Evidence-based guidance is key to pushing medtech innovation

  • Posted on 31.08.2016

Evidence-based guidance is key to pushing medtech innovation


Mirella Marlow

Programme Director – Devices and Diagnostic Systems, Centre for Health Technology Evaluation, National Institute for Health and Care Excellence (NICE)


I’m greatly looking forward to the European MedTech Forum meeting in Brussels in December, where I’ll be talking at the plenary about payers and hospitals aligning expectations and sharing values. I’ll also be taking part in a panel session on personalised and precision technologies.   

NICE is ideally placed to help the medical technology and diagnostics industries to meet increasingly challenging expectations in resource-constrained health systems.  Through our Medical Technologies Evaluation  and Diagnostics Assessment Programmes we produce evidence-based guidance and advice on innovative medical and diagnostic technologies for the National Health Service (NHS) in England, recommending those that are clinically and cost-effective. 

Payers are often most uncertain about the value of a new technology at the point where an adoption decision is needed for the whole health system. NICE is able to help in these situations by targeting further evidence development on the specific uncertainties remaining about the use of the product once we have done our evaluation. We work with academic evidence assessors to produce a protocol which the company can then use to target their research on those uncertain outcomes, enabling us to update our guidance at a future point.  Of course, we would prefer companies to undergo a NICE evaluation with the correct evidence already in place, so we also offer a Scientific Advice service to companies as they plan their trials.

The cost of developing evidence is a major concern to companies facing short patent lives, “fast-followers” and frequent device iterations. NICE is involved in a work stream of EUnetHTA Joint Action 3 that seeks to create a quality tool for registers being used to collect health outcome data. The aim is to give guidance to register developers (including companies) and those using the data for HTA, a common set of standards so that companies don’t waste resources on low-quality datasets. HTA and payer bodies can also be reassured that high quality registers may be used in their evaluations to answer key uncertainties that can appropriately be addressed through non-randomised data.

What could the future look like?  We have the opportunity to make ever more use of health-based data sources by sophisticated linkage between individual patient records and other health-related data sources. Software embedded in technologies is already the norm. For some products, this will allow patient-level data to be collected at relatively low cost during diagnosis or treatment, and, some of those data will directly relate to outcomes of interest in determining value. Looking further ahead, quantum technologies which bring together the physical, digital and biological worlds are starting to emerge with the potential to transform understanding of diseases and support the personalisation of treatment. 

But however advanced and exciting the science may be, it will always be necessary to have a value proposition that locates products in a treatment pathway. Even novel products must be studied in scenarios and populations that are relevant to real-life health delivery, to produce evidence of their clinical utility that will be persuasive for payers. NICE works with companies to achieve this, and now has the NICE Office for Market Access which is our first point of contact for the life sciences industry wanting to talk to NICE about future products. The European MedTech Forum will be an excellent opportunity to discuss approaches for supporting the adoption of effective innovative medical technologies.

Further information about the National Institute for Health and Care Excellence (NICE):





Interested in this topic? Join the European MedTech Forum which will be held on 30 November-2 December 2016. Mirella Marlow’s session,“Shared Values – Payers and Hospitals Aligning Expectations”, will take place on 2nd December. More information about the Forum is available at medtechforum.eu and under #MTF2016. 

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