Medical Device Service Evaluation

← Back to Case Studies

The Challenge

A medical device company had achieved CE marking for their innovative device but needed real-world evidence to support a Drug Tariff application. This evidence was critical for NHS reimbursement and commercial success in the UK market.

Traditional clinical trials presented significant challenges:

• 12-18 month timelines from protocol to completion
• High costs associated with RCT design and ethics approvals
• Complex regulatory requirements
• Delays in market access while waiting for evidence

The company needed a faster, more pragmatic approach that would generate credible real-world evidence without the complexity and cost of a formal clinical trial.

Our Solution

Regulatory Pathway Assessment

We used the HRA Decision Tool to classify the project as a Service Evaluation rather than research. This critical determination meant:

• No Research Ethics Committee (REC) approval required
• Simplified governance procedures
• Faster setup timeline
• Evaluation conducted within standard care parameters
• Maintained robust oversight and data quality standards

Site Selection

We identified a GP practice with:

• Appropriate patient demographics for the device indication
• Clinical interest in the therapeutic area
• Experience with clinical documentation and data collection
• Willingness to evaluate the device within routine care
• Infrastructure to support systematic data capture

Protocol Development

We developed a pragmatic evaluation protocol that:

• Fit within standard care parameters (no additional visits or procedures)
• Captured outcomes relevant to Drug Tariff submission requirements
• Included patient-reported outcomes and clinician assessments
• Met regulatory standards for evidence quality
• Minimized burden on practice staff and patients

Training & Support

• Provided comprehensive device training for practice staff
• Created simple data collection templates
• Established systems for ongoing support and queries
• Monitored data quality throughout the evaluation

Agreement Structure

We developed an agreement that balanced the needs of both parties:

• Practice retained independence in clinical decision-making
• Company received rights to use data for regulatory submissions
• Provision for independent publication of results
• Clear IP protection and confidentiality terms

Key Results

Why Primary Care for Device Evaluations

Direct Patient Access

GP practices have immediate access to appropriate patient populations in their routine care settings, eliminating recruitment delays common in hospital-based studies.

Real-World Conditions

Evaluations conducted in primary care capture authentic "real-world" evidence – showing how devices perform in routine clinical practice rather than the artificial environment of a research study.

Faster Setup

Primary care sites can typically be activated much faster than hospital sites, with simpler governance and approval processes.

Cost-Effective

Lower overheads compared to hospital-based studies, with more streamlined processes and fewer administrative layers.

Clinically Relevant Data

Evidence generated in the settings where devices will actually be used provides more relevant and compelling data for payers and commissioners.

The Result

The device company completed their evaluation in just 9 weeks total (3 weeks setup + 6 weeks data collection). The quality real-world evidence was used successfully in their Drug Tariff application.

Additional benefits included:

• Cost savings of approximately 70% compared to traditional RCT approach
• Evidence generated 6-12 months faster than a formal clinical trial
• Practice gained experience with the device and has continued using it
• Practice expressed interest in future commercial collaborations
• Patient feedback was overwhelmingly positive

Impact

This case demonstrates the power of service evaluations for generating regulatory and commercial evidence quickly and cost-effectively. By understanding the regulatory landscape and leveraging our primary care network, we enabled rapid evidence generation without compromising on quality or credibility.

The company subsequently used this model for evaluations in additional therapeutic areas, establishing service evaluation as their preferred approach for real-world evidence generation.