Welsh Government
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Industry

Background

Oral anticoagulation therapy reduces blood clots, and is prescribed for the prevention of thromboembolic disease in certain groups of patients. Warfarin, the most commonly prescribed drug, is unpredictable, affected by state of health, diet and medication. As a result, regular monitoring is necessary to help prevent life threatening events resulting from over- or under-dose. There has been a huge growth in the number of patients attending GP surgeries for therapeutic monitoring.  

Microvisk have developed a device called the CoagMax®. This monitors how quickly blood clots, which allows the dose of anticoagulant to be adjusted as required. The device can be used both at home and in a GP surgery. 

The challenge 

Microvisk are based on the St Asaph Business Park in North Wales. They needed to find clinical partners to conduct performance evaluation studies on the CoagMax®.  The CE mark denotes mandatory compliance with all applicable EU Directives for diagnostic medical devices, clearing products for sale in the European Union. Microvisk needed to test the system with the intended users of the device, including patients, nurses and healthcare assistants in primary and secondary care.

The solution 

Microvisk were referred to Health Research Wales by MediWales in 2013 and an Industry Manager was assigned to the company. The Industry Manager made introductions to the Consultant Haematologist and Thrombosis team in Betsi Cadwaladr University Health Board. They also introduced Microvisk to 16 GP surgeries, who would recruit most of the patients. 

The availability of the Primary Care Research Incentive Scheme (PiCRIS), which supports GP surgeries to become research active, and the allocated Industry Manager, who had already built a research relationship with surgeries in her previous role as Research Nurse for the National Institute for Social Care and Health Research Clinical Research Centre, helped make the recruitment process easier. The Industry Manager worked closely with Microvisk to select appropriate research sites and carry out study set-up visits. Health Research Wales were also able to provide support in developing contacts and assisting with the global and local regulatory requirements for ethical and Research & Development permissions in Wales. 

Throughout the conduct of the Performance Evaluation studies, the Industry Manager has maintained contact with Microvisk, providing support when required. The Performance Evaluation studies have been completed across 16 sites in Wales and Microvisk have obtained their CE mark and are now marketing their device.

Impact 

  • Surgeries new to research found taking part in the studies a positive experience because the study and materials were well-designed. 
  • Surgery staff received training and gained research experience which they can apply to future studies.
  • The increased involvement of surgeries in research means more patients will have access to research studies.
  • The practice staff have reported excellent feedback from their patients’ experiences.
  • Many patients look forward to the device being available to purchase for home use. The burden of regular clinic attendance can affect both working and family life. The frequency of these visits is reduced or negated for patients able to carry out monitoring at home.