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CoaguSense developed the first point-of-care prothrombin time/Internationalized Normalized Ratio (PT/INR) monitoring system for cardiac patients who have been prescribed warfarin. The gen three model goes from a connected device to a disconnected one. Find out why!
Speed-to-data determines go-to-market success for medical devices. You need to inform critical decisions with user data, technical demonstration data, and clinical data. We interview med tech leaders about the critical data-driven decisions they make during their product development projects.
Hey everybody.
Welcome back to the next episode of
MedTech Speed to Data, a Key Tech podcast.
I'm your host, Andy Rogers, here,
two guests today.
First, we have Mike Acosta from Coagusense,
Mike, welcome to the show.
And we have Wade Schroeder
from Greenlight Guru, Wade,
welcome to the show.
Thank you, Andy. Yeah, you got it.
You're the first vendor to
come on the show.
This is our first kind of like three person
sort of interview,
in my recollection, so excited for today
to tell the story about Coagusense,
where you've been,
where they've been, where they're going,
where are they now,
and really how Coagusense has helped
has worked with Greenlight Guru
to get their ducks in a row,
for regulatory approval.
We’ll talk about Speed to Data,
maybe a little bit more efficiency
to data and what data is needed.
But still, you know, a great story nonetheless.
So without further ado,
let's get into it, guys.
So, Mike, we'll start with you.
Can you talk a little bit about your background,
your history in med devices and IVD
and kind of where you are today with Coagusense.
Sure, I’d be glad to.
I'm going to date myself,
but I've been doing this for over 40 years now.
All right.
All in biotech,
so grown up the ranks from a lab tech
all the way to the executive staff,
of various companies,
have had my own successful consulting company
for a period of time as well.
So again, have worked with
everything you could imagine,
from pharma, to biologics, to IVDs
med devices, etc., etc.
So that experience basically
with Coagusense, I came on board
as a consultant on the beginning of the company.
So I have been with them for the last 12, 13 years
and eventually became a full-time employee
at the executive level
and I really believe in the technology,
the platform, hence why really trying to
take this to the next level if you will.
With new technology, new state of the art
improvements, etc., etc..
Awesome.
So Mike, for our audience,
can you just describe the Coagusense platform?
What is it used for?
What are the patients?
And you know, generally, how does it work?
So basically the intended
use of the device, it is considered an IVD
where we basically are monitoring patients
who are on a Warfarin type
anticoagulation therapy.
So similar to, again, diabetics,
monitoring continually to assure
that they're within their ranges.
Extremely critical
for these types of patients
who are on the blood thinner Warfarin
only to maintain within that therapeutic range,
obviously to avoid throwing blood clots,
and obviously the events that could happen from there.
So the Coagusense is used to do a PT/INR measurement.
So tell us a little bit more
about these patients, Mike.
These patients have gone through some type
of cardiovascular event
or they're required
to be on anticoagulant therapy.
So could be short term.
Could be long term.
So basically, our device is intended
to monitor them
over the period of time
that they would be on Warfarin.
They must be within the therapeutic range
because obviously going too thin or
too thick on their blood could present
an adverse event to these patients.
Got it.
We'll definitely get into more about
the use environment and the use case.
But Mike, that's a great overview of Coagusense.
Thank you. Over to you, Wade.
So tell us a little bit
about your background.
Again, thanks for coming on the podcast.
Absolutely.
Happy to be here.
So a little bit about my background.
I'm a Medical Device Guru,
here at Greenlight.
Get that fun title from having worked
in the medical device industry
before coming here to Greenlight.
So I spent about ten years,
not quite as many as Mike
in the medical device industry,
primarily in product development,
started out as an electrical engineer, back in the day.
Product development and quality
work for a couple of different
medical device manufacturers.
The previous one to Greenlight
was an IVD company as well,
so they did cholesterol testing and A1C there.
So yeah, being here at Greenlight
three years now.
So tell us a little bit more
about how Greenlight Guru helps companies
like Mike's get their products to market.
Yeah, absolutely.
So, Greenlight is an out of the box
electronic quality management system built
specifically for medical device companies.
So we only work with medical device companies,
and that’s how we're able to build the solution
out of the box
to align with the regulations and set up
medical device companies
like Coagusense to be successful
by putting all of those guardrails in place
to align everything
with those medical device regulations
right there.
So everything's in one system.
Greenlight is, your source of truth,
everything's traceable in the format,
that is easy to submit to the FDA when you get to
that part of your journey,
you know, easy to go through audits.
We like to say it's always audit
ready in the system.
So yeah,
help them get to market fast and stay compliant.
Oh, it sounds too easy.
I personally haven't used it before, but
it certainly makes sense.
Right? You're building off of
known quantity.
You know, in the startup world is
and in the case of Coagusense
it's not necessarily a startup,
it’s been around for for a while.
But it's helpful to point to something
that's a known good quantity
and focus on the
challenges on getting to market.
So Mike, back to you.
So, how did you guys decide
to go with an outsourced quality management
system, versus building your own internally?
I know a lot of our viewers
are faced with this question as well.
Yeah,
we started out obviously
like everybody else as a manual system.
And, you know,
after building, building after 12 years,
you come to a point
in time where you're looking for that efficiency,
you're looking for that speed to market.
I think, as Wade had commented about,
it is a big challenge.
And I think to the point of
I think one of you had said,
if I look back at the number of startups
that I worked for.
Had I gone out the gate
with this type of offering and what Greenlight
Guru offers meaning, procedures, templates,
all these things,
you could save a tremendous
amount of time
getting an established quality management system.
So even though for us 12 years manual paper
based system, it is a large undertaking,
but it's going to be well worth it
when we're finally fully implemented.
I think some of the keys as even Wade
said, what really drew me to Greenlight Guru,
after evaluating, I will say the top three.
Was the fact that they are
very specific to the medical device industry.
They're well recognized
by some of the regulatory authorities,
which makes life easier for us
and the audits
that we will eventually be going through.
So all those things combined
basically led us to believe
this is the best offering for us.
And the last thing
I'll just mention, you know,
is that one of the few offerings I saw that
truly had the design control aspect,
which is first and foremost, I mean,
obviously starting out with an idea
really, truly getting the design control down
upfront will help a company
all the way through the submission portion.
Got it.
So how long is the integration process?
How long does that take?
Depends who you ask.
I would like to say,
you know, 3 to 6 month timeframe.
But we have faced some challenges
internally with resources
and some changing of focus
in recent months, dealing with some issues
with the regulatory submissions.
So it's hard for me to say pinpoint directly
that if we put in all
resources into it,
we probably could have been done
in 3 to 6 months.
But again, we've had some challenges,
so a little bit longer.
But again, no fault of anybody
other than again
just making sure we had the proper support.
Yeah, I imagine Wade that you can,
you know,
march down the product development path
in parallel with getting integrated.
Is that right?
Do you have like a bare bones model to get,
to not get in the way of of the project
getting to market.
Again, a podcast titled Speed to Data, right?
So what data is most important?
Sometimes it's clinical data,
sometimes it's bench data,
you know,
so you can get going while it's being integrated.
Is that fair?
Yeah, absolutely.
And we even have those processes built in.
We call it bootstrapping
to get you to where the point you need
to be to submit to the FDA
and not necessarily
overburden yourself
with all of those things
that could come after you submit.
So yeah, absolutely.
It's a fully,
I guess,
customizable system
where you can decide what aspects of it
you want to work with
at the beginning
and then what you can add on later.
Cool, so Mike, let’s talk
more about the Coag-Sense,
clear waived point of care use
assume it's used in the home environment.
Correct.
Talk about the platform,
so you've been on the market for a while.
Where are you in development?
Obviously, you're working with Greenlight Guru.
You're developing the next generation.
Just to talk about the current product
and where you're going.
Yeah, the indications for use
or both, point of care
as well as patient self-testing at home.
And obviously with the pandemic,
the pandemic really pushed more focus
on the patient's self-testing
rather than patients coming into
clinic, hospitals, doctor's offices, obviously.
So we're seeing that aspect of the business
truly growing here in the U.S., no question.
Okay.
As a result of that, the current version
that we have out in
the marketplace was cleared in 2019, has done
very well in both point of care as well as PST.
But we also
decided to develop the third generation,
which is a much more simpler device
for the patient self testers,
especially the elderly.
All right.
The elderly don't care about
all the bells and whistles, the connectivity, etc., etc..
So we then decided to,
if you will, develop this downgraded version
for that marketplace specifically.
So that's where we are currently.
We are under review with FDA.
There have been a lot of challenges
only because of the pandemic, because of the
so many different companies
trying to get EUA approval for COVID tests.
It has really delayed the FDA review time
and we're seeing that as a big challenge
and that's what we're working through right now,
repeating some performance studies, etc.
So we're hoping that
we will gain clearance for this third generation.
I would say
hopefully before the end of the year,
if not sooner.
When we talked in prepping for this interview,
you mentioned
what I think is kind of a monumental point here,
a downgrade of functionality, which is just
you don't hear that very often,
at least where I sit,
everyone's trying to make it
stronger, faster, you know, more specific,
you know, cheaper, higher volumes, everything.
And what I'm hearing from you is
the market wants something that's simpler.
Obviously, ease of use is important,
but features, reduction in features.
So Wade quick question for you.
Are you seeing that as a trend in your space?
You know,
companies that are
trying to simplify their products,
the features in their products to address
maybe an elderly audience.
Are you guys seeing that a Greenlight?
Yeah, I wouldn’t say necessarily a trend
specifically toward that,
you know, feature set of,
decreasing the amount of features
for the elderly,
but definitely a trend toward usability.
In the sense of, really looking at
who is your intended user
and designing it specifically for them.
Definitely a trend in focusing on that more.
Gotcha. So Mike, you mentioned
the connectivity functionality
like perhaps that's going to be removed.
I'm just picturing like,
my stepfather has a, he's on Warfarin
on occasion and
I'm sure he's using some form of this test.
I didn't ask him.
But, you know,
how are you going to track these elderly patients
if they're using this as a,
as you call it, a patient self-test in home,
if if there's no connectivity?
What we're finding is there's a development
and they've been around for a while,
but something we refer to as IDTFs,
independent diagnostic testing facilities.
And what's happening is
those facilities are really managing
these self testers.
So essentially and again because of the elderly,
they may not necessarily
have computers at home or, you know,
savvy with connecting it to Wi-Fi or even smartphones.
So the point is, is that these IDTFs
are able to manage large populations
of patients by the old method.
Call in my results whenever I test
and then basically they will help report it
back to the doctor,
assure that if there are any dosage changes,
it gets relayed in that same fashion.
Contradictory to that though,
if you think we were talking
about trends, telehealth, telehealth is really
where a lot is happening right now.
And ironically, I was in this space
many, many years ago, but it was premature.
And now I'm seeing where telehealth
is so critical.
Contrary to what we did with the third version.
But it is still very important for our current
version that's out in the marketplace right now.
In fact, we are working
with some additional companies
to help increase that telehealth communication,
not just through Wi-Fi, Bluetooth
by other means as well.
So, you know, what we were talking about
is really serving the community,
serving what we know to be the elderly,
to make it much easier for them. Yeah, I know.
This is a really interesting trend.
It reminds me of,
doing work here at Key Tech
in the drug delivery space where,
you know,
call it like a diabetes patient or something.
And you lay out,
you know, you're like,
oh, here's their simple workflow.
They come up to the kitchen counter
and they remove the cap and they clean it
and they, you know, inject
and they pair it with their smartphone.
And look, it's straightforward.
You've got it.
Well, the reality is
these patients are stepping up to the counter
with ten drugs, ten different workstreams.
And so as you were describing that,
I can see where
if you're on
a call like this,
if you're an elderly person on telehealth and,
you know, they're asking about your,
you know, your Warfrarin,
are you taking it and,
what are your PT/INR readings and
and they're just confused.
Like I thought I uploaded it to the cloud
and, you know, who am I talking?
So I can see that having a simple device,
multiple devices and that kind of one line
of communication through telehealth being a more
reliable, maybe not as scalable,
but reliable way to manage remote patients.
So I hadn't really thought about it
that way until just now.
And I think the patients have a
little bit better comfort level as well.
You know,
like we talk about old school,
you know, again, you're
talking patients well over 65, 70
who are on Warfarin long term,
and having to test, having to report the results.
And I think there is a level of comfort there
by continuing to,
be able to be managed by these IDTFs
or similar offices.
You mentioned also in your response about,
FDA reviews and with COVID things being delayed,
can you just again,
Sped to Data is the name of the podcast.
So talk a little bit about the data that
you have to collect now that
maybe you didn't in Gen2,
the one that's on the market today,
but the one, you know,
what do you have to collect now?
What data to get through and get clearance?
You know, with clearances with the FDA
it can change every submission
every reviewer in this particular case.
Again, Gen3 of a device
that we thought would be a very simple
what we call a special submission,
which means 30 day review for the 510K.
here we are pushing almost a year
that this is still being under review.
Okay.
In my opinion,
it should have been pretty much a slam dunk,
I believe, because, again, out the gate
we were informed about the potential delays
because of EUAs, COVID, etc.
These are the challenges you go through.
So our reviewer,
as we got the first set of questions from him,
we responded,
which we felt would be adequate
and don't hear anything.
And then all of a sudden we find out he retired.
So now you get pushed over to new reviewers.
It's like starting the clock over again.
Okay.
I think again, like any product,
when you have different reviewers,
everybody has their own specialty
and they're going to hit their hot button,
relative to what they want additional information.
So this round and again, talking about data,
this round or this particular product
has really been focusing
around this statistical analysis.
What used to be very simple
of submitting regression, you know,
graphics, Bland-Altman’s, things of that sort
has now turned
into a much larger scope of their expectations.
So that's what we're dealing with right now
is really doing multiple days of testing.
It's all bench testing.
We don't have to be in the clinicals
for this particular next gen,
but it's very, very time consuming
and like I said,
that's where we are right now,
trying to complete the five days of testing,
making sure that we're providing
the right statistical analysis to the FDA.
So obviously,
that data is so critical,
having the expertize of statisticians
to help us out, to really decipher the data
and present
to what we believe the FDA will accept now.
Yeah, just did my homework
on my statistics from,
from high school and freshman year of college.
Just, if I may,
at its simplest comparing
to different populations or samples?
You've got data from your Gen2
and data from your Gen3
using the same blood analog
and proving that they're equivalent.
Is that basically what you're trying to prove?
That's what we went out to get.
And what we have been doing
is all I'm trying to do, is prove,
that my third gen is equivalent to my second gen
right, substantially equivalent.
All right.
FDA took this a step further now.
And even though we're running controlled samples,
what they want to see
is also operator to operator.
So that's something new
that was thrown
into the protocol,
thrown into the requirements or requests of data.
And so that's what we're dealing with.
I mean, we all know techniques can vary slightly,
you know, from different technicians, but,
until you really get into the nitty gritty of it,
do you understand, wow, that little difference
of, let's say, point one can throw your percent CV off
dramatically.
So it's all about how do you look at the data,
how do you present the data
so that it is acceptable for them?
Hey, wait on for Greenlight Guru.
Do you guys have
document templates and such for these sort of,
I guess, test reports to
to use in support of regulatory submission?
Or do you kind of
focus more on your primary process
check and review, and not really go to that level.
To what level of detail does Greenlight go here?
The templates we have
that we provide with purchase of Greenlight is
they're more encompassing
all of the procedures were constructed,
you need to
create and set up your quality management system
more to align with 1345 and part 820.
But those technical type of documentation,
it's hard to get too specific
with generic templates
for those since every device is so different.
But we provide high level at least to
help you get started
so you're not starting from scratch.
Awesome. Well, Mike, best of luck
with getting through the latest
round of reviews and,
you know, getting on the market here soon.
And again,
I just love the story of going
from connected product to,
a disconnected product in a way
Is the connectivity functionality worth it,
you know, for your distributed at home
device, you know,
clearly you're going from a connected device
to getting rid of these bells and whistles,
to use your terminology.
How are you leveraging the connectivity
with your Gen2?
As I'm sure there's clear value in it, like
how are you guys using it?
I think the connectivity is really more of a need
for the professional
for the point of care, more
so than the patient self tester.
So hence Gen2 will still
mantian a PST version for those younger,
I will call it more technology savvy patients
who do enjoy the connectivity,
who do enjoy all the bells and whistles.
So really
I think we had to adapt
or have this
PT3, the offshoot, the third gen
mainly more so for the elderly patients, right.
So it's adapting to the marketplace
whether and this is obviously demographics here,
you know, for the aged,
this will make it a lot easier for them,
for the tech savvy people.
They're still going to go with the second gen,
no question,
because they do like all the bells and whistles.
For the tech savvy and for your customers,
your customers aren't necessarily the
the patients taking the test at home.
It’s their provider groups
or whatever that are distributing
those tests to them.
Are your customers monitoring them at home
just real time across
hundreds of devices?
Just talk a little bit
more about how the patient self-test
connected device is being used by
you know, your clinic customers.
Yeah, I think, you know, all the patients
who are using
these devices are either
reporting directly
to their physician office, obviously, or again,
these are IDTFs that I mentioned which manage
several patients.
They do the troubleshooting,
they do all of that for these patients.
So it is a wide variety, if you will,
across the U.S..
And again, like I said, I believe it's
a growing marketplace here.
Even though, we've seen some changes internationally
by patients being prescribed other types of drugs
that don't require monitoring.
Warfarin and is still very prominent
here in the U.S.
And I believe it will remain that way
and continue to grow.
So it's like we've been talking about is
how do you adapt,
how do you adjust to the market technology,
everything that goes along with it
to really continue to grow the company?
You know, we're working on some other assays
that will be using the same platform.
All those things are important to us dealing
with all the regulations,
even the international front,
which is always changing.
So it's really just about,
you know, making things more efficient
and really adapting to that marketplace,
if you will.
Wade, for these international markets
and other markets.
And just in general,
how is Greenlight sort of constantly
revising their offering to
keep things optimized in terms of like what
what really needs to be reviewed versus
what might be seen as as excess?
Yeah, absolutely.
The biggest thing from Greenlight side,
as I mentioned, built specifically
for medical device
and being an out of the box solution
that all of our customers are getting,
the same thing is that we're able to
since we validate it for our customers,
we're able to release new versions
of the software consistently.
Right now we do it quarterly,
and so we're always able to stay up to date
with the newest regulations,
you know, and new ISO versions.
ISO standards come, or MDR is released,
we're able to stay up to date with those.
I would say internationally, the biggest thing
with MDR
is all about traceability in the postmarket
and that we have tools built specifically for that.
We call it Visualize.
Actually, the shirt
I'm wearing today, which is kind of funny, but
you're able to see
full traceability since it's all in one system,
one source of truth there.
You can see this mind map
of how everything's connected in your system.
So you can understand if I change this,
what could it impact?
And things like that.
Yeah, it's pretty powerful.
If you know that quarterly
your getting the latest version
of what may be in the prior quarter
somebody had been audited against
and was shown to be not necessary.
So I'm sure Mike is reaping those benefits.
He just might not know it. Right.
Well, and another point, I mean,
and I've talked to Wade about this
as well as some of his colleagues is
you also have to understand that
when you go through audits,
the different notified bodies, the different agencies,
I mean, you have different interpretations
that occur over time.
In fact, Wade and I talked about this relative to
the corrective and preventive action module.
That I had four clients in a row,
get challenged on something
that was unbeknownst to us that
we're already doing it,
but they wanted to see it in a specific sequence,
if you will.
So we had talked about that
so that, again, it's ever changing out there.
And I think that's the beauty
with Greenlight Guru is that okay,
they'll listen
and when they can incorporate something,
if they do see it as a trend
or the other thing I like about it
and not that it's fully customizable,
but to Wade's point earlier, is that
they have certain things that you can customize
so you can satisfy the future auditors, okay.
By rolling
in this additional step that they want to see.
So it's so critical
not only for industry but also for, you know,
vendors, suppliers like Greenlight Guru,
is to keep up with the trends
and the evolution as well,
just to make it easier for all of us,
you know, out there.
And I expect that will continue on
no matter what.
Yeah, Mike, you used the word trends.
I mean, two things come to mind
when I'm talking to both of you. The first is
preventative care. Prevention.
In ten years, we are going to be doing blood tests
to check
the biopsy assays, whether we're at risk for cancer,
you know,
so prevention.
And then the other trend is drugs
requiring monitoring.
I think just sticking with cancer,
at Key Tech here, we do a lot of work
in oncology,
drug preparation, drug administration.
And,
you know, at home,
you're going to want to make sure
you're getting the right dosing
for the right drug.
And, you know,
you have to administer the drug
and then you have to do a blood test
to make sure that, you know,
your quality of care is
you're getting the right dosage
basically, dose monitoring.
So what you're doing it
Coagusense Mike I think is
you know very similar
like you know diabetes care
where you're monitoring,
you know, your insulin and
administering glucose as needed or monitoring
your glucose, administering insulin as needed.
And so I think there's a lot to be learned by
this use case here at Coagusense where,
you know, it's at home,
it’s patient administered self tests in the COVID era
or it's point of care in a clinic.
There's going to be
I mean, I think that the use case
is generally going
to be the same right, collect blood
and put it in the analyzer.
But I just think that there's going to be,
two or three orders of magnitude
more people doing this type
of testing in ten years.
So what I wanted to open the floor to discuss
here is
what can be leveraged by what you've learned
at Coagusense
and Wade, what you're seeing with,
you know, customers like Coagusense,
so that you know, in ten years
that use experience
is just that much that much better.
What can we leverage, Mike you talked about
just staying ahead and,
you know, elderly patients want simpler
functionality and just a
simpler device to interact with.
But, you know, on the other side of the coin,
some patients want more functionality
and more connectivity.
So, you know,
if it's a couple order of magnitude
more patients
that are using your product,
what can we learn from what you're doing now?
I think the big thing and again,
being in the industry for so long
is the fact that trying to take more
of the laboratory testing
into the home testing or point of care testing,
right?
People don't like going into the lab,
having their blood drawn, etc., etc..
And I look back in my career as an example
when proteomics and genomics
really started to be a hotbed.
A lot of my clients back then, were going
from an R&D assay
and wanting to get into a commercial assay,
and you're talking about this large
instrumentation, equipment
that was being developed and used
and then trying to miniaturize it
to get more into the laboratory setting.
And I think now it's pushing it more to
what can you do to either
get a point of care
or the actual testing at home.
And I really believe
that's going to be the continuation,
the trends that we're going to see,
what other assays, HBA1C,
that counters along with the glucose testing
that used to be large
equipment, laboratory instrumentation.
Now we're seeing that getting down
to a point of care
or potentially even home use,
at some point in time.
So personally, that's where I think the trends
will go, as well as I think enhancing further
the simplicity of reporting the information
to your attending physicians.
And the other way
to kind of think about this,
what you're learning now is
if two orders of
magnitude more people are using your product,
that's going to make the data
you need to collect for regulatory approval
that much greater too, right,
because you're going to have to account
for that variability
in the different use case, right?
Well, I think what's most important
tied to that right now is with,
you know, Wade alluded to the MDR.
Obviously we are impacted by the IVDR
is what we call the post-market surveillance.
I mean, that is now collecting actual use data
that's going on out there
to really help
support, you know, the company,
it's a requirement.
So I think that's really what
it's coming down to.
How well can we capture that postmarket data
moving forward here?
Because that's going to feed back
in for potential improvements,
for increased potential risks
or mitigation of risks,
all those things that come to play
during the development
as well as the lifecycle of the product.
Wade, what are you seeing at Greenlight with,
you know, the shift towards
consumer health, and just,
larger quantities of these devices
being used at home.
And like I said, ten years from now,
two orders of magnitude
more people doing blood based tests.
What are you seeing?
I think circling back to the usability,
that's the biggest trend that I'm seeing is
people, customers,
you know, companies that we work with are
hitting and contacting
their potential customers much earlier on
and doing those preliminary usability studies.
The, you know,
trying to figure out ahead of time,
how should we design this device,
what is actually needed,
what do they want from this?
Rather than the approach of
we know what they want
and our engineers are going to build it.
Actually going out there
and getting that information
that has been a big trend
I've seen just in the last two years even,
is just a bigger focus on that.
And that's even a business strategy
almost as much as it is a medical device strategy.
And I think that's going to drive
a lot of at home use as well.
Yeah, we're seeing that as well.
We're seeing we're doing more VOC studies
now than we ever have,
global companies,
trying to answer the question,
is this product,
what our potential customers want.
So I agree with you.
All right.
That was all ahead on my end.
So, you know, Wade,
thank you so much for coming on the show.
And Mike, always a pleasure and
great to get to know you here
the last couple of weeks or so.
And you know, all the best with Coagusense
getting this Gen3 on the market and
scaling up the company like you've described
Thank you.
It's been a pleasure to be here and enjoyed the
the chat. No question.
All right.
Yeah., thank you Andy.
That's it, everybody.
Yeah, that's it, everybody.
We'll see you on the next episode of
Med Tech Speed of Data. Take care.