Medical device, clinical trials is facing a lot of challenges.
And the biggest one that comes to mind is regulatory.
So as we just mentioned, there are some regulatory changes in Europe.
In fact, we did some of the maths and we found that in the past five years
there have been around 120K of regulatory changes.
So you can imagine there was a regulatory change every 20 minutes.
This is like the biggest challenge.
But then there are other challenges as well.
There's regulatory, then there's the complexity of clinical trials,
like you just mentioned, about wearables.
Well, it's so easy to get a drug trial, get people to try it
and find out, okay, this is more effective than the other.
Now, think about a medical device which is coupled with the software,
and it's so hard even to find out,
is it a software glitch even or is it a patient glitch?
So just as you mentioned about the Watch thing,
so the trials are getting more and more complex and you have to keep up
with that patients, you know, how do you retain them
and get them to work with a medical device for clinical trials?
So all of this are adding a lot of challenges.
So right from regulatory your clinical trials
and then you have the whole lot of complete factor
into this where there's so many companies that come in
and the clinical device has to be recalled and then they have to go through
a whole gamut of things of how to get that back on track again.
While it might be a little more simpler if you have something that is like
the imaging machine or something, but imagine if it's an implantable device.
And to add to the mix, you have the cybersecurity scare,
where there's software, there is a cybersecurity scare.
How do you deal with all that?
And then there is the identification of the person who is using that device.
So you have the information of the person
which has to be identified as, you know, there are a lot of regulations around it.
And again, there's a very geo specific regulation,
like regulation in California is different from the one in Texas.
So there is within the US also there are different regulation
and of course there is Europe and then this whole global trend to it.
So yes, these are like top challenges.
And then of course.
You know, in the world of diagnostics,
you build it, you build a product and the product tested for something.
So let's just think about a simple blood diagnostic know,
and it came back with an analytical result of trying to do a blood
drive and say, here's your HDL or LDL level.
Well, it's just an analytical result with no clinical claim.
Anyone can do it.
There's no need for a a medical authority to get involved.
Yeah, right, Right.
It actually turns out that even in the US, which is such an advanced country,
we have a very, very large loophole
in the US governance of in-vitro devices.
Ibd's, which is called the Clear Read the Clinical Lab Improvement
Amendment Act, which originated because
doctors and providers
of hospital systems said through agencies,
you can use the agency like an FDA
cannot be telling me that when a doctor takes a blood pressure reading
it somehow just has to be authorized by the FDA.
He's not taking the monitor, reading and making a clinical decision.
But they wanted protection from that.
So they had clear pass through Congress.
It has become this giant loophole in the sense
for labs to say, let us working with a physician
who will interpret the results on behalf of the patient.
Now, take samples, do the analysis, build
a quantitative result, and our physician will do the interpretation.
So, in effect, it's still a physician patient relationship.
There's been a lot of pushback for clear to develop tests
versus IBD tests to the point that the team I mean,
it's this kind of a regulatory hodgepodge
that we are seeing is creating more and more complex issues
for med-tech companies, medical device and diagnostics companies say.
What Like how do we conform with a clear rule for guard bands and studies
versus an FDA rule for I mean, absolutely what you got and what it means?