Tariq, you’re an eye doctor who has invented an app to help children use spacers and inhalers more effectively – tell us how it all started?
Tariq: I started as a consultant at Manchester Royal Eye Hospital about five years ago. In my post I’m actually an ophthalmologist, a lot of my time is around research – I’ve already been working on systems to get children to comply with specific vision tests using gamification.
When I got to Manchester, my eldest son who was about three began suffering quite badly with a viral-induced wheeze. When he’d get a cold, he’d start getting very wheezy and he’d need Salbutamol treatment, but it would have to be given through a mask and a spacer. Quite often we’d have to get to hospital and we might need nebulisers – he was admitted a few times.
How did that affect you as a family?
Tariq: Apart from worrying about the illness itself, the worst thing for us was trying to get this treatment into him when he was already very upset and having difficulty breathing.
Getting a child of that age to try and breathe normally while you’re putting a mask on his face and he’s already very worked up was distressing for everyone –he hated it. It really had a big impact on our lives because we got worried every time he got the tiniest sniffle.
So when did the idea for the app occur to you?
Tariq: I noticed one time that he got distracted by a nurse blowing bubbles while he was using the spacer – but he soon got bored of that. But one evening I had an idea that you might be able to adapt this mobile phone app I’d seen which listens out for when you breathe in and out.
I managed to rig something up to attach it to the spacer device. It was just something that was based on blowing – if the app detected the blowing, you could see a bubble on the phone. We attached that with a little bit of electronics to the spacer that he had and I took it to him. Instead of screaming he was mesmerised by this screen and just breathed normally.
This was about two o’clock in the morning, he carried on breathing and the completed his dose and at the end of it he said: “That was really good Daddy, can we do it again in the morning.” That was when I knew that there was something here.
It sounds like a eureka moment – what happened next?
Tariq: I knew it needed a lot of work to make that into something that would be repeatable and could be used again and again. I started working on developing it into an app and so I wrote software for use on a mobile phone. The app itself has changed very little since I initially programmed it. Initially what happened is that there is a microphone and it’s attached to the outflow valve of the spacer. So when the child breathes out, it detected this noise and that’s what moved the game on.
After I tried it a few more times with my son, I thought it was time that I got in touch with a respiratory expert to find out whether this idea really could benefit a wider group of young people.
Over to you Clare – you’re a respiratory paediatrician at the University of Manchester, tell us how you got involved?
Clare: I think Tariq simply Googled me as respiratory paediatrician based at the University of Manchester. He got in touch and told me all about his situation and what he’d done – and he asked what I thought about it all.
I thought it was a great idea because we don’t really have any way of using incentive devices with spacers. Some children just take to it, it’s fine. But there’s a number, particularly the little ones, who either get somewhat frightened by it or just are bored by it and don’t want to do it.
So I thought having something that would entertain them and potentially could improve their inhaler technique at the same time would be a great idea.
How did you move the project on from here?
Clare: We applied for a grant from the Central Manchester Foundation Trust and some other small grants which would allow us to move the project on a bit further. Tariq did a bit more programming and finessed the app and we also got a special clip made which attached the phone to the actual spacer device.
Once it was a bit more robust, we took this prototype and did this very small trial on about 15 young children on the wards here in Manchester to see how it worked and what everyone thought of it. The feedback on that mini-trial was very, very positive and in fact that’s what we presented as a poster at the British Thoracic Society Winter Meeting in 2014.
It’s been very much a team effort. It's something that just wouldn't have come together without the three of us working together. Having the combination of a clinician, a scientist and somebody who knows the market very well is a very good position to be in.
Between doing that study and before we presented it at the BTS Winter meeting, we approached a number of different people to talk about how it might be commercialised.
Neither of us are business people, so this was an area where we really wanted some input. After talking to GSK, they put us in touch with Mark Sanders, the Managing Director at Clement Clarke, which is a company that does a lot of work around inhalers, spacers and peak flow meters.
How did Mark get involved initially?
Clare: He was really enthusiastic about the project and he actually took it to the European Respiratory Society 2014 meeting, which was a really valuable process. One of the key bits of feedback that he got was that while they really liked the idea of the device, they were a bit disappointed that it was measuring exhalation rather than inhalation.
He also helped us to work out a realistic price for selling the product commercially, which was going to be in the region of £25 to £30. We all thought that cost would be quite prohibitive for most parents, particularly for something which they didn’t know whether it would actually help their child.
So how did you go about resolving these potential barriers?
Clare: We scratched our heads and started thinking about what we could do that maybe would reduce the cost of the whole thing and measure inhalation rather than exhalation.
What we came up with is that Clement Clarke makes a device called Flo-Tone: a little plastic device that you can slot into your MDI [metered dose inhaler] and if you inhale at the correct flow rate it emits a tone at a specific frequency. That device can go on various MDIs and also can fit onto your spacer device. It can also fit within your spacer device so that you slot it into your spacer and then you put your MDI in the other end, you squirt it and you inhale through the spacer and through the Flo-Tone, so you make the tone.
Mark – can you tell us a bit more about the Flo-Tone?
Mark: Originally we designed the Flo-Tone as a training tool to help people to use their inhalers properly. We recognised that with a normal aerosol inhaler, if we put a mouthpiece with a whistle onto it, we could achieve several things.
We could engineer it so that the whistle goes off at a certain flow rate, that the whistle sound then became the signal to press and that the duration of the sound became a clue to how long and deep the inhalation was.
How has it been received?
Mark: We've achieved a fair amount of success over the last couple of years with Flo-Tone being used as a training tool, a kind of a mini-spacer with flow guidance, but this is a departure from its use straight onto the inhaler by using it on a spacer, or on the inhaler into a spacer to give us a signal in-line.
Back to you Clare, how has the project developed using the RafiTone app with the FloTone?
Clare:What Tariq has now done is rewritten the program so that it picks up that exact tone. So you have to have a good seal, you have to be breathing in correctly to make the tone, then the app picks up the tone and moves the game forward on hearing it.
The good thing is the Flo-Tone is very well validated. There is lots of information to show that, 1. it doesn't affect lung deposition at all by having the Flo-Tone within the device and, 2. it's very well validated to show that it only makes the tone when you’re breathing at the correct flow rate.
Therefore not only are we hopefully engaging children with the game and making them associate using their inhaler with the game, but also you can encourage them to actually inhale properly with your spacer device.
Tariq: We’ve also set the game up so that you can set it with different sensitivities. So perhaps when you’re first trying to engage the child you can have it fairly low sensitivity. That means they don't have to have an absolute perfect technique the first time they use it to get the game to work.
Over time, you can increase that sensitivity, so that only when the is technique perfect will they create the right tone to move the game on.
And has this approach had an impact on the potential cost price?
Clare: Definitely. Firstly the Flo-Tone is available on prescription and a parent can go to a GP or asthma nurse and ask for one.
You can also buy the Flo-Tone over the counter from various pharmacies and the retail cost is from about £2.90. We plan to market the app for the standard price of about £3, so it makes the whole solution much more affordable.
So what’s happening now?
Clare: The Flo-Tone is already CE marked but at the moment we’re also looking to get the RafiTone app CE marked as a medical device. So we’re not going to actively market the device until we’ve achieved that, hopefully towards the end of the year.
The other thing we're looking at is trying to put some other features into it. We’re trying to put some features such as a calendar so that it would actually record whether it had been used, so you could use it as a kind of adherence tool.
And one of the other really interesting things that we’re looking at with Clement Clarke is how you could use it as a training tool for healthcare professionals to make sure they’re demonstrating correct usage of inhalers and spacers and the like.
It all sounds very exciting – Mark, what do you think you’ve learnt from being involved with this project?
Mark: It’s been really fascinating and actually that has opened our eyes to some tremendous opportunities going forward. Not only is the Flo-Tone an audible signal, but when you analyse that whistle on an electronic frequency measure you get a particular characteristic signature meaning you can distinguish a correctly used Flo-Tone from an incorrectly used effort.
By programming that into an app that gives us a very easy way of guiding the correct use of inhalers. So whether it’s for healthcare professionals or for patients, that means two really important things: that they can record both adherence and quality of technique.
I believe the group in Manchester are about to start an evaluation process where nurses will be able to access the app and we will provide Flo-Tones to them so that they can see if this helps their teaching of children to use the spacer.
Back to you Tariq, how have you found working with Clement Clarke?
Tariq: It’s been great working really closely with Clement Clarke and in particular with Mark. It's really impressive actually because although he's a commercial agent, he's got very strong ethos in terms of producing things that he wants to help as many people as possible. So Clement Clarkes makes its own spacer but he's personally spent a long time making sure this Flo-Tone actually fits all sorts of spacers.
So what’s next?
Tariq: Clare and I were really keen for this not to just be something we publish and then it just disappears. We both wanted it to be out there and available to kids to use. That's what we would regard as success – if it was being widely used and helpful, even if it's just to 20% of those children that need it, that's a large number for the UK as a whole.
Since we spoke to Clement Clarke we've got a Smart Award as well, which is a government award. We've also been given an award on the basis of us being a social enterprise, which is very much where we're sort of placed in terms of our overall objectives and ethos.
So we've got a couple of awards in different places to basically try and get to a situation where people can very easily find out about it and press a few buttons and then have it in front of them.
Because it's not just an app, it also requires the Flo-Tone, that makes the commercialisation a little bit more complicated. But hopefully by December time we should have something that is more widely known and that people can access quite easily and cheaply.
And what would be your message to respiratory professionals?
Tariq: The key message is that we're developing this and we're very happy to get any feedback or comments that they have. Our overall aim is to produce something that is really beneficial for all our patients – so we’re always thinking about how we can improve that.
Finally, can you sum up your experience of working on this project?
Tariq: It’s been very much a team effort. It's something that just wouldn't have come together without the three of us working together. Having the combination of a clinician, a scientist and somebody who knows the market very well is a very good position to be in – hopefully we’ll make it successful.
It means we can adapt quite quickly and make sure it remains true to what its inception was, which was to basically help kids and parents get through this period and reduce the morbidity overall with asthma – that’s the long-term objective.
Tariq, Clare and Mark – thanks very much and good luck with everything.