Why Data, Interoperability and Real-World Practice Are Critical to Success in the NHS

By Jarred Evans, Director at PDR and Seetal Sall, Point of Care Testing (PoCT) Lead, Cardiff & Vale University Health Board.

Over the last decade, the NHS has steadily shifted from viewing medical devices as isolated clinical tools toward understanding them as data-generating, connected systems that sit within a much wider digital and governance ecosystem.

Nowhere is this more apparent than in the growing role of Point of Care Testing (POCT) and other agile, community-based diagnostic technologies.

The promise is clear: faster diagnostics, better clinical decision-making, improved patient flow, and care delivered closer to home and to the point of care. However, the reality of implementing connected devices in live NHS environments is far more complex than most product roadmaps acknowledge.

This is not a technology problem alone. It is a systems, governance, and service design challenge.

The shifting diagnostic landscape

The Point of Care Test team in a large NHS Trust that works closely with PDR are seeing a rapid expansion in the use of portable, connected, and semi-autonomous medical devices across primary care, community services, and pre-hospital settings. Examples now in everyday use include:

• Point of Care Testing platforms across primary and acute care
• Portable ultrasound systems (e.g. POCUS)
• Community ventilators and CPAP devices connected to cloud-based management platforms
• Continuous glucose monitoring systems
• Wearables and remote patient monitoring (RPM) technologies
• RFID-enabled asset tracking and device management systems

These technologies are fundamental enablers of key NHS strategies. As the focus shifts from episodic hospital-based care to longitudinal, distributed patient management, connected devices become essential infrastructure rather than optional innovation.

As mainstream Laboratory technology miniaturises, many manufacturers supply Laboratory- style analysers as a benchtop system, claiming to be a POCT platform. Although these systems may comply with regulatory requirements for design manufacture and technical validity, they often fail to comply with the fundamental requirements of a robust POCT platform. Every new device introduced brings with it data flows, integration dependencies, quality control obligations, and governance burdens that must be actively managed.

Why Point of Care Test Devices are a useful lens

Seetal Sall and her Point of Care Test Team, through their work and experience provide a unique and invaluable insight in this area, providing a particularly useful lens through which to understand the wider challenge. While often below the radar to many organisations the POCT team role is critical and sits within NHS health care provision at the intersection of:

• Diagnostics
• Pathway re-design
• Clinical decision-making
• Data quality and traceability
• Multi-disciplinary workflows
• Technical and clinical evaluation
• Regulatory oversight
• Patient Safety
• Business Intelligence/ efficiency
• Clinical effectiveness

When we start to look at this in the context of Point of Care Devices in particular, a single POCT result is rarely simply a number. It is so often tied to data that includes:

• A patient identity
• An operator identity
• A device configuration
• A consumable lot number
• A timestamp and clinical context

For that result to be clinically meaningful and legally defensible, it must move accurately and securely into Laboratory Information Management Systems (LIMS), Electronic Patient Records (EPRs), and often onward into national data repositories.

It’s an area so many companies seem to ignore and where many well-intentioned device designs begin to struggle.

Connectivity is not just “plug and play”

From the outside, device connectivity is often framed as a simple technical problem: does the device connect to the network? In practice, NHS connectivity operates across multiple layers:

• Device-to-gateway communication
• Local network security and segmentation
• Middleware and integration engines
• National and regional data repositories
• Identity, access, and role management
• Audit, traceability, and quality management
• Cyber security
• Information Governance protocols

For POCT and other connected diagnostics, interoperability is not optional. Devices must be capable of interfacing with existing national and regional platforms, such as pathology systems, shared care records, and workforce credentialing systems.

The real-world implementation challenge

One of the most under-acknowledged issues in connected device deployment is that implementation capability rarely scales at the same pace as device adoption. As more connected devices are introduced across community, primary, and home-based settings, NHS organisations, alongside many other health care providers globally face increasing pressure on:

• Device onboarding and validation
• Connectivity testing and configuration
• Operator training and competency management
• Remote monitoring and fault resolution
• Data capture and quality assurance
• Risk management
• Regulatory, accreditation and governance reporting

Connected devices promise transformation, but only if the surrounding service infrastructure is designed to support them.

What this means for designers and manufacturers

For anyone designing point-of-care or connected medical devices, there are some non-negotiable considerations.

1. Design for the ecosystem, not the device

A device does not exist in isolation. It must, critically, be conceived as part of a clearly understood clinical pathway. It needs to operate within existing and future digital infrastructure and IT architecture and within the governance framework of the NHS.

Design decisions around user interface, workflow, and configuration have direct consequences for downstream data handling and compliance.

2. Data provenance matters as much as accuracy

It is not enough for a device to generate accurate results. Designers must consider who uses the device, under what conditions, with which consumables, how software updates work in a real working environment as well as routine maintenance and data security.

We're not just talking about usability considerations at the device level and compliance with usability regulation. That’s a level of consideration most designers (I hope!) have a good grasp of now. It’s a system level understanding and consideration of the data eco-system that is needed and to include things like understanding traceability as a core safety requirement, not an administrative afterthought.

3. Interoperability has to be designed in, not retrofitted

Too many devices rely on proprietary cloud platforms that often sit awkwardly alongside NHS infrastructure. Successful products increasingly support open standards where possible, allow flexible integration architecture and acknowledge that NHS systems evolve over time. Rigid, closed ecosystems typically create friction and limit adoption.

4. Connectivity introduces new failure modes

A key consideration is understanding how a connected device can fail silently in so many ways that a standalone device cannot. Common failures the POCT team see includes, data not being transmitted, results that are delayed or misattributed, systems that are out of sync and data loss.

Design teams must consider graceful degradation, clear error signalling, and transparent recovery pathways.

5. Governance and safety are part of the user experience

For POCT and similar devices, quality control processes are not peripheral—they are central. Getting an understanding of quality control and governance procedures within a healthcare provider set up, especially perhaps the NHS can be one of the biggest leaps forward for a device provider in gaining adoption, traction and maximum clinical effectiveness. Devices that simplify QC workflows make compliance visible, reduce administrative burden, they often ensure error reduction/ reduce medico-legalities and reduce manual entry. Ultimately effective compliance and design to sit effectively within internal QC processes assists hugely in improving patient safety and are far more likely to be embraced by clinical services.

6. The service model is part of the product

In real NHS settings, the “product” includes so much more than the physical device. It has to include training, support, monitoring and reporting systems and functionality.

Designers who ignore this reality deliver technically impressive devices that struggle to gain traction.

Designing for the future NHS

Connected medical devices are rightly seen as enablers of a more distributed, preventative, and patient-centred NHS. But realising that vision depends on designing with deep respect for the complexity of clinical environments and data governance.

POCT, remote monitoring, and community diagnostics will continue to grow. The question is whether they will do so in a way that is sustainable, safe, integrated, value based and trusted.

That outcome depends as much on design thinking and systems understanding as it does on technology. One of the drivers behind the collaboration of the POCT Team with Cardiff and Vale University Health Board and PDR to work together to support companies design better, more effective devices, systems and diagnostics that better align to the needs of real clinical practice

Designing devices that work in the real world

As connected medical devices become central to how care is delivered across primary, community and pre-hospital settings, the gap between technological capability and real-world implementation is becoming increasingly visible.

Bridging that gap requires more than good engineering or clever connectivity. It requires early, informed design decisions grounded in real NHS practice — an understanding of clinical workflows, data governance, interoperability, quality control and the operational realities faced by services such as POCT.

This work, developed collaboratively between PDR and clinical and technical leaders within the NHS, reflects a shared belief - that the most successful medical devices of the next decade will be those designed with healthcare systems, not simply for them.

For companies developing point-of-care diagnostics, connected devices or data-enabled medical technologies, now is the moment to engage early — to test assumptions, stress-test connectivity models, and design products that can scale safely and sustainably within NHS environments.

PDR, working closely with the POCT team operate at the intersection of design, engineering and real clinical insight, collaborating closely to help organisations navigate this complexity and turn ambition into deployable, trusted solutions.

If you are developing connected medical devices and want to ensure they succeed in the real world we’d welcome the conversation.