Better design tests needed for medical devices, say engineers
The medical technology sector needs better ways of demonstrating the safety, effectiveness and performance of its products, says a new report.
Medical device developers could adopt methods from the engineering sector to help improve assessment where the kind of trials used to test new drugs are not appropriate, according to the report from the Royal Academy of Engineering.
The UK’s strong research base and the NHS mean the country is well placed to generate the necessary high-quality evidence for such devices, said the report, produced following a roundtable discussion on the topic that brought together clinicians and engineers from healthcare, industry and academia.
Sir Alasdair Breckenridge, chair of the Medicines and Healthcare products Regulatory Agency, said: ‘As medical devices become more complex, their regulation needs to keep up with the underlying science.
‘The current devolved European regulatory system requires a drastic overhaul to reflect these changes and collaboration between engineers, clinicians and regulators will become even more important.’
The report, published in collaboration with the Academy of Medical sciences, focused on the problem of testing medical devices when randomised controlled trials (RCTs) are not possible or appropriate.
Devices, unlike medicines, are increasingly used as one aspect of complex treatments where it is difficult to create a control group. The report said that, with appropriate design and guidance, meaningful trials for medical devices can and should be undertaken.
The report, “Establishing high-level evidence for the safety and efficacy of medical devices and systems”, examined the engineering model for assessing safety, which it said has been built by dialogue between industry and regulators.
June 20, 2013
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