The differences between medical device and pharmaceuticals are, firstly, Medical devices are based on biomedical engineering and, as a general rule, either permanently or temporarily replace a body function. By contrast, pharmaceuticals are medicines, designed to engage the body’s chemistry. Secondly, Medical devices have different efficacy dynamics to pharmaceuticals.The effectiveness of a medical device depends upon many more variables – the care setting, individual patient characteristics and the skills and experience of the clinician ‘applying’ the device. Finally, Research and development (R&D) models are different
Most medical devices cannot be evaluated using randomised clinical trials due to ethical and practical issues in the choice of comparator