FDA Direct, Ep. 10: An Eye on CDRH: Regulating for a New Era of Medical Devices
Michelle Tarver. Great to see you.
Great to see you.
CDRH Head at FDA.
So tell us what is CDRH?
And tell us about something
that just came out out of CDRH recently.
So our Center regulates
all medical devices that are used
in the diagnosis, management
and treatment of medical conditions.
And in fact, you probably just heard
in the news that we just brought on
to market a device
that is used to diagnose Alzheimer's.
There it is.
Yeah.
Big time news.
Yeah.
And it moved from a device
that was previously used in this
to take spinal fluid
and test it for certain types of proteins
to now being able to have that available
by looking at people's blood.
So accessible to more people.
And it also helps with the population
where it may
very, very much be difficult
to get samples of spinal fluid from them.
So it really opens up the opportunity
of diagnosing earlier
and changing health care outcomes.
And as we get earlier treatments,
maybe it could help
open a window
to start intervening earlier.
Absolutely.
So, CDRH, first of all, did you come up
with that acronym for your Center?
Because it's kind of a funny acronym.
It predated me. I'll just say that.
Center for Devices and Radiological Health.
Correct.
We may want to.
Yeah. So
yeah, we need a better name for that
or a shorter roll off the tongue.
Have you thought about newer or better
different names
for the center? You're probably like
I wouldn't want to have this conversation now.
I'll pass on that.
How about I take a rain check
and come back later?
Center for Device Innovation.
I'm just floating it out there.
How about Medtech Innovation?
Ooh, I like that. Touché.
Good.
Because there's a lot of innovation
you're overseeing, right?
So it's not just
the Alzheimer's diagnostics,
but there's a range of devices,
the traditional ones
we think about in hospitals.
But are there more consumer facing devices
as well?
Absolutely.
I mean, I think one of the first steps
we took at the Center for Devices is the,
the continuous glucose monitors.
And you may
really know about that technology.
Amazing.
Because it changed how we manage
diabetes in this country.
I mean, it went from working
with companies,
having a conversation about
can we work on interoperability?
Can we make it more accessible to people?
And each decision that we make.
And it opened it to type one diabetics
then to type two diabetics.
And now it's available over the counter
for many people to use.
Really transforms
how we look at metabolic management.
I mean, it's amazing
the same food will cause a different
insulin spike and sugar
spike in two different people differently.
So the only way to know
how you're going to respond to
sushi or,
coconut water or whatever it is
you like to eat in the course of a day
is to have a continuous glucose monitor
or stick yourself, which nobody is
Is that you had for lunch
today. That's top of mind?
It is in our beautiful cafeteria.
I just, over the window here.
But I mean it
It's really
the ultimate in patient empowerment.
I mean, there's a lot of things
that empower patients
with good information or people, humans.
But that is that is really an amazing
revolution in health now,
because for the first time ever, people
are educated on their glycemic
index, can track it
and can follow it over the course of days
and peg it to certain foods
so they can learn, hey, this food's
not really good on my pancreas.
This food is softer on my insulin levels,
so it's pretty amazing.
I think your point about giving people
the information they need to make informed
decisions is critical.
I mean, it's something that has driven
our center for years
because we know
that if people have that information,
they can make some really good decisions
about their health care
and help empower them
to have a more fluid conversation
with their health care provider,
which is part of what
we were supposed to help offer.
So how did a renowned ophthalmologist
from Johns Hopkins
get involved in devices?
Well, devices are our bread and butter
in ophthalmology.
We're surgeons.
Right.
And surgeons like to be able
to make accurate diagnoses.
So the devices
that are coming on the market
that allow us to get more precise
into diagnosing conditions,
that's right in our, in our wheelhouse,
the tools that are using in the operating
room, right in our wheelhouse.
And so all of that is what we bring
to the table at the Center for Devices
and Radiological Health.
So it's a natural fit.
And then, you know, I come from a long
line of public servants, and this was,
a merging of two passions
science, medicine and public service.
What kind of public service
was in your family?
My my dad was in the Navy.
My grandfather served, both of them
served in World War two.
Oh, wow. Where?
And so, and in France and so, you know,
we've got a long history that. I have
siblings who have served in the military.
And so that is part of who we are.
I was raised on the sentiment
of being at a service to this nation.
So I'm here for that. Yeah.
That's awesome.
So, you know, when I got to know you,
when I started here, you know,
I asked you,
you know, you've seen a lot across
this agency, a lot of innovation,
the technology side, consumer demand.
But I know that the Commissioner
has been asking everyone, you know,
what are things you're wanting to do
or be thinking about going forward
that you haven't really had the space
to do before?
Big ideas. We love big ideas.
Yeah, I got them.
And we'd love Michelle Tarver.
I will say, you know, one of the things
that you've probably heard me
talk a lot about, which is ways to bring
health care home, I mean, we have seen
that people who are living with
chronic diseases account for about $
trillion of our health care expenditures,
according to the CDC.
It's % of all health.
It's extraordinarily high.
And a lot of that isn't just
how do you manage the disease?
We're mainly seeing people in clinics just
to make sure something's not appearing.
If we could bring that ability for people
to make that decision home
where they're more likely to do it,
wouldn't
have to worry about missed clinic visits,
and we can get ahead of the condition so
that we can improve health care outcomes.
I mean, that's a wonderful opportunity
and that we hope, medical devices
will pave the way for that to become
a reality for more and more Americans.
And so that is one of the efforts
that we are working on right now.
How do we help foster and create
a predictable pathway for that to happen,
so that people who live in rural South
Carolina, as well as people who live in
New York
City, will have at their fingertips
in their homes devices
that can help them figure out
whether or not they need
to see their doctor, help them manage and
and control the measurements they're getting
in their devices,
as well as intervene at a time
where we can actually make a difference
without having to hospitalize them.
It is kind of cool.
I mean, you're at the center
of moving the hospital
and health care setting into a home.
I mean, if you think about it, the reason
that we kept patients in the hospital
for crazy amounts of time,
I mean, people used to stay
in the hospital after cataract for, what,
like two weeks or something like that
after cataract procedure.
And what were we thinking?
We were thinking, well, it's
good to have eyes on them.
Right.
And but we can still do that now
in the home
setting in certain circumstances
and reduce the risk of somebody
waking up in the middle of the night
and having to step up to go
to a little bathroom that they're
not familiar with at a high fall risk
wearing some kind of crazy funny slippers
we give them or
they get an infection at the hospital
that is not, present in the home setting.
Right?
There's no succumbing to infections.
So, I mean, we're starting to realize that
with good devices, sensors, cameras,
other
things that can monitor an individual,
you can actually move
some of that care to the home,
and you're really at the forefront of it.
And we're trying to help accelerate it.
I mean, as you said,
there's a rich opportunity here
for us to make, an indelible impact on cost
as well as potentially integrating care
in a way that is more holistic.
And that is what we're hoping
to help facilitate.
We have created a virtual reality
prototype for the medical device industry
to say a lot of the people who are doing
R&D never see a patient's home.
They don't know what that experience is
like. By them putting on the headset
we've had some of the industry members
tell us that is what we're working with.
We're designing for this space,
for this experience, and it really does
put it into context that they can provide
or develop a solution
that actually meets the people
where they are,
and is more likely to be used by them.
So we're really excited about it.
We're having a lot of conversations
and wanting
to bring all those components together.
But we also talked about payment.
I mean payment is such a big part
of helping to foster innovation.
And when you have a predictable
reimbursement and payment,
at the back end, it helps to encourage
front end development.
How are you thinking about that
given, you know, we have
a very particular purview of what we can
and cannot do as relates to payment.
Well, you know, in our last user fee
negotiations, we talked about
how do we help make that pathway
to commercialization more predictable?
What is the evidence that the payers are
going to need to make a coverage decision?
What's the evidence that a provider
is going to need to say,
yeah, I'm
going to adopt this into my care.
And then what kind of information does
a patient need to say, okay,
I raise my hand, I'll take that.
And so we said let's ask them at the time
when you're developing your study
that you're going to collect
for your pre-market device,
talk to the patients,
talk to the providers, talk to the payers,
get a sense of what kind of things
they want
and incorporate that
in your clinical trial at the inception,
so you're more likely to have the data
you need by the time you get through
the regulatory process,
so that you're prepared for the payment,
processor, payor for the care,
preferred practice conversations.
And that is what we've been working on
through our Total Product Life
Cycle Advisory Program called TAP.
Oh, love the efficiencies there.
So that's a better name right.
TAP, yes. Yes.
Yeah it is.
And so how about kind of internally you
talk about a lot of external innovation.
But internally
I know you're also modernizing
a lot of the how the team works.
And you know we've been talking about ELSA
a lot in previous conversations.
Oh yeah.
I know I've heard
from some of your medical officers
that they're having fun learning it and,
you know, generating different prompts.
How's that going within the center?
You know,
we love new innovation in our center.
So, they couldn't
wait to get their hands on it.
Oh, yes.
And it's really been used already.
A number of folks have started
looking at it.
Can they identify opportunities
to take notes in meetings?
I mean, one of the tasks that we have
is that we have to document
a lot of our interactions.
Can ELSA generate the summary from the
transcript of the meeting minutes.
And it has been used successfully
to do that.
We're having,
folks use it to find guidance documents
that can help them, as they're looking
at their reviews, to look at standards
that a sponsor may have been using to show
that this test method works.
Well, the standards documents
sometimes are huge.
Can we just look at it, summarize
what it says in the section,
give me a reference where it is,
and then I can put it in my review.
Creating tools
that help the reviewers move through
that review process more efficiently
and effectively helps to prevent burnout,
and can really help move the process
forward.
Being a reviewer is hard work.
Oh, absolutely.
And they're they're incredibly devoted
folks.
I mean, they are, top notch scientists,
clinicians and
and statisticians, and they
show up
for long, long hours, really,
to make sure that these devices
get to the hands of the US public
as quickly as possible when they're shown
to be reasonably safe and effective.
It's amazing.
Yeah, I've been impressed with everybody
that I've met.
And so,
the ELSA tool is going to be,
augmented and ELSA
if I don't know
if that's the official name for it,
should be released
by the end of the month
and it'll have access to more information.
I think PubMed
is all going to be encompassed with it.
And so the greater body
of the medical literature
and look, whatever the reviewers
need to do their job well,
we want to be able to help innovate,
to provide better tools.
But we've been tracking
the number of unique users of the
AI tool ELSA here at the FDA,
and people are using it.
I mean, it's optional, it's voluntary,
but we've got thousands of daily
unique users within the agency staff
who are using it, so
people must be finding value in it.
Yeah, I agree,
I think it's definitely a huge appetite
for things that can help make their work
more efficient.
So.
Right.
So what are you most excited about
as you think about the
the next few months ahead?
She's always excited.
I know.
I learn something every time.
I mean, I think,
I think the, the possibility of data
and the more that data
can be unleashed to help inform
not only our pre-market processes,
but also help us with our post-market
evaluation of products.
I think it's really exciting.
I think there's a lot of things
kind of cooking
that I'm looking forward
to seeing come, come to life, and,
and that I think
is going to be important.
The one thing that I always come back to
with data is good quality data.
You know, and you probably have heard us
talk about the challenges
we've had with some data integrity issues,
for different,
test labs, in China
that we've gotten and other countries
as well
that have submitted to us and those,
you know, that information is hard for us
to make an informed decision about the
safety and effectiveness of medical device
if we can't trust the data
that's informing that decision.
And so quality data is important
across the board.
Got to have good data.
Absolutely.
Or else it's,
unfair to people who trust our brand.
And I, I do believe the FDA is
one of the greatest brands in the world.
Agree.
And so when people look to that brand,
we need to be able to,
you know, vouch for standards
as much as humanly possible.
Right.
We're not watching the researchers,
you know, pull a chair up alongside
their desk and watch them do their work,
you know, every single day. But,
at the, you know, the researchers
who are submitting data, so, I mean, we
we do our best.
Yeah.
I think there's a lot of opportunities
in data. To your point.
You know, we've talked a lot
about just streamlining,
even how we collect and measure that data.
So you can see more of these relationships
because it's such a clunky
reporting system
for the post-market monitoring.
And so it'll be exciting
to see how we work through that.
Yeah. Looking forward to it.
Definitely looking forward to that.
One last question.
How do you think about
breakthrough designations?
It seems to be a,
an exciting sort of leap forward
within CDRH, within your center.
And, I've heard
a lot of enthusiasm around it.
Can you just tell me how you think?
Think about breakthrough designation?
Yeah, breakthrough
designations are in our law, right?
And it came about,
I think, during st Century Cures
it came out as a provision of that,
where it allows for novel technologies
that are going to be life
saving, life sustaining,
to come to market with a little bit
well, to come to market with a little bit
more interactions, a little bit
more attention
and prioritization by our reviewers
if they meet certain criteria.
And some of those criteria include
there's no other alternatives like that
right there in the, in the,
in that particular condition to treat it.
There is not it's a new technology
that we've never seen before
and that it offers benefits to patients.
And so that is something
we can all get behind.
Right.
How can we help accelerate those solutions
should they be shown
to be reasonably safe and effective?
And I will say that the standards for the
evidence that we need is not compromised.
It is still the same bar,
but it allows for more frequent
interactions to help expedite
the questions being addressed
in a more timely way
so that it can get into the hands
of the patients and providers
that need it more quickly.
Great.
And that's come up a lot in the CEO
listening forums, too.
And so I think that that's people
are really, appreciate
that frequent communication.
Yeah.
Yeah. We did a, listening tour.
We're in the middle of it
nationally with pharmaceutical CEOs.
We'd like to do,
we'd like to do one with device CEOs.
To complement the visit
I did to the AdvaMed Board
where we,
we heard from a bunch of, industry CEOs,
we have to be able to learn
and get ideas from industry and people.
You know, some people
think there should be this firewall
where we don't interact with industry.
We don't believe that.
We think that we've got to have a user
friendly process.
We serve the American people,
and that means American businesses
and any developer that has a product
that wants that FDA seal,
we have a process,
there are user fees for it.
And that process is such
that they send us an application
and we make a determination
about safety and efficacy.
So, keep up the great work.
Michelle, it's great to have you.
It's great to work with
you here at FDA and, anything else?
Sanjula, you can think of?
No. I mean, I wish there was more
you could share with us publicly
without disclosing products. I bet you see
a lot of cool technology in the pipeline.
So we're excited to, to see,
what's to come.
I thought you were going to say
I wish you were a Baltimore Ravens fan.
But she might be like,
Yeah, I am.
There you go.
Got it.
I'm a Bucs fan,
so I can't relate, but
It's going to be great.
Yeah, thanks Michelle.
Thank you. Thank you both.
Great to see you.
Likewise.
All right folks,
thanks for listening to our conversation.
And we'll do it again.