Medical Design Briefs - July 2023 - 30

with information that may assist them
with the successful development of medical
devices. In addition, the FDA can always
be contacted before an approval
procedure to make preapproval arrangements
and obtain technical assistance.
Currently, the EU has taken a different
approach and has severely restricted all
communication between Notified Bodies
and manufacturers prior to a conformity
assessment procedure. Notified Bodies
are facing the risk of being classified as
consultants and are thus very reluctant to
take a proactive approach to this problem.
The biggest challenges in this context are
uncertainty and lack of transparency.
n " Fail Early, Fail Cheap " - Early
Tests Reduce Risks
What can manufacturers do today to
improve their odds for successfully placing
an innovative medical device on the
EU market tomorrow? One option is to
collaborate with accredited testing laboratories,
which closely follow regulatory
developments and can adjust to the latest
requirements. These testing laboratories
can test products from an early stage of
development. Manufacturers that opt for
such collaboration add certainty to their
future conformity assessment procedure.
Well-known laboratory tests are already
in place in fields such as electrical safety or
biological compatibility. Less known but
equally important is the topic of cybersecurity.
A few accredited laboratories already
offer tests in this area, scrutinizing medical
devices for vulnerabilities. By pointing out
areas in need of improvement, they help
companies avoid having to remedy problems
in the market under high (time)
pressure and in the media spotlight. Future
quality audits of AI systems or their
development in terms of AI quality management
also make good sense and are already
being considered in the EU's AI Act.
TÜV SÜD is one of the few testing laboratories
to offer this kind of service.
Failures that are identified at an early
stage do not hold up the conformity assessment
procedure. Of course, some challenges
will remain, and early testing cannot
eliminate all problems. However, while
manufacturers will continue to face the
challenging shortage of resources in the
regulatory field, every test that is expertly
performed and passed will lead to better
predictability - and thus legal certainty.
This article was written by Martin Witte,
Senior Director Strategic Business Development,
TÜV SÜD Product Service
GmbH,
Munich, Germany. Contact:
medicaldevice@tuvsud.com. For more
information, visit https://www.tuvsud.
com/en/industries/healthcare-andmedical-devices.
Thermoelectric
Generator: Reliable Power for Wearable
Electronics
The TEG continuously
generates electricity from
the sun.
Optica
Washington, DC
Researchers have developed a thermoelectric
generator (TEG) that can continuously
generate electricity using heat
from the sun and a radiative element that
releases heat into the air. Because it works
during the day or night and in cloudy
conditions, the self-powered TEG could
provide a reliable power source for small
electronic devices such as wearables.
" Traditional power sources like batteries
are limited in capacity and require
regular replacement
or recharging,
which can be inconvenient and unsustainable, "
says research team leader Jing
Liu from Jimei University in China. " Our
new TEG design could offer a sustainable
and continuous energy solution for small
devices, addressing the constraints of traditional
power sources like batteries. "
TEGs are solid-state devices that use
temperature differences to generate electricity
without any moving parts. In the
journal Optics Express, Liu and a multi-institutional
team of researchers describe
30
and demonstrate a new TEG that can simultaneously
generate the heat and cold
necessary to create a temperature difference
large enough to generate electricity
even when the sun isn't out. The passive
power source is made of components that
can easily be manufactured.
" The unique design of our self-powered
thermoelectric generator allows it
to work continuously, no matter the
weather, " says Liu. " With further development,
our TEG has the potential to
impact a wide range of applications,
from remote sensors to wearable electronics,
promoting a more sustainable
and ecofriendly approach to powering
our daily lives. "
2 cm
The self-powered thermoelectric generator device
uses an ultra-broadband solar absorber (UBSA) to
capture sunlight, which heats the generator. Another
component called a planar radiative cooling
emitter (RCE) cools part of the device by releasing
heat. (Credit: Haoyuan Cai/Jimei University)
www.medicaldesignbriefs.com
n Boosting TEG Performance
When a thermoelectric material experiences
a temperature gradient, electrons
will flow from the hot portion to
the cold portion, generating an electric
current. Although TEGs based on this
phenomenon exist, they tend to produce
unstable temperature differences
and don't generate enough electricity to
be useful.
To address these limitations, the researchers
developed a new type of TEG.
It uses a component called an ultrabroadband
solar absorber (UBSA) to capture
sunlight, which heats one side of
the generator. Simultaneously, another
component called a planar radiative cooling
emitter (RCE) cools down the other
side by releasing heat. Both the UBSA
and RCE can be applied to a flexible substrate,
which could be useful for powering
wearable devices, for example.
Because the heating power of the
UBSA is significantly greater than the
Medical Design Briefs, July 2023
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Medical Design Briefs - July 2023

Table of Contents for the Digital Edition of Medical Design Briefs - July 2023

Medical Design Briefs - July 2023 - Cov1A
Medical Design Briefs - July 2023 - Cov1B
Medical Design Briefs - July 2023 - Cov1
Medical Design Briefs - July 2023 - Cov2
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Medical Design Briefs - July 2023 - Cov3
Medical Design Briefs - July 2023 - Cov4
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