Clinical Evaluation of Medical Devices

The economic evaluation of medical products and services is increasingly prioritised by healthcare decision makers and plays a key role in informing funding allocation decisions. It is well known that there are a number of methodological difficulties in the health technology assessment of medical devices, particularly in the provision of efficacy evidence. By contrasting devices with pharmaceuticals, the way in which the differing systems of innovation mould the UK's industry landscape is described and substantiated with market statistics. In recognition of the challenges faced by industry, as well as the growing need for cost-effective allocation of National Health Service (NHS) resources, the National Institute for Health and Care Excellence (NICE) led the development of the Medical Technologies Evaluation Programme (MTEP), which launched in 2009/2010. The review of the UK's medical devices market supports the programme's three principal aims: to simplify access to evaluation, speed up the process, and increase evaluative capacity for devices within NICE. However, an analysis of the output of MTEP's first 3 years suggests that it has some way to go to meet each of these aims.

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Clinical Evaluation of Medical Devices

Cited by 6 publications

References 26 publications

Clinical and Regulatory Challenges for Medical Devices

Clinical and Regulatory Challenges for Medical Devices

Theoretical Reflections on Medical Devices and the Sociocultural Context in the Locale of Japan

Are the UK Systems of Innovation and Evaluation of Medical Devices Compatible? The Role of NICE’s Medical Technologies Evaluation Programme (MTEP)

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