Dr John Scott Frazer, a doctor from North West Anglia NHS Foundation Trust, works predominantly in anaesthetics and intensive care with a keen interest in managing medical emergencies safely.
Scott has worked with Health Tech Enterprise (HTE) to develop his concept for the PediJect device, a dose adjustable prefilled medication syringe for use in children’s emergencies. Scott, and Debbie Carmichael, research and innovation lead at the Trust, requested HTE’s support to review the commercial potential for the device, and needed expert advice on intellectual property protection options, regulatory strategies and obtaining funding to develop the idea.
Read the interview with Scott to find out more.
“The inspiration for my device came from looking after unwell children in the emergency department. We always struggle with preparing drugs correctly and from an anaesthetics background we’re usually the ones preparing the drugs directly or helping the nurses to prepare them in an emergency. It’s a very time-consuming process and requires a lot of concentration which can make it quite difficult in a busy department. After just a few of those emergencies, I thought there must be a better way to do this.
We do have prefilled syringes for adults and it really speeds things up in a cardiac arrest because with that you get the same consistent dose each time, and you don’t have to spend time preparing the medication from scratch. I thought it would be useful to have a prefilled syringe for a child that you can easily adjust and then the innovation developed from there.
My Innovation
My idea is a device called the PediJect. Essentially, it’s a dose adjustable, prefilled medication syringe for use in children’s emergencies. One of the major problems with drug dosing in children’s emergencies is that because children are various different weights, they require precisely tailored doses of drugs. Unfortunately, that means we see lots of errors with wrong concentrations of drugs used or wrong doses, wrong calculations, wrong preparations. This device is designed to reduce all of those errors and improve safety for medication delivery in children.
We know that in paediatric intensive care about 15% of the drugs that are given are either prescribed or given incorrectly and just over 2% of children in paediatric intensive care experience harm as a result of that. In simulated medical emergency scenarios, only 20% of the medications that are given are actually the correct use.
There are other adjustable syringes that exist for things like insulin pens but they can be quite complicated. They’re really for quite precise tiny doses and they’re usually reusable. They have a cartridge that allows you to administer multiple doses. With my device, the unique selling point really is that it’s a disposable dose adjustable syringe that is relatively cheap to manufacture and very user friendly to set just one dose.
Impacts
In the testing that we’ve done so far, we’ve shown reduced incidence of medication errors in a realistic simulation scenario, from about 50% down to 25%. So, we have managed to half the errors with the prototype version that we’ve developed so far. We’re optimistic that with continued innovation in the device design we can reduce those errors down even further.
The other problem we are tackling is delays in administration of the medication. We know that it takes somewhere between a minute and a half and two minutes for somebody to prepare a dose of adrenaline for the child and mortality increases by 9% every minute that adrenaline is delayed in cardiac arrest. With our device that was reduced to about 30 seconds or so. These are really quite big reductions in a time-critical situation.
Outcomes
Currently we’ve developed our proof of concept prototype and performed some initial testing in a simulation environment of paediatric emergencies. We’re now applying for an NIHR product development award grant essentially to take the prototyping and development further. If successful, and all goes to plan over the next 3 years, we would be ready to enter the market around 2027.
There have been a few challenges along the way. At the start I was a bit naive to the medical device regulatory processes that surround this sort of device. Especially because it’s a prefilled syringe and it contains a drug, it just makes it more complex and deciding how to approach that has needed expert advice which I’ve been able to obtain through HTE’s help.
I’ve also found that just explaining the idea to people that aren’t from a medical background is not that easy. Talking to my fellow healthcare professionals, such as doctors and nurses, is easy because they instantly say, oh, yes, that’s a big problem. Talking to non-clinical people that aren’t familiar with medical emergencies in hospitals and the drugs that you have to prepare and how you do it has been more challenging. Illustrating that problem to non-clinical people I’ve found to be a challenge, but an interesting way to help conceptualise the idea.
At the start I was thinking about going it alone and trying to develop my innovation without Trust support, but once I approached the research and development department and asked them for help the Trust have been extremely responsive to this and very helpful. It’s opened a lot of doors to things like support with grant applications that I just wouldn’t have had access to otherwise.”
Working with HTE has also been really valuable, for the whole project. I’ve been able to access expert advice from all aspects of the product development pathway, from introductions to engineering companies, contacts with patent attorneys and just guidance on how to navigate the regulatory system and apply for funding to progress the device. Karen Law, HTE’s Head of Innovation, in particular has been really knowledgeable and very responsive to contact.
