Discovering and identifying options to address shortfalls in public health

The Opportunity

NHSX is a joint unit bringing together teams from the Department of Health and Social Care, NHS England and NHS Improvement to drive the largest digital transformation of care programmes in the world. With investment of more than £1 billion pounds a year nationally and a significant additional spend locally, NHSX has been created to give staff and citizens the technology they need.

Reporting directly to the Secretary of State for Health and Social Care, and the Chief Executive of NHS England and NHS Improvement; NHSX are leading the largest digital health and social care transformation programme in the world.

NHSX required options to address significant public health shortfalls resulting from the use of implantable medical devices. There were a number of challenges in the project that were required to overcome.

  • Pressing timescales driven by ensuing Cumberlege report
  • Compared to other areas of medicines, regulation and in-life studies not applied to the same levels
  • In the instance of alerts/recalls, implanted devices cannot be traced to patients
  • Diverse stakeholder groups

 

The Approach

RedRock Managed Professional Service engagements are underpinned by the same core values of Client Enablement, Teams of Excellence, Impartiality and Ownership. Each engagement is directly overseen by one of our Technical Directors to ensure this. 

With the limited time available, our approach centred on two practical improvement measures:

  • Rapid start through success, involvement and synergies within Medical Devices at the MHRA
  • Launch IMD event created effective launchpad, involving C-level representatives from NHSD, NJR, IMMDS, MHRA, DHSC and Clinicians

Our Team

RedRock’s team consisted of a core team and a number of on demand subject matter experts.

Core Team:

  • RedRock Delivery Director
  • Transformation Lead
  • Senior Delivery Manager
  • User Researcher
  • Senior Business Analyst

Subject Matter Experts on demand Call-Off:

  • Medical Device Regulation 
  • Data Science
  • EUDAMED
  • SME Contribution & Validation

 

 

The Solution

RedRock tackled these two practical improvement measures in the following areas:

Regulation

  • Exploring Integration (Data & Process) with UK MDR regulatory solution for UDI availability and reuse
  • The definition of full UDI over revised range of medical device categories

User Research

Applied processes and tools that followed GDS standards and practices:

  • We placed patients at the centre, understanding the end-to-end impact on lives 
  • Validated the need for a Patient Info Decisioning Tool
  • Conducted extensive research involving Patients,  Clinicians including Urogynecologist, Hip, Vascular, Orthopaedic Surgeons and Manufacturers
  • Participant recruitment
  • Full UR planning & preparation
  • Team involvement & inclusion (eg, UR session observers)
  • UR interviews with & without User Testing of prototypes
  • UR Surveys
  • Vulnerable participants
  • Regular playback presentations with team and stakeholders
  • Collation of comprehensive ‘User Needs’ and User Problem Statements
  • Iterations of materials and methods
  • Documented for GDS Service Assessments

Point of Care Traceability 

We defined and evaluated:

  • Operating Theatre procedures 
  • The reduction of burden on clinicians 
  • Registry levels beyond patient and device data (compliance +)
  • Electronic data capture (barcodes & RFID technologies), Scan4Safety, Tactical scanning solution

Service Design

We defined and evaluated Six-Sigma based study:

  • Governance,
  • Benefits
  • Value Model
  • National Joint Registry: as world leading exemplar.

 

The Outcome

RedRock has successfully achieved the goals set by NHSX:

  • User research and personas drove our messages forwards, across a diverse group of engaged stakeholders, 
  • People affected or involved had a voice, 
  • Improvement measures, onward programme workstreams, structure defined
  • Blended IMD Core team assembled
  • Construction and launch of IMD Steering Group: driving patient safety while supporting novel procedures and innovation
  • Senior Clinical Advisor nominated
  • On-time, and on-budget project delivery
  • The most positive meeting and outcome with the Secretary-of-State for Health: “That’s a bulls-eye”.

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