Medical Design Briefs - July 2021 - 4

FROM
THE EDITOR
Medtronic's Carol Malnati Talks
about the Future of Remote
Cardiac Device Monitoring
M
illions of Americans
with irregular
heart rhythms
are leading full lives
today, thanks to Medtronic
implanted cardiac
devices and remote
monitoring capabilities
- including implantable cardioverter
defibrillators (ICDs), which
Carol Malnati was instrumental in developing
as a product development engineer
earlier in her career.
An active and honored member of the
Society of Women Engineers, today
Malnati is vice president, Cardiac Im -
plantables Technology Development
Center at Medtronic, where she leads
R&D and engineering efforts for the
Cardiac Rhythm businesses. Medtronic is
among the world's largest medical technology,
services, and solutions companies
- alleviating pain, restoring health, and
extending life for millions.
In 2020, we saw a flood of medical
news on the growing use of telemedicine
- and more specifically, how cardiac
arrhythmia patients were relying on
remote monitoring technologies during
the pandemic. Was the pandemic a catalyst
for this technology?
We saw a dramatic jump in usage of our
remote monitoring solutions for cardiac
devices. The majority of our implantable
electronic heart devices are supported by
advanced Internet-based remote monitoring
technology. And, our remote monitoring
capabilities were a game changer for
patients and healthcare providers during
the global pandemic because these solutions
enabled routine device checks to be
completed remotely from the patients'
homes rather than requiring them to
come into the clinic and potentially be
exposed to the coronavirus.
Specifically, in 2020, we saw a 116 percent
increase in CareLink Express
mobile placements. CareLink Express
mo bile uses a tablet to check a patient's
cardiac device in a variety of healthcare
settings (e.g., emergency rooms, operating
rooms, procedural areas, hospital
nursing floors). The COVID-19 pandemic
created a skyrocketing usage of
remote monitoring, with more than
1,700 new patients being added to our
4
Intro
Cov
CareLink Internet-based remote monitoring
network each day.
We saw this as a moment - for physicians
and patients - that underscored
the value of digital healthcare. In the case
of remote cardiac monitoring, it meant
being able to record timely device and
physiologic data - and to send that data
securely over the Internet to the patient's
healthcare team. It not only kept countless
cardiac patients out of the ER and
helped them avoid in-person clinic visits,
but it also helped limit use of personal
protective equipment (PPE) and freed up
hospital beds for critical-care patients.
Today, not only can we receive data on
patients' cardiac functions, but we can
actually reprogram some device settings
from afar, such as for patients who are
undergoing MRI scans, as well as remotely
reprogramming our newest insertable cardiac
monitor (ICM), called LINQ II™.
This means we can provide technical support
without having our field personnel in
the same room - again, reducing exposure
and saving valuable time for patients
and healthcare providers.
From the perspective of a product development
engineer, would you say it's been
a steady evolution of the technology design
and applications to get to this point?
Looking back on the past few decades
of our development process, it seems
inevitable that we'd have remote monitoring
systems that are this functional,
intuitive, and reliable today.
But you could say there were
three primary make-or-break
technology developments
that paved the way: 1) access
to the internet and eventual
cloud connectivity, 2) the proliferation
of consumer electronics
and Bluetooth communication
technology, and
3) advances in sensors and
diagnostic technology.
In parallel with these
advances, we also benefited
from refinements in microelectronic
circuitry, increased speed of
data transmission, and a recognition of
the importance of user-experience de -
sign. Medtronic continuously fueled prog -
ress by investing in specialized engineering
expertise in systems architecture, software
design, and human factors.
The first technology enabler - the
Internet - allowed patients' devices to be
remotely monitored. And even in the
www.medicaldesignbriefs.com
ToC
+
-
A
1990s, long before Google was a household
name, we had a bold vision of managing
cardiac device patients utilizing the
Internet. We began working with the FCC
in 1999 to dedicate a frequency band for
medical device transmissions, known as
MICS in the U.S. and MICS/MEDS elsewhere
in the world. We also built a secure
back-end system to protect patient health
information, clinician-facing websites and
in-home patient monitors.
By 2002, we had launched our first cardiac
remote monitoring system in the U.S.,
called the CareLink network, and within a
few years began seeing significant gains in
patient adherence and health outcomes.
The second technology advance was
around the proliferation of consumer electronics,
which meant we could finally meet
patients where they were - instead of
requiring them to come to the clinic or
hospital. Bluetooth® technology and modern
mobile consumer electronics were still
in development when we identified the
need to pivot from our proprietary telemetry
to an open, but protected, platform.
But the first iteration of Bluetooth
wasn't well-suited to medical applications;
it didn't meet our security standards, and
it drained batteries too quickly. That
prompted our engineers to develop something
we called BlueSync™, which uses a
low-energy form of Bluetooth and solved
both of those problems.
After rigorous testing for reliability
and security in real-world conditions, we
implemented BlueSync across
our entire family of implantable
devices, which required a
complete changeout in electronics
and firmware and a
whole new mechanical package.
Now more than 365,000
patients across 35 countries
experience the ease of BlueSync
monitoring.
What direction are you seeing
in remote monitoring technology
today?
It was a huge breakthrough
for patients in 2017 when we could monitor
their pacemakers via smartphone,
instead of a bedside monitor. Today, 25
percent of patients use their smartphones
and a Medtronic app as their
heart monitor. And with app-based monitoring
comes significant increases in
patient adherence to their doctor's
guidelines - we saw an increase from 77
percent to 95 percent when they
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Medical Design Briefs - July 2021

Table of Contents for the Digital Edition of Medical Design Briefs - July 2021

Medical Design Briefs - July 2021 - Intro
Medical Design Briefs - July 2021 - Cov4
Medical Design Briefs - July 2021 - Cov1
Medical Design Briefs - July 2021 - Cov2
Medical Design Briefs - July 2021 - 1
Medical Design Briefs - July 2021 - 2
Medical Design Briefs - July 2021 - 3
Medical Design Briefs - July 2021 - 4
Medical Design Briefs - July 2021 - 5
Medical Design Briefs - July 2021 - 6
Medical Design Briefs - July 2021 - 7
Medical Design Briefs - July 2021 - 8
Medical Design Briefs - July 2021 - 9
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Medical Design Briefs - July 2021 - 40
Medical Design Briefs - July 2021 - Cov3
Medical Design Briefs - July 2021 - Cov4a
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