This is Carly Beam with the Becker Spine
and Orthopedics podcast.
I'm thrilled to be joined today by doctor
Darryl De Lima, director of orthopedic research at
Scripps Health. Darryl, thank you so much for
being here today.
My pleasure. Thanks for the invitation.
Absolutely.
Before we dive into our main discussion, can
you share a bit more about yourself and
your background?
Yes. As you said, I'm a director of
orthopedic research at Scripps Health. I
trained as an orthopedic surgeon in India.
And after I came to The US, I
got a PhD in bioengineering
at UC San Diego.
In my role, I lead an outstanding team
of,
researchers and physician scientists at, what is called
the Shiley Institute of Orthopedic Research and Education
at Scripps Clinic.
We call it SCORE for short.
And,
my employer is Scripps Health, which is,
one of the leading orthopedic surgery
programs in the country and perhaps even the
world.
Excellent.
And I know you you're coming on here
today to talk about smart joints replacement
implants. Can you first just give a
quick primer on what these are and what
and how they stand out compared to other
joint replacement implants?
Right. So my definition of a smart joint,
replacement
implant,
it has to serve at least two main
purposes. First, it has to function like a
regular conventional
joint replacement implant
that would be standard of care for the
patient,
and help them regain function after surgery.
But more importantly and secondly, it also serves
as a research and scientific tool.
So the device would then contain
sensors
and,
telemetry
and a computer system for communication, for collecting
data and transmitting data from inside the patient
to,
say, a cell phone or a
receiving device or even a website.
And, the technology might include things like, you
know, advanced sensors,
a chip for storing data,
and, obviously,
some sort of power supply. Our
first choice is rechargeable power, so it could
last the lifetime
of the, the patient and the implant.
Got it. So it sounds like with these
devices, you're able to access more
patient data than you ever could have imagined
even a few years ago.
Correct. Right. So
we think we usually bring patients to the
lab,
and then we,
you know, we give we advise them on
certain
activities to be done, and then we collect
data while they're performing those actions.
And it's very carefully choreographed.
We have
motions,
motion tracking through video cameras.
We have,
force plate, force sensors in the on on
the floor
to measure the reaction
forces as they walk.
We have EMG that, collects, data from,
from muscle activity.
And then
we then publish this data and say this
is how patients actually perform these activities outside
in the field.
Unfortunately,
that's not what what patients do
in real life.
So
the data that we are collecting in the
lab, in my opinion, is somewhat artificial.
And and
we are hoping with the smart implant that
we will take the lab
and put the lab inside the patient's shoulder.
And therefore, the we will we'll be able
to track and monitor these patients remotely outside,
the lab and get more accurate, more valid
information about how these patients perform, what sort
of activities are they,
are are commonly performed,
and more importantly, which activities
might be risky for the patient
and which activities might be beneficial for the
patient.
Yeah. And I'd love to hear more about
this shoulder research that you're talking about. Can
you share more details?
Right. So,
we're still in the early phases
of this project.
We are developing a laboratory
prototype, which,
initially will just be a benchtop
prototype to make sure all the different components
that I mentioned, the sensors, the computer chip,
the radio, the rechargeable battery, all of them
work.
And then we assemble them together in a
working prototype
that may not be implantable just yet because
we need
FDA approval and human subjects committee approval before
we can implant this in patients, but would
actually function
like an implantable device
and pass all the testing, the structural testing,
the fatigue testing,
the, bio,
toxicity
and biohazard
testing,
that that a conventional implant would have to
pass.
And then
but would not, you
know, might not be, implantable
just yet. So that's our,
present to your plan.
Got it. And
what's been the most challenging
aspect of developing this implant?
That's a good question.
I mean, we divide the the challenges into
the technical challenges, and those are the ones
that I enjoy
solving.
How do we miniaturize
all the components to fit inside,
the implant, and how do we maximize
the performance,
for example, of, the electronics so that,
we require the minimal,
battery,
storage
for charging the implant.
Then the second is the clinical challenges because
we obviously don't want
to put the patients at any risk. And
so that then we have to rigorously test
every component to make sure it's safe to
be implanted in the body. And that's that
can be challenging because, you know, we are
hoping that these implants would last in patients
for ten to twenty years.
At least the life life expectancy
of the patient.
And then the third challenge, which, is not
directly in my control, is the regulatory challenge.
So that is getting
approval from the FDA and the human subjects
committee because
they obviously
want to protect a the patient population at
large.
And, any risks that they perceive, we would
have to satisfy them that those risks are
acceptable.
And do you have a rough timeline of
when you hope to see this implant being
tested in patients?
Yes. So I do have a timeline, although
it can be a moving target because,
regulations
on
so called,
implantable electronics keeps changing.
There's also now additional risk,
that might,
that we'll have to resolve things like cybersecurity
because this data is being transmitted and it
contains, you know, patient information.
So our present time line is at the
end of two years, we'll hope to have
an implantable,
a design of an implantable product prototype.
In the meantime, we would partner with an
implant manufacturing
company.
Neither script sales nor I want to actually
manufacture
these implants.
And then in partnership with the implant manufacturing
company, we would then apply for FDA approval
initially just to do a research,
trial.
But if there's any commercial
benefit
of having of actually,
selling the smart implant because,
patients might want them because now they can
track the activity
and also get feedback
about what activities they should be performing and
what activities they should be avoiding.
So that yeah. The second timeline is probably
more, like, five years.
Okay. So so relatively
in the near future.
And I know we've seen,
the smart implant technology for knee replacements.
Why is it important to focus on the
shoulder for this particular implant?
Right. I mean, that's, you know, a very
good question because when we worked on the
first the world's first knee implant, which doctor
Caldwell
from Scripps Clinic had implanted,
twenty years ago. And at that time, we
didn't know much about knee biomechanics, and we
were designing
implants. By we, I mean,
the the field of, joint replacement for knees,
and not me personally. But,
the field was designing joint,
implants
and then having to wait until these were
surgically implanted in patients and then
and then fixing any problems that,
that arose from the new design. And that
cycle was just too long, too expensive, and
too risky for patients. So
our goal at that time was to actually
track the activity and the forces
in vivo so that we could more intelligently,
design,
knee implants. And that was, you know, very
successful. We won, you know, several awards for
our
research efforts.
We did not commercialize that, that smart implant
because we felt that it was mainly a
research tool just to get information to help
the industry develop better designs.
But in the shoulder, it's actually much more
complex than the knee, And we know less
about the shoulder than, than we know about,
knee replacement.
And it's actually the number of shoulder replacements
in The US is rising,
dramatically.
And so we
need to
collect
information that would,
that would raise our understanding of shoulder biomechanics.
And then not only benefit
the benefits, I think, are fairly broad. One
is benefiting me as a scientist because now
I know more about the shoulder, know more
about the biomechanics,
and we increase
the the value of shoulder biomechanics in the
field as a whole.
The second benefit is to implant manufacturers.
They can now design better implants because now
they know what forces and activities
the patients is going to, undergo after surgery.
The second benefit is to the hospitals and
surgeons because
surgeons can now
optimize or change their surgical technique because
we can then provide them with
our
intraoperative
alignment of the implants actually
relates or is associated with or predicts postoperative,
function.
So they can place these implants to say,
for example, improve range of motion
after,
after surgery or
increase the longevity of the implant by placing
it in a position that's less less risky
to the patient.
The third benefit is to the patients themselves
because now they can get feedback during rehab,
and rehab is a
continuous process. So what we tell them on
month one will change by the time they're
in month,
ten or at the end of the first
year.
So they can be now told in a
very granular fashion and intelligently
and more important patient specific.
So someone,
you know, who is very active,
might need a different rehab protocol versus someone
who's who's
was relatively inactive or had
a bad,
arthritis of the shoulder and therefore would have
to be much more careful
in, easing into the rehab and recovery
phase of the the surgery.
So it sounds like a real win win
win for
everyone.
And then I was wondering, you know, do
you think the smart shoulder implant
technology will eventually become the standard of care
for patients in the future?
So that is my hope,
and, I just don't know how long it
will take because
the two
the two unknowns for me are the cost.
If if we can,
if we can commercialize smart shoulder implants without
increasing the cost, then, yes,
I'm optimistic that would become standard of care.
And, the second reason why I'm optimistic is
that these implants
we we implant hundreds of thousands of patients.
So we have this opportunity of putting in
sense
sensing technology and,
wireless communication technology, which also is going to
improve over the over the future. So as
that technology matures,
we will be able
to investigate
far more than just musculoskeletal
biomechanics, which is my expertise. But, for example,
let's say we can now track we can
put dye, glucose sensors and track diabetic,
you know, response to diabetic treatment, or we
could put in motion sensors that can actually
track neurodegenerative
disorders and
predict fall fall risk.
So I'm optimistic that this will happen. I
just don't know when because it's a combination
of of,
business,
the business environment,
the regulatory environment,
and
the
risk benefit ratio.
If the mag as we keep improving the
magnitude of the benefit to the patient,
then I I believe more and more patients
will adopt us and surgeons will adopt us,
and then it'll eventually become standard of care.
Absolutely.
And then I was wondering what other orthopedic
technologies
you're keeping your eye on right now.
Right. So my lab is pretty diverse, and
what I'm particularly proud of is that we
have a very multidisciplinary
team of scientists, engineers,
computer programmers,
physicians,
and, biomechanical,
researchers.
And so
within
what we call score, we do,
the entire range of orthopedic research from,
discovery in the lab to
translational.
That means testing it, before it's ready for
clinical use to actually implementing it and following
patients after,
the the technology has has become clinically relevant.
And so the other area that we're working
on so I
my training wasn't, joint replacement,
but the areas that we are working on
is actually
what's next after joint replacement. So we're trying
to treat patients
before they need joint replacement and either delay
or perhaps even remove,
the need for, joint replacement.
So in that, we have several projects that
we are working on, and one is for
knee for example, for knee arthritis,
we are growing bone and cartilage in the
lab.
And,
we think that we we can
if this makes it to the clinic, we
then will be able to treat patients that
have got bone and cartilage lesions
in the early stage of arthritis,
which we don't have,
right now. We don't have a treatment portfolio
for these patients right now that's very consistent
and works in all patients.
And if that works, then perhaps these patients
may not need a joint replacement in the
future. Otherwise, in today's technology, they will end
up needing joint replacements.
We're also working on the meniscus,
growing the meniscus. That's another unmet need. There
is no clinically approved meniscus replacement,
which, works and prevents, arthritis in the long
term. And on the shoulder,
same applies to rotator cuff repair.
It's a very common injury and especially in
older patients with large tears.
Even after surgery, they don't heal.
And so we're growing what we're calling bio
tendons
in the lab to enhance the recovery.
And we're also dabbling with something called bioprinting.
Mhmm. We can print live cells and tissue,
and we can keep these tissues alive in
the lab.
That's a very optimistic goal and is a
very, very long term project because
our objective is not just printing tissues in
the lab
with the hope of implanting them.
We want to take the bio printer to
the Operating Room and actually print inside the
patient's body.
If we can do that, then
we not only customize the treatment for patients,
but we're also printing living tissue, which
theoretically
is has got a potential
to
to live the life of the patient unlike
artificial materials, which, might break down.
Absolutely fascinating.
And that's all the time we do have
for today. I wanna thank you for joining
us on the podcast. It's been a pleasure
speaking with you, doctor Dilemma, and I look
forward to connecting with you again in the
future.
Thanks very much, Carly. Appreciate the opportunity.