10 Most Trusted Medical and Clinical Laboratories in 2022V3 1.pdf

NAMSA
Translating Innovative Ideas into Transformational MedTech Products
Robust Upgradation
Integration of IT into
Laboratory Systems
Health Economics
The Potential Impact of
Diagnostic Capabilities
Dr. Christophe
Berthoux
1Most Trusted
Medical and
Clinical
Laboratories in 2022
August
Issue 05
2022

The best and
most ef cient pharmacy
is within your own
system.

Editor’s
Note
rtificial intelligence and robotics are two
Atechnologies that have demonstrated the potential
to address and solve many contemporary issues.
Robotics has long been used in the manufacturing industry.
However, over the last three decades, robots have been used
in a variety of other industries, including laboratory
research, earth and space exploration, transportation, and
many others. The use of robots has reduced production
costs and increased productivity, resulting in the creation of
many new jobs in the tech sector, as well as economic
growth. Robots are typically used for repetitive and
monotonous tasks; however, with artificial intelligence
(AI), the scope is expanding. They are taking the place of
human workers and providing efficient results.
As the application and capabilities of robots improve,
sectors such as healthcare and its allied fields are adopting
A New Dimension
in Healthcare:
Robotics

them for various tasks. Robots are now used for complex
surgeries, clinical training, medicine dispensing, personal
care, and a variety of other tasks.
Robots are changing how surgeries are performed in the
medical field, streamlining supply delivery and disinfection,
and freeing up time for providers to interact with patients.
In addition to the operating room, they are now used in
clinical settings to assist health workers and improve patient
care. Focusing on innovations in technology in the medical
field, Robotics has the potential to revolutionize the sector
due to its various applications and benefits being
advantageous to both healthcare providers and patients.
In the latest edition of Insights Care's 10 Most Trusted
Medical and Clinical Laboratories in 2022, we walk you
through the companies whose goals are aligned with the
current market technology, trends and innovations, bringing
in a wider range of opportunities in treatment catering to
patients' needs.
Hope you have an interesting read!
- Pooja Shah

London Medical
Laboratory
Assurance of Reliability and Excellence
16 24
P23 Labs
Equipping Diagnosis with Trust
32
Aicl
Integration of IT into
Laboratory Systems
Robust Upgradation
The Potential Impact of
Diagnostic Capabilities
Health Economics
20 28
UTAK
Laboratories Inc.
Facilitating Wide Range of Comprehensive
Stock and Custom Quality Controls to
the Healthcare World

NAMSA
Translating Innovative Ideas
into Transformational
MedTech Products
Cov Sty
Ctts
08

Editor-in-Chief
Merry D'souza
Senior Editor
Anish Miller
Managing Editor
Pooja Shah
Assisting Editors
Saloni Agarwal
Visualiser
David King
Art & Design Head
Mrunalinee Deshmukh
Co-designer
Paul Belin
Art & Picture Editor
Sonia Raizada
Business Development
Manager
Amy Jones
Marketing Manager
John Smith
Business Development
Executives
Sarah Wilson, John Smith,
Alex Vincent
Sales Executives
Kelli, Bill, Anna
Technical Head
Jacob Smile
Assistant Technical Head
Prachi Mokashi
Technical Consultants
David, Robert
Digital Marketing
Manager
Alina Sege
Assistant Digital
Marketing Manager
Renuka Kulkarni
SME-SMO Executives
Gemson
Research Analyst
Eric Smith
Circulation Manager
Tanaji Fartade
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August, 2022
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Description
Company
Featuring
Person
CATHOLIC HEALTH
SYSTEM
chsbuffalo.org
Barbara
McManus
VP Marketing
Catholic health care providers are committed to providing
the highest quality health care to all people in their
communities and using their resources to promote the
health of the communities they serve.
Danaher Corporation
danaher.com
Blair Rainer
CEO
Danaher is a global science and technology innovator
committed to helping its customers solve complex
challenges and improve quality of life around the
world.
DaVita Inc
davita.com
Javier Rodriguez
CEO
DaVita Inc's mission is to be the Provider, Partner and
Employer of Choice, and it is building the greatest health
care community the world has ever seen, guided by its core
values of: Service Excellence, Integrity, Team, Continuous
Improvement, Accountability, Fulﬁllment, and Fun.
Kronos Bio
kronosbio.com
Marni Kottle
VP of Corp
Comms
Kronos Bio is a clinical-stage biopharmaceutical company
developing therapeutics that target the dysregulated
transcription that causes cancer and other serious diseases.
Flavia
Araujo-Rankin
Co-founder and
Joint CEO
London Medical Laboratory is the UK's largest phlebotomy
network providing blood tests and health checks for
employers, clinicians and individuals. Next day results with a
doctor’s comments at a very competitive price.
Dr. Christophe
Berthoux
CEO
Helping medical device Sponsors improve healthcare since
1967, NAMSA is the world’s leading MedTech Contract
Research Organization (CRO) offering global end-to-end
development services.
Cameron Poole
BDA
New Orleans BioInnovation Center is empowering
Louisiana innovators to create successful biotech
businesses by providing them with access to customized
commercialization services, premier facilities, and a
comprehensive support network.
Proteomics
International
proteomics.com.au
Richard
Lipscombe
MD
Proteomics International is a medical technology
company focused on proteomics – the industrial-scale
study of the structure and function of proteins.
UTAK
Laboratories Inc.
utak.com
Larry Plutchak
Founder
UTAK is proud to call itself “control freaks”, but not in the
way you might think. That’s because its obsession lies not
in taking control but in giving control—to the testing labs
that need the ﬁnest quality control materials for its clinical
and forensic toxicology test methods.
10 Most Trusted Medical and Clinical Laboratories in 2022
P23 Labs
p23labs.com
Tiffany
Montgomery
CEO & MD
A full service reference laboratory and CRO specializing in
molecular genetic testing and DNA analysis located in
Savannah, GA, Hilton Head, SC and Guaynabo, PR. Now
testing infectious diseases like STI's, Bacterial Vaginosis and
COVID-19 with an EUA from the FDA issued on May 21, 2020.
London Medical
Laboratory
londonmedicallaboratory.co.uk
NAMSA
namsa.com
New Orleans
BioInnovation
Center
neworleansbio.com

Cover
Story
NAMSA
Translating Innovative Ideas into Transformational MedTech Products
NAMSA's services
have grown to include regulatory,
reimbursement, quality consulting,
product development strategy
and clinical research solutions.

At NAMSA, the organization
utilizes over 55 years of
experience in assisting Clients
with virtually every development
hurdle/obstacle to help them
achieve success.
addition to medical device laboratory testing, NAMSA's
services have grown to include regulatory, reimbursement,
quality consulting, product development strategy and
clinical research solutions.
These service additions have helped pave the way for
NAMSA to become the industry's premier choice for global
manufacturers seeking CRO services—offering established,
strategic solutions throughout the full development
continuum—to allow Sponsors to fast-track
commercialization efforts while achieving time and cost
efficiencies in every major market of the world.
Guided by Strategic Leadership
Dr. Christophe Berthoux began his career in the healthcare
industry in 1990 with Charles River Laboratories, an
international company dedicated to early-stage
development and safe manufacture of novel drugs and
therapeutics. Throughout Dr. Berthoux's 19-year career at
Charles River, he held several leadership positions,
ultimately serving as Executive Corporate Vice
President of Global Sales and Marketing and Chief
Commercial Officer.
Following this, he acted as the Chief Executive
Officer (CEO) of Synexus, a firm assisting
global medical device Sponsors with patient
recruitment for clinical trials and research
site challenges.
In March 2021, NAMSA named Dr.
Berthoux CEO, where he brought his
many talents and expertise in the areas
of strategic vision, M&A,
diversification, operations and
leadership of global, multicultural
teams.
Medical device companies' demand for clinical
evidence has upsurged like never before.
Professionals want to see more clinical data
before and after approving marketed devices. This task
often lies on the shoulders of Contract Research
Organizations (CROs), such as NAMSA, a global company
providing MedTech Sponsors with trusted end-to-end
development services.
Driven by its global regulatory expertise and in-depth
therapeutic knowledge, NAMSA is dedicated to
accelerating medical device product development, offering
only the most proven solutions to move Clients' products
through the development lifecycle efficiently and cost-
effectively as possible.
NAMSA is the industry's premier, trusted partner for
successful development and commercialization outcomes:
from medical device testing and preclinical research to
regulatory, reimbursement, quality consulting and clinical
research services. NAMSA employs over 1,700 Associates
across 20 locations throughout the Americas, APAC and the
EU.
An Inspirational Journey
In 1967, a glass manufacturer in Toledo, Ohio approached a
clinical laboratory to test polymeric materials for
pharmaceutical container testing. Dr. Theodore Gorski, a
scientist-entrepreneur, recognized the opportunity and
accepted the project.
By following methods outlined in the United States
Pharmacopeia, he successfully performed the requested
testing. Thereafter, Dr. Gorski established Science
Associates, a Contract Research Organization (CRO)
focused on medical device and materials testing. Nearly a
decade later, the United States Congress authorized the U.S.
FDA to regulate medical devices.
By that time, NAMSA had already developed a testing
matrix to assure the biological safety of medical devices
and materials, which was later incorporated into the
Tripartite Guidance, TC194 and is part of today's ISO
10993 requirements.
Over the last several years, while regulations have
continued to evolve and become more complex, NAMSA
has proudly played an integral role in developing domestic
and international standards for testing medical devices,
materials, and In Vitro Diagnostic (IVD) products. In

NAMSA has proudly
played an integral role in
developing domestic and
international standards for
testing medical devices, materials
and In Vitro Diagnostic
(IVD) products.
Today, his dedicated focus is on supporting NAMSA as the
world's leading full-continuum MedTech Contract Research
Organization (CRO), including growth through significant
outsourcing deals and helping Clients understand the
incredible benefits of working with a partner that provides
full-service development solutions under one roof.
"NAMSA provides unparalleled medical device testing
capabilities, strategic guidance and tactical support to fast-
track market introduction of innovative MedTech products
around the world. I'm excited to work with a team
committed to helping Clients overcome development
hurdles, mitigate concerns, streamline commercialization
efforts and deliver exceptional outcomes throughout every
stage of the development journey," Dr. Berthoux stated.
"I'm inspired by the work our global team of 1,700+
Associates conducts each and every day and the direct
impact it has on accelerating the delivery of life-saving
medical technology and improving healthcare outcomes
around the world," he concluded.
Dr. Berthoux is a Doctor of Veterinary Medicine and also
holds an Executive MBA from Purdue University and a
Microsurgery Degree from Lyon Medical School-Alexis
Carrel.
A Well-Planned Product Development Process
While elaborating on development and testing in the
healthcare industry, Dr. Berthoux observes, "In the product
development process, a key, essential factor is creating a
robust Product Development Plan and a clear execution
strategy."
He further explains that it should integrate the key pillars of
medical device commercialization, including manufacturing
and prototype development, regulatory and quality
requirements, preclinical and clinical research,
reimbursement, and scientific communications to receive
regulatory approval based on expected target markets.
One of the most critical factors in the testing process is
compliance with global regulatory requirements. This can
be highly challenging for MedTech Sponsors due to
constantly shifting global regulatory environments. The
risks of non-compliance are several: significant time delays,
increased cost and potential market erosion from
competitive product entry.
In addition, experience is a key factor of success for any
testing laboratory. At NAMSA, the organization utilizes 55
years' experience in assisting Clients with virtually every
development hurdle to help them achieve success. Based on
this experience and real-world knowledge, NAMSA offers
only the most proven development solutions to allow
Clients to achieve cost-efficient, timely, successful
development outcomes.
Flexibility is critical to product development and testing.
While this sounds contradictory in a highly regulated
environment, it is because of the intense scrutiny that
flexibility is necessary. Starting with a well-thought-out
plan is the first step, but then once data is produced,
understanding the implications and acting quickly is the
key to success.
The device development process takes a considerable
amount of time in the best-case scenarios. Still,
when unexpected challenges arise, NAMSA moves
swiftly to address each situation and provide a
path forward that will set the stage for safe,
accelerated and effective market introduction.
Dr. Berthoux concluded by stating, "While
patient safety is everyone's goal, the
regulators must be satisfied first.
Sometimes, the only solution is
conducting more testing or having
extensive written justifications. A
company must know when and how to
apply these tools."

Catering to the Global Medical Industry
The medical device testing industry continues to grow. In
2022, the global medical device market size is estimate to
reach $516B with continued growth of 3% CAGR through
2024 {GlobalData}. It has a positive outlook as MedTech
companies focus on product development of new and
innovative devices to drive growth, revenue and
profitability.
A key driver of success in the product development process
is speed-to-market. Today, many companies are
experiencing launch delays as the market is still recovering
from COVID-19-related demand, placing extreme
constraints on Sponsors' internal resources and those of
their outsourced development partners (including the global
testing industry).
NAMSA is acutely aware of the current global constraints
on the laboratory testing market and continues to be
committed to doing their part to find a resolution. This has
been done by making significant investments in both
NAMSA's future and the future of the medical device
industry through the continued adoption of technology,
service advancements and expansion of global laboratory
capacity.
Integration of Technological Know-How
When speaking about the inculcation of technology, Dr.
Berthoux asserts, "Advances in technology are changing
how testing is accomplished." He further states that early in
silico models can rule out certain materials very early in the
process, so time and effort are not spent on biological
testing. In vitro testing models are continuing to evolve,
replacing In Vivo testing (medical tests and experiments on
living organisms and animals). And last, improvements in
chemical characterization approaches are leading to better
quantitative safety assessments and the avoidance of in vivo
testing in certain cases. These shifts provide more
actionable data that allow for early and better product
development decisions.
For the Product Development Process:
The advancement and increased use of technology in the
MedTech marketplace certainly impact the product
development process. Software as a Medical Device
(SaMD), use of Artificial Intelligence (AI), Human Factors
Engineering and cybersecurity—to name a few—are
creating significant improvements in saving and improving
human lives.
However, these advancements also create challenges for
Sponsors and the global regulatory institutions that are
continually evolving requirements to keep pace with the
rapid change in technology. As a result, MedTech
companies need to closely monitor and understand these
regulatory changes and quickly adapt product development
plans to ensure success in such an environment.
Dr. Berthoux believes, "At NAMSA, we maintain a
dedicated team of regulatory and testing experts specifically
focused on such issues to ensure we are at the forefront
driving international regulatory requirements, as well as
implementing those requirements for Clients so they may
streamline the product development process and be
equipped with the necessary tools for success."
Complexities on the Way
Today, NAMSA has significant opportunities in the growing
MedTech CRO space. Many of today's challenges are
similar to those seen in most areas of the global MedTech
market, which include high demand (many COVID-19
related), limited global capacity, supply chain constraints
and a limited pool of qualified talent.
Additionally, the growing complexity of both medical
devices and testing that is required to suitably address
safety and efficacy in a changing regulatory environment
means that capacity is a critical management point. The
complexity of testing can demand more resources and time;
for example, chemical characterization today identifies far
more chemical entities than the basic screens conducted a
mere five years ago.
A Note Worth Remembering
When Dr. Berthoux was asked about his advice to budding
entrepreneurs, he suggested, "Invest in multi-disciplinary
education and spend time understanding how all of the
various testing modalities contribute to the overall
understanding of safety and efficacy."
He further asserted that this should also be balanced by a
rock-solid foundation in understanding testing guidance and
how the regulatory decision-making process is achieved. It
is imperative to understand that regulatory bodies need
high-quality data and insightful and detailed analysis of that
data.

London Medical
Laboratory Assurance of Reliability
and Excellence
Over the past several years, we have witnessed a
paradigm shift in the way pharmacies and
laboratories operate in order to cater to the
changing dynamic needs of the healthcare space. This shift
has resulted in the re-evaluation of the traditional channel
or multichannel model and upgrading it to a clinical
omnichannel approach that will seamlessly integrate
various distribution mediums.
And that's exactly where the clinical market disruptor,
London Medical Laboratory, enters to combat the
healthcare industry through its technologically advanced
blood testing approach. The organization has introduced the
omnichannel approach to blood testing, which is rudimental
in the UK's clinical history. Through its wide range of life-
saving finger-prick blood testing kits, the organization
guarantees reliability and excellence to its customers.
Spearheading this innovation is LML's Co-founder and
Joint CEO, Flavia Araujo-Rankin. She believes access to
blood tests can save many lives. Hence, Flavia is working
towards the mission of making blood testing easily
accessible in order to improve the UK's health statistics.
We at Insights Care got an opportunity to interview Flavia.
She orates about LML and how its omnichannel approach
provides a fast and easy way for people to start taking
charge of their health.
Below are the interview highlights:
Please brief our audience about London Medical
Laboratory. Kindly tell us the source of inspiration for
starting a medical and clinical laboratory.
London Medical Laboratory (LML) is a market disruptor,
building on the benefits of new direct-to-consumer (D2C)
opportunities. In 2016 I founded LML, together with my
husband, with the intention of it becoming the UK's first
laboratory to take a truly omnichannel approach to provide
testing services directly to the patients.
We work with a nationwide network of pharmacies and
clinics offering every method there is to get blood tests
done. We provide phlebotomy training to all our sites so
that anyone can have their blood taken and couriered back
to our laboratory and processed overnight. This means that
anyone anywhere in the UK can have their results sent back
to them the next day with a doctor's commentary attached!
We also provide a wide range of life-saving finger-prick
blood testing kits, which can be purchased online, or off the
shelf with results similarly returned the day of arrival in our
laboratory. Because we are vertically integrated and own
the entire pathway, we are able to guarantee reliability and
excellent customer service. LML's mission is to make blood
testing easily accessible and improve our country's health
statistics. Access to blood tests can save lives.
NHS waiting times for blood tests are continually
increasing. There's currently an 18+ weeks wait for non-
urgent cases, and that rises to 21 weeks in London. LML
can reduce the workload on GPs by both undertaking
traditional blood tests ordered by surgeries and by
providing tests to customers directly. This feeds into the
growing trend for individuals to take greater responsibility
for their own well-being and healthcare.
The key to LML's long-term growth strategy is the
continuous development of the D2C opportunity for both
blood tests and infectious diseases. Our clinical testing
service provides clients and customers with a one-stop
solution to improve their people's wellness.
Whether people are concerned about their health, simply
curious, or perhaps are managing an existing condition,
blood tests provide a fast and easy way for them to start
taking charge of their health.
Flavia, kindly brief us about yourself and shed some
light on your journey in the medical product and
development niche.
August 2022
16|www.insightscare.com

Our convenient
direct-to-customer
finger-prick self-testing
kits give people easy
access to blood tests
that people can do in
the comfort of
their homes and
post the samples
back to us.
Previously I created and managed a range of successful
businesses in the United Kingdom, Brazil and Australia, in
retail, import/export, and education. When one of my
children developed diabetes, I realized there was a notable
lack of access to rapid, continual blood testing to keep
families fully informed.
Out of necessity came invention. My husband, Dr Seth
Rankin, had extensive experience in both the NHS and
private healthcare. He spent many years working in
international medical assistance, then as the managing
partner of a large NHS general practice. When we realized
the huge need for direct-to-consumer blood tests, I saw how
Seth's medical expertise and my business experience could
revolutionize the health care market.
My family's experience also shaped LML's core value, that
every test is a person. Behind every medical test is a fellow
human who deserves our very best. Their lives may depend
on it. This is the core of what LML believes in.
Tell us more about the services that make London
Medical Laboratory stand out from the competition.
LML is the first omnichannel blood testing, diagnostic and
health check business in the UK. We offer phlebotomy
services in franchised High Street health check shops,
licensed pharmacies, and finger-prick blood tests direct to
customers ordered online and sent through the mail.
Our convenient direct-to-customer finger-prick self-testing
kits give people easy access to blood tests that people can
do in the comfort of their homes and post the samples back
to us. Our tests cover a wide range of conditions, from
cholesterol and thyroid profiles though to fertility and heart
health.
Our High Street services are also growing rapidly. We now
offer blood tests in many pharmacies and health stores
across the UK, including a partnership with Holland &
Barrett. Blood samples usually take no more than ten
minutes, and patients usually receive their results the next
working day.
What is the current scenario of the medical product
development and testing industry?
In terms of blood testing, these are exciting times, bringing
tests directly to patients and developing tests for an ever-
wider range of conditions, from diabetes to heart disease or
erectile dysfunction, using the latest advances.
Flavia Araujo-Rankin
Co-founder, and
Joint CEO
August 2022

What is your opinion on healthcare providers' aligning
their offerings with newer technological developments,
especially when it comes to catering to the dynamic
needs of the healthcare sector?
LML was founded on the belief that the latest technological
developments in blood testing are a key part of the evolving
healthcare space. It's only through the growth in online
technology that LML's revolutionary omnichannel blood
test services could exist.
In many countries, private routine health checks and blood
tests are regularly conducted, but this is less common in the
UK. For example, there are as many as one million people
in our country with undiagnosed type 2 diabetes. A simple
blood test can categorically let them know whether they
have it or not. Knowing will add years to their lives!
What advice would you like to give to the budding
entrepreneurs and enthusiasts aspiring to venture into
the medical product and development niche?
Come and work for LML! As we expand into new areas, in
terms of both healthcare and locations, we are always
looking to develop new talent.
Creating LML was a lot of hard but rewarding work. It was
difficult at the beginning and took a lot of time and
investment. In the past three years, we have grown
tremendously from only eight people to over 150 staff with
six LML branches–and more are on the way!
With so many advances in technology, working in
healthcare is very exciting and fulfilling. Work hard, find
good people and ensure you focus on developing products
customers will buy. Focus on the common goal–to improve
people's health and have fun doing it.
How do you envision scaling London Medical
Laboratory's services and operations in 2022 and
beyond?
There has been a significant rise in patient awareness
regarding self-testing. Millennials have become the
"wellness generation," and the increasing elderly population
needs better access to testing.
Just as consumers abandoned the High Street for online
stores during the pandemic, so many looked for effective
alternatives, such as regular blood testing, to avoid GP
surgeries during the height of lockdowns. People realize
how effective and reassuring regular blood tests can be, and
we are constantly introducing new tests to give people a
comprehensive picture of their current health.
We are currently expanding rapidly and have plenty of ideas
for the future. We are scaling up our range of tests rapidly,
from new comprehensive allergy tests to a wider range of
hormone tests to be easily available in high street shops so
that everyone has quick and easy access to blood tests and
general health checks.
We are involved with many organizations' staff healthcare
programs, and we're making our tests available in an ever-
increasing range of pharmacies, health food stores, etc.
LML is actively looking for new pharmacy partners across
the UK who want to access these new services. My ultimate
vision is for blood testing to be available in every pharmacy
and healthcare shop throughout the country, enabling
people to take charge of their health.
August 2022

August 2022

Diagntic
Capabili es
The Poten al
Impact of
t is known that patients can live healthier and longer
Ilives if the progression of the disease is prevented,
delayed or reversed by timely diagnosis and
appropriate clinical treatment. Diagnostics provide useful
information to patients, enabling the choice of appropriate
treatment, helping health professionals to choose
appropriate preventive measures, and providing important
prognostic information that can optimize treatment options
and care.
Diagnostic information can also enable informed choices
about, for example, reproduction, nutrition and lifestyle
changes. In addition, diagnostic information can help avoid
or shorten hospitalizations, reduce inappropriate drug use,
or shorten the duration of sick leave, bringing economic
value to cost containment and contributing to better health
outcomes, ultimately leading to more effective drug use
resources.
Unlike therapy, whose direct clinical effects can often be
directly demonstrated, diagnostics provide information that
indirectly affects patient care and the economic efficiency of
health systems. Evidence showing the full potential of
Health Economics
August 2022

diagnostic data is often more difficult to produce than
providing such evidence for therapeutic agents and may
require a different approach.
Let's dive into the potential impact of diagnostic
information beyond traditional cost-effectiveness measures,
encompassing both the value of the information and the
improvement in quality of life resulting from this
information acquisition.
Impact for Healthcare Professionals
Diagnostic information provides value to healthcare
professionals by directly guiding appropriate treatment
decisions and related clinical behavior. Diagnostics produce
data (such as blood sugar levels, the presence of an
infection or a cardiac or oncological sign at the genetic
level) that can be transformed into information (data) and
thus support clinical decisions.
For example, blood glucose values (obtained from a
laboratory or care or blood glucose meter) can be recorded
and shared with healthcare providers in real time to advise
on appropriate treatment actions (such as changing insulin
therapy). This may not only lead to the patient's desired
health but may also avoid the need for subsequent or more
invasive tests, side effects and/or delays in implementing
the best possible treatment.
Effectiveness can also be increased based on informed
decisions: selecting a group of patients who are likely to
benefit from a particular treatment. Another example is the
rapid detection of a sign of acute coronary disease, which
allows rapid identification of a patient's risk, followed by
rapid diagnostic processing and, if necessary, the initiation
of life-saving measures.
For Patients, Families and Caregivers
From the perspective of the patient and family, diagnostic
information has value both through the promotion of
clinical benefit and the value of knowledge.
Clinical benefit comes from post-test decisions about
patient care. These treatment decisions affect the health of
patients. Therefore, the diagnostic information can have
clinical and medical utility. It depends on contextual factors
of the health pathway, including access to treatment after
diagnostic information, effectiveness of treatment and
management strategies for diagnosed conditions, standards
of care, prevalence and other condition-specific
characteristics, and individual experience, which interprets
and uses information. Assessing the clinical utility of
diagnostic tests requires an integrated approach that
considers all contextual factors and multiple outcomes,
including interactions and effects on subsequent
interventions in the treatment. This may require
mathematical or simulation modelling of these
relationships.
Regarding the value of knowledge, for example, patients
can have greater peace of mind if they know that they have
a disease or not and can benefit from treatment if it is
available. Patients or parents of young patients can get
value from information about their (child's) health status,
disease, or prognosis, regardless of whether this
information would influence treatment decisions. In
addition, knowing the risk or possibilities of a disease can
enable informed decisions.
For Health Systems and Institutions
The information provided by diagnostic technologies can
have a significant impact on healthcare systems and
healthcare facilities. Diagnostic information can support
costs by identifying patients in early stages of chronic
disease or at risk for disease (eg, diabetes, cancer). Timely
preventive and therapeutic interventions can then be
implemented to reduce the risk and rate of disease
progression and the long-term costs of chronic disease care
and disability. Diagnostic information can also lead to early
diagnosis of acute conditions such as heart attacks, thereby
reducing lost lives and disability-related outcomes.
Wrapping Up
The effects of testing on life expectancy, number of diseases
detected, health-related quality of life and health care costs
are generally considered in traditional health economic
evaluations (cost-effectiveness or cost-effectiveness
analyses). This is based on the importance of these
characteristics, the existence of systematic approaches to
measure them, and advice on their value to society (e.g.
through liquidity or cost-effectiveness thresholds).
However, some important diagnostic related attributes may
not be directly related to health-related quality of life or
costs, and therefore are often not included in standard
health economic evaluation tests.
- Saloni Agrawal
August 2022

Equipping Diagnosis with Trust
P23Labs
Trust – is a strong yet delicate emotion. As long as it
takes to get built, it takes less than half of that time
for it to turn fragile.
Therefore, an obvious question to individuals as well as
organizations is, “what builds trust and how can one
maintain it throughout?”
Answering this, the research literature suggests that trust
gets built by ethics and leadership qualities imbibed by the
leader of the organization along with other attributes of
honesty, psychological safety, respect, and others.
This component of trust gets very important in the
healthcare niche where a patient puts his life entirely into
the hands of the doctor. And especially at the first level of
diagnosis, which is done by medical and clinical
Laboratories whose accurate results help the doctor to
arrive at a reliable solution, strengthening the trust.
Paying utmost attention to this value is Savannah’s P23
Labs, which is focused on improving the relationship and
trust between the healthcare system and minority groups,
who have historically been mistreated and misrepresented
throughout medical history.
This trust has been multiplied by the pivotal role played by
the laboratory’s leaders – its Medical Director - Dr.
Bernadette M. Mandes-Wildemore, MD, and CEO, Dr.
Tiffany Montgomery, whose passion for helping and
serving the underserved has placed the laboratory among
the most trusted in the industry.
Without further ado, let’s go through their journey in the
following interview:
Please brief our audience about your organization.
Kindly tell us the source of inspiration for starting a
medical and clinical laboratory.
P23 Labs is a Black-owned high complexity molecular
diagnostic laboratory headquartered in Savannah, GA.
We were born from a drive to improve the relationship and
trust between the healthcare system and minority groups,
who have historically been mistreated and misrepresented
throughout medical history. We have 3 clinical labs
operating in Savannah, GA, Hilton Head, SC, and
Guaynabo, Puerto Rico.
P23 Labs offers a full suite of molecular diagnostic tests
that also include COVID-19, respiratory pathogen profiles,
and other infectious diseases rapidly identified via our state-
of-the-art molecular methods.
Since opening, we have processed over 1.2million tests and
served high-profile clients across the country. The tests are
primarily focused on the individual, with many of them
“ “
We see a need for health
and fitness backed by
science, which is why we
have launched our P23
Health Membership program.
August 2022

based on the person’s DNA and the RNA of the targeted
infectious disease. P23 Labs employ methods like PCR,
Mass Array, Genetic Sequencing and ELISA to provide the
best available, state-of-the-art actionable results. This
allows educating and empowering patients and partnering
with providers for the best outcomes.
Brief us about the featured person and shed some light
on their journey in the medical product and
development niche.
Our laboratory medical director is Dr. Bernadette M.
Mandes-Wildemore, MD, and our CEO is Dr. Tiﬀany
Montgomery, Ph.D. Dr. Montgomery completed population
health and disease doctoral studies in Honduras, which
cultured her love of helping the underserved. She has a
Master of Public Health and Bachelor of Science from US-
based and accredited schools.
Tell us more about the services that make your
organization stand out from the competition.
When it comes to competition, the majority of our
competitors provide laboratory testing for doctor surgeries,
hospitals, etc. We are putting control in the hands of our
patients and providing access to health testing outside of
their healthcare plans. Whether they are looking for
information on their genetic makeup, testing for infectious
disease, or other health-related issues, we can work with
them. We are also helping employers provide access to
health testing to their employees beyond COVID-19 tests.
We work with large corporations to provide Safe-ID testing
– to prevent common illnesses from spreading rapidly
through groups who work closely together.
The medical product development and testing industry is
seeing huge growth. As the world becomes more connected,
we are seeing developments in the way of physical health
applications, better quality data communication and
ultra-tailored preventative measures. P23 recognizes these
trends and is all-in when it comes to personalized,
preventative health care.
August 2022

What is your opinion on healthcare providers’ aligning
needs of the healthcare space?
As healthcare providers, you have to adapt to what the
market needs. Today it isn’t one-size-fits-all, and we are
seeing more and more that our customers want to be in
control of their health and wellness. We started as a
molecular diagnostics laboratory, and while we continue to
see great success in that area, we recognize the needs of our
market and ever-evolving industry. It has allowed us to
analyze and diversify our product offerings to meet the
needs we are seeing in the healthcare space.
the medical industry that you are catering to?
There’s enough room for all of us. We’re lucky to be in a
growing industry, with estimated market size of over
$800bn ($10trillion globally). Find your niche and chase
your dreams. We’re in the business of helping people live
their healthiest, longest life, and if you are too, we think
that’s amazing (and would love to collaborate).
How do you envision scaling your organization’s
services and operations in 2022 and beyond?
Scaling our business and operations is definitely a balance
between our vision, customer demand and market
forecasting. We have big ambitions for P23, and we are
lucky to have a team that will work with us to get there. We
see a need for health and fitness backed by science, which is
why we have launched our P23 Health Membership
program. It is split into 4 different programs, the benefits of
each progressing with the price point.
Give us a few testimonials from your clients and awards
or recognition that accurately highlight your
organization’s position in the market.
“The premier customer service! They always go above and
beyond.”
“We were of the first to contract P23s COVID-19 testing
solution over a year ago. P23, Dr. Montgomery and her
amazing team have relentlessly served our clients that are
very demanding and require white glove services with
expedited testing needs. P23 did a great job.”
“We have worked with P23 from the beginning of the
pandemic. We have worked in the trenches late into the
night to enable PCR testing for our mutual clients, and P23
has provided a great service to us and our consumer
clients.”
“The customer service was amazing. I felt very
comfortable. I was in and out, fast testing and results.”
“The company is amazing. My test results came back right
away, and the customer service was outstanding. Will
always use this company.”
In addition to building trust and providing world class
services, is there anything else you think sets P23 Labs
apart from the competition?
We have actively engaged in philanthropic endeavors to
care for POCI groups, including diagnostic testing for
COVID-19 for those who struggled to gain reliable access
to testing, as well as making generous contributions to
Black-owned grassroots charities.
August 2022

Stay in touch.
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Laboratory
Systems
Integration of
IT into
aboratory systems in use today are not designed for
Lsystem-wide integration. They are built by vendors
and developers to perform specific tasks, and
connections to other systems are either not considered or
avoided for competitive reasons. If we want to consider the
possibility of building integrated systems, the following five
elements are necessary:
Education
Installations equipped with integrated systems are built by
trained people. But the educational issues do not end there.
Laboratory management must understand its role in
technology management. It is not enough to understand
science and people management as it was 30 or 40 years
ago. Managers must understand how the work is done and
what technology is used in it. Effective use/abuse of
technology can have as much impact on productivity as
anything else. Science must also be adapted for advanced
laboratory techniques. When developing methods, the
implementation of the method should be considered - can
this technology be automated?
Robust Upgradation
August 2022

August 2022

Obligation of User Community
Vendors and developers do not intend to provide integration
capabilities unless requested by the user community.
Vendors must spend resources to meet integration
requirements, and they will not do so unless there is a clear
market need and users are pushing them to meet that need.
If we continue with "business as usual" practices where we
negotiate things and are unhappy with the outcome, where
is the incentive for vendors to spend development money?
The options are: buy only products that meet your
integration needs, use resources to integrate systems that
are not designed for it or keep your labs running the way
they have been for the last 30 years - bit by bit.
Improvements.
Standards
The creation of integrable systems depends mainly on two
elements: standardized file formats and
communication/connection systems that allow one vendor's
software to communicate with another's software.
File Format Standards - Device output must be in an
industry-standard file format that allows it to be used with
any suitable application. The structure of this file format
must be published and contain instrument output and other
related information such as date, time, device ID, sample ID
read by barcode or other mechanism, instrument
parameters, etc.
Ideally, the standard format would be the instrument
engineering format. The data collected by the device would
be in this format and would be completed and used by each
provider. In fact, it would be possible for the instrument to
have a circuit board that would act as a network node. It
would collect and store device data and transfer it to
another computer for long-term storage, analysis and
reporting, separating data collection and use. A similar
situation currently exists with equipment suppliers using
online data acquisition modules.
Communication Standards
Developers and vendors design software
independently - the software works as if nothing else exists
and is self-sufficient for all critical tasks. This is a
reasonable point of view because it may be true. There is no
standard laboratory software. It is also true that software
exists and works with other software, and it may be
necessary to exchange data elements. We need a standard
for communication between tasks. The emergence of ELNs
only adds to the complexity. Files can be
imported/exported, but if we want integration, we need
communication between elements. This includes sample
preparation modules as well as large instrument data
systems, LIMS and ELNs. Some vendors use PDF files as a
data exchange medium. While this works, it's not an ideal
situation for scheduled messages.
Modular Systems
The preceding paragraph states that vendors must assume
that their software can operate in a particular environment
to ensure that all necessary facilities are available to meet
user needs. This can lead to duplication of activities. Both
the multi-user instrument information system and the LIMS
require a template login. With both systems in the lab, you
have two examples of login systems. The problem can be
made worse by adding additional multi-instrument
packages.
Where Do We Go From Here?
At some point, the described actions must be performed.
Until now, laboratories tie the results of their work to
products and formats over which they have little control.
The use of proprietary file formats that limit working with
company data should be replaced by industry-standard
formats that give users the flexibility to work with any
product they choose.
Overcoming obstacles to the integration of laboratory
systems requires a change in the mindset of laboratory
management and people working in laboratories. This
change will bring a significant difference in the way
laboratories work, which will increase productivity,
improve the work environment and improve the return on
investment made in the company's laboratory operations.
Waiting for changes will not bring the necessary results.
The user community needs to take the lead and come
together and provide guidance to developers.
- Saloni Agrawal
August 2022

Ali M. Alaouie, PhD
Director of Product and
Technical Support
UTAK Laboratories Inc.
August 2022

Providing reliable patient results and ensuring utmost
patient safety has been one of the most highly
discussed concerns in laboratory medicine.
In the modern healthcare setup, while laboratory medicine
has become a cost-effective solution to building chronic
illnesses, errors in patients' management and inaccurate
diagnostic measures have caused serious harm to patients.
On such a note, the Journal of Laboratory and Precision in
the year 2022 pointed out that the reliability of a result has
been attributed to its analytical processes, which called for
additional attention and consideration.
In order to minimize these errors, several clinical
laboratories today are taking responsibility for the
development and implementation of processes that
emphasize quality control of the services and products
offered to patients.
One of the companies, UTAK Laboratories Inc. through
its implementation of the latest scientific advancements and
high industry standards, has maintained quality control
measures, further supporting labs with the materials they
require to prioritize patient safety.
Insights Care recognizes the company’s potential by
speaking with Ali M. Alaouie, the Director of Product and
Technical Support at UTAK
Below are the highlights of the interview.
Please brief our audience about your organization.
Kindly tell us the source of inspiration for starting a
medical and clinical laboratory.
Founded in 1973, UTAK has been sourcing 100% REAL
human matrices and the purest drugs possible to provide
labs with the controls they need for every kind of analysis.
At UTAK, we’re proud to call ourselves “control freaks,”
but not in the way you might think. That’s because our
obsession lies not in taking control but in giving
control—to the testing labs that need the finest quality
control materials for their clinical and forensic toxicology
test methods. Our close-knit group of Control Freaks crafts
the quality controls these labs depend upon for every kind
of analysis, including a wide range of comprehensive stock
controls in 100% REAL human urine, serum, blood, and
more, as well as starting matrices for laboratories seeking to
develop in-house quality control material. We also create
custom control solutions to support the new methods and
ground-breaking research.
We originated the manufacturing of complex, personalized
quality controls, making controls that no one else could.
And we're still doing it today.
Tell us more about the services that make your
organization stand out from the competition.
Custom QC since 1973. We have made over 10,000 custom
quality controls in the last 10 years. With our custom
control solutions, you choose the analytes, you choose the
matrix, you choose the form, you choose the size…. We
give you control.
Technological advancement, particularly in analytical
instrumentation with respect to selectivity, sensitivity,
specificity and detection limits, enables scientific testing to
extend into much broader areas of medical and/or forensic
interest. Moreover, the scope of testing within a particular
subdiscipline can also expand. During instrumental
analysis, quality control measures necessitate the use of
reference material to ensure reliability of test methods and
integrity of test results. Accordingly, since testing and
Laboratories Inc.
UT
AK
Facilitating Wide Range of
Comprehensive Stock and
Custom Quality Controls to
the Healthcare World
August 2022

product development are coupled to each other, growth in
testing capabilities leads to increased demand for medical
product development.
What is your opinion on healthcare providers' aligning
needs of the healthcare space?
On a fundamental basis, any effort leading to improving the
quality of life and saving lives is always welcome news. In
parallel, technological developments in the field always
invite the question of mass data generation and handling.
Upfront transparency with respect to data management
efforts and associated risks is the easy answer.
the medical industry that you are catering to?
At first, the viability of new products or services must be
conducted through market research. If venturing into the
medical industry is decided, then planning and assembling a
core support team of subject matter experts becomes vital.
Identifying experts with working experience in regulatory
affairs, accreditation, quality management and
scientific/clinical research is essential. It is important for
entrepreneurs to understand that the medical industry is
heavily regulated, whereby requirements can vary
substantially from one country to another.
How do you envision scaling your organization's
services and operations in 2022 and beyond?
UTAK’s vision for the future centers around its core
mission of contributing to public safety and public health.
Since inception, UTAK has played a key role in the
manufacturing of medical devices (quality controls) to be
utilized in laboratory settings encompassing forensic
science to healthcare. Over the past year, UTAK has
devoted concerted effort and resources into the
establishment of an active R&D department with the intent
of broadening its contributions to public safety and public
health through in-house research initiatives as well as
external collaborative efforts. Operationally, we realize that
our continued success is dependent on quality products and
UTAK’s vision for the
future centers around
its core mission of
contributing to public
safety and public
health.
Ali M. Alaouie, PhD, is the
Director of Product and Technical
Support at UTAK. Ali is an
experienced research scien st
with a diverse scien fic, technical,
and administra ve background.
He oversees the R&D, Quality,
Regulatory, and Customer Service
Departments at UTAK
Laboratories. Prior to that, he was
the Manager of the Breath Tes ng
Unit at the New Jersey State Police
Office of Forensic Sciences and
has contributed to a number of
peer-reviewed publica ons across
mul ple scien fic fields.
One of a Kind Leader
August 2022

a positive customer experience. In line with that realization,
maintaining active ISO accreditation for our Quality
Management System is one way of communicating our
commitment to ensuring both functions are being met.
Give us a few testimonials from your clients, and awards
or recognition that accurately highlight your
organization's position in the market.
UTAK products continue to maintain strong citation in high
level scientiﬁc research as evidenced by peer-reviewed
publications like, “Assessment of gadolinium and iodine
concentrations in kidney stones and correlation with
contrast agent exposure, stone matrix composition, and
patient demographic factors-ScienceDirect”.
Additionally, below is a testimonial from a client:
Our laboratory was running an “In-house developed”
fractionated 25-OH Vitamin D test on our LC/MSMS
system. We were making our own standards and it was very
labor intensive. We needed a precise but economical
solution. UTAK was able to manufacture a custom set of six
controls that had been validated by a third party, which we
could use for calibrators. They even were able to package
them in vials that we supplied to use at our pipetting station,
so there was no need to transfer them for use by the staﬀ.
—Debra Swigart, Quest Diagnostic
August 2022

10 Most Trusted Medical and Clinical Laboratories in 2022V3 1.pdf

10 Most Trusted Medical and Clinical Laboratories in 2022V3 1.pdf

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