Types of R&D undertaken

The types of R&D undertaken:

Look See - To see if a product is appropriate to be used as a dressing. The 'look see' is deisgned to look at the potential of a product and it's possible product positioning. It will not look at the efficacy or clinical performance of a product. Typically products will be reviewed on two patients with a maximum of 3 dressing applications.The product must have appropriate CE marking and a simple report (maximum of 2 pages) will be issued providing information on when, how and where the dressing could be used. This can be extended into a case study or clinical evaluation if required. 

Case Study (ies) - These form the largest part of the R&D activity within the WHC. We are often requested to review products that are already on the market to the NHS, having undergone CE Mark testing and clinical testing. The case study follows the patient pathway to wound healing. Case Studies are also often undertaken for seating/ cushions and mattresses. Normally case studies involve one or three patients only.

Clinical Evaluations - These generally involve a larger group of patients (approximately 10 – 15). They are commissioned when the customer has some clinical evidence to support the efficacy of a specific product, but require more in order to disseminate the results to a wider population e.g. Peer Reviewed Journals / Conferences. These products also CE Marked, or require MHRA approval and are commonly used in the NHS.

Randomised Controlled Trials (RCT’s) - These are strictly controlled trials that MUST gain ethical approval from Central Office for Research Ethics Committees (COREC). These are usually undertaken where the sponsor wishes to obtain comparative results on two or more products, both of which purport to have the same clinical outcome. The WHC is currently involved in two multi-centred RCT’s, both of which have gained ethical approval.

Ethics - The R&D activity undertaken by the WHC complies with the Declaration of Helsinki, 1964.