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Medical devices: IF, WHEN & HOW to generate clinical evidence

Who is this event for? All healthcare innovators! Whether you’ve a device, application, pharmaceutical or a diagnostic tool, this event is for you.


The rules and regulations around medical devices can be very confusing and it’s not always easy to know what you need to do, let alone how to do it. 


The National Institute for Health Research (NIHR) is the research arm of the NHS.  It works in partnership with medical device and diagnostics companies to help them translate ideas into innovative medical technologies for use in the NHS.


NIHR experts are based within NHS trusts and universities. They can support medical device and diagnostic companies across all stages of product development: from identifying unmet clinical needs to designing and running clinical studies.


During this talk we'll be answering the following questions:

What is the NIHR and what can it do for healthcare innovators?

Do you need to generate clinical evidence for your technology?

What areas of the NIHR infrastructure would be suitable for you to carry out your clinical research?

How can you access NIHR funding for your research?

How can you connect with key opinion leaders in your field?


To answer these, we'll be hearing from the NIHR Office for Clinical Research Infrastructure (NOCRI) about how this NIHR expertise can be accessed by industry. The NIHR clinical research infrastructure includes expert individuals, research facilities and technology platforms that have been designed to support high quality clinical research across the innovation pathway, from invention to adoption. NOCRI provides a direct route to these experts and facilities and can support companies to set up collaborations with one or more research centres in a streamlined and efficient way. NOCRI is government funded and the services it provides are free.


The talk will cover some of the NIHR infrastructure which is available to healthcare innovators:


NIHR Healthcare Technology Cooperatives (HTCs):

There are eight HTCs across England, each focusing on a different area of unmet clinical need. They were set up to catalyse NHS “pull” of  innovative healthcare technologies that will really benefit patients. This involves working collaboratively with industry to develop and evaluate new technologies and generate evidence of their clinical benefit and utility.


NIHR Diagnostic Evidence Cooperatives (DECs):

The DECs are centres which bring together multidisciplinary teams who can evaluate novel diagnostics to help generate information on the clinical and cost-effectiveness of in vitro diagnostic devices.


NIHR Funding Programmes:

There are a number of NIHR programmes which will provide funding to industry looking to carry out clinical research in the NIHR. We’ll take a look at the i4i programme and the EME programme during this talk.