Methods of value demonstration in IVD technology
This article was originally published in Clinica
As evidentiary requirements in the in vitro diagnostic (IVD) market increase, manufacturers are under greater pressure to demonstrate the value of their products as soon as they enter the market in order to ensure routine coverage by healthcare insurers. "Value" in this case has a broad definition, covering both clinical and economic applications, with individual requirements often hinging on a combination of product price, market size and clinical impact. Thus far, no specific prescription for value seems applicable to all IVD technologies, making data development both a guessing game and a financial risk for manufacturers.
You may also be interested in...
Israel is well-known as a medtech hot-spot, with a focus on academic research and strong government support helping the country punch well above its weight when it comes to innovative devices.
St Jude Medical had a heavy focus on its intravascular imaging offering at this year’s EuroPCR meeting, presenting data supporting its optical coherence tomography (OCT) technology. OCT provides intravascular images to help assess culprit lesions, which can improve stent selection and deployment, according to St Jude.
A big topic at this year’s EuroPCR, held in Paris on 19-22 May, was drug-coated balloons (DCBs). One of the leaders in the field, Medtronic, presented positive data from two studies of its IN.PACT Admiral balloon, which could support an expanded indication for the device.