July 1, 2021 • 42 mins
This week we are joined by Neonatologist, Dr Don Sharkey to discuss innovation, research and technology within neonatal care.
Dr Sharkey is Clinical Associate Professor of Neonatal Medicine at the University of Nottingham and Neonatal Intensivist at Nottingham University Hospitals NHS Trust in the UK.
Don is an academic neonatologist with a broad research portfolio aimed at reducing major morbidities in newborn infants.
Don’s main research focus is in healthcare technologies for babies and children, focused on neonatal resuscitation, neonatal monitoring and diagnostics, and computer vision and machine learning techniques.
This was a very powerful and thought provoking conversation and we hope you take as much from it as we did.
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Episode Transcript
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Don (00:00):
How would people feel about entering a very sick child in an
(00:05):
intensive care setting into aclinical trial, particularly
when many of the things that wedo don't benefit that child at
that time. But actually, I foundparents in particular, were
really open and receptive tobeing part of it, they saw that
actually, there was something tobe had for the future. And what
I often say to parents when Italk to them is around your
child today is being cared foron the background of a huge
(00:29):
amount of research that parentshave signed up to before. You
know, the reason I know how toventilate your baby. Now today
is because of what we've learnedbefore from other research
studies, from medical studiesthat this treatment works
better. And what we want to dois keep making that better.
David (00:51):
Welcome back, everybody.
This is Episode Three of thethird season of the not mini
adults, podcast pioneers forchildren's health care and
wellbeing. My name is DavidCole. And once again, I'm joined
by my wife Hannah, and we arethe cofounders of UK children's
charity Thinking of Oscar. Thisweek, we are joined by Dr. Don
Sharkey, and we're going to bediscussing Innovation Research
and Technology within neonatalcare. Dr. Sharkey is clinical
(01:13):
Associate Professor of neonatalMedicine at the University of
Nottingham, and neonatalintensivist, at Nottingham
University Hospital NHS Trust inthe UK. Dawn is an academic
neonatologist with a broadresearch portfolio aimed at
reducing Major morbidities innewborn infants. Don's main
research focuses in healthcaretechnology for babies and
(01:36):
children focused on neonatalresuscitation, neonatal
monitoring and diagnostics, andalso computer vision and machine
learning techniques. We alsodiscussed the sometimes
difficult conversation ofresearch within Child Health and
neonatal care. We have a trulypowerful conversation with Don.
And we hope that you take asmuch from it as we did. Don, Hi,
(01:57):
thank you so much for joining uson the not mini adults podcast.
Don (02:06):
Hi David good morning.
Thank you for inviting me.
David (02:08):
Absolute pleasure. I think as I was saying
beforehand, you're our firstconversation around neonatology.
So really, really lookingforward to kind of delving into
some of the things that you havebeen doing and your career. And
with that, I guess, where wetend to start in in a lot of our
conversations is just talking alittle bit about you, if you
don't mind and kind of how yougot to you know what you're
doing today.
Don (02:29):
I guess I combined unusual route. I kind of left school
with minimal qualifications,which many people don't really
realise. I went straight intoelectronics and engineering. My
apprenticeship, was doing thatfor a few years and then really
got into into Computing andEngineering through a variety of
companies. And then eventuallyrealised that my calling was
(02:52):
greater than what I wasachieving at that time. And
being a young teenager and setout went back to do my way A
levels at college beforedeciding, somebody convinced me
that I should probably considermedicine because I had the
attributes for it. So at the ageof 21, I entered into planning
that and managed. I was luckyenough to get a place at
University of Nottingham grewfrom there and I guess it was
(03:14):
during my paediatrics attachmentat the University of Nottingham
as an undergraduate. I was luckyenough to be based in Darpshire
Children's Hospital, where atthe time there were and still
are a couple of veryinspirational paediatricians who
really got me thinking aboutpaediatrics. I never really
considered it. When I went in Ithink like many students, and
especially I was going to bemaybe an orthopaedic surgeon or
(03:36):
something like that, withoutrealising what orthopaedic
surgery was, and then got intopaediatrics and realised it was
for me it covered everything youthought about the whole family,
the child, the kind of settingthings up for the child for the
future. And that's how I reallygot into paediatrics. And it was
really cemented when I did myhouse officer jobs in adult
medicine and I struggle to treatpatients who were doing harm to
(03:59):
themselves through theirlifestyle choices. They come in,
I'd fix them in hospital for ashort period, they go home, do
the same thing again, usuallyaround smoking or drinking, come
back to me and I really struggledealing with those sorts of
patients. And what I reallywanted and what appealed to me
about paediatrics was settingchildren up for the kind of, you
know, the lifestyle that theydeserved. If we could get things
(04:21):
right early in life, thennaturally that would be known
for the rest of their life. Sothat's really where it all came
from. And particularlyneonatology. So that's how I
eventually got into neonatologybecause of all this kind of
specialties in paediatrics, ifyou get things right in in
neonatology, actually, you know,the twizzle of the ventilator
knob in the right direction atthe right time, really can make
(04:42):
a big difference for that childand for the rest of their life.
And, of course, that child'swell being fulfils the whole
family's well being and setsthem all up for a good life. So
that's really how I got into itin space of two minutes.
David (04:55):
It is a fantastic story.
So thank you. Thank you forsharing and I guess since you've
found your calling as it were,and, you know, now working in
this space. So, you know, someof the things that we're going
to talk about are some of theprojects that you've been
working on. And, and I guess nowwe can see the correlation
between kind of a passion from atechnological perspective. And
also, you know, I guess, as youcall it, a calling, which, yes,
(05:15):
in some respects, we feel thesame way kind of Oscars giving
us that calling to try and dowhat we're doing from from a
charitable perspective, but ifyou could kind of talk to us a
little bit about the work thatyou're now doing in the role
that you are and bringing thosekind of two elements together,
Don (05:31):
I've always been fascinated in intensive care. So I really
enjoyed my time, both inneonatal intensive care and
paediatric intensive care. And Ithink it was the technology side
of things that really excitedme, I reached a fork in my
career path where I had todecide on one of the intensive
care specialties. And I like theability to follow patients and
see them long term which you getin neonatology, you know, to
(05:54):
see, I guess, the outcome of thecare that you delivered. So that
was the era embarked on and theneventually started to forge an
academic career. And, again,doing most of my research in
Nottingham, I was lucky enoughto work with a number of
different groups, fromfundamental scientists through
(06:14):
to engineers. And I was quite anearly year registrar. So that's
kind of a middle grade trainee,in paediatrics, and was doing my
PHD. And just came across alecture once from a colleague
now who was an engineer who cameover to our department to do a
seminar. And he just happened tomention in his kind of summing
(06:38):
up phrase, he mentioned thatthey developed a system where
you could monitor the heart rateand temperature of miners
underground, through wearingtheir their safety hat. So
miners underground are exposedto extremes of stress. And the
deeper they go, the more they'reexposed to these stresses. So
they needed some way ofmonitoring needs. So I guess
this was, I mean, this wasprobably more than 15 years ago
(07:00):
now. And what they really wantedto do was look at wearable
technology for these miners. Andit got me thinking at the time
in 2000, I think this was therewas a real problem around
neonatal resuscitation and howwe monitor babies in the
delivery room, no one reallyknew the best way to do it. And
we were trying all sorts ofdifferent things. People were
(07:20):
putting on all sorts of limitersthat were designed for adults or
ECG machines that were designedfor adults, but they would
never, you know, the problemscame, you know, you put an ECG
on a baby, and it would fall offbecause the baby's got wet skin.
So it was never designed for wetskin, or it would strip the skin
of a very premature baby, thepulse oximeters they didn't
respond to good perfusion,babies are always blue when
(07:42):
they're born. So theirsaturations are always low. So
they're not really optimised forthat transition period. And I
just, it just got me thinking,actually, if we could monitor
the heart rate using somethingthat was perhaps built into a
cap, because we always put capson our very small babies just to
maintain that temperature. Andthen we just had had a small
conversation after the seminarwith my generic colleague,
(08:03):
Professor Crowe. And it wasthere that we really kind of
kicked off my research interestin in technologies. And we got
together with a group of thosewith engineers, and with
research and as I was workingwith at the time, and we put in
an application to actuallymedical research, you were one
of the kind of main charitablefunders of paediatric research
(08:25):
at the time. And we were luckyenough they funded us and that
kind of kicked off quite ajourney, in fact, because we
then went on and subsequentlydeveloped commercialised
products for newbornresuscitation, it was created a
company on the back of it that'shad, you know, significant
investment, millions of pounds,millions of pounds of research
funding, and it's growingfurther. And I guess that was
(08:47):
really the very first point inwhich I got involved in
technologies. And through that,just sitting and listening to
colleagues who are reallyworking at the fundamental
science level, discovering newthings be it a new polymer, a
new way of designing ordeveloping something or a new
engineering technique, and justbeing able to translate what
(09:10):
we're discovering into somethingthat might actually work in the
clinic. And for me, that that'sbeen an area of immense
interest. And somewhere Ispecialised. There are people
obviously focus on on biggerpopulations in adults, but very
few who look at it inneonatology. And so it's an area
that I've kind of grown areputation for and will be very
excited about and I've got manydifferent projects running now,
(09:34):
all in parallel. And at times, Ifelt overwhelmed of being at
capacity and felt this desire totry and get all of these
technologies into neonatologyand wish there were more people
coming through. So one of myother passions are around
technologies is kind of growingfuture leaders in this domain as
well. So I have a number ofstudents, PhD students in
(09:55):
particular, across a variety ofdifferent specialties, which I
think is unusual for an academicclinician, where, you know, I
certainly in the last year, I'vehad two PhD students, one from
computer science, one fromengineering who have graduated
with their PhDs. I've had twoclinical fellows, who both
graduated with their PhDs intechnology related aspects,
(10:16):
again in the last year, so allof these things is about growing
as people get people interestedin them and seeing that,
actually, just because we adoptall of these things from adult
technologies, it doesn't meanthat they necessarily give us
the right information or work inthe right way. And that
actually, we need to work withthose fundamental scientists to
develop things that are specificfor children and particularly
(10:38):
for babies.
Hannah (10:39):
what you've just landed on is a question that's been
bubbling in my mind for a fewminutes. Now, I was interested
in your take on we called thepodcast, not just mini adults,
not mini adults, in fact I havegot it wrong, classic, and it's
not limited to the devices butthis idea of intervention versus
adaptation, and that so manysolutions that exist in
(10:59):
paediatrics, including neonateshave been derived from a
solution from healthcare foradults. And so what's your point
of view of adaptation versusinvention? When? When is it the
right time to invent and when isit better to adapt?
Don (11:15):
I guess as paediatricians, it's one of the first things
that we're all taught as soon aswe embark on a career in
paediatrics is that childrenaren't small adults, even
adolescents are not necessarilysmall adults, they have
different things that need to beaddressed differently. And I
think as you go down the ages,it becomes more apparent. And
there are certainly technologiesthat can be adapted from adults.
(11:35):
And I guess things around, youknow, imaging is probably a good
example is that imagingmodalities, you can adapt
usually the software quitestraightforwardly to accommodate
with that. And I guess, when itcomes to other technologies, you
need to start to think about thedisease processes that are
slightly different in children.
And it's well described thingslike this particular diseases in
(11:57):
children movements relate toorphan diseases that they're
often called, whether they'reextremely rare, they occur
usually from birth, or usuallywithin first months of life. And
they're very rare. And actually,sadly, most children who have
these, the most severe end ofthese, they don't survive. And
partly that is because I thinkpreviously, people have not
(12:17):
invested in trying to come upwith solutions or treatments or
management plans for thoseparticular children. Because
there's such a small population.
And I think it was probablyabout 10 or 15 years ago,
certainly in the EU, there was abig switch to try and to address
this, I think that really kickedoff in pharmaceuticals to begin
with, where they realise youjust couldn't just chop and
(12:40):
change something to suit theseparticular children. And I think
that's really where it's grown,that people are recognised that
those children need specifictreatments and need investment
in it. But the end of the daypeople are is that there are a
very small population, and thereisn't a huge amount of guests or
shareholder money to be made.
And so we've had to come up withnovel ways tempting people in to
study these particular groups.
(13:02):
And I think we're starting tosee some of that now migrating
to what we've seen ininnovation, because you call it
in technologies for children andparticularly for babies.
Realising that 100 kilo adultsin their 60s who's got Heart
disease is very different to a500 gram baby he's just been
born. He's got a respiratoryproblem that is unique to the
newborn who's got the risk of abrain injury that's unique to
(13:25):
the newborn, all of those thingsare things that we need to
tackle differently. And I thinkthat's where I've been coming at
things from is trying to come upmore from the event, and it's
specifically for that populationrather than adapting it. Now,
some of the technologies will bethe kind of platform will be an
adaption. But it will be youknow, just making some subtle
changes to the design will makeit more suitable for that
(13:47):
population. And I think oftenthat's where people have been
falling in that territory,because it's much easier to do
that. But now we're seeing moreand more of a push for devices
in particular to be designed forchildren. And typically for
babies that actually there'smore investment in those. And I
think that's been recognised byfunders. Again, we've seen it in
(14:08):
the UK in particular, and evenacross in the States, probably
10, at least 10 years ago, theyrealised that there were real
issues here. And they set upmultiple institutions that had
these paediatric medical deviceexpertise, so that they could
fast track and develop newtechnologies for children. And
specifically looking at, youknow, how do we do clinical
(14:30):
trials using these new devicesand development for children? I
think there was a report five orsix years ago that looked at 20,
maybe 25, high risk medicaldevices that were licenced for
use in children and babies. Andwhen they look back at the
regulatory aspects, those, Ithink, 85% of them that had no
(14:53):
clinical trials in children atall. So they were designed for
adults and tested in adults, butthey developed and they got to
licenced for use in children.
And that was without knowingthat they had any, any use in
children or there were otherproblems. And I think a good
example is probably the ECG, weall got to using ECG in the
delivery room. And it's verygood. But as we've got more used
(15:14):
to using ECG monitoring, we findthat it does have some
limitations, children who have aslow heart rate, which is
basically obviously higher at60. But it may be that the ECG
shows the rate of 60. Butthere's no adequate heart rate
outputs is not, the heart isn'tbeating well enough. So you can
be misled by that. And the sameis true of pulse oximeter. So we
(15:35):
just adopted pulse oximetersfrom adults, but actually, in
the first few minutes of life,they've been shown to be
inaccurate. And that's becausethe diffusion issues that just
don't pick up the signal wellenough. So there are areas where
we just need to be careful thatyou just can't adopt these
things. And that's why I'vetried to focus on coming at the
angle from the innovation ratherthan pure adaption,
David (15:55):
You make a fascinating point, I have to pick up on it,
because I've literally just beenreading about kind of orphan
drugs and orphan conditions,need to do a bit more research
into it. But actually, you know,a lot of what we talk about, and
I have conversations all thetime at various different levels
around, you know, the need formore investment, more
concentration around paediatriccare, neonatal care, but you
know, in that spectrum. But thenthe the negative aspects of it
(16:18):
is that actually the return oninvestment is not necessarily
there, the pool of you know,patients, the size is not
relative to the the amountinvestment that we need to go
into it to make a difference.
But actually, there's somestudies being done, especially
around orphan drugs, that a lotof or a vast proportion, a much
larger proportion than you wouldanticipate, of profits that are
made by Big Pharma have comefrom often very small, very kind
(16:40):
of challenging, I guess,therapeutics that have needed to
happen for certain cases. And Ithink there's some work there,
or some thoughts that maybe needto go into looking at that and
trying to translate that into,you know, the potential for
paediatric care as well. And totry and rebuff the criticism or
the thought process that, youknow, it's just not, it's just
(17:00):
not worth investing in. Slighttangent, sorry, but I've
literally just been readingabout that this morning. So it
was a, it was in my mind as itwere. Coming back to some of the
areas that you're working in,and you talked about the company
that you've formed, which isSurepost Medical, and using the
cap, and I guess, you know,people can find information on
that and the opportunity forthat. And we'll put a link on
(17:22):
that. But on the on the web asit were, but you're also doing
quite a lot around neonataltransportation and trying to, I
guess, move babies from thedelivery ward to intensive care
or wherever it might be. Buttalk to us a little bit about
that, because you've spent quitea lot of time looking at that.
Don (17:39):
I guess for over 20 years, many parts of the world,
particularly in America andAustralia, they had this
centralised system where thehighest risk infants would go to
these big centres it often inbig cities, because it would, it
would improve the outcomes forthese children. But in order to
do that, obviously, in ageographical area, you have many
(18:01):
births occurring all over. Andso you need to be able to move
the babies into those centres.
And it was back in 2003, the UKdecided to go for centralization
of intensive care for newborns.
And so they set up probably inthe late 2000s, a number of
transport teams, dedicatedtransport teams for newborns
(18:23):
that would move babies fromareas where they were born, I
guess in the wrong place intothese intensive care centres. So
in the UK, we have about 190maternity birthing centres and
about 50 to 60. it fluctuates, alittle bit of neonatal intensive
care centres, but actually, youknow, more than half of the
births occur outside of anintensive care centre. And if
(18:46):
your baby is extremely pretermor is born with a congenital
anomaly or with birth relatedproblems, and they need to go to
these intensive care centres,and so, geographically, the UK
is very small and most centresare within one to two hours of a
major Intensive Care Centre. Butit still means moving the baby
and actually, what we do in theback of the ambulance is we take
(19:08):
in effect a complete intensivecare cot space with a dedicated
nurse, dedicated trainedprofessional and that's usually
in the form of a doctor or anadvanced nurse practitioner who
goes out to retrieve the childfrom their birthing hospital and
bring them into Intensive CareCentre. Now my area of interest
(19:29):
is having ridden in the back ofmany ambulances with many sick
babies is actually watching thembounce around in the back of an
ambulance in an incubator isn'ta nice thing to observe, it's
good for them in that it willimprove their mortality that by
going to the centre they're morelikely to survive. But actually,
although we've seen improvementsin mortality, it's been less
impressive with other importantoutcomes such as brain injury in
(19:54):
these children. And I guessthat's what got me interested,
you know, is the environmentthat there are being transported
Then, is it optimal? Or could weimprove that to improve their
outcomes. And then there's beena number of studies, including
some recent UK data that wasreally powerful that showed
babies who were transported inthis way were at greater risk of
(20:15):
having a severe brain injury, sothat more than would survive,
but more of them would survivewith severe brain injury. And
although it's still a very rareevent, it's an important event
for that child and that family.
And so my focus has been tryingto tackle that and see if there
are ways that we can understandwhat what the mechanisms are,
and what we can then do toaddress it, particularly from a
technological approach. So I'vebeen working with some small
(20:39):
transport companies, I lead asthe research lead for the UK
neonatal transport group, whichare all 15 of the neonatal
transport teams across the UK,we collect data, and we plan
about how we can improve thesetransport pathways. And I've had
a number of research fellows whohave helped study this, thanks
to funding from the likes of deMachar in particular, working
(21:01):
with my engineering colleagues,we've been able to explore it
more, with a view to adaptingthe transport system that we use
to make it safer. So lots ofpeople don't know. But it's
quite a common thing for babiesto move around the country, so
much so that there are about16,000, newborn transfers by
ambulance between hospitalsevery year in the UK. So they're
(21:22):
huge numbers, and often formany, many miles. So families, I
think about 40% of them that ourtransit is over a over 100
kilometres of return journey toand from their house. So so
they're big distances that thesebabies are going and that
there's a period that doesexpose them to these additional
environmental stresses. Now,unfortunately, the risk of
(21:43):
having a severe brain bleed inthese very preterm infants is
often in the first day or two oflife, and that is the time that
you transfer them. So they'reborn in the wrong sense, they
need to go to the centre sowe're moving them at a time,
that's the greatest risk. And sowe've been studying the
mechanisms there, and some ofthe stresses that they are
exposed to. So just to give youan example, when we measured it,
(22:04):
the kind of head exposure thatnewborn's head is exposed to in
terms of its vibration. It's farabove what is being legal and
legal safe limit of vibrationfor a normal adult in their day
to day work. So if you're atruck driver, you're expected to
fall below a certain thresholdof vibration. If you don't by
(22:25):
law, there are laws that protectyou that say your employments do
something about it, reduce thatexposure, because you're more
likely to get musculoskeletalproblems, backache, headaches,
be off work chronically sick,but there's no such levels in
terms of transporting babies. Sowe've looked at all that. And
we've defined what the levels ofvibration that these babies are
(22:45):
exposed to. And it's often twoor three times what an adult
would be allowed to be exposedto. And so we've been trying to
tackle that from an engineeringperspective and trying to reduce
the amount of exposure that theyhave both from noise from
vibration, temperaturefluctuations and really studying
that. We've done that from atechnological perspective. But
also we've used UK wide data toexplore, you know, where are the
(23:09):
problems in these patients interms of their movement, can we
get more babies move in utero,so the mom is moved rather than
before she's born before thebaby's born rather than
afterwards, because that's thesafe environment. That's the
ultimate transport incubator ineffect, but there are challenges
there from a midwifery andobstetric colleagues that needs
to be addressed. And it wasprobably five years ago, nearly
(23:32):
Jeremy Hunt as the healthSecretary the time threw down
the gauntlet for us to reducebrain injury in these babies by
50% by the year 2025, so we areonly three and a bit years away
from that. And that's a hugeundertaking, and that's going to
be that's going to requiremultiple ways of tackling it
both removing more babies inutero to tackling the postnatal
(23:52):
environment making that safer.
And, you know, we've beenlooking at safety so that babies
do have accidents in ambulanceswhen they're being transported
there is well documented casesthere. And the restraints we use
that the only requirement isthat after an accident, if an
ambulance were to turn to itsside that the baby remains in
(24:13):
the same position, it was at thestart of the accident, and at
the end, and the restraints arevery good at doing that they can
hold the baby in place. Butsadly, many of the babies when
we've modelled it would probablydie from their restraining
injuries. And so we need tothink differently. And it's not
just a case of putting aseatbelt on a baby or strapping
a baby in with with a harness,you need to think about how you
(24:34):
access it. And so we've beenworking with around Human
Factors with engineers trying todevelop those material
scientists, what are the bestmattress configurations that you
can come up with? Andthankfully, we went to the NHR,
you know, it takes more than amillion pounds to raise a child
with cerebral palsy. So ourargument at the end of our
presentation was for the firstwe wanted a billion pounds to
(24:55):
try and start this research intothe first child's brain it saves
froma severe a brain injurywould have paid for itself. It's
that easy. And I think they wereswitched on to that. And they
Sally Davis, who was theprevious Chief Medical Officer,
she made a point of it in her2012 report. We've got to tackle
the the issues aroundprematurity around brain injury,
(25:16):
because these are lifelong, thatchild gets a brain injury, it's
with them for life. And if thatchild lives for 50 to 100 years,
that's a lot of healthcare, alot of resources that goes into
that. So that's really how I gotinto that. And we're pushing
forward on that. And hopefully,in the next maybe five years or
so we'll have something thatwill make this a much safer
system for the babies.
David (25:37):
Is there anything that you can kind of discuss now in
terms of some of theadvancements that you're seeing,
you know, some of the thingsthat are most exciting,
Don (25:44):
I guess the things we've been looking at really are
reducing vibration, what weneeded to do was to, to look at
ways we could perhaps modifycurrent systems rather than
producing a completely newsystem, partly because all of
these systems, they have to be a10 year life, and we couldn't
see everybody just overnightreplacing their system. So how
can we adapt what people areusing at the moment and just put
(26:05):
in some new components. So we'vebeen exploring that. And we
found some really, really nice,useful data from that, that
hopefully, we can, we can rollout, we've been looking at how
we might reduce the noise. Sothere are there are quite a
number of times when the back ofan ambulance, the noise is so
loud, it exceeds the noise thatyou probably get with a chainsaw
going up next to your ear. Andif you're a highly fragile baby,
(26:28):
you know, on multiple bloodpressure, multiple ventilator
support, having that noise goingoff next to your ear, for
however long your journey is,this isn't a good thing. We know
it causes fluctuations in brainblood flow. So we've explored
some ways about how we canreduce the noise exposure that
they have. And, you know, it'snot as easy as thinking you can
just miniaturise, people havetried that, and they don't work.
(26:51):
So we've been coming up withsome some nice new ways of
trying to do that, again, withour engineering colleagues. But
as you might expect, there aresome ideas around IP and things
in there that I just need to becareful about talking too much
about.
David (27:03):
Now, of course, of course, thank you what I mean,
the project sounds like it couldbe, as you say, you know that
the numbers speak for themselvesif you can, if you can save one
patient. So it's an amazingproject. And you know, we've
seen a few things where othersare looking to do something
similar. And so you know, wewish you every every every luck
with that. Absolutely. Just acouple of other things that I
(27:25):
think would be reallyinteresting to talk about. One
is that I guess you you startedyour career in Nottingham, I'm
assuming that and you've stayedthere, I'm assuming that that
has been all encapsulatingopportunity for you. But one of
the interesting things happeningin Nottingham, I think, is this
centre for health technologies,which you mentioned to me when
when we first started having adiscussion and I, again, through
(27:46):
our discussions and doing someresearch, there seems to be some
really interesting things goingon there. So anything that you
can talk to us about just interms of the centre, but also,
you know, some of the projectsthat you've seen there as well?
Don (27:58):
Yeah, I guess it kind of went back to what I mentioned
earlier about this, theinterface between getting
fundamental science engineeringpeople to talk to the clinical
people to say, you know, whatare the problems you've got?
And, you know, are there anyother solutions that we have
that can can address that, andthat that was a real issue for
(28:18):
us, because I was workingclosely with engineers, and
computer scientists, withfundamental scientists, about
six years ago, with someengineering colleagues, we
decided that we would put in acase to the university that
actually we should createsomething that pulls us all
together, stops us working inour silos. And I think that's
the only way you can you canforge forward now I think we've
(28:40):
researched and the universitywas very supportive. They were
excellent. They saw thestrengths, they saw the
importance of healthcaretechnologies. It's a growing
area that the future of medicinewhere things were going. And so
we got together as a group, andwe formed the Centre for
healthcare technologies. One ofthe unique things is that
there's a nice partnershipbetween the university and one
(29:04):
of the largest trusts in the UKthat Nottingham University
Hospitals. And it's quite nice,because both of them, what we
call our, where our engineeringand our science bases on the
university is literally joinedby a bridge that crosses over
and one of the ring roads thatgoes through Nottingham to the
hospital. So we have we are insuch close proximity, but it
(29:25):
really just pulled us togethermade us think, and I was one of
the founding clinicians whohelped launch that. And we've
got it going still. And we Theaim is that, as I say, it pulls
all of those interested partiestogether. We have things we
organise things like speeddating, so we get scientists,
engineers, you know, we go outfor a bite to eat and a beer
(29:47):
maybe and we sit down withclinicians from a particular
specialty. And we just speakdate for five minutes you grab
your beer you move on to thenext person. You just chat about
what they're doing. And we'vehad a number of really great and
fruitful collaborations growfrom that, that's allowed us
just to develop new ideas, youknow how we can take what
(30:07):
somebody in engineering anddeveloped around, you know, a
new MRI technique, for example,and how we can apply it in the
clinic. And it's allowed us toget the funding in to prove that
the concept works to then go onto clinical trials. And that's
how many of my collaborationshave grown. And we've done that.
And what we're doing now iswe're working on our external
partners, bringing in commercialindustry partners, bringing in
(30:29):
other institutions in order thatwe can try and work together.
It's still in its early years,but actually, it's grown quite
nicely. And we've had somereally great successes from it.
And I've enjoyed being part ofit. I met colleague there
recently, well, two or threeyears ago, who's created some
really nice new polymers thatare materials that you can coat
(30:52):
pretty much any plastic orsilicone with and for my
population where infections inneonates cause huge morbidity,
huge mortality, I just thought,Well, we've got to take these
and put them onto some of ourmedical devices. And, you know,
we've got some some nice fundingto get that going some PhD
students, and again, we'restarting to explore that. So he
(31:12):
was focused on adults. Andclearly, that's a big
population. But for me, it wasabout getting over to the him
actually, you know, it mightcause a big problem in adults,
so from having urine infectionson from a catheter, but in
babies, it causes death andlifelong disability when they
get an infection. So that's anarea that we really need to
(31:32):
target. And when we talking, wetalk about quality of life
quality adjusted years,depending on how you measure
these things, actually, when youstart to talk about neonates and
children, it's an easy story tosell. Although we are a small
population, we're dealing withthose quality of life years are
there to be had. So that'sreally where it all came from.
(31:53):
And it's an exciting thing. Wedon't just look at engineering
and chemistry, we don't justlook at biology, new imaging
techniques, but I working withcomputer scientists as well. And
we've been developing a numberof AI approaches, which have
been, you know, have been reallysuccessful and things that we
hopefully we can we can keeppushing forward for.
Hannah (32:15):
And moving on from that, what's your experience of kind
of the practical pragmaticexperience to implementing some
of the ideas that you've beenworking on over the years, and
from my background, where I wascoming from was, so much of what
you're involved with now has gotdata involved with it. So even
if you're talking about adevice, often you'll be
(32:35):
collecting data about a verysmall baby in order to make
decisions soon, or improve thedecision making process, for
example. But with that comeschallenges of like, where the
data sits and integrating withhospital systems. But actually,
the question is wider than that,because you've made me think
about other areas to considerwhether it's the IP
considerations that youmentioned, or whether it has to
(32:58):
do with risk and the role ofclinical trials, but how do you
go for it, because for me, itjust feels like it could be very
difficult to to have a brilliantidea. And then but then be able
to turn that into something thathospital organisations are happy
to have implemented.
Don (33:17):
I think in my field, in particular, the two barriers, I
always I always felt that wouldbe the thing that would hold our
research back. The first wasaround technology adoption and
how you move through it and howyou move the technology through
its adopted stages. And for me,that's always been the major
hindrance. So you're often atthe early stages, you come up
(33:38):
with a great idea, you know,you've got a new sensor or a new
using that example I had beforea new polymer that you can, you
can code to prevent code deviceinfection, you come up with
that, and then it's then gettingit into those early clinical
trials. And there's always adip, you know, you get your
data, you have to wait, you putin your applications, your
funding, you get bounced Thefirst time you put it in again.
(34:00):
So there's an inherent lag of,you know, 18 months. So it
really slows you down as aresearcher that slows down this
adoption, to get in it to thepatients that really need it,
you know, you then get your nextround of funding and then prove
in a preclinical or clinicalsmall clinical trial that it
works. And then you have to waitand put that data in for the
next application. So, you know,you then do the big trial, and
(34:23):
then eventually, you know, youget the funding for that. And
then there's a lag, getting thatone finished and getting the
data out and people thenadopting it going through all
the regulatory aspects. So thatstill is and always will be, I
think, a major hindrance. Ithink lots of the funders now
switched on to that and they'renow trying to fund a bigger,
more balls programmes ratherthan individuals short projects
(34:46):
that that will stop and start inthat way. They want to try and
fund a really brilliant idea allthe way through. The other one
that I thought might be ahindrance was that I guess kind
of what you're alluding to wasaround how would people feel
about it? Entering a very sickchild in an intensive care
setting into a clinical trial,particularly when many of the
(35:06):
things that we do don't benefitthat child at that time. But
actually, I found parents inparticular, were really open and
receptive to being part of it,they saw that actually, there
was something to be had for thefuture. And, and what I often
say to parents, when I talk tothem is around your child today
is being cared for, on thebackground of a huge amount of
(35:28):
research that parents havesigned up to before. You know,
the reason I know how toventilate your baby now today is
because of what we've learnedbefore from other research
studies, from, you know, medicalstudies that this treatment
works better. And what we wantto do is keep making that
better. And I thought that mightbe hindrance, but actually, it's
surprising how many parents evenat the time of extreme worry,
(35:51):
anxiety for them, when they'rebabies at their sickest they
will agree to participate in theresearch because they can see
the benefits for that. And Iguess on the back of that, it's
been reflected in how hospitalsand how ethics bodies, for
example, they see this research,and they, I think are more open
to that now, they realise thatsome of this really is at a time
(36:11):
when children can be at theirmost vulnerable. And sadly, I've
had children who've been in mymedical device studies that
haven't survived, because of thenature I work in intensive care.
And it's not, it's not relatedto the study they were doing,
they would they would die ofother causes. And, you know,
it's a horrendous privilege fora clinician researcher, to be
(36:34):
able to say, you know, to, withthat family to sit down and say,
you know, what we've learnedfrom this has been amazing, it's
been a real privilege to haveyou, you know being a part of
it. And, you know, it'sextremely sad that their child
has died. And I don't know whatthey feel when they when they
talk about that to lose a child.
But actually, the number offamilies that said to me that
(36:54):
they feel as though they'vecontributed in some way that
they're, although they losttheir child that it's had some
weight will have a benefit forthe children. And I think that's
one of the things that drives usall on is conditions,
particularly in those settingswhere not every child does
survive. And actually I think,you know, many of the systems we
have now around ethics andhospitals, are geared up for,
they recognise that's a reallytricky environment to go in. And
(37:16):
you know, they'd be verysupportive of us now, there is a
lack of joined up, you know,collecting data, for example,
just routine data has been verytricky previously. And the
number of hoops you have to jumpthrough in order to collect that
in order to learn about yourpatients and study things in an
offline way, can be verydifficult. But again, they are
(37:37):
becoming more open to that. AndI think, you know, there are
steps going forward about makingeverybody's data more available
in an anonymized way that youcan pull together. And we can
look at that. And we've donelots of research, looking at
those big databases as well, andutilising those, and I guess,
part of that's built into someof the machine learning the
(37:57):
artificial intelligence workthat we've been developing.
David (38:03):
Don, thank you, we could talk to you for hours, I think a
lot of what you're doing isreally, really inspirational. So
it's been fantastic learningmore about it. One of the things
I will certainly take from theconversation, front least what
we just discussed, and I thinkthat's, you know, really, I
guess, personally, a lot ofthings that we tried to do as
well, but also the way thatyou're working, you know,
(38:24):
between yourselves and theuniversity. Anecdotally, I kind
of use an example of one thatactually has spurred us on quite
a lot of Atlanta Children'sHospital and Georgia Tech coming
together and doing very similarthings. And a friend of ours and
a friend of the not mini adultsof podcast, Sherry Ferrugia.
was, you know, the the kind ofcatalyst for that. And and I'm,
(38:45):
I'm glad to say that we have,you know, I guess a similar
instance in the UK that we candiscuss, as well. The final
question, though, which we kindof ask all of our guests is, if
you could change anything withinpaediatric healthcare, what
would it be?
Don (38:59):
There are lots of things I think I've talked about lots of
positives that have happenedover certainly over the 15 years
I've been I've been studyingdevice technology development in
this field. I think for me, itreally would be not just from a
funding perspective, or from thetraditional funders in the UK,
but from industry, as well wouldbe to recognise, although there
(39:24):
may not be huge amounts of moneyto be earned from developing
these things, actually, thequality of life and the buying
in to, you know, a child'sfuture is really important. You
know, Paul Dimitris head of thechildren's and young peoples
medtech that I'm part of, wehave this saying about, you
know, the children may be asmall part of the population,
(39:46):
but they are the future. Andthat's true and if we can
improve the lives of children,by rapidly developing new ideas
and translating them into newthings that will improve their
health. their well being andultimately their life chances
that actually that's a goodthing. And I think the funders
(40:07):
in the UK, certainly from thegovernment side of things have
recognised that now, what I'dreally like to do is to see,
there are there are goodexamples out there. And I'm not
applying this to everybody. Butfor the big pharma and big
medical device companies tostart to invest more in them
realising that, although it's asmall population, there may not
be much money to have, butactually, there are big gains to
(40:29):
be had. It's important, I think,you know, that we can help
extend lives and keep them well.
But I see huge amounts of moneygoing into extending somebody's
life by four months, you know,at the end of their life from a
cancer treatment, but verylittle going into into
preventing a brain injury in aaby. And I think that's perhaps
here we need to thinkifferently. And as it's not a
uge population, it doesn'tequire huge amounts of
(40:51):
nvestment, but it just needshat right investment with the
ight teams to really acceleratet. And every day that that's
eld back, you know, there'snother child who suddenly will
ave a brain injury for the next0 to 100 years of their life.
David (41:06):
Don thank you so much.
t's been a real privilege talkinto you, and delighted to hear a
out all the work that you're ding good luck with it all.
Don (41:12):
Thank you, David.
David (41:15):
Thank you so much to Dr.
Sharkey for joining us on thenot mini adults podcast, and I'm
sure that you would agree apretty powerful conversation
that we had. And it'sinteresting because we're seeing
a lot of innovation withinneonatal care at this point in
time, which is I think, youknow, wonderful to see. Next
week, we will be joined bypaediatric neurosurgeon, Dr.
(41:36):
Jayamohan. And who is going tobe coming and talking to us
about empathy, and theimportance of having that
connection with not only thepatient, but also those around
them. When looking after a childin hospital. We really hope that
you can join us then please dosubscribe to the podcast. And if
you're enjoying it, please doleave us a review as well. We
(41:58):
hope you'll join us again next week.
How would people feel about entering a very sick child in an
(00:05):
intensive care setting into aclinical trial, particularly
when many of the things that wedo don't benefit that child at
that time. But actually, I foundparents in particular, were
really open and receptive tobeing part of it, they saw that
actually, there was something tobe had for the future. And what
I often say to parents when Italk to them is around your
child today is being cared foron the background of a huge
(00:29):
amount of research that parentshave signed up to before. You
know, the reason I know how toventilate your baby. Now today
is because of what we've learnedbefore from other research
studies, from medical studiesthat this treatment works
better. And what we want to dois keep making that better.
David (00:51):
Welcome back, everybody.
This is Episode Three of thethird season of the not mini
adults, podcast pioneers forchildren's health care and
wellbeing. My name is DavidCole. And once again, I'm joined
by my wife Hannah, and we arethe cofounders of UK children's
charity Thinking of Oscar. Thisweek, we are joined by Dr. Don
Sharkey, and we're going to bediscussing Innovation Research
and Technology within neonatalcare. Dr. Sharkey is clinical
(01:13):
Associate Professor of neonatalMedicine at the University of
Nottingham, and neonatalintensivist, at Nottingham
University Hospital NHS Trust inthe UK. Dawn is an academic
neonatologist with a broadresearch portfolio aimed at
reducing Major morbidities innewborn infants. Don's main
research focuses in healthcaretechnology for babies and
(01:36):
children focused on neonatalresuscitation, neonatal
monitoring and diagnostics, andalso computer vision and machine
learning techniques. We alsodiscussed the sometimes
difficult conversation ofresearch within Child Health and
neonatal care. We have a trulypowerful conversation with Don.
And we hope that you take asmuch from it as we did. Don, Hi,
(01:57):
thank you so much for joining uson the not mini adults podcast.
Don (02:06):
Hi David good morning.
Thank you for inviting me.
David (02:08):
Absolute pleasure. I think as I was saying
beforehand, you're our firstconversation around neonatology.
So really, really lookingforward to kind of delving into
some of the things that you havebeen doing and your career. And
with that, I guess, where wetend to start in in a lot of our
conversations is just talking alittle bit about you, if you
don't mind and kind of how yougot to you know what you're
doing today.
Don (02:29):
I guess I combined unusual route. I kind of left school
with minimal qualifications,which many people don't really
realise. I went straight intoelectronics and engineering. My
apprenticeship, was doing thatfor a few years and then really
got into into Computing andEngineering through a variety of
companies. And then eventuallyrealised that my calling was
(02:52):
greater than what I wasachieving at that time. And
being a young teenager and setout went back to do my way A
levels at college beforedeciding, somebody convinced me
that I should probably considermedicine because I had the
attributes for it. So at the ageof 21, I entered into planning
that and managed. I was luckyenough to get a place at
University of Nottingham grewfrom there and I guess it was
(03:14):
during my paediatrics attachmentat the University of Nottingham
as an undergraduate. I was luckyenough to be based in Darpshire
Children's Hospital, where atthe time there were and still
are a couple of veryinspirational paediatricians who
really got me thinking aboutpaediatrics. I never really
considered it. When I went in Ithink like many students, and
especially I was going to bemaybe an orthopaedic surgeon or
(03:36):
something like that, withoutrealising what orthopaedic
surgery was, and then got intopaediatrics and realised it was
for me it covered everything youthought about the whole family,
the child, the kind of settingthings up for the child for the
future. And that's how I reallygot into paediatrics. And it was
really cemented when I did myhouse officer jobs in adult
medicine and I struggle to treatpatients who were doing harm to
(03:59):
themselves through theirlifestyle choices. They come in,
I'd fix them in hospital for ashort period, they go home, do
the same thing again, usuallyaround smoking or drinking, come
back to me and I really struggledealing with those sorts of
patients. And what I reallywanted and what appealed to me
about paediatrics was settingchildren up for the kind of, you
know, the lifestyle that theydeserved. If we could get things
(04:21):
right early in life, thennaturally that would be known
for the rest of their life. Sothat's really where it all came
from. And particularlyneonatology. So that's how I
eventually got into neonatologybecause of all this kind of
specialties in paediatrics, ifyou get things right in in
neonatology, actually, you know,the twizzle of the ventilator
knob in the right direction atthe right time, really can make
(04:42):
a big difference for that childand for the rest of their life.
And, of course, that child'swell being fulfils the whole
family's well being and setsthem all up for a good life. So
that's really how I got into itin space of two minutes.
David (04:55):
It is a fantastic story.
So thank you. Thank you forsharing and I guess since you've
found your calling as it were,and, you know, now working in
this space. So, you know, someof the things that we're going
to talk about are some of theprojects that you've been
working on. And, and I guess nowwe can see the correlation
between kind of a passion from atechnological perspective. And
also, you know, I guess, as youcall it, a calling, which, yes,
(05:15):
in some respects, we feel thesame way kind of Oscars giving
us that calling to try and dowhat we're doing from from a
charitable perspective, but ifyou could kind of talk to us a
little bit about the work thatyou're now doing in the role
that you are and bringing thosekind of two elements together,
Don (05:31):
I've always been fascinated in intensive care. So I really
enjoyed my time, both inneonatal intensive care and
paediatric intensive care. And Ithink it was the technology side
of things that really excitedme, I reached a fork in my
career path where I had todecide on one of the intensive
care specialties. And I like theability to follow patients and
see them long term which you getin neonatology, you know, to
(05:54):
see, I guess, the outcome of thecare that you delivered. So that
was the era embarked on and theneventually started to forge an
academic career. And, again,doing most of my research in
Nottingham, I was lucky enoughto work with a number of
different groups, fromfundamental scientists through
(06:14):
to engineers. And I was quite anearly year registrar. So that's
kind of a middle grade trainee,in paediatrics, and was doing my
PHD. And just came across alecture once from a colleague
now who was an engineer who cameover to our department to do a
seminar. And he just happened tomention in his kind of summing
(06:38):
up phrase, he mentioned thatthey developed a system where
you could monitor the heart rateand temperature of miners
underground, through wearingtheir their safety hat. So
miners underground are exposedto extremes of stress. And the
deeper they go, the more they'reexposed to these stresses. So
they needed some way ofmonitoring needs. So I guess
this was, I mean, this wasprobably more than 15 years ago
(07:00):
now. And what they really wantedto do was look at wearable
technology for these miners. Andit got me thinking at the time
in 2000, I think this was therewas a real problem around
neonatal resuscitation and howwe monitor babies in the
delivery room, no one reallyknew the best way to do it. And
we were trying all sorts ofdifferent things. People were
(07:20):
putting on all sorts of limitersthat were designed for adults or
ECG machines that were designedfor adults, but they would
never, you know, the problemscame, you know, you put an ECG
on a baby, and it would fall offbecause the baby's got wet skin.
So it was never designed for wetskin, or it would strip the skin
of a very premature baby, thepulse oximeters they didn't
respond to good perfusion,babies are always blue when
(07:42):
they're born. So theirsaturations are always low. So
they're not really optimised forthat transition period. And I
just, it just got me thinking,actually, if we could monitor
the heart rate using somethingthat was perhaps built into a
cap, because we always put capson our very small babies just to
maintain that temperature. Andthen we just had had a small
conversation after the seminarwith my generic colleague,
(08:03):
Professor Crowe. And it wasthere that we really kind of
kicked off my research interestin in technologies. And we got
together with a group of thosewith engineers, and with
research and as I was workingwith at the time, and we put in
an application to actuallymedical research, you were one
of the kind of main charitablefunders of paediatric research
(08:25):
at the time. And we were luckyenough they funded us and that
kind of kicked off quite ajourney, in fact, because we
then went on and subsequentlydeveloped commercialised
products for newbornresuscitation, it was created a
company on the back of it that'shad, you know, significant
investment, millions of pounds,millions of pounds of research
funding, and it's growingfurther. And I guess that was
(08:47):
really the very first point inwhich I got involved in
technologies. And through that,just sitting and listening to
colleagues who are reallyworking at the fundamental
science level, discovering newthings be it a new polymer, a
new way of designing ordeveloping something or a new
engineering technique, and justbeing able to translate what
(09:10):
we're discovering into somethingthat might actually work in the
clinic. And for me, that that'sbeen an area of immense
interest. And somewhere Ispecialised. There are people
obviously focus on on biggerpopulations in adults, but very
few who look at it inneonatology. And so it's an area
that I've kind of grown areputation for and will be very
excited about and I've got manydifferent projects running now,
(09:34):
all in parallel. And at times, Ifelt overwhelmed of being at
capacity and felt this desire totry and get all of these
technologies into neonatologyand wish there were more people
coming through. So one of myother passions are around
technologies is kind of growingfuture leaders in this domain as
well. So I have a number ofstudents, PhD students in
(09:55):
particular, across a variety ofdifferent specialties, which I
think is unusual for an academicclinician, where, you know, I
certainly in the last year, I'vehad two PhD students, one from
computer science, one fromengineering who have graduated
with their PhDs. I've had twoclinical fellows, who both
graduated with their PhDs intechnology related aspects,
(10:16):
again in the last year, so allof these things is about growing
as people get people interestedin them and seeing that,
actually, just because we adoptall of these things from adult
technologies, it doesn't meanthat they necessarily give us
the right information or work inthe right way. And that
actually, we need to work withthose fundamental scientists to
develop things that are specificfor children and particularly
(10:38):
for babies.
Hannah (10:39):
what you've just landed on is a question that's been
bubbling in my mind for a fewminutes. Now, I was interested
in your take on we called thepodcast, not just mini adults,
not mini adults, in fact I havegot it wrong, classic, and it's
not limited to the devices butthis idea of intervention versus
adaptation, and that so manysolutions that exist in
(10:59):
paediatrics, including neonateshave been derived from a
solution from healthcare foradults. And so what's your point
of view of adaptation versusinvention? When? When is it the
right time to invent and when isit better to adapt?
Don (11:15):
I guess as paediatricians, it's one of the first things
that we're all taught as soon aswe embark on a career in
paediatrics is that childrenaren't small adults, even
adolescents are not necessarilysmall adults, they have
different things that need to beaddressed differently. And I
think as you go down the ages,it becomes more apparent. And
there are certainly technologiesthat can be adapted from adults.
(11:35):
And I guess things around, youknow, imaging is probably a good
example is that imagingmodalities, you can adapt
usually the software quitestraightforwardly to accommodate
with that. And I guess, when itcomes to other technologies, you
need to start to think about thedisease processes that are
slightly different in children.
And it's well described thingslike this particular diseases in
(11:57):
children movements relate toorphan diseases that they're
often called, whether they'reextremely rare, they occur
usually from birth, or usuallywithin first months of life. And
they're very rare. And actually,sadly, most children who have
these, the most severe end ofthese, they don't survive. And
partly that is because I thinkpreviously, people have not
(12:17):
invested in trying to come upwith solutions or treatments or
management plans for thoseparticular children. Because
there's such a small population.
And I think it was probablyabout 10 or 15 years ago,
certainly in the EU, there was abig switch to try and to address
this, I think that really kickedoff in pharmaceuticals to begin
with, where they realise youjust couldn't just chop and
(12:40):
change something to suit theseparticular children. And I think
that's really where it's grown,that people are recognised that
those children need specifictreatments and need investment
in it. But the end of the daypeople are is that there are a
very small population, and thereisn't a huge amount of guests or
shareholder money to be made.
And so we've had to come up withnovel ways tempting people in to
study these particular groups.
(13:02):
And I think we're starting tosee some of that now migrating
to what we've seen ininnovation, because you call it
in technologies for children andparticularly for babies.
Realising that 100 kilo adultsin their 60s who's got Heart
disease is very different to a500 gram baby he's just been
born. He's got a respiratoryproblem that is unique to the
newborn who's got the risk of abrain injury that's unique to
(13:25):
the newborn, all of those thingsare things that we need to
tackle differently. And I thinkthat's where I've been coming at
things from is trying to come upmore from the event, and it's
specifically for that populationrather than adapting it. Now,
some of the technologies will bethe kind of platform will be an
adaption. But it will be youknow, just making some subtle
changes to the design will makeit more suitable for that
(13:47):
population. And I think oftenthat's where people have been
falling in that territory,because it's much easier to do
that. But now we're seeing moreand more of a push for devices
in particular to be designed forchildren. And typically for
babies that actually there'smore investment in those. And I
think that's been recognised byfunders. Again, we've seen it in
(14:08):
the UK in particular, and evenacross in the States, probably
10, at least 10 years ago, theyrealised that there were real
issues here. And they set upmultiple institutions that had
these paediatric medical deviceexpertise, so that they could
fast track and develop newtechnologies for children. And
specifically looking at, youknow, how do we do clinical
(14:30):
trials using these new devicesand development for children? I
think there was a report five orsix years ago that looked at 20,
maybe 25, high risk medicaldevices that were licenced for
use in children and babies. Andwhen they look back at the
regulatory aspects, those, Ithink, 85% of them that had no
(14:53):
clinical trials in children atall. So they were designed for
adults and tested in adults, butthey developed and they got to
licenced for use in children.
And that was without knowingthat they had any, any use in
children or there were otherproblems. And I think a good
example is probably the ECG, weall got to using ECG in the
delivery room. And it's verygood. But as we've got more used
(15:14):
to using ECG monitoring, we findthat it does have some
limitations, children who have aslow heart rate, which is
basically obviously higher at60. But it may be that the ECG
shows the rate of 60. Butthere's no adequate heart rate
outputs is not, the heart isn'tbeating well enough. So you can
be misled by that. And the sameis true of pulse oximeter. So we
(15:35):
just adopted pulse oximetersfrom adults, but actually, in
the first few minutes of life,they've been shown to be
inaccurate. And that's becausethe diffusion issues that just
don't pick up the signal wellenough. So there are areas where
we just need to be careful thatyou just can't adopt these
things. And that's why I'vetried to focus on coming at the
angle from the innovation ratherthan pure adaption,
David (15:55):
You make a fascinating point, I have to pick up on it,
because I've literally just beenreading about kind of orphan
drugs and orphan conditions,need to do a bit more research
into it. But actually, you know,a lot of what we talk about, and
I have conversations all thetime at various different levels
around, you know, the need formore investment, more
concentration around paediatriccare, neonatal care, but you
know, in that spectrum. But thenthe the negative aspects of it
(16:18):
is that actually the return oninvestment is not necessarily
there, the pool of you know,patients, the size is not
relative to the the amountinvestment that we need to go
into it to make a difference.
But actually, there's somestudies being done, especially
around orphan drugs, that a lotof or a vast proportion, a much
larger proportion than you wouldanticipate, of profits that are
made by Big Pharma have comefrom often very small, very kind
(16:40):
of challenging, I guess,therapeutics that have needed to
happen for certain cases. And Ithink there's some work there,
or some thoughts that maybe needto go into looking at that and
trying to translate that into,you know, the potential for
paediatric care as well. And totry and rebuff the criticism or
the thought process that, youknow, it's just not, it's just
(17:00):
not worth investing in. Slighttangent, sorry, but I've
literally just been readingabout that this morning. So it
was a, it was in my mind as itwere. Coming back to some of the
areas that you're working in,and you talked about the company
that you've formed, which isSurepost Medical, and using the
cap, and I guess, you know,people can find information on
that and the opportunity forthat. And we'll put a link on
(17:22):
that. But on the on the web asit were, but you're also doing
quite a lot around neonataltransportation and trying to, I
guess, move babies from thedelivery ward to intensive care
or wherever it might be. Buttalk to us a little bit about
that, because you've spent quitea lot of time looking at that.
Don (17:39):
I guess for over 20 years, many parts of the world,
particularly in America andAustralia, they had this
centralised system where thehighest risk infants would go to
these big centres it often inbig cities, because it would, it
would improve the outcomes forthese children. But in order to
do that, obviously, in ageographical area, you have many
(18:01):
births occurring all over. Andso you need to be able to move
the babies into those centres.
And it was back in 2003, the UKdecided to go for centralization
of intensive care for newborns.
And so they set up probably inthe late 2000s, a number of
transport teams, dedicatedtransport teams for newborns
(18:23):
that would move babies fromareas where they were born, I
guess in the wrong place intothese intensive care centres. So
in the UK, we have about 190maternity birthing centres and
about 50 to 60. it fluctuates, alittle bit of neonatal intensive
care centres, but actually, youknow, more than half of the
births occur outside of anintensive care centre. And if
(18:46):
your baby is extremely pretermor is born with a congenital
anomaly or with birth relatedproblems, and they need to go to
these intensive care centres,and so, geographically, the UK
is very small and most centresare within one to two hours of a
major Intensive Care Centre. Butit still means moving the baby
and actually, what we do in theback of the ambulance is we take
(19:08):
in effect a complete intensivecare cot space with a dedicated
nurse, dedicated trainedprofessional and that's usually
in the form of a doctor or anadvanced nurse practitioner who
goes out to retrieve the childfrom their birthing hospital and
bring them into Intensive CareCentre. Now my area of interest
(19:29):
is having ridden in the back ofmany ambulances with many sick
babies is actually watching thembounce around in the back of an
ambulance in an incubator isn'ta nice thing to observe, it's
good for them in that it willimprove their mortality that by
going to the centre they're morelikely to survive. But actually,
although we've seen improvementsin mortality, it's been less
impressive with other importantoutcomes such as brain injury in
(19:54):
these children. And I guessthat's what got me interested,
you know, is the environmentthat there are being transported
Then, is it optimal? Or could weimprove that to improve their
outcomes. And then there's beena number of studies, including
some recent UK data that wasreally powerful that showed
babies who were transported inthis way were at greater risk of
(20:15):
having a severe brain injury, sothat more than would survive,
but more of them would survivewith severe brain injury. And
although it's still a very rareevent, it's an important event
for that child and that family.
And so my focus has been tryingto tackle that and see if there
are ways that we can understandwhat what the mechanisms are,
and what we can then do toaddress it, particularly from a
technological approach. So I'vebeen working with some small
(20:39):
transport companies, I lead asthe research lead for the UK
neonatal transport group, whichare all 15 of the neonatal
transport teams across the UK,we collect data, and we plan
about how we can improve thesetransport pathways. And I've had
a number of research fellows whohave helped study this, thanks
to funding from the likes of deMachar in particular, working
(21:01):
with my engineering colleagues,we've been able to explore it
more, with a view to adaptingthe transport system that we use
to make it safer. So lots ofpeople don't know. But it's
quite a common thing for babiesto move around the country, so
much so that there are about16,000, newborn transfers by
ambulance between hospitalsevery year in the UK. So they're
(21:22):
huge numbers, and often formany, many miles. So families, I
think about 40% of them that ourtransit is over a over 100
kilometres of return journey toand from their house. So so
they're big distances that thesebabies are going and that
there's a period that doesexpose them to these additional
environmental stresses. Now,unfortunately, the risk of
(21:43):
having a severe brain bleed inthese very preterm infants is
often in the first day or two oflife, and that is the time that
you transfer them. So they'reborn in the wrong sense, they
need to go to the centre sowe're moving them at a time,
that's the greatest risk. And sowe've been studying the
mechanisms there, and some ofthe stresses that they are
exposed to. So just to give youan example, when we measured it,
(22:04):
the kind of head exposure thatnewborn's head is exposed to in
terms of its vibration. It's farabove what is being legal and
legal safe limit of vibrationfor a normal adult in their day
to day work. So if you're atruck driver, you're expected to
fall below a certain thresholdof vibration. If you don't by
(22:25):
law, there are laws that protectyou that say your employments do
something about it, reduce thatexposure, because you're more
likely to get musculoskeletalproblems, backache, headaches,
be off work chronically sick,but there's no such levels in
terms of transporting babies. Sowe've looked at all that. And
we've defined what the levels ofvibration that these babies are
(22:45):
exposed to. And it's often twoor three times what an adult
would be allowed to be exposedto. And so we've been trying to
tackle that from an engineeringperspective and trying to reduce
the amount of exposure that theyhave both from noise from
vibration, temperaturefluctuations and really studying
that. We've done that from atechnological perspective. But
also we've used UK wide data toexplore, you know, where are the
(23:09):
problems in these patients interms of their movement, can we
get more babies move in utero,so the mom is moved rather than
before she's born before thebaby's born rather than
afterwards, because that's thesafe environment. That's the
ultimate transport incubator ineffect, but there are challenges
there from a midwifery andobstetric colleagues that needs
to be addressed. And it wasprobably five years ago, nearly
(23:32):
Jeremy Hunt as the healthSecretary the time threw down
the gauntlet for us to reducebrain injury in these babies by
50% by the year 2025, so we areonly three and a bit years away
from that. And that's a hugeundertaking, and that's going to
be that's going to requiremultiple ways of tackling it
both removing more babies inutero to tackling the postnatal
(23:52):
environment making that safer.
And, you know, we've beenlooking at safety so that babies
do have accidents in ambulanceswhen they're being transported
there is well documented casesthere. And the restraints we use
that the only requirement isthat after an accident, if an
ambulance were to turn to itsside that the baby remains in
(24:13):
the same position, it was at thestart of the accident, and at
the end, and the restraints arevery good at doing that they can
hold the baby in place. Butsadly, many of the babies when
we've modelled it would probablydie from their restraining
injuries. And so we need tothink differently. And it's not
just a case of putting aseatbelt on a baby or strapping
a baby in with with a harness,you need to think about how you
(24:34):
access it. And so we've beenworking with around Human
Factors with engineers trying todevelop those material
scientists, what are the bestmattress configurations that you
can come up with? Andthankfully, we went to the NHR,
you know, it takes more than amillion pounds to raise a child
with cerebral palsy. So ourargument at the end of our
presentation was for the firstwe wanted a billion pounds to
(24:55):
try and start this research intothe first child's brain it saves
froma severe a brain injurywould have paid for itself. It's
that easy. And I think they wereswitched on to that. And they
Sally Davis, who was theprevious Chief Medical Officer,
she made a point of it in her2012 report. We've got to tackle
the the issues aroundprematurity around brain injury,
(25:16):
because these are lifelong, thatchild gets a brain injury, it's
with them for life. And if thatchild lives for 50 to 100 years,
that's a lot of healthcare, alot of resources that goes into
that. So that's really how I gotinto that. And we're pushing
forward on that. And hopefully,in the next maybe five years or
so we'll have something thatwill make this a much safer
system for the babies.
David (25:37):
Is there anything that you can kind of discuss now in
terms of some of theadvancements that you're seeing,
you know, some of the thingsthat are most exciting,
Don (25:44):
I guess the things we've been looking at really are
reducing vibration, what weneeded to do was to, to look at
ways we could perhaps modifycurrent systems rather than
producing a completely newsystem, partly because all of
these systems, they have to be a10 year life, and we couldn't
see everybody just overnightreplacing their system. So how
can we adapt what people areusing at the moment and just put
(26:05):
in some new components. So we'vebeen exploring that. And we
found some really, really nice,useful data from that, that
hopefully, we can, we can rollout, we've been looking at how
we might reduce the noise. Sothere are there are quite a
number of times when the back ofan ambulance, the noise is so
loud, it exceeds the noise thatyou probably get with a chainsaw
going up next to your ear. Andif you're a highly fragile baby,
(26:28):
you know, on multiple bloodpressure, multiple ventilator
support, having that noise goingoff next to your ear, for
however long your journey is,this isn't a good thing. We know
it causes fluctuations in brainblood flow. So we've explored
some ways about how we canreduce the noise exposure that
they have. And, you know, it'snot as easy as thinking you can
just miniaturise, people havetried that, and they don't work.
(26:51):
So we've been coming up withsome some nice new ways of
trying to do that, again, withour engineering colleagues. But
as you might expect, there aresome ideas around IP and things
in there that I just need to becareful about talking too much
about.
David (27:03):
Now, of course, of course, thank you what I mean,
the project sounds like it couldbe, as you say, you know that
the numbers speak for themselvesif you can, if you can save one
patient. So it's an amazingproject. And you know, we've
seen a few things where othersare looking to do something
similar. And so you know, wewish you every every every luck
with that. Absolutely. Just acouple of other things that I
(27:25):
think would be reallyinteresting to talk about. One
is that I guess you you startedyour career in Nottingham, I'm
assuming that and you've stayedthere, I'm assuming that that
has been all encapsulatingopportunity for you. But one of
the interesting things happeningin Nottingham, I think, is this
centre for health technologies,which you mentioned to me when
when we first started having adiscussion and I, again, through
(27:46):
our discussions and doing someresearch, there seems to be some
really interesting things goingon there. So anything that you
can talk to us about just interms of the centre, but also,
you know, some of the projectsthat you've seen there as well?
Don (27:58):
Yeah, I guess it kind of went back to what I mentioned
earlier about this, theinterface between getting
fundamental science engineeringpeople to talk to the clinical
people to say, you know, whatare the problems you've got?
And, you know, are there anyother solutions that we have
that can can address that, andthat that was a real issue for
(28:18):
us, because I was workingclosely with engineers, and
computer scientists, withfundamental scientists, about
six years ago, with someengineering colleagues, we
decided that we would put in acase to the university that
actually we should createsomething that pulls us all
together, stops us working inour silos. And I think that's
the only way you can you canforge forward now I think we've
(28:40):
researched and the universitywas very supportive. They were
excellent. They saw thestrengths, they saw the
importance of healthcaretechnologies. It's a growing
area that the future of medicinewhere things were going. And so
we got together as a group, andwe formed the Centre for
healthcare technologies. One ofthe unique things is that
there's a nice partnershipbetween the university and one
(29:04):
of the largest trusts in the UKthat Nottingham University
Hospitals. And it's quite nice,because both of them, what we
call our, where our engineeringand our science bases on the
university is literally joinedby a bridge that crosses over
and one of the ring roads thatgoes through Nottingham to the
hospital. So we have we are insuch close proximity, but it
(29:25):
really just pulled us togethermade us think, and I was one of
the founding clinicians whohelped launch that. And we've
got it going still. And we Theaim is that, as I say, it pulls
all of those interested partiestogether. We have things we
organise things like speeddating, so we get scientists,
engineers, you know, we go outfor a bite to eat and a beer
(29:47):
maybe and we sit down withclinicians from a particular
specialty. And we just speakdate for five minutes you grab
your beer you move on to thenext person. You just chat about
what they're doing. And we'vehad a number of really great and
fruitful collaborations growfrom that, that's allowed us
just to develop new ideas, youknow how we can take what
(30:07):
somebody in engineering anddeveloped around, you know, a
new MRI technique, for example,and how we can apply it in the
clinic. And it's allowed us toget the funding in to prove that
the concept works to then go onto clinical trials. And that's
how many of my collaborationshave grown. And we've done that.
And what we're doing now iswe're working on our external
partners, bringing in commercialindustry partners, bringing in
(30:29):
other institutions in order thatwe can try and work together.
It's still in its early years,but actually, it's grown quite
nicely. And we've had somereally great successes from it.
And I've enjoyed being part ofit. I met colleague there
recently, well, two or threeyears ago, who's created some
really nice new polymers thatare materials that you can coat
(30:52):
pretty much any plastic orsilicone with and for my
population where infections inneonates cause huge morbidity,
huge mortality, I just thought,Well, we've got to take these
and put them onto some of ourmedical devices. And, you know,
we've got some some nice fundingto get that going some PhD
students, and again, we'restarting to explore that. So he
(31:12):
was focused on adults. Andclearly, that's a big
population. But for me, it wasabout getting over to the him
actually, you know, it mightcause a big problem in adults,
so from having urine infectionson from a catheter, but in
babies, it causes death andlifelong disability when they
get an infection. So that's anarea that we really need to
(31:32):
target. And when we talking, wetalk about quality of life
quality adjusted years,depending on how you measure
these things, actually, when youstart to talk about neonates and
children, it's an easy story tosell. Although we are a small
population, we're dealing withthose quality of life years are
there to be had. So that'sreally where it all came from.
(31:53):
And it's an exciting thing. Wedon't just look at engineering
and chemistry, we don't justlook at biology, new imaging
techniques, but I working withcomputer scientists as well. And
we've been developing a numberof AI approaches, which have
been, you know, have been reallysuccessful and things that we
hopefully we can we can keeppushing forward for.
Hannah (32:15):
And moving on from that, what's your experience of kind
of the practical pragmaticexperience to implementing some
of the ideas that you've beenworking on over the years, and
from my background, where I wascoming from was, so much of what
you're involved with now has gotdata involved with it. So even
if you're talking about adevice, often you'll be
(32:35):
collecting data about a verysmall baby in order to make
decisions soon, or improve thedecision making process, for
example. But with that comeschallenges of like, where the
data sits and integrating withhospital systems. But actually,
the question is wider than that,because you've made me think
about other areas to considerwhether it's the IP
considerations that youmentioned, or whether it has to
(32:58):
do with risk and the role ofclinical trials, but how do you
go for it, because for me, itjust feels like it could be very
difficult to to have a brilliantidea. And then but then be able
to turn that into something thathospital organisations are happy
to have implemented.
Don (33:17):
I think in my field, in particular, the two barriers, I
always I always felt that wouldbe the thing that would hold our
research back. The first wasaround technology adoption and
how you move through it and howyou move the technology through
its adopted stages. And for me,that's always been the major
hindrance. So you're often atthe early stages, you come up
(33:38):
with a great idea, you know,you've got a new sensor or a new
using that example I had beforea new polymer that you can, you
can code to prevent code deviceinfection, you come up with
that, and then it's then gettingit into those early clinical
trials. And there's always adip, you know, you get your
data, you have to wait, you putin your applications, your
funding, you get bounced Thefirst time you put it in again.
(34:00):
So there's an inherent lag of,you know, 18 months. So it
really slows you down as aresearcher that slows down this
adoption, to get in it to thepatients that really need it,
you know, you then get your nextround of funding and then prove
in a preclinical or clinicalsmall clinical trial that it
works. And then you have to waitand put that data in for the
next application. So, you know,you then do the big trial, and
(34:23):
then eventually, you know, youget the funding for that. And
then there's a lag, getting thatone finished and getting the
data out and people thenadopting it going through all
the regulatory aspects. So thatstill is and always will be, I
think, a major hindrance. Ithink lots of the funders now
switched on to that and they'renow trying to fund a bigger,
more balls programmes ratherthan individuals short projects
(34:46):
that that will stop and start inthat way. They want to try and
fund a really brilliant idea allthe way through. The other one
that I thought might be ahindrance was that I guess kind
of what you're alluding to wasaround how would people feel
about it? Entering a very sickchild in an intensive care
setting into a clinical trial,particularly when many of the
(35:06):
things that we do don't benefitthat child at that time. But
actually, I found parents inparticular, were really open and
receptive to being part of it,they saw that actually, there
was something to be had for thefuture. And, and what I often
say to parents, when I talk tothem is around your child today
is being cared for, on thebackground of a huge amount of
(35:28):
research that parents havesigned up to before. You know,
the reason I know how toventilate your baby now today is
because of what we've learnedbefore from other research
studies, from, you know, medicalstudies that this treatment
works better. And what we wantto do is keep making that
better. And I thought that mightbe hindrance, but actually, it's
surprising how many parents evenat the time of extreme worry,
(35:51):
anxiety for them, when they'rebabies at their sickest they
will agree to participate in theresearch because they can see
the benefits for that. And Iguess on the back of that, it's
been reflected in how hospitalsand how ethics bodies, for
example, they see this research,and they, I think are more open
to that now, they realise thatsome of this really is at a time
(36:11):
when children can be at theirmost vulnerable. And sadly, I've
had children who've been in mymedical device studies that
haven't survived, because of thenature I work in intensive care.
And it's not, it's not relatedto the study they were doing,
they would they would die ofother causes. And, you know,
it's a horrendous privilege fora clinician researcher, to be
(36:34):
able to say, you know, to, withthat family to sit down and say,
you know, what we've learnedfrom this has been amazing, it's
been a real privilege to haveyou, you know being a part of
it. And, you know, it'sextremely sad that their child
has died. And I don't know whatthey feel when they when they
talk about that to lose a child.
But actually, the number offamilies that said to me that
(36:54):
they feel as though they'vecontributed in some way that
they're, although they losttheir child that it's had some
weight will have a benefit forthe children. And I think that's
one of the things that drives usall on is conditions,
particularly in those settingswhere not every child does
survive. And actually I think,you know, many of the systems we
have now around ethics andhospitals, are geared up for,
they recognise that's a reallytricky environment to go in. And
(37:16):
you know, they'd be verysupportive of us now, there is a
lack of joined up, you know,collecting data, for example,
just routine data has been verytricky previously. And the
number of hoops you have to jumpthrough in order to collect that
in order to learn about yourpatients and study things in an
offline way, can be verydifficult. But again, they are
(37:37):
becoming more open to that. AndI think, you know, there are
steps going forward about makingeverybody's data more available
in an anonymized way that youcan pull together. And we can
look at that. And we've donelots of research, looking at
those big databases as well, andutilising those, and I guess,
part of that's built into someof the machine learning the
(37:57):
artificial intelligence workthat we've been developing.
David (38:03):
Don, thank you, we could talk to you for hours, I think a
lot of what you're doing isreally, really inspirational. So
it's been fantastic learningmore about it. One of the things
I will certainly take from theconversation, front least what
we just discussed, and I thinkthat's, you know, really, I
guess, personally, a lot ofthings that we tried to do as
well, but also the way thatyou're working, you know,
(38:24):
between yourselves and theuniversity. Anecdotally, I kind
of use an example of one thatactually has spurred us on quite
a lot of Atlanta Children'sHospital and Georgia Tech coming
together and doing very similarthings. And a friend of ours and
a friend of the not mini adultsof podcast, Sherry Ferrugia.
was, you know, the the kind ofcatalyst for that. And and I'm,
(38:45):
I'm glad to say that we have,you know, I guess a similar
instance in the UK that we candiscuss, as well. The final
question, though, which we kindof ask all of our guests is, if
you could change anything withinpaediatric healthcare, what
would it be?
Don (38:59):
There are lots of things I think I've talked about lots of
positives that have happenedover certainly over the 15 years
I've been I've been studyingdevice technology development in
this field. I think for me, itreally would be not just from a
funding perspective, or from thetraditional funders in the UK,
but from industry, as well wouldbe to recognise, although there
(39:24):
may not be huge amounts of moneyto be earned from developing
these things, actually, thequality of life and the buying
in to, you know, a child'sfuture is really important. You
know, Paul Dimitris head of thechildren's and young peoples
medtech that I'm part of, wehave this saying about, you
know, the children may be asmall part of the population,
(39:46):
but they are the future. Andthat's true and if we can
improve the lives of children,by rapidly developing new ideas
and translating them into newthings that will improve their
health. their well being andultimately their life chances
that actually that's a goodthing. And I think the funders
(40:07):
in the UK, certainly from thegovernment side of things have
recognised that now, what I'dreally like to do is to see,
there are there are goodexamples out there. And I'm not
applying this to everybody. Butfor the big pharma and big
medical device companies tostart to invest more in them
realising that, although it's asmall population, there may not
be much money to have, butactually, there are big gains to
(40:29):
be had. It's important, I think,you know, that we can help
extend lives and keep them well.
But I see huge amounts of moneygoing into extending somebody's
life by four months, you know,at the end of their life from a
cancer treatment, but verylittle going into into
preventing a brain injury in aaby. And I think that's perhaps
here we need to thinkifferently. And as it's not a
uge population, it doesn'tequire huge amounts of
(40:51):
nvestment, but it just needshat right investment with the
ight teams to really acceleratet. And every day that that's
eld back, you know, there'snother child who suddenly will
ave a brain injury for the next0 to 100 years of their life.
David (41:06):
Don thank you so much.
t's been a real privilege talkinto you, and delighted to hear a
out all the work that you're ding good luck with it all.
Don (41:12):
Thank you, David.
David (41:15):
Thank you so much to Dr.
Sharkey for joining us on thenot mini adults podcast, and I'm
sure that you would agree apretty powerful conversation
that we had. And it'sinteresting because we're seeing
a lot of innovation withinneonatal care at this point in
time, which is I think, youknow, wonderful to see. Next
week, we will be joined bypaediatric neurosurgeon, Dr.
(41:36):
Jayamohan. And who is going tobe coming and talking to us
about empathy, and theimportance of having that
connection with not only thepatient, but also those around
them. When looking after a childin hospital. We really hope that
you can join us then please dosubscribe to the podcast. And if
you're enjoying it, please doleave us a review as well. We
(41:58):
hope you'll join us again next week.
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