Here Sarah Bolton, Business Manager at the Centre for Healthcare Equipment and Technology Adoption (CHEATA), experts in evidence gathering for NHS adoption, talks about the importance of the different types of evidence medtech innovators can use to support their commercialisation and adoption.
Here at CHEATA we meet developers of medical technology regularly and more often than not, the question that is asked is – ‘What can we do to get our device adopted by the NHS?’ The answer is never straightforward, but it usually revolves around one thing – evidence.
Evidence is crucial to device commercialisation and adoption. The sooner you start to compile your evidence base, the easier it will be to start engaging with the relevant people, whether that’s clinical champions, procurement specialists, Supply Chain, or NICE. A robust evidence base can be used to demonstrate to potential adopters and purchasers of your device that ‘it does exactly what it says on the tin’. There is also a much greater push for evidence-based procurement from both Supply Chain and Procurement Specialists with NHS Trusts so do make sure you have an up-to-date Value Proposition that includes a summary of your evidence base before you engage.
Randomised control trials – do I need one?
Most obviously, evidence is used to support the CE marking process and is largely drawn from clinical investigations undertaken in an appropriate patient population and written up and published in a peer-reviewed journal. Large randomised controlled trials are often seen as a ‘must-have’ in order to gain widespread adoption post CE-mark but this isn’t necessarily the case for medical devices. They are usually on a much more modest scale (10s or 100s of patients) compared to typical drug trials (1000s of patients) and it can be very difficult or even impossible to do a blinded or placebo/dummy controlled trial with a medical device. A well-designed and robustly executed comparative trial even in a small number of patients, can have a big impact on your device commercialisation and adoption.
HealthTechConnect Portal
Fortunately, NICE looks at a range of evidence when deciding what medical technologies to select for NICE advice or guidance though of course randomised controlled trials and comparative studies are still considered the most important components in the evidence portfolio. The new HealthTechConnect (HTC) portal is now the ‘front door’ for NICE and is the place where you can upload your device details and evidence so that it can be reviewed by NICE and any other stakeholders that you choose. There are several categories of evidence including randomised and non-randomised trials, comparative studies, conference abstracts, expert opinion as well as unpublished data.
NICE will review products uploaded to the HTC and in the first instance will consider them for Medical Innovation Briefing (MIB) – this is a really useful summary of the product and includes a review of relevant published evidence and the likely costs of using the technology. MIBs are ‘designed to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies’ but in our opinion, they can also be a very useful sales tool for medtech developers to use when discussing their product with potential purchasers and adopters and we would recommend that companies look to getting their evidence onto the HTC as a key step in their commercialisation pathway. CHEATA is currently working with two companies to upload their evidence onto HTC and we look forward to working with them and NICE to get a better understanding of how the process works and how it benefits patients, the NHS and the medtech manufacturers.
Evidence for new opportunities
Similarly, evidence can also be used by medtech manufacturers to explore and develop potential new areas for deployment. A company came to CHEATA with a medical device which had been on the market a while in a particular clinical area and was selling well. However, they felt that it could be used in a different clinical area but were unsure where to focus their efforts. After a wide-ranging literature search we identified several areas where the device could additionally be used and contacted clinicians working in one area for their input. We summarised the evidence, both published and expert clinical opinion describing the use of the device in the new area which could then be used by their sales force to drive engagement and sales in new areas.
The best devices usually incorporate a strong element of clinical pull rather than commercial push. The evidence base is a live portfolio that needs to be fed and nurtured with new data and studies in order to allow your product to grow, so it’s never too late to review your evidence needs – especially if sales are not as expected or you want to switch focus to another area.
To find out more about CHEATA and the services they offer to medtech innovators, you can visit their website: www.cheata.co.uk/
Author
Sarah Bolton, Business Manager at the Centre for Healthcare Equipment and Technology Adoption (CHEATA)