • Anonymous, CIO, Hospital in Midwest US
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