The Challenge

The Department of Health and Social Care (DHSC) was undertaking a critical programme of work to address public health risks associated with implantable medical devices (IMDs). At the time of this engagement, the work was highly visible and reported directly to the Secretary of State for Health and Social Care and senior leadership within NHS England and NHS Improvement.

DHSC required urgent, evidence-based options to address significant public health shortfalls linked to the use of implantable medical devices. These issues had been highlighted by the forthcoming Cumberlege Review and posed risks to patient safety, public confidence and system accountability.

The challenge was complex and time-critical:

• Pressing timescales driven by national policy commitments and regulatory scrutiny
• Regulation and in-life monitoring of devices lagging behind established approaches used for medicines
• Limited ability to trace implanted devices back to individual patients in the event of alerts or recalls
• A highly diverse stakeholder landscape, spanning clinicians, regulators, policymakers, industry and patients
• DHSC needed a rapid, credible and collaborative approach to define practical improvement options that could be progressed at pace.

 

Our Approach

RedRock’s Managed Professional Service engagements are underpinned by the core values of Client Enablement, Teams of Excellence, Impartiality and Ownership. This engagement was overseen by a Delivery Director to ensure pace, quality and alignment with DHSC priorities.

Given the urgency of the work, RedRock mobilised a focused core team, supported by on-demand subject matter experts who provided specialist input as required. This flexible model ensured access to deep regulatory, clinical and digital expertise without slowing delivery.

With limited time available, the approach focused on two practical improvement measures designed to create early momentum:

• A rapid start by leveraging existing expertise, successes and synergies within medical devices at the Medicines and Healthcare products Regulatory Agency (MHRA)
• The launch of a national IMD event to create a shared launchpad, involving senior leaders and C-level representatives from NHS Digital, the National Joint Registry (NJR), IMMDs, MHRA, DHSC and the clinical community

These measures accelerated alignment, enabled early decision-making and established a foundation for sustained collaboration.

 

Our Solution

RedRock structured the work across four key areas, ensuring that patients remained at the centre of all decisions.

Regulation
The team explored the integration of Unique Device Identifiers (UDI) across data and regulatory processes within the UK Medical Device Regulation framework. This included defining UDI requirements across a revised range of medical device categories to support improved traceability and governance.

User Research
A user-centred approach placed patients at the heart of the work, enabling a clearer understanding of the real-world impact of IMD failures and gaps in oversight. Extensive research was conducted with patients, clinicians, manufacturers and specialist groups including urogynaecology, orthopaedics, vascular and hip surgery. This research validated the need for a Patient Information and Decision-Support Tool and ensured all processes followed Government Digital Service (GDS) standards, with outputs documented for service assessments.

Point-of-Care Traceability
The team defined and evaluated multiple approaches for recording devices, equipment and drugs at the point of care. This included electronic data capture using barcodes and RFID technologies, Scan4Safety initiatives, tactical scanning solutions and enhanced registry models. These approaches aimed to reduce errors, improve patient safety and significantly reduce the administrative burden on clinicians.

Service Design
A Six Sigma-based study was undertaken to assess governance models, benefits realisation and value frameworks. Using the National Joint Registry as a world-leading exemplar, the team evaluated how robust data, governance and service design could support safer innovation and better outcomes across the health system.

 

The Outcome

RedRock successfully delivered against DHSC’s objectives, providing clear, actionable options within demanding timescales.

The engagement resulted in:

• Evidence-based recommendations driven by user research and patient personas
• A strong and inclusive voice for patients, clinicians and other affected stakeholders
• Clearly defined improvement measures and onward programme workstreams
• Formation of a blended IMD core team to take the work forward
• Establishment and launch of an IMD Steering Group focused on patient safety while enabling innovation
• Nomination of a Senior Clinical Advisor to provide clinical leadership
• On-time and on-budget delivery

The work was extremely well received at the highest level, with feedback from the Secretary of State for Health and Social Care describing the outcome as “a bulls-eye”.

This engagement laid critical foundations for improving patient safety, strengthening regulation and enabling a more transparent, data-driven approach to implantable medical devices across the health and care system.