Bringing innovation to the NHS: trials without the tribulations

Innovation is the lifeblood of the National Health Service (NHS). It’s an essential ingredient for a public healthcare system facing the major health pressures of a modern society, such as the mental health crisis, or diabetes and the plethora of associated health problems it brings. But translating innovative ideas in to the clinical setting is no mean feat.

You’re a small company, you’ve got a great idea or product. You want to get it into the NHS because you know that there are benefits to be gained by patients and the NHS alike - whether that’s better patient outcomes, less invasive procedures, saving clinician time, or good just old-fashioned cost savings... to name a few. However, you’re not a clinician, scientist, or statistician. So it’s difficult to know where to begin when it comes to generating the evidence to prove your product works and get that crucial CE mark. Sound familiar?

Matt Cooper is the Business Development and Marketing Director for the National Institute for Health Research (NIHR) Clinical Research Network, an organisation that helps the life sciences industry to deliver clinical research in the NHS. He says:

“Previously clinical research was not a specific requirement for MedTech companies seeking a CE marking. But since 26 May 2017, when the EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR) came into being, companies are now having to think longer and harder about their evidence strategy. Generating robust clinical and health economic data is an essential part of bringing a product to market in the UK’s health service. It’s a competitive playing field and cost pressures in the NHS mean that the requirement for health economic data, in particular, is increasing. And that data has to be relevant. For example, presenting the results of studies of a particular technology in other countries or health systems, is unlikely to meet the required standards. Delivering a clinical study in the NHS, with the intended patient population, is undoubtedly the most effective way of enhancing your marketing strategy.”

This was certainly the experience of Steve Hutchinson, Managing Director of the Microcurrent Site and UK distributor of the AlphaStim Aid - a medical device that uses cranial electrotherapy stimulation to treat anxiety, depression, insomnia and pain. Despite over 100 studies of the underlying technology having already taken place in the USA, he was advised by NICE to focus his attention on the NHS - which inspired him to contact the NIHR:

“I first discovered the NIHR through a Google search after meeting with NICE in Manchester. The outcome of the meeting with NICE was very positive but they did say we needed to set up a research project specifically in the NHS. The NIHR stood out to me as an organisation that could help. They have a centre in Nottingham, where I’m from, called MindTech. So I contacted them and I got a rapid response saying yes this is something they’d like to help us with... and it’s basically gone from there.”

MindTech is one of eight NIHR-funded centres in England which help companies to successfully translate ideas into innovative medical technologies for use in the NHS. They do this initially by helping to develop a study protocol and then by connecting companies with the NIHR Study Support Service, which is facilitated by an NIHR-funded dedicated research workforce, embedded throughout the NHS, to help find investigators and sites and to deliver the study. If a company already has a draft protocol, the NIHR Study Support Service also has the ability to gain feedback from NHS clinical experts on the compatibility of the research with current NHS practice. Jonathan Abraham is CEO and Co-Founder of Healum - a company which creates digital solutions that enable healthcare professionals to support and motivate patients to self manage long-term health conditions. Healum accessed a range of NIHR support:

“We initially approached the NIHR for help putting the study protocol together. They provided guidance, which was really easy to follow. That helped us to come up with a skeleton study framework for the NIHR to circulate among relevant clinical experts. We then used the feedback we received to refine the protocol and make certain that it was ready for the NHS.

“We worked really hard to put the protocol together based on NIHR advice, and then the moment they sent it round to the list of research-active primary care sites was a huge ‘aha’ moment for us. Within two days 117 research-ready practices had responded and signed an expression of interest. We were high-fiving in the office because we were going from a place of not knowing how we were going to run this research project, and wondering how we were going to identify who to work with from thousands of GP practices - to a place where, not only did we have some great sites, but we also had really in-depth information about who those sites were, and how we could work with them.”

“Without that support, I don’t believe that we would have been so far in our journey and be a this stage; ready for the study to go live in the next couple of months. And I also don’t think that, as a company, we would really understand how we would develop our evidence strategy at this stage in our life cycle.”

Being slightly further along that same journey, Steve Hutchinson reflects on how his study benefited from the support of both Mindtech and the hands-on expertise of front-line clinical research nurses who are part of the NIHR-funded research-ready infrastructure embedded in the NHS:

“We had a waiting list of patients to approach with a letter of introduction and study information. Initially the research nurses found that they were not getting the uptake that they were expecting. They decided to take a slightly different approach and gathered feedback from the patients who had responded, which they then used to revise the letter. This was approved by ethics and the second batch was far more effective in terms of uptake. But we were then up against it in terms of timescales; our target was 120 patients in six months. However, every challenge was overcome with absolute gusto by the research nurses. I cannot emphasise enough, they were so enthusiastic about getting the study done effectively, and ultimately they achieved what we all set out to do.”

“Without the support of MindTech and the NIHR, there is no way that this study would have got off the ground. I’m a layman, it’s the first time I have done something like this and although we’ve got a great product, I don’t profess to have any of the connections required to do a research project in the NHS. We are now sat here with a study being finished and we are just about ready for publication, and that’s primarily down to those guys.”

According to Matt Cooper this is a typical experience for smaller MedTech companies accessing the NIHR’s support services, and will continue to be for the foreseeable:

“Innovation and evolution are key factors in the sustainability and longevity of our NHS. That is why the NIHR is funded by the Government to provide this type of support, completely free of charge, to help companies of all sizes and shapes to bring their creative ideas into the NHS clinical setting. Last year (2017/18) we worked with 127 MedTech companies and 27 Clinical Research Organisations to support 186 MedTech studies - which makes up about 15 per cent of our entire NIHR Clinical Research Portfolio. What’s even more impressive, is that 88 per cent of the MedTech studies we supported, which closed last year, achieved their recruitment target on time. We recruited 14,443 patients into MedTech studies compared to 9,326 the previous year.

“These figures will continue to rise because in the past MedTech companies only had to demonstrate equivalence, which was normally done through documentation rather than clinical evidence generated through clinical studies or trials. The May 2017 EU directive changes that and more MedTech companies are seeking our support as a result. One thing that we can be absolutely sure of, is that the requirement for relevant clinical and health economics data will continue to be an essential part of the journey for companies seeking to introduce their products to the NHS.”

The NIHR has launched a new web page including a number of videos from MedTech companies describing the NIHR support that they have received, and how it has impacted their business. To find out more go to: www.nihr.ac.uk/medtech