Medical Design Briefs - July 2023 - 29

switches that are predicted to be excellent
protein sensors, and then we tested
them. Our design algorithm is called the
Riboswitch Calculator. "
Salis and the researchers tested their
new technology to detect three proteins:
MS2, a small protein found in a bacterial
phage, as a proof-of-principle test; and
the medically relevant biomarkers human
monomeric C-reactive protein and
human interleukin-32 gamma. The researchers
engineered 32 riboswitches,
most of which successfully sensed their
target proteins.
" Current assays require expensive
detection reagents, expensive and
bulky instruments, sample cold chain
storage and distribution, and trained
personnel, " Salis says. " By applying
modeling and computational design,
we engineered low-cost protein sensors
that can be freeze-dried and rehydrated.
The next step is to develop
an easy-to-use device that allows researchers
and clinicians to use this
new technology. "
Salis is also affiliated with the Penn
State Institutes of Energy and Environment.
The Defense Advanced Research
Projects Agency and the Air Force Office
of Scientific Research supported
this research.
This article was written by Ashley Wenners
Herron, Penn State University. Contact:
Howard Salis, at salis@psu.edu. For
more information, visit www.psu.edu/news.
Artificial Intelligence: Making Innovations Fit for the MDR
Early testing reduces risks
associated with new
technologies.
TÜV SÜD
Munich, Germany
Thanks to artificial intelligence (AI),
augmented reality (AR) has long shaped
product development across a variety of
areas, including the medtech industry.
Use of these trends can significantly improve
diagnostics and, therefore, treatment.
This applies, for example, to surgery
and to the adjustment of medication
regimens to reflect the patient's needs.
To do this, medical practitioners use recommendations
provided by AI, which in
turn draws on a broad digital database.
Increasingly small and
energyefficient
sensors are contributing to this
and deliver a constant stream of information.
They can be worn close to the
body and monitor various body functions.
Smartwatches already offer a host
of these measurement options.
Tiny sensors, implanted into the body,
take the process one step further. They
use specific measuring techniques to
monitor all body functions.
First products of this type are now
used for conditions such as cardiac insufficiency
by permanently monitoring
the heart rate. Similarly, sensors are already
in use that continuously measure
blood sugar levels in diabetes sufferers.
In both cases, the goal is timely initiation
of appropriate measures to prevent
the patients' condition from worsening
or potentially turning life-threatening.
Other products monitor bone healing
after fractures to provide individualized
therapy.
Medical Design Briefs, July 2023
n Challenges: Data Protection and
the MDR
Manufacturers developing these types
of products need to consider a host of
different aspects. First, they need to ensure
compliance with data-protection
regulations: Data must be stored and
processed safely and protected from access
by unauthorized parties. And manufacturers
must also answer a question
that constantly arises in connection with
AI: are the AI's decision-making capacity,
accuracy, and correctness ensured? In
this context, problems can arise if validation
data sets lead to bias in AI. In preparing
its Artificial Intelligence Act (AI
Act), the EU is currently working actively
on legislation. The requirements of the
AI Act are likely to make the already extensive
regulatory acts that govern medical
devices even stricter.
Five years ago, the Medical Device Regulation
(EU 2017/745) replaced the
Medical Device Directives (93/42/EEC
and 90/385/EEC) that had previously
applied. Ever since, there has been a simmering
debate over whether the provisions
of the MDR are supportive of innovation
or hostile toward it. Is the MDR's
improvement of patient
safety based
merely on the status quo, or does it also
permit innovation? While this question
cannot yet be answered conclusively, initial
indications show that companies first
tend to introduce their innovations in
other markets such as the USA. The FDA
has set up numerous programs to provide
manufacturers as early as possible
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. (Credit: wladimir1804/AdobeStock)
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Medical Design Briefs - July 2023

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