Medical Design Briefs - January 2022 - 10

Inside the OEM
Ensuring Quality
M
edtronic requires its suppliers to " develop and maintain highly
capable processes that produce quality products and services, "
and specifically details the expectations it as of its suppliers
on its web site. It has even put together a 34-page " Supplier
Quality Excellence Manual " that can be downloaded. Medtronic says
is considers its suppliers to be " a key partner in our pursuit of quality
for our customers, and the patients who depend on our products and
therapies. "
As part of that commitment to quality, Medtronic is actively
involved in MedAccred, a program designed to ensure critical manufacturing
process quality throughout the medical device supply chain.
Administered by the Performance Review Institute, MedAccred offers
device OEMs value because it conducts rigorous audits of critical
processes deep within the supply chain.
" As a leader in the medical device industry, Medtronic is strongly
committed to the MedAccred program to drive improvement in proding
app-based monitoring has shown increased
adherence to their doctor's guidelines. "
According to a study published in Heart
Rhythm O2, adherence increased from 77 percent
to 95 percent when patients switched to
the mobile app from bedside monitors.
" Smartphone and app-based technology is
constantly evolving, and consumer preferences
and our technological landscape is
changing as well, " said Meissner. " Especially
with the pandemic, patients want these new
options
and
new
ways
of monitoring.
Convenience is important, and so is
easy-to-use interfaces that get patients
the information they need (in order
to know that everything is working
properly) and the information they
want so they can be in control of their
lives and health. At Medtronic, we are
always working to further enhance
our patient mobile app. App-based
monitoring is available across our
entire cardiac device portfolio. "
Meissner said that remote monitoring
technology such as wearables and
new smartphone apps will continue to
grow and be available to monitor,
diagnose, and even treat various
health conditions. He said patients
want more personalized solutions so
that they and their health teams can
make a care plan that is incredibly tailored
but also can give each individual
patient the level of feedback and
information they are looking for.
" We've seen this sort of customization
and personalization in other
aspects of our lives and technology,
so it only makes sense that it is
applied to heart devices and the
10
Cov
uct quality, and most importantly patient safety, " said Connie Conboy,
director, MedAccred. " Medtronic is actively involved in the
MedAccred Management Council, along with many of the strategic
subteams and technical task groups and has championed this transformational
approach to critical manufacturing process supply chain
oversight. "
Medtronic " is really about looking at special processes [in which]
we can't detect defects either through receiving inspection or even in
manufacturing inline inspection, " Ann Sheldon, vice president, product
security and former vice president of global supplier quality noted
about the program during a session at MD&M Minneapolis in 2019.
" A lot of times we will see latent failures that are process related and
undetectable. So, this will go in and look much deeper at a process
than we would through any sort of a QMS audit and be able to show
the repeatability of the process and the materials we'll be getting.
For more information, visit https://p-r-i.org/MedAccred.
patients that use them. And at Medtronic, we
are continuing to innovate in order to constantly
enhance the patient experience. "
Investing in People
" We've instilled new cultural traits, including
acting boldly, competing to win, moving
with speed and decisiveness in everything we
do, and getting results with getting them the
right way, " said Martha. Medtronic, he said,
has spent a lot of time deploying capital and
thinking about how to do that through investments
in organic R&D as well as disciplined
M&A to leverage its balance sheet. And then
there are the people.
" Employee engagement at Medtronic is at
the highest levels we've ever had. I think
they're excited about this new approach and
the aggressiveness, but they're also excited
about our pipeline, " said Martha.
Meissner said that, for him, working with a
team that supports such important work as
remote monitoring technology has given him
the privilege to see how it can directly help
patients live better lives.
" Throughout my career, I've
watched the medtech field evolve,
but I see the potential for further
innovation to manage various health
conditions with technology. I think
that this technology has and will
continue to be incredibly relevant
for improving response times and
saving lives when a transmission
indicates that a heart device patient
needs immediate attention, " said
Meissner.
" The patient and their care team
can act fast to remedy the situation,
which is something that, not all that
long ago, wouldn't have been possible.
In the early days, patients
received no feedback on their transmissions
until they went in to see the
doctor. That's clearly not the case
anymore; by growing this technology,
we will positively impact even
more lives. "
This article was written by Sherrie
Azure™ is enabled with BlueSync™ technology, allowing for tabletbased
programming and app-based remote monitoring. These
devices include exclusive algorithms to manage atrial fibrillation (AF)
in pacemaker patients. (Credit: Medtronic)
www.medicaldesignbriefs.com
ToC
Trigg, Editor and Director of Medical
Content. She can be reached at
sherrie.trigg@saemediagroup.com.
Medical Design Briefs, January 2022
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Medical Design Briefs - January 2022

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