A Medical Dilemma
Alan Sexton found a problem that troubled him.
As an anaesthetist, when intubating an overweight or obese patient, it’s critical to be able to see the vocal chords to make absolutely sure the tube is inserted correctly and in the right position. It must not go into the stomach, which can lead to death in 28% of anaesthetic related deaths.
If the tube goes into the stomach, the valve can open and the patient can aspirate as food enters the airways. It’s especially important to have a clear view in emergency intubation, when you have a patient who’s been in an accident or requires emergency surgery and hasn’t been fasting.
For anaesthetists to get a clear view of a patient’s vocal cords, the head must be elevated slightly, at a very precise angle. The current practice is to manually lift the head, but there are several issues with this, and with heads often weighing more than 5kgs, manual lifting is not the best practice. Also in many cases, teeth are damaged when the laryngoscope is inserted.
The current solution for head elevation is to send valuable nursing staff out of the theatres to find additional pillows and towels to prop the head up.
Let’s find a Better Solution
So Alan Sexton decided to do something about it.
‘I needed to find an alternative. I thought the equivalent of a head elevator would be good, so I made some models in my garage at home. The device looked quite professional, but there were many questions surrounding head rotation, neck lines, radius of rotation etc.’
He needed some help – in the form of some engineering brilliance.
Human Life needs a little Certainty
With a pillow placed under a patient’s head, the anesthetist is guaranteed a good head elevation, regardless of how heavy the head is – and with no excessive force on the laryngoscope.
Alan got to work on some prototypes in his garage, and started researching how to commercialise them. He found an innovative and forward thinking company called Avantec, that made an initial model, but the lifting mechanism had gears and it wasn’t flexing the right way.
Avantec recommended Neil Wilson from Romar – Avantec thought Romar may be interested in taking a look at the project.
As medical device specialists, Romar were happy to take on the challenge.
Reconsider, Redevelop, Redesign
‘Together with Romar, we took a good look at the ratcheting and lifting mechanism – and found it wasn’t a good system to build and produce on a mass scale.
The best way forward was to use a mechanical gearbox – an up/down system.’
And so the relationship began, and Romar worked with Alan to put the machine engineered models together.
Romar joined forces with Design for Manufacture specialists D + I to come up with the best possible schedule for modelling – to maintain all the engineering advantages, improve the cosmetic side and make it commercially viable.
‘Romar are very collaborative. You can talk to them about what you want to change and it all comes together.’
Romar now work regularly with D + I they respect each other’s strengths, and are using them for other collaborations also.
‘There is real strength in working together locally.’
A Moral Investment
‘My device will save lives. Romar’s involvement is as much a moral commitment as a financial commitment. When you have a product that you believe will save lives and benefit people on a grand scale, it’s a responsibility to continue, in spite of any negativity.
Romar tuned into that and realised how enormously beneficial HiSpy would be.
HiSpy also paves the way for a more level playing field. It empowers all anaesthetists as they don’t have to move heavy heads to establish airways.’
And a Financial Investment
It’s incredibly difficult to win awards in the medical device space (the competition is fierce), and six months of work on a $50k grant application proved unsuccessful.
Romar needed the money to machine engineer seven or eight models that would be trialled at different hospitals. But with no grant, they were in an uneasy position.
‘Romar felt this project was impossible to ignore – and they didn’t want the project to die.’
Incredibly, Romar offered to make the models Alan required for free, because they believed in the project and were committed to the concept.
They felt it was important enough to continue.
‘Romar felt these devices could make a real difference. I deeply respect Neil Wilson, and the people he works with. They believed in the product. They saw benefit and passion, and they invested in its future.’
A Successful Partnership
Once the models were manufactured, Romar’s quality assurance and testing ensured their viability and success.
‘Our injection moulded process was refined, and with some help from the CSIRO, we have been able to get FDA approval in the USA, TGA approval here in Australia, and we are about to apply for approval in Canada.
Romar’s testing processes are world class, and we are very lucky to have these processes onshore and available to us.’
Alan believes the price you pay for manufacture offshore is too high. And because he chooses to manufacture HiSpy devices in Sydney with Romar, he retains control, quality, deliverability and scalability.
The road ahead for Alan and his HiSpy device is exciting and filled with opportunity.
‘My relationship with Romar is excellent. I know there is nothing like my product in the world – it’s a great innovation. Thankfully Romar can see the potential for this device and for now it’s a question of being patient, getting some studies done and moving forward.’
‘Neil Wilson has a great humanity and a great personality – he doesn’t place unnatural expectations on things. He’s just as patient as I am.’
And while we’ve seen some early HiSpy success, further success is only a matter of time.