Evaluation

Assistance with the clinical evaluation of new medical devices and diagnostic products can be provided, which is an essential requirement for securing regulatory approval. An appropriate strategy to secure CE marking is vital to ensure that the most cost and time effective route is adopted. This in turn requires reliable clinical resources to design and conduct the evaluation, as well as a solid infrastructure to comply with ethics requirements. Furthermore, this can generate the evidence required to validate the claims of improved patient care, cost benefits, and improved service quality.

Key Features:

  • Access to advice from a department with expertise in med-tech health technology assessment and which hosts a NICE External Assessment Centre
  • Provision of assistance from the NIHR Clinical Research Network North East and North Cumbria and MedConNecT North in accessing key clinical expertise for peer review or to aid adoption within NHS organisations in the region
  • Provision of assistance from City Hospitals Sunderland NHS Foundation Trust to provide specific support around the adoption and evidence required for ophthalmic interventions, products or services
  • Provision of assistance with regulatory affairs for medical technologies
  • Availability of expertise relating to regulatory strategy within the regional supply chain

Benefits:

  • Generation of high quality ‘evidence of benefit’ to encourage and drive adoption of the new product or service by NHS organisations

Pathway Case Study

Light Therapy Treatment for Degenerative Sight Threatening Conditions

Pathway in Action

Validating a regional model of Familial Hypercholesterolaemia diagnostic and cascade testing

Rapid Testing for Carbapenamase Producing Enterobacteriaceae

A New Diagnostic Test for Acute Exacerbation of COPD

Clinical Performance Evaluation of a Rapid Near Patient Test for Influenza A and B