Freedom Without Fear - Making injections effortless with autoinjector tech to saves lives, with Conor Cullinane of Pirouette Medical

In one sentence: A needle shaped like a hockey puck is a ‘revolutionary’ medical device that can deliver epinephrine during a severe allergic reaction on Earth or in space.  
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Overview
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EpiPens and other emergency auto-injectors have changed little for decades, though there are known limitations in their accidental (mis)use. Conor Cullinane, co-founder of Pirouette Medical, shows us his team’s surprisingly non-needlelike auto-injector that is shaped smooth, flat, and round, and easily totable so those at risk can have, in the company’s words, “freedom without fear”.

Following a patient-centered design process supported by the founders’ expertise in human factors engineering for bioastronautics applications, the team is shepherding their medical device through the US Food & Drug Administration review process. We have a front row seat in how they are managing the translational process of medical device design and development.
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Show Notes
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• Episode page, transcript, and podcast listening links: https://toughtechtoday.com/making-injections-effortless/
• Conor Cullinane on LinkedIn: https://www.linkedin.com/in/conorrcullinane/
• Pirouette Medical (company): https://www.pirouettemedical.com/
• Subscribe with your favorite podcast service: https://www.buzzsprout.com/1169378/7277551
• Watch this show on Youtube: https://youtu.be/AMX2ans63UA

Episode Transcript

Conor Cullinane (00:00):
It's very intimidating, very
anxiety-driving, veryfear-driving, and all of these
things add up to where when wewere looking at our study of
patients that were just usingtrainer devices in a calm,
clinical setting 15% of theseindividuals refused to actually

(00:22):
try and perform an injection.

Announcer (00:24):
Welcome to Tough Tech Today with Meyen and Miller.
This is the premiere showfeaturing trailblazers who are
building technologies today tosolve tomorrow's toughest
challenges.

Forrest Meyen (00:39):
Welcome to Tough Tech Today! We have a special
guest, Conor Cullinane. Conor isthe CEO of Pirouette Medical, a
company that is making arevolutionary new auto injector
device. Hi, Conor, welcome tothe show.

Conor Cullinane (00:54):
Hey, Forrest, thank you for having me. Thank
you, Jonathan. It's great to seeboth of you and get to share a
little bit about my journey.

Forrest Meyen (01:03):
So Pirouette Medical, what kind of company is
that? Do you make some sort ofmedical ballet slippers? Or what
is what is your company about?
Why did you pick that name?

Conor Cullinane (01:14):
Yeah, so that's a great question. One we we
often get, I think a lot ofpeople are always intrigued by
the name, we found it to be veryhelpful. As far as its origins
and what the company does, weare a medical device
manufacturer and design company.

(01:36):
So we found a need in in themedical space, we developed a
device to meet that need. We'recurrently taking that that
design, to practicemanufacturing, and then through
FDA approval, and onto themarket. That's the overall
process of what we've set out todo as a company. Why Pirouette

(02:00):
Medical? It is based on theactual dance move a little bit.
So what you know, and you do apure wet, it's a it's a
revolution, it's a spin. We liketo play on that a little bit
because of the the design of ourdevice, as well as, because of

(02:21):
the connotation that it has withthat revolution. We saw what we
were doing as very differentthan what had been done before.
Rather than saying we'rerevolutionising that space, we
like to say that we're making apirouette in that space. I
really liked the name and, andwe've, we've, we've definitely

(02:44):
had a great time, sort ofleading with that and continuing
to keep that thought process. Aswe look at different
technologies, or differentapplications of our technology,
and really focus on continuingto make that revolution or that
pure wet in, in the medicaltechnology space.

Jonathan (03:02):
Thank you for explaining that. That's a nice
tie-in in terms of the way thatthe device works and the
philosophy that you have for thecompany, for our listeners and
our viewers. Could you elaborateon the problem area that you had
identified, you mentioned thatyou found this opportunity in
the medical space? Could youelaborate on what that is, why

(03:25):
it's important? Why we shouldcare?

Conor Cullinane (03:26):
Yeah, you bet.
It was at a period of time whenI was completing my PhD, and
essentially, came across acouple of news articles over a
very short period of time. Soyou know, one day I basically
read an article about a childwho was exposed to a light, a

(03:49):
life threatening allergen, Ithink the the first article I
had read was a exposure to apeanut at a school cafeteria,
the child unfortunately, didn'treceive a life saving dose of
epinephrine in time, and, andunfortunately, passed away. And
so it's a very sad story and,you know, something that popped

(04:11):
up and, and, you know, be my somy PhD focus was medical
engineering and medical physics.
And so, you know, sort of aspace I was already really
interested in, and, you know, itdefinitely struck a chord. And,
you know, a couple of days goby, and I, all of a sudden see

(04:32):
an order another article. Andit's another child who was
exposed to an allergen, in thiscase of the sting out playing in
a field at a park and didn'treceive their life saving dose
of epinephrine in time andunfortunately passed away. And,
you know, one of those articles,you see that and it's, you know,

(04:53):
whoa, you know, something,something is is wrong here. And
then you see two of those in amatter of of days, you know,
this was all within a week. Andit's like, okay, let's, let's
take a look here and see what'sactually going on. You know,
it's, it's tough to hear it,that, that that's actually still

(05:14):
happening. And so we started todive into that that aspect of a
medical device that reallydidn't seem to be solving the
problem that it was really thereto solve. And, you know, our
thought process was, well, well,why why didn't these children
receive their life saving dosein time, you know, it's, it's

(05:37):
very evident, you know, how theybecame exposed to an allergen,
you know, you're never going tobe able to escape those 100%,
you know, you and your familyand your parents or whoever can
do everything they can toprotect you from exposure. But
oftentimes, those exposureshappen at a time when, you know,
you have you have no idea and noexpectation. And so our initial

(06:01):
thought process was, Well, hey,this is a, this is a portability
issue. And so we looked atexisting injection devices, and
we said, they're too big,they're too bulky, they're too
hard for, you know, a 12 yearold kid to carry around and try
and remember it, when they goanywhere. And that's, that's
sort of where we started

Jonathan (06:20):
Is injection, the only way to mitigate these effects,
once the allergies are occurs,the reaction?

Conor Cullinane (06:27):
Once the allergy occurs, the the current
emergency treatment is anintramuscular injection of
epinephrine. There are othertreatments on the horizon. There
are other companies looking atways in which we can have other
emergency treatments that couldpotentially mitigate these these
issues. But currently, that'sthe, that's the only way, we

(06:50):
have to save a life in this inthis scenario. And, you know,
you you hope that when you'reexposed, you're you don't have a
severe enough allergic reaction,that there's going to be a life
threatening issue. Butunfortunately, that's not always
the case for everybody. Andoftentimes, the individuals who
have theseThese reactions that are life

(07:15):
threatening, those situationsare extremely rapid, as well.
After exposure, some of theseindividuals can actually pass
away within five minutes, ifthey don't receive that aboard
of the life saving dose in time.
So it's, it's extremely scary,and you and you can start to
think about, well what needs tohappen during that period. You

(07:37):
know, if let's say you've gotyour device in a backpack, or
it's in the glove box, or yourcar, or wherever it is, right,
you first have to find thedevice, then you have to get it
to the individual that needs it.
So if it's yourself, you know,you've got to find it and, and
then be able to use it onyourself, if it's a parent with
a child, they need to be able todig through that backpack and
grab it or, you know, run backto the car and grab it, bring it

(07:59):
back to that child and then useit and five minutes is not a
long time. Right and, and, youknow, it's it's a very scary
scenario. And, and one of thebig things that we really
started to figure out, as wewent out and talk to patients
and potential, you know, userswho rely on these devices to
save their life is, you know, ahuge part of their life is just

(08:22):
filled with constant fear.
Because if you're allergic to abee sting, or if you're allergic
to a peanut, you don't know whenyou're going to come into
contact with one of thesethings. And so, you know, you
could be out mowing the lawn,you know, I have a really good
friend who, who is severelyallergic to bee stings life,

(08:42):
they're in one of these lifethreatening manners, just like
we were talking about. And hehas been out mowing the lawn
before, was stung by a bee and,and barely survived. And, you
know, this is an individual whoactually did perform an
injection on himself, actuallycarries currently carries an epi
pen and carries that epi pen ona holster on his on his belt.

(09:09):
And so, you know, if, if you'rethinking about, you know, this
is an adult, right, and they're,they're constantly in fear of a
situation where they might needa life saving dose so much to
the, you know, to the extentthat they need this on their
belt, you know, no matter whatthey're doing wherever they go
outside, right, because a beak,you know, could get them at any

(09:29):
point. And then you thinkAlright, well, you know, as a
child going to have that samediscipline to make sure they
have that and that's where itstarts to get really scary and
sort of dangerous as you youlook across not everybody has
that discipline. And he he if hedidn't have it with him that
close it would have been fatal.
So it's it's extremely scary forthese individuals. This problem

(09:50):
has been around and since sincesince humans have had severe
allergies and so what then gapDid you see to be able to make a
A one and novel medical devicefor this patent of patents were
granted and pending, and thenbegan wrapping a company around
it, because that's a wholedifferent thing of here's a
problem, but then coming downthe path of finding a way to be

(10:12):
reimbursed for this kind ofmedical engineering that you're
doing. Exactly, yeah. So when westarted to, to initially Look at
this, this landscape, and thecurrent devices that were there,
you know, you can kind of traceit back all the way to, you
know, when injection started,and, you know, the first types

(10:33):
of devices, which were reallysyringe like, and then you kind
of have the full blown syringesafety syringes, those sorts of
things. And they developed, youknow, over time to the point
where, you know, providing anintramuscular injection is
something routine can easily bedone, but this is really
healthcare provider dependent,right, you're, you're, you're
receiving an injection bysomebody who has the training to

(10:54):
provide that injection, right,you're dealing with a needle,
you're dealing with a syringe,you're dealing with the drug,
you have to get all three ofthose components together, you
have to get it, you have to getthe drug at the correct volume,
the correct dose, right. Andthen all of that has to happen
in one of these, you know, highstress, blood pumping
environments where, you know,you use somebody's life is on

(11:17):
the line. And so you come fromthat, that sort of preliminary
world where it really worksgreat for, you know, a lot of
the early injections, but in anemergency use scenario, it
really wasn't cutting it. And sothen, in the 70s, there, there
was the development of the autoinjector. And so, you know, this

(11:39):
essentially was the automationof the use of a syringe. So
that's sort of kind of how thistechnology came to be. Right?
You know, you, you have all thisfear. And this anxiety
associated with overcoming theuse of existing technology that
was such a barrier, that at homedelivery of these injections was

(12:00):
was, especially on a mass scale,you know, we're talking about
today, 10 million devices a yearor more, you know, is was
prohibitive, right. And so then,you know, the auto injector came
around, and it was essentially,like I said, that automation of
that injection. And, you know,you really can think of those
technologies as just that youbasically have inside of those

(12:23):
technologies, the needle, theglass vial or syringe that's
actually holding the drug, youknow, a plunger, the stem. And
when I say that's automated,it's basically got has a big
spring that sits on top. Andwhen you try to perform, when
you go to perform the injection,you're basically releasing that
spring, the spring pushes thatneedle down, it pushes the

(12:46):
plunger down, forces the drugout of the needle, and you're
basically, you know, automatinga syringe, right? So it's a,
it's that sort of how thattechnology kind of in a in a, in
a very iterative way came to beright, it was trying to try to
take that injection out of thehealthcare providers hands and
place it into the, into thepatient's hands. That way at a

(13:10):
time when you know, you're,you're, you're in that life
threatening scenario, you tryand remove as much guessing as
possible. Well, what we foundout was, you know, even though
these technologies are somewhatsolving that problem, they're
not completely solving thatproblem. So, as you mentioned,
it's difficult for, for kids touse the current system. Yep.

(13:35):
Yeah. So that's what that isthat the big pain point that
you've been addressing is makingthis so like 10 year olds can do
a self administered autoinjection. Yeah, so our thought
process is sort of a, you know,basically three pillars. So we
think about affordability,portability, and usability. So

(13:57):
if I take you through all threeof those, it really describes
sort of what the current issuesare, and, and why we saw a space
in that market for what wedeveloped. So on the
affordability side, you know,there has been a lot of talk
especially in this epinephrinespace about the increase in
price, especially over time inthe United States, where you

(14:18):
know, the the epi pen got to a$610 price tag for a two pack,
right. So you you Yeah, exactly.
So you have these devices, whichare essentially springs plastic,
and what is a, you know, a 15cent syringe? Like, it's like
the cost of the drug in there.
Yeah, exactly. And, you know,

Forrest Meyen (14:40):
In your pocket!

Conor Cullinane (14:42):
Exactly, and, and, I mean, so this is a, it's
still a price that most peoplearen't paying with insurance and
things like that, but, you know,your out of pocket prices are
still just extraordinarily high.
One of the things that'sinteresting there from the
affordability side is, even ifyour insurance does cover One of
these epinephrine autoinjectors, oftentimes families

(15:05):
want more than what they'recapable of purchasing on on
their health plan. And so, youknow, you have individuals that,
you know, want to have one attheir neighbor's house want to
have one at school want to haveone in their car, right. And so
you're left with buying them onyour own at a at a cash price.
And, you know, there are ways toget coupons and discounts and

(15:25):
things like that. But, you know,it's, it's, it's very difficult
for these families to have tofocus on that, and, and then it
becomes a yearly purchase,right? It's, you know, my kids
going back to school, I need tobuy another one of these, you
know, I throw out all of theones that we didn't use last
year. So I why why do you haveto throw them out? Yeah, so that
that's something that is sort ofanother wrinkle to sort of big

(15:50):
issues that that currentpatients have with with devices,
and that's on the,the actual shelf life of the
device. So epinephrine is apretty finicky drug, it's
susceptible to degradation in anumber of ways. One of those is
temperature excursion. So ifit's not at room temperature, if
it gets too hot, or it gets toocold, the efficacy of the drug

(16:12):
can actually go down. If it'sexposed to oxygen over time, you
know, you've got that plungerand the glass and the needle.
And if any of those seal offpoints around the drug during
your, you know, year of storage,have leakage of oxygen, then
then the efficacy of the drugwill will degrade over time. And

(16:33):
so, you know, if you look at anepi pen today, there's actually
a window on there, where you canlook in and you're, you're
you're actually supposed toinspect the drug or be able to
inspect the drug prior toperforming an injection, and
what you're looking for whileyou're like, suffocated, and
stuff you're supposed to like,exactly, exactly. I mean, what

(16:56):
you know, though, the hope isthat you have patients who will
routinely look at their device,you know, take it out and say,
okay, you know, it's still good.
Let me look at the expirationdate, let me look at the drug.
But we all know that's, that'sby and large, probably not
happening. And so, you know, andthen do you expect a patient to
be looking at the the drug forclarity and color, right before

(17:19):
they're performing injection tosave their own life or somebody
else's life in a five minute,you know, maybe five minute
window? Probably not, right? Andso. So what happens is, it just
becomes a cycle and you say, youknow, it's gonna last me let's
say, this year, I'll throw themout, I'll get a new one, right.
And then you start facing thataffordability piece as well. And

(17:41):
so, you know, I broke it up intothose three pillars, because we
tried to think about the patientexperience. That's really what
purohit is all about, you know,what, what issues does the
patient have? And how can weresolve those? And so, you know,
it goes all the way fromprocurement on this, on this
affordability side to theportability piece, you know, how

(18:02):
can they bring it? How can wemake it so that it's easy for
them to bring it wherever theygo to the usability side, when
it when it comes right down tothe final? You know, okay, this
is it, I need to perform aninjection, how do we make that
easier as well. So we've talkedabout the affordability side, a
little bit about the, the theshelf life and, you know, the
actual stability of the drugand, and how that that actually

(18:24):
plays into more of theaffordability piece as well. And
you know, if that can beextended, and that's helpful.
When we go to the portabilitypiece, that's actually where
we've we first focused, it was,you know, kind of why we started
pure wet, it was a, it was athought process on. All right,
the existing devices today arefairly bulky. Most individuals

(18:47):
that are prescribed thesedevices are told Hey, carry too,
especially for reliabilitypurposes, when you're when
you're talking about a devicethat may malfunction. Or if the
efficacy of that drug hasreduced, it may not actually
save your life. So carry too. Soif you inject that first one,
and it doesn't work, go aheadand inject a second, right? And
so you think about one of thesedevices, which is about six

(19:10):
inches tall, it's a long, youknow, one inch wide, pen shaped
device. And then there's kind ofthis s clip that will pair two
of those devices together. Andthen you're supposed to stick
that somewhere, right and beable to take that with you
wherever you go. And I told youI gave you the anecdote of my
friend who

Jonathan (19:31):
One thing is that, as you describe this, you make it
sound like it's obvious thatthis is something that could be
changed, but I'm sure that whenyou when we backtrace to the
past 'you', you mentioned thatthere's a patient-centered
design process, like humanfactors engineering, and that's

(19:53):
something I think, would bereally interesting to understand
is the process of how did youstart you and your colleagues
figure out that this is aproblem that needs solved? One
thing is seeing the problem, andone is the discovery of that.
Then how to figure out a decentsolution or in this case, a
really clever way of addressingthose human centered challenges.

Conor Cullinane (20:16):
Oh, you bet.
Yeah. So we we did it in twoways. So essentially, we started
with what do we think theproblem is based on our
understanding of the, of thecurrent landscape, the current
devices just sort of lookingthere? And like I said, we
started with portability. We'relike, these things are huge and
bulky, you know, how couldanyone carry them around? And so
we're, we basically thought,alright, how can we make an

(20:38):
injector smaller? But, you know,your question is a little bit
bigger than that. And it's, it'svery interesting as well,
because you start to think aboutwell, you know, I was, I was
telling you guys how these werearound in the 70s. Right, so now
it's, you know, 2017. Back,which is sort of the time I'm
referencing, we started to talkabout this portability issue.

(21:00):
And it's like, Alright, well,you know, obviously, there's an
issue with, you know, makingthese devices smaller, how come
nobody's done it. And there,there's quite a, quite a bit
that goes into that. Some of itis really this whole sort of
iteration type design, whereyou've got something that's
working, and it's like, how dowe make it a little bit better,

(21:21):
you know, these guys have anauto injector, let's make an
auto injector. And then if youstart to compare all these auto
injectors to each other, rightthere, they look the same, they
feel the same, they sort of workthe same, they have the same
general shape. And, and a lot ofthat came from Well, it's
working, you know, to someextent, we with the epi pen, for

(21:45):
example, by 2016, they hadcaptured over 97% of the market
was something that was, youknow, essentially not the
perfect solution, but asolution. Right. And so why
change that. And so, so there's,there's a little bit of that,
and then there's a little bit ofiteration,

Jonathan (22:05):
Iteration wouldn't be a way to get to get on the path
toward having like a reallyinnovative solution, or do you
think that iteration isabsolutely sort of a
prerequisite activity? thatcould lead to a really kind of
game changing medical devicetranslational engineering?

Conor Cullinane (22:23):
No, I think it was really an economical
decision of how much how muchR&D do we want to put into this
when we're already capturinghuge percentage of the markets,
and it's already shown to work.
And I think you're right, youknow, iterations are great. But
at the end of the day, if youwant to have a giant leap in
this sort of change intechnology, or, you know, as we
describe it, this pure wet andtechnology, you kind of have to

(22:46):
start with a blank slate, whichis what we did, and we and to go
back to sort of that humancentric design that you were
referring to, we love thatthat's what we focused on from
the very, very beginning. And Imentioned earlier, we sort of
did that in two ways. So the twoways we did that were the first
was by performing patientsurveys. So we literally tried

(23:08):
to contact as many patients aspossible, who rely on these
devices have who have used allthe various types of existing
epinephrine auto injectors. Andwe basically performed 1000 of
these where we, we, we developeda survey, we went out, we tried
to get them completed, and wesaid, you know, what device do
you use? What do you like aboutit? What don't you like about

(23:29):
it? You know, obviously, it wasa lot more questions than that.
But that was essentially the thebasis of what we were looking
for, right? You know, what areyour issues with existing
devices? And then can we takethat information and build that
into our design requirements?
And then start with a cleanslate and say, how do we solve
this problem? Not how do we makea little bit better device than

(23:52):
this one that exists already soso we did that. And then we also
performed we we brought aadvisor on board who's a Board
Certified allergist, who youknow, prescribes these
epinephrine auto injectors on aon a daily basis. And he often
spends a lot of time trainingpatients on how to use the
device. He works with children,trains them on how to use it

(24:13):
trains their parents on how touse it. And so he sees a lot of
the pitfalls with existingdevices, what do they do wrong
with it? And so we worked withhim to conduct sort of a small
study where he was basicallyhanding a trainer device of the
existing technology to thesepatients saying, Okay, go ahead
and perform the injection. Andthen monitoring, you know, okay,

(24:36):
if they if this was a realdevice, they would have done it
right. Or they would have doneit wrong, or they would have
done it, you know, if they didit wrong, here's what would have
went wrong. And so, two of thethings that we've so I guess we
found a lot of information thatwe really hadn't thought about I
mentioned we were sort of reallyfocused on this portability
piece making the device smaller,but we built out so much more

(24:59):
than that. When we really talkedto these patients and found out,
you know, everything that theywere, they were really thinking
about. And I kind of alluded italluded to this earlier. But
really what we discovered wasalong that entire pipeline from
procurement, to maintenance andbad maintenance, I mean,
bringing the device where youmaintaining it wherever you go,

(25:19):
and then actual administrationof that of that election. Along
that entire process, there wasessentially this overarching,
what we describe as fear andanxiety. So patients were
worried about how they're goingto pay for it, how they're going
to procure it, they were worriedabout how do I bring this with
me wherever I go, what happensif I, if I come in contact with

(25:41):
it with an allergen like a beesting, and I don't have it, you
know, what it what it? What arethe options for me there, and
then I'm super scared to usethis device. And that was where
we really, it really started todawn on us that like, okay, you
may have removed the health careprovider. But you really haven't
made this mainstream, so easy touse, that you've removed that

(26:05):
anxiety and fear. And therestill is quite a hurdle that
these patients have to overcome,to go through the process of
performing an injection. Andeven if they overcome that
hurdle, we see problems thatarise even at that stage. And so
from that usability piece, wereally focused on two injury

(26:26):
mechanisms that can occur duringthat process. So one of them is
an accidental injection, wherethe device is used upside down.
And they can actually get aneedle into their thumb, for
example, we also call that thelast dose hazard, because you
know, you're not necessarilygoing to be causing much health
risks, you you do have a lot ofvasoconstriction, because of the

(26:47):
epinephrine drug that willhappen in that location. And you
do have to oftentimes treat thatthumb or other finger or other
digit that gets that injection.
But at the end of the day, whatthe what the scary pieces there
is if you're, let's say a dad,and you're injecting your child,
you know, who just got stung bya bee. You swing this thing, and

(27:08):
you've got your injection intoyour thumb. And we call that the
last dose hazard, because nowthat child doesn't receive a
dose, and they still are in alife threatening scenario,
right. So that's very scary. Andnow you basically have two
patients instead of one. And theother mechanism we looked at the
injury mechanism we looked atwas lacerations, which is where

(27:30):
you basically have these tallskinny injection devices, and
you try and perform aninjection, it's very hard to
control the position of thatinjection. So if I, if I show
you, you know, my pencil here,right, this is typically how
you're holding a pen injector,right? And so you're basically
making this motion, it'scontacting the injection

(27:51):
surface, and the needle is thenthen going down into the tissue.
But you can see where my hand isseveral inches away from the
injection site. And it's, youhave very poor control over the
actual needle. And what happensis, oftentimes, that injection
system can slide and you'redragging a needle through tissue
causing a laceration. And whatwe often see is a V shaped

(28:14):
laceration, where the first cuthappens, and you try and correct
for it, and you actually cut inthe other direction. And so it's
it's, you know, veryintimidating, very anxiety
driving, very fear driving. Andall of these things add up to
where when we were looking atour study of patients that were
just using trainer devices, in acalm, you know, clinical setting

(28:38):
15% of these individuals refusedto actually try and perform an
injection out of fear andanxiety alone. And this is
something we never thoughttrainer device with a trainer
device. So there's no needle, nodrug. And 15% of people said,
heck, no, I'm not doing it. It'stoo scary. We actually had
reports from that study wherethere were children running out

(29:01):
of the room, because they didn'twant to receive an injection.
And, you know, if you're, ifyou're performing an injection
on yourself, it's often a littlebit easier to maintain control
over the injection device,because you kind of know where
your leg is going and what it'sdoing. But if you're trying to
perform an injection on a childwho's so scared that they're
ready to run out of the room,imagine trying to swing this

(29:22):
thing onto their leg and hold itsteady with your hand several
inches away from that injectionsite while the child is pulling
their leg away, right? Yes, it'salmost impossible. And so you
see research articles now thatactually talk about, you know,
hey, if you're going to performan injection on a child, you
know, with one of these devices,you're basically putting them

(29:43):
into a you know, WWE wrestlingmove in order to lock all
motion, and then try and performthat injection. It's just, you
know, as we sort of see it, notan ideal solution. And so that's
really...

Jonathan (29:56):
This is a great characterization of the problem
and what I think a lot of peopleeven today experience. Do you
have a show and tell, of whatyou have, because it is
fascinating and it does not looklike a needle or anything like
that it's completely different.
It's like a hockey puck.

Conor Cullinane (30:16):
Exactly. So I have one here. And as I show
it...

Forrest Meyen (30:21):
Can you demonstrate on yourself?

Conor Cullinane (30:23):
I can't demonstrate it today. The
version I have is a is basicallya show device for for giving
pitches and talks and thingslike that. And unfortunately,
right now, with us workingremote, the devices that we have
that are currently functioningare actually at my CTOs office,
and I wasn't able to get one intime for this for this

(30:44):
demonstration, but he so we havereduced these to practice. We
have the devices, you know,delivering the drug with the
needle extending and butunfortunately, those those fully
functioning versions of thedevice are currently at at his
office. So but I do have thedevice that will show you that
process. And I'll walk youthrough, you know how that how

(31:07):
that would work. And so to giveyou sort of that high level view
again, you know, we thoughtabout affordability,
portability, usability. And aswe talk to the patients and
perform these studies, thethings that we thought about
were the patient anxiety andwhat drives that anxiety, all of
those pain points that built uptowards that overall patient

(31:30):
anxiety, and how can we changethat total patient experience?
So you know, you're exactlyright, our device doesn't look
anything like the existingtechnologies, it's, as we
describe it, sort of a lowprofile disc, you mentioned a
hockey puck, we used to call ita hockey puck all the time. But
what happens is, people thinkof, you know, the size of a

(31:51):
hockey puck, and they're, youknow, it starts to grow in their
mind about how big it is. Andyou know, if you see it in my
hand, it's it's not as big as ahockey puck, it's a little bit
smaller. But we tried to find ahappy medium as well, because
you're gonna have people who,you know, need to manipulate
this device, at the end of theday, you obviously want it to be
as portable as possible, throwit in your pocket, take it

(32:12):
wherever you go. But at the endof the day, you know, somebody
needs to operate the device, useit to administer an injection,
and to do that, you know, it hasto be at least, you know, a
certain size to to manipulatethe surfaces. So the way it
works, right, it's like a Canadatobacco, you know, just put it
in your back pocket. Yeah,exactly. We got a way to sell it

(32:34):
to the kids. Yeah, in terms ofsize and shape, it's very
similar. But yeah, you know,it's in that regard, I think,
talks, you know, to the pointsof portability. In terms of
usability, we tried to reducethe process to, you know, what
we saw as low barrier steps, aswell as highly controllable

(32:57):
steps so that at no point werewe driving anxiety for the
patient. And our whole thoughtprocess is if if somebody walks
by who's never seen our devicebefore, they can pick it up,
read the visual instructions onthe top, so we have the graphics
that represent those threesteps, and say, Oh, that's easy,
I can I can do that. And I cansave this person's life, you

(33:19):
know, with with their device intheir pocket, right. So that was
the that was really the push onthe usability side. So what you
actually do is, and, and theCompare and contrast piece, we
basically took those tall,skinny devices and went to a
short, flatter device, right. Soit kind of will remind you more

(33:42):
of a of a patch pump typeinjection system, but the big
difference is, rather than likea subcutaneous injection, we're
still fully intramuscular. Soeven though our devices low
profile and much closer to theinjection site, we're still

(34:02):
hitting that intramuscularinjection depth. And which, you
know, brings us back to thatdirect comparison with the, with
the auto injectors of today,right so So essentially, the
three easy steps that we gothrough are twist and remove
this safety plate, so there's ared safety plate on the bottom.
After you twist and remove thered safety plate, you place the

(34:25):
injector down on your injectionsite. In the case of
epinephrine, we're talking aboutthe vastus lateralis. So you're
sort of top outer thigh, just soyou guys can see it. I'll sort
of demonstrate it on the deltoidintramuscular location, but
essentially you would removethat safety plate, and then
you're going to place theinjector on to wherever your

(34:46):
injection site is for you guys.
I'll use my deltoid todemonstrate the injection.
So basically you twist or removethe safety plate on the bottom.
It's a very easy twist motion.
there's a there's a lot ofnarrowing and ridges on the
device and places for yourfingers to hold. Once you once
you do that and open the device,it's already correctly oriented

(35:09):
in your hand for placement onthe injection site. So you would
just place it and we actuallycould say use the term apply it,
apply it to the injection site.
And one of the uniquecharacteristics of our device in
comparison to the otherinjection systems is we have
this large, flat surface areathat comes into contact with

(35:30):
that injection site. And so whatwe did there is we actually
covered that injection site witha with an adhesive. So we're
helping hold that device onlocation in a number of ways.
One is that form factor beinglow profile and close to the
injection site. You know, wetalked about having your hands
several inches off the injectionsite before now you can sort of

(35:52):
see, you barely can even see thedevice, right? If I move my
fingers, you know, there it is.
But if I place my hand on thedevice to perform an injection,
you barely see it, you know, andnow my hand is basically flat
and pushing up against theinjection site, I can actually
grab on to my arm and pin thatdevice in between. and at this
stage, you simply push down. Soit's easy steps, remove the

(36:15):
safety cover, apply that deviceonto your injection location,
and push down. And one of thereally unique things. Yeah, so
we kind of, you know, we don'twant to get in any copyright
trouble. But it's basically likepushing a big easy button,
right. So, you know, we reallydescribe it as trying to reduce
the administration of performingan injection, the administration

(36:39):
of injection to as easy aspushing a button. And really,
that's what you know, the wholeprocess was driving towards by
reducing that anxiety, making itso simple. And one of the unique
things is when I when I pushdown to perform an injection,
that force that I'm pushing downwith is not actually pushing the
needle into the tissue, it's notforcing the drug out of the

(37:00):
device, it's simply activatingthe device. So no matter how
fast you push down, how slow youpush down how hard you push, all
you have to do is bottom outthat device, then when you when
you push that button down, thedevice is going to perform the
injection for you with a tunedamount of force every time the
needle is going to extend to thesame length to get to that at
that same intramuscular depth,the same amount of drug is going

(37:24):
to be delivered, right, so allthe guesswork is gone, all
you've got to do is push downand it does everything else.
After a year you let go of thatdevice, it actually pops back up
to its height before you pushthe big button. And it locks out
completely. And three flagsappear circumferentially around
the device, with a big red flagwith white letters saying used,

(37:48):
one of the things we wanted toavoid is the issue that we
learned about when talking topatients were devices that they
have previously used and thenput on the ground, someone will
come by and have no idea thatthat device has already been
used and try and use it again.
Mm hmm. So this device locksout, you can never push it down
again, you never see the needlebefore you never see the needle

(38:08):
after which also removesanxiety, it's a much less
assuming shape. So you know, oneof the things we heard from
patients as well was, you know,the whole thing looks like a
needle to me, it's super scary.
So we tried to remove that aswell. And it all kind of you
know, was able to build togetherinto you know, the device was
smaller to begin with, it waslower profile that had benefits

(38:29):
for portability that hadbenefits for usability. And then
at the end of the day, we callit an elegant design, because it
uses as many standard off theshelves, technologies in the
pharma industry that are alreadyused today, we tried to
streamline that entire process,we tried to streamline the
manufacturing. So you know, youhave this improved

(38:50):
functionality. But you don'thave big cost drivers behind
that. So you're in terms of yourcost of goods, you're basically
the same as other injectiontechnologies, but you have this
leap in functionality. So that'swhy we call it sort of an
elegant design as well.

Jonathan (39:04):
This is really clever engineering, though, as we've
got engineers in the room here.
We know that to build somethingcool in an elegant design,
there's, there's a satisfactionin that. But that's also not the
only battle that you would haveto be able to translate this to
be able to work in the market toget it like if I were a loved

(39:26):
one could benefit from this kindof device. Can I get it now? And
if not, what's the what's thepathway that you're pursuing to
be able to get it to people whoneed this?

Conor Cullinane (39:35):
And that's always something that, you know,
is is always tough for us tohear, because we'll talk to
people who, you know, rely onthese devices. And they you
know, the question is, you know,when can I get it and, you know,
at the end of the day, it's ait's a long road for medical
devices. And what we have hereis a combination product. So
it's a, you know, injectiontechnology that we've paired

(39:57):
with a specific drug and thathas to go through regulatory
approval, and when we're talkingabout here in the United States,
that's FDA approval. For ourspecific device to dive a little
deeper there, we're talkingabout a sort of streamlined
pathway, but it's still, youknow, a very rigorous pathway.

(40:18):
And well, it should be, youknow, it. And so there is a lot
of time and a lot of money thatgoes into taking a device from
reduced to practice to a pointwhere, you know, it's safe and
effective for consumption by bythe the patient, right. So, you
know, we we were not, you know,I, I would say we're not against

(40:46):
going through these steps, it'sjust that it is a process that
takes a lot of time. And that'sthe hard part, when we're
talking to patients, we tellthem, you know, is a great
device, it's on the way, but,you know, there's a lot we have
to do between now and FDAapproval and going to market and
bringing you this device. Andso, to give you a little bit of

(41:06):
perspective on what has tohappen is so, you know, we we
talked to the patients, weperformed our studies, we, we
took all that information, weput it together, and we set that
into our we were able to convertthat into design requirements.
And then we go through ourpreliminary design, our detailed

(41:26):
design, we go through a lot ofiteration in that design based
on putting some of those earlyconcepts, early prototypes in
the hands of the patient. Sothese are all things pieces of
the this pipeline that we'vedone. And then based on that
information, we went back,change the design to make it
even easier. And that's how wegot to these, you know, three
super streamlined, easy toovercome steps. And the form

(41:50):
factor that we have today, notmaking it too small, but making
it something that people canactually, you know, work with
and handle, especially if it's apatient that, you know, may have
limited dexterity or whatever.
So you know, all these thingsthat continue to come up. And
then we look and we took everysingle component. And we went to
potential manufacturers and wesaid, Hey, you know, what would

(42:11):
it cost to manufacture one ofthese? And how would you do it?
What would it cost amanufacturer 1000 1,000,010
million, right? And you gothrough that process of what are
the cost drivers? And, you know,can we change or remove those
major cost drivers while stillmaintaining the reliability and
functionality of our device. Andso we did that on a component by

(42:31):
component level. And then wewent and now we're going through
that process on a larger scale,which is a sort of manufacturing
and assembly scale, where we'reactually going through these
process developments tounderstand, you know, okay, we
can do this with one device. Butcan we do it with millions and
millions of these as we wouldcontinue to scale this out for

(42:53):
epinephrine or a futureapplication. And so, by doing
that, you know, we continue toincrease the elegancy of the
device, you know, the reducingthe cost on a per component
basis, but also on an assemblybasis. But from here where we
have to go after this, the stagethat we're in right now, which
is going through that processdevelopment for that large

(43:14):
scale, manufacturability Thenext step is to go through
basically a full litany oftesting that is required by
these regulatory agencies in ourcase, you know, we're talking
about the FDA, for example. So,you know, there's certain tests
that we have to perform, whichare, you know, as we describe

(43:35):
them, kind of into in differentbuckets. But some of that is
what we would describe as humanfactors, which you which you
sort of alluded to Jonathanearlier, which is, you know,
okay, you know, you went andasked the patient, what they
wanted, or what they didn'twant, and then you set that into
your design requirements, andyou built something, but how do

(43:56):
we know it's really addressingwhat they what they were
targeting. And so that piece oftesting is literally putting it
in the hands of a user andsaying, I'm not gonna tell you
how to use it, you go and useit, and we're gonna watch you.
And basically, it's the, youknow, the classic one way
mirror, right? And you're,you're in a scenario, whether

(44:18):
it's a school cafeteria, orwhatever, and that users
basically left to their owndevices to you know, either have
the device sink or float, youknow, did it work the way we
work?

Forrest Meyen (44:30):
They're left to your devices.

Conor Cullinane (44:31):
Yeah, they're left to our devices yeah,
exactly. So that'll be a big andexciting step. And one of the
reasons why we did a lot of sortof some of that iterative
testing early on, because wewanted to know going into that,
you know, hey, you know, we wantto be pretty confident that this
is going to be successful whenwe get far along in this in this

(44:52):
adventure. So, so that's a bigchunk of the testing that has to
be performed and all that datahas to be collected. Then, and
presented to the regulatoryagency for approval for
approval. And so and that's onepiece of it. Then another
another piece is actual deviceperformance testing, you know,
does the device perform exactlythe way you said it's going to

(45:15):
perform? And does it performthat way over and over and over
again, when we're talking abouta, a emergency device that's
going to be used to save a lifein those five minutes. There's a
very high bar for reliability.
And, you know, you heard mementioned before that a lot of
these devices, they say, hey,carry two of them. If it doesn't

(45:37):
work, the first time or theefficacy has dropped, you know,
inject a second, we're talkingabout trying to have such high
reliability that, you know, youcould potentially just carry one
number would that be like, onein 100,000 failure rate, or
what? Yeah. So it would be a lotbetter than that. So we're

(45:57):
talking about what we describeas five nines of reliability. So
that 190 9.999%, so to actuallyhit that, you know, you're
talking about, you know,specific statistical methods in
order to look at that samplingfor your testing. And you're
talking about very extremereliability. So, you know, one

(46:19):
of the things that you canalready, if you start to think
about that process of developingand manufacturing these devices,
you could really alreadybasically just remove humans
from that process. Because ifyou put somebody in there who's
assembling one of these by hand,you're, you're gonna have a hard
time hitting high reliabilitylevels. And so, you know, this

(46:39):
is this is a computer automatedprocess that's putting devices
together. So a robot has toassemble the entire device.
Yeah, not only that, but you'regoing to be checking subsystems
throughout that entire assemblyprocess. So, you know, your,
your devices put together, youknow, via complete automation.

(47:02):
And at the same time, each ofthose steps are verified, you
know, whatever that that methodis, you have to make sure that,
Okay, this one that we just puttogether was put together
correctly, right. And so you,you basically have those in
process checks throughout thatpiece, as well, which is, you
know, it's a, it kind of getsback to something that's on the

(47:23):
top of, of all of this, which isas a funding piece, right. So,
you know, it takes a lot of timeto perform this testing, it
takes a lot of time to, youknow, go through putting that
data, you know, into a formatthat needs to that's easy to be
reviewed, easy to be understood,easy to be seen, you know, you

(47:44):
take a lot of time in themanufacturing process, you take
a lot of time in the designprocess, all of it's a lot of
time, but you know, it's also alot of money. And a lot of
upfront capital, the, you know,fully automated assembly lines
aren't cheap, you know, ingeneral, when you're talking
about a combination product, theballpark I like to throw around
is, you know, $70 million in 10years, right to develop one of

(48:07):
these types of devices. So, it'svery, it's a very uphill battle.
Where us being a smaller, youknow, more nimble company, we
try to undershoot both of those,so, you know, do it faster and
do it cheaper. And, you know, alot of that relies on us as
founders, you know, and, andemployees to, you know, figure

(48:30):
out ways in which we can dothings ourselves rather than
outsource. And one of thereasons why I love having a
founding team that's made up ofengineers, you know, with with
great engineering backgrounds,as you know, we didn't have to
outsource that early designprocess, we knew and understood
human centric design, we knewand understood that combination

(48:52):
of humans and system. And youknow, where does our device lie
in that process? And how do weactually design each of these
parts? How do we design thetotal system? How does it get
put together? And, you know, ifyou outsource that you're
talking about a lot of time anda lot of capital that's
required, in addition, and ifyou can do it on your own, you
save a lot of that you can staymuch smaller earlier on, which

(49:17):
we which we tried to do andremain capital efficient through
that process.

Jonathan (49:22):
The relationship with Covestro, is that to help on a
sort of manufacturing, and someof the say the tactical aspects
of the design life to the pointof like figuring out which kind
of plastic is useful that maybeyou that your founding team of
engineers may not have had knownthat certain types of polymer
chemistry that would work forthis middle grade medical grade

(49:43):
kind of application. Why apartner with a large company
like this, was that the onlypathway available?

Conor Cullinane (49:51):
That's a great question. One of the sets of
testing that we didn't talkabout beyond sort of that device
performance testing is lookingat the materials that are
actually in your device andmaking sure that those aren't
going to irritate somebody'sskin or affect, you know,
effectively cause a reactionwhere we're trying to save a
reaction, right. And so one ofthe things that we can do by

(50:13):
working with one of these resinsuppliers is basically say,
okay, we need it to be medicalgrade from the beginning. And
already that D risks a hugeportion of that downstream
testing, because that plasticmaterial has already been shown,
has already been shown toeffectively pass that testing.
And then by combining multipletypes of that plastic material,

(50:36):
we know that we're notintroducing any materials into
the device that are going toharm a potential patient. So we
start there, but then you're theexactly what you mentioned,
which was, you know, can we alsorely on their expertise to say,
okay, hey, we need a part thatlooks like this, here's how we
designed it. And here's theforces it needs to stand up to

(50:58):
needs to be medical grade, whatdo you got, right, and so they
can come back and say, hey,we've got these two resins, that
can withstand the huge forcesthat you're talking about, you
know, and then fit all the restof your requirements. And
that's, you know, I, I love thevideo you're alluding to,
because I'm not sure where Icame up with that on the fly.

(51:19):
But I said, you know,essentially, what we're trying
to do is pack a little punchinto a big punch into a little
package, right. And that kind ofgoes back to what I had
mentioned before, with theexisting devices being these
big, tall, skinny devices thathave these huge springs, and
they're basically pushing a tonof force through to get to the

(51:39):
intramuscular space, it's noteasy to have to have an
automated system to deliver aneedle that deep into the
tissue, and then get your drugto bolus through. We cut off
this device an inch above thesurface, and we still need to
get down to that depth. And so,you know, some of our our parts

(52:02):
that are smaller, because we'rein a little package, need to
withstand fairly large forces inorder to do what we're asking
them to do, and reliability andreliably and not fail. Right.
And so that was sort of thatrelationship there. It's like,
you know, we need some reallygood resins, what do you have,
and that was that,

Jonathan (52:23):
I think that's something really important and
for fans of the podcast, theYouTube channel, it's that if
you're looking at medical devicedesign, and you mentioned
earlier that, you know, we, wepretty much had to start with a
blank clean sheet designed forthis kind of problem.

Conor Cullinane (52:37):
Yeah.

Jonathan (52:38):
But the the asterisk on that, I'd say is that it's a
clean sheet with both some veryspecific sort of design criteria
that you're thinking ofdesigning for manufacturability.
And so that we do have a downselection, it reduces your sort
of search space, which is reallyhelpful to to be able to come up
with a new type of medicaldevice. And so I'm curious then,

(53:01):
given that you're hittingtargets on like, reliability,
durability, shelf life, andaffordability, how have you
considered not just, you know,working with the FDA, of course,
for, say, the United Statesmarket, but also in some of the
perhaps lesser developed or lessmature medical ecosystems around
the world are there because Iknow I've talked with medical

(53:23):
device companies that are like,oh, we're gonna test it in
somewhere else, and get a lotmore sort of clinical numbers
earlier there, and then comeback to the FDA.

Conor Cullinane (53:33):
In terms of our strategic vision there, it's a
little bit different from, I'dsay, a more typical med device
space where, you know, that issort of an option. And and the
reason I say that is the firstplace we looked at, for a number
of reasons, you know, not onlybecause it was the first
introduction into autoinjectors, but the first place

(53:56):
we looked is epinephrine, right?
And there are, so there are anumber of reasons why we're
talking about the United Statesfirst. So one of them is the
actual regulatory process to getan approval for an epinephrine
combination product is a littlebit more streamlined than just a

(54:17):
typical combination product. Andthat's because the FDA sort of
understands and knows about someof these existing issues, and
wants to see more competition,it helps with innovation around
the device, the functionalityaround the device, it also helps
with affordability, you know,with with additional players in
the space. So I think there issome pressure to see, especially

(54:38):
based on sort of the you know,media coverage and political
pressure, there's there'sdefinitely pressure to see new
devices in this space. And Ithink that's why we have started
to see new devices in this spaceas well as you know, potential
new incumbents like us arecoming you're coming into the
space. And then the other theother piece of that is the
market. So you know, the UnitedStates today is In the vast

(55:01):
majority, the you know,epinephrine auto injector
market. And so we're pairing,you know, our pathway to
approve, we're the pathway toapproval with post approval,
revenue generation capabilityand making our decision for FDA
US market first.

Forrest Meyen (55:20):
Is that because people in the United States have
more allergies, or is it theseproducts sell for more? Why is
the US the biggest market?

Conor Cullinane (55:35):
There are definitely different factors.
Some of it is awareness, theactual prescriptions, the
prescriptions are growing atabout 8% annually. And that that
really is based on sort of an A,A awareness of these of these
allergies. And, you know, evenif you're not an individual

(55:57):
who's that five minute, a fatalindividual, and you still have
some allergic reaction to it,oftentimes, you'll still be
prescribed and injector. And so,you know, because at the end of
the day, we don't know how theseallergies are gonna be
progressed. If you're stung by abee one day, and you're fine. Or

(56:17):
you're having an allergy, butyou're, you're okay, and you can
work through it with someBenadryl, for example, that
doesn't mean that, you know, amonth later, it's going to be
that same process. And so, youknow, there, there's that
thought process there. And then,you know, one of the other big
allergens that we talked aboutis allergens to medication. And
we we have an elderly populationas well, that takes a lot of new

(56:39):
medication and a lot ofmedication in general. And those
individuals are also oftensusceptible to severe allergic
reactions with their, with theirmedication.

Jonathan (56:51):
As we come to the to the top of our time together,
Conor, you've been through a lotin this process. Is there some
advice that you'd have for thepast you, the up and coming
engineer who's just hot, like, Ithink I might try to build a
magnet medical device and savelives? What advice would you

(57:11):
have to that person?

Conor Cullinane (57:13):
Yeah, that's a really good question. So I think
in general, some of the thingsthat I did that were, I think,
most helpful for me that, youknow, it, which is advice that I
would give is, you know, firstof all, be patient, you know,
these things take a lot of timeand, you know, just getting the
design done and getting, youknow, reduced to practice,

(57:35):
that's only the beginning. Andwe've talked a lot about that.
So I think, you know, be patientis one another is surround
yourself with people that canhelp make the barriers to, to
the finish line. Lower, right?
So if you can pair yourself upwith somebody who's gone through

(57:55):
this process before or, youknow, you know, has been through
the FDA process before, whetherit's with a combination product
or not, or, you know, hasexperience working with a lot of
these larger pharmaceuticals,right, you know, all of that
type of, of experience is reallyuseful. And I think one of the

(58:16):
things that we struggled withearly on was, you know, hey,
we've got a great new device,but we're going up against, you
know, what is a thrivingindustry where there are a lot
of large players who are tryingto, you know, hold on to or grow
market share, and we need to beable to play in that space. And,
you know, it's going to be it,we need a lot of power in our

(58:38):
corner to do that. So I think, Ithink that was, you know,
something that I would, I wouldalways say to somebody who's
getting into this space is, youknow, do your best to, you know,
reach out to people who youthink, you know, will will be
really interested in what you'redoing want to help you and can
be effective in sort of reducingthe bar that it takes to get to
to the finish line.

Jonathan (58:59):
One question or comment is that I understand
this is a topic shift. Conor, Iunderstand that you have a
publication coming out theEncyclopedia of Bioastronautics,
is that right?

Conor Cullinane (59:13):
Yeah, it is.

Forrest Meyen (59:15):
What is that?

Jonathan (59:18):
What is that?

Conor Cullinane (59:22):
I'll go back a little bit more and kind of just
give you guys a little bit of asort of more of a story of my
background. I think that'lladdress what that is and why
it's important to me. So I grewup in Southern New Hampshire,
right next to a grass stripairfield. My window was looking
at the airplanes go by all day.

(59:43):
So I really was into intoaviation. I wanted to be a
pilot. I started by flying youknow, a little RC planes and
eventually went on to get mypilot's license and my undergrad
degree was in aeronauticalengineering. So you know,
basically the basis ofmechanical engineering, but
you're really applying that to,you know, the development of

(01:00:04):
flight hardware and, and, andplanes in general. Right. So
that was a lot of fun. Andinterestingly enough, when I was
in undergrad, this was atClarkson University in upstate
New York. I, I also added aminor in biomedical engineering,
I was really interested in themedicine side as well, I worked

(01:00:25):
on a vibrotactile feedbacksystem for lower limb
prosthetics, you know, I wasalways really interested in that
combination of taking the humanbody and medicine and combining
that with engineering and andduring that period, I started to
think, Hey, you know, maybe Iwant to go to medical school and

(01:00:46):
become a physician. But aftergetting involved in a lot of
these projects, in undergrad,these engineering projects, I
was like, you know, these, thisengineering is way too fun, I
want to stick with this. So Iended up going after a PhD. And
I basically settled on what Ifound to be the perfect Ph. D.

(01:01:06):
Program, which was it's calledthe Health Sciences and
Technology program. It's a jointMIT and Harvard Medical School
program, where, essentially,you're doing just that you're
combining engineering withmedicine, it actually came out
of a conversation with MITboosters who wanted MIT to start
a medical school and MITbasically went through some

(01:01:29):
analysis and said, Hey, youknow, we've got Harvard Medical
School right down the street,rather than starting our own,
let's just collaborate. And thethought process behind HST was,
rather than taking physicians,and trying to teach them to
think like an engineer, so thatthey can solve problems in the
clinical setting, they tookengineers, and showed them the

(01:01:50):
clinical setting and broughtthem into that world and, and
allowed them to, you know,continue to think like an
engineer and solve problems, butunderstand that clinical
settings so that you know, whatthey're developing, didn't go to
the clinical setting, and thenjust become obsolete because
they didn't really understandthat process. So it was really
the marriage of the two whichreally fell into what I was

(01:02:12):
doing. But as part of thatprogram, you you're able to
choose a concentration. Myconcentration was, of course,
aeronautics and astronautics. SoI was I was in the AeroAstro
program at MIT. And then withinthe HST program, Health Science
and Technology, there are twospecialized training programs.

(01:02:33):
One is in bio imaging, the otherwas what they call this bio
astronautics training program,which is going sort of deeper
from Aero Astro, it's the it'sbasically the human body in
space. So my expertise after myPhD, and the work that I had
done, there was really onanything that can happen and

(01:02:55):
does happen to the human body inspace. So I really was able to
pull all that like love foraviation, aerospace, as well as
medicine together at the righttime. And actually, you know,
one of my clinical rotations waswith the flight surgeons at
NASA. And I was able to do sortof a lot of really fun things
during that period that, youknow, it was just a blast got to

(01:03:17):
work with the spacesuits, thatwas what my thesis was on, sort
of developing a spacesuit, whichwas really that close marriage
of the human body medicine and,and technology and engineering
side. So it's been a lot of fun.
But yeah, one of the things thatI worked on while I was as part
of while I was part of thatprogram was the Encyclopedia of
bio astronautics, which wasbasically an opportunity for me

(01:03:42):
to work with one of theprofessors at MIT, Larry young,
as well as with the NationalSpace Biomedical Research
Institute to and Springer who ispublishing this, this, this
work, as well as all the SMEs,right, the subject matter
experts in these space spacesand, you know, talk to them on a

(01:04:04):
daily weekly basis, take theirknowledge integrated into this
into this work, you know, andand that was probably one of the
best experiences I had, youknow, having the ability to
interface with all of theseamazing people who were the
experts at the top of theirfield in bio astronautics, which
I had, you know, just got mydegree and, and, and help put

(01:04:25):
this work together. So, yeah,it's very exciting.

Jonathan (01:04:28):
That's so cool. Let's hope that maybe eventually close
the loop and be able to sendsome of pure wet medicals, you
know, medical devices up intospace, because even though there
might not be as many bumblebeesup there, there may be, I mean,
it's

Forrest Meyen (01:04:44):
So it'll work in space, right?

Conor Cullinane (01:04:46):
It will. And, you know, we're talking about
epinephrine first, but there arethere are obviously other
applications that would be verywell suited to an easy to use
and portable injection systemand I think mentioning, for
example, space, there is a greatway to just sort of wrap that
all up into one and say there'splenty of other places that a

(01:05:08):
technology like this can go aswe think about, you know, how do
we expand beyond epinephrine?
How do we expand beyond theUnited States? And maybe how do
we expand beyond the world?
Well, that wraps it up forepisode. Thank you very much for
joining us today, Conor.

Jonathan (01:05:23):
Thank you, Conor.

Conor Cullinane (01:05:23):
I'm Conor Cullinane, and I'm one of the
cofounders and CEO of PirouetteMedical. Stay tough!