we have a independent balloon cuff that is
a donut balloon made out of silicone that’s very soft and compliant and can create – conform
to all kinds of shapes. Because it’s a donut you can slip it around the endotracheal tube
and advance it down the tube into the trachea where you can inflate it to create a seal.
the purpose of having this balloon that’s very compliant is that we can, when it inflates
in the trachea, we can create a seal preventing fluid from getting past it and leading to
aspiration. the first prototype we were looking into all
sort of materials that would be water resistant thin, and you could turn it in to some sort
of donut shape. So coming back from a meeting at the Florey Institute for some reason we
stopped at a CVS on the way and Kate and I essentially bought all the different types
of condoms on the market with all sorts of materials to design our first few balloons
and try them and see how much flexibility each material had and so it was a easy, cheap,
way to get our prototypes going. And then I think it was – I mean to move
forward you have to go beyond – you can’t use condoms that you’re forming yourself
in human …. it’s just kind of the evolution of the company that you have to make it more
real. in the Bio-design process it’s not just
about finding a clinical need and coming up with a cool technology it has to be commercially
viable. So when you’re trying to assess whether or not something has commercial viability
you have to do some initial planning on how long is it gonna take us to develop this?
How much is it gonna cost? So that’s sort of the next step. There’s kind of basic
project planning tools that you would use for that and there’s a standard product
development cycle that you could kind of chart out for your project.
I think time is one thing. I mean I laugh looking at our project. you’re so optimistic
and you have to be, I think, to go into it, because if you knew what it would actually
take you might think twice at the beginning. But I mean it’s always surprising how long
things take and it’s even if it’s simple you will run into challenges; things you don’t
expect. And it’s one of those things that it’s
not like you can say nobody warned me. You present this plan to everybody and everybody
says “Okay you can double that timeline.” You’re like “No I’ve been using conservative
estimates. I thought it was gonna take one month I actually wrote down two.” And then
everybody’s like “No it’s gonna take double.” It actually does and everybody
else is right. as soon as you can, get in to the cadavers,
get in to live animals, whatever your best most realistic model is for a live breathing
human, use that to gauge how close you are because anything else is really just not realistic
enough. getting in to human models as fast as possible
is important but also understanding the variation that there is from human to human. For us
our first cadavers were all, for whatever reason, they were relatively large men and
so we got – or not even – like six foot tall men. So we iterated and iterated and
got to a design that we thought was frozen and we were ready and then the next cadaver
we got happened to be kind of 5’5” woman, average, a little on the small side, and nothing
worked at all because she was just – everything was just smaller, it was harder; pushability,
tortuosity, everything was much harder. So that was surprising for us. I think it’s
really important to understand the full range of what you’re going to be working in and
start with worst case, design for worst case. after fundraising you can actually sort of
literally afford to iterate faster, which I mean there’s literally no down side and
you want to do that, but early on you’re bound by the amount of money and time you
can put in to it. but even when you have a little bit of money
don’t be afraid to spend the money to make engineering progress . Even if you have $5000
I mean every dollar is precious but spending $1000 to get a prototype that actually looks
like what yours is gonna look like might be the catalyst that gets you to fundraising.
So I think that was something we kind of went through as we got more money realizing okay
we have to spend money to continue getting money and to make progress .
there will be ups and downs. I mean there will be days where you think there’s no
way this’ll ever work. But I think having gone through enough of those cycles where
we thought we had reached a roadblock that was insurmountable if you keep thinking about
it and keep working on it and just keep putting one foot in front of the other and you will
overcome them.