Medical Design Briefs - September 2021 - 36

■ Staying One Step Ahead
EU-based manufacturers and UK im -
porters are likely to see an uptick in ad -
ministrative tasks relating to importing
and exporting medical devices along
with associated costs. Most importantly
of all, however, they will need to manage
their internal resources efficiently. Fur -
ther practical issues within the supply
chain may emerge after June 2023 once
the CE mark is no longer recognized,
making it vital that all parties are clear
on the implications of any new procedures
and controls. Close contact with
the relevant regulatory authorities will
help businesses stay ahead of the emerging
situation and of the competition.
As the deadline for UKCA marking
draws near and more and more businesses
start submitting their UKCA documentation,
common pitfalls are likely to
begin to emerge. At the same time, the
MHRA and UK Approved Bodies will
most likely provide new sets of clarifications
and guidance, making it critical for
manufacturers to always keep abreast of
new developments. The MHRA has
already published guidance on some
aspects of clinical trials that are another
important area of attention for manufacturers,
especially when these are carried
out across multiple EU and non-EU sites.
Some additional key areas to keep
under review include newly listed UK
Approved Bodies, implementation of
policy advice from the Cumberlege
Review, potential fast-track conformity
assessments for CE-marked devices, liability
insurance issues, the publication
of new versions of standards listed as
designated standards, labeling guidelines,
documentation, and data
exchange protocols, as well as any
emerging UK-EU equivalency. The volume
of work required to ensure compliance
across countries and in such a
dynamic environment is clearly high,
but thorough planning and relying on
past experience for EU MDR and IVDR,
medical device businesses can rise to
the challenge effectively and perhaps
even realize unexpected commercial
objectives.
This article was written by Ed Ball, Senior
Associate, RQM+, Monroeville, PA. For more
information, visit http://info.hotims.com/
79417-346.
Optical Device Offers Improved Thyroid Cancer
Screening
The device combines near
infrared light, time
resolved spectroscopy,
and diffuse correlation
spectroscopy.
IFCO
Castelldefels, Spain
Thyroid
nodules
with
higher
are
a common
pathology having a prevalence of 19-76
percent when screened with ultrasound,
frequencies
in
women.
Current medical methods used
to assess the malignancy of a nodule
consist in performing an ultrasound,
followed by a Doppler ultrasound, and
then a biopsy. However, unfortunately,
these methods present both low specificity
and low sensitivity. This insufficient
effectiveness in accurately being
able to diagnose thyroid tumors leads
to many unclear or unnoticed cases as
well as many others that undergo
unnecessary surgeries (false positives)
and increase the cost of medical healthcare,
not to mention the reduction of
quality of life of patients.
The EU-funded project Laser and
Ultrasound Co-analyzer for Thyroid
Nodules (LUCA) started in 2016, and
over its five years of duration, it worked
on the development of a new low-cost
near-infrared optical device combined
with ultrasound that searched to provide
doctors with enhanced information
required to provide better and more
specific results in thyroid nodule screening.
The goal of such device was mainly
to enable a better diagnosis of this type
of cancer because so far, there was no
accurate way of determining whether a
thyroid tumor as benign or malignant.
The LUCA device is a multi-modal
platform combining near infrared light,
time resolved spectroscopy (TRS), diffuse
correlation spectroscopy (DCS),
and ultrasound in one single device.
■ Clinical Testing with LUCA
The study recently published in
Biomedical Optics Express and authored by
members of the consortium reports on
several study cases and clinical tests conducted
to validate the accuracy and high
quality of measurements achieved by the
LUCA device.
First lab tests in 2019 of the LUCA device at ICFO research center in Barcelona. Dr. Mattia Squarcia
tests the probe on a healthy patient to see the performance of the measurements. (Credit: IFCO)
36
Intro
Cov
www.medicaldesignbriefs.com
ToC
+
-
A
As a first step, the TRS and DCS modules
were tested independently using
phantom1 tests to validate the performance
of both under the different
European medical standardization protocols.
For the former module, a set of
solid phantoms with different absorptions
and scatterings was used to assess
the capability of the device to detect
absorption and scattering changes,
while for the latter, a set of liquid phantoms
with different viscosities was used
to assess the capability of the device of
measuring the movement of the partiMedical
Design Briefs, September 2021
µ
È
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Medical Design Briefs - September 2021

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