Maria Nyakern
Founder
AKRN Scientific
Consulting S.L.
Nyakern
Maria
Empowering the MedTech
Sector with Efficient
Clinical Research
November
Issue 08
2022
Embracing
Innovations
Digital Transforma ons in
Healthcare to Look
Out for in 2023
Telehealth and its Scope
in the Post-Pandemic World
Digital Health

Helping one person
might not change the
world, but it could
change the world for
one person.

ver the past decade, the MedTech industry
Ohas been growing at an exponential rate. As a
result of this high amount of growth,
companies and startups within this industry
are returning favorable profits to investors,
which ensures that these investors continue providing
funding to the industry. Many early-stage MedTech startups
are being acquired by larger firms, which is leading to the
creation of numerous innovations that are taking the
healthcare industry by storm.
The ever-growing nature of the MedTech industry means
that advancements are being made on a continual basis.
Because of these advancements, healthcare is becoming
more effective, more affordable, and more accessible for
people all around the world. From AI technology to needle-
less diabetes care, the most recent innovations within the
MedTech industry have already proven to be highly
effective at delivering quantifiable results to people in need.
Today's world is driven by technology, which is why the
majority of people prefer digital services that can be
conveniently accessed whenever necessary. The creation of
digital healthcare services and telehealth has allowed the
medical industry to provide much-needed medical care to
patients through digital devices, which means that a patient
can obtain medical care without waiting to book a face-to-
face appointment.
This technology is improving with each passing day and is
already available through a variety of personalized mobile
The Starlets and
The Novelties

applications. Patients can speak with their physicians to
receive a quick diagnosis and helpful medical advice when
needed, which is particularly beneficial for people who are
managing long-term health conditions. This technology will
only improve from here on out.
Recent innovations in MedTech have not only helped
accelerate the growth of the industry but have also helped
create technology that will improve lives and medical care
for generations to come. As technology grows and our
capability to offer less expensive, safer, and more successful
medical care -- the MedTech industry will prove to be
fruitful for all parties involved and an exciting venture for
both startups and industry leaders alike.
In the modern healthcare industry, these innovations are
being empowered by starlets who are shining bright with
exemplary ideas that spark transformations in the sector.
Insights Care, on its quest to embrace the odyssey of these
staunch leaders, came across the 5 Most Empowering
Women Leaders in MedTech Industry in 2022.
Flip through the pages to indulge in the inspirational
journey of these leaders, who are revolutionizing the ever-
evolving healthcare industry.
Have a Delightful Read!
-Abhishek Joshi

Cover
Story
08
Maria Nyakern
Empowering the MedTech Sector with
Efficient Clinical Research

Articles
Bridging Healthcare with
Technology Leadership
Angie Conley
22
SONS ARE MORE
IMPORTANT THAN
DAUGHTERS
CXO
26
Transforming the Methods
for Early Eyecare with
Innova ve Tech Solu ons
Mabel Gimeno
32
C
C
C O
O
O N
N
N T
T
T E
E
E N
N
N T
T
T
30
18
Embracing
Innovations
Digital Transforma ons in
Healthcare to Look Out for in 2023
Digital Health
Telehealth and its Scope
in the Post-Pandemic World

Co-designer Paul Belin
Art & Picture Editor Sonia Raizada
Art & Design Head
Editor-in-Chief Pooja Bansal
Managing Editor Abhishek Joshi
Senior Editor Anish Miller
Visualiser David King
Research Analyst Eric Smith
Sarah Wilson, John Smith, Alex Vincent
Business Development Executives
Amy Jones
Business Development Manager
Sales Executives Kelli, Bill, Anna
SME-SMO Executives Gemson
Digital Marketing Manager Alina Sege
Technical Consultants David, Robert
Technical Head Jacob Smile
Marketing Manager John Smith
Assistant Technical Head Amar Sawant
Assistant Digital Marketing Manager Renuka Kulkarni
Assisting Editors Saloni, Abhilasha
Mrunalinee Deshmukh
Circulation Manager Tanaji Fartade
Copyright © 2022 Insights Success Media and Technology Pvt. Ltd., All rights reserved. The content and images used in this magazine should not be reproduced or
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Reprint rights remain solely with Insights Success Media and Technology Pvt. Ltd. Insights Care is powered by Insights Success Media and Technology Pvt. Ltd.
November, 2022
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Brief
Featuring Person
Angie Conley
CEO
Abilitech Medical Inc.
abilitechmedical.com
Angie has developed a robo c ortho c to help
people who live with muscle weakness or injury to
use their arms so they may live more independently.
Kelly Feist
Managing Director
Ascom Americas
ascom.com
Kelly brings a proven track record of delivering
profitable growth and industry impact.
DIVE Medical
dive-medical.com
Mabel Gimeno
CEO and Co-founder
Under Mabel's leadership, DIVE Medical's vision is to
ensure that everyone lives at their full poten al across a
life me through early vision diagnosis and treatment.
Maria Nyakern
Founder
AKRN Scien fic
Consul ng S.L.
akrnconsul ng.com
Maria is a clinical research scien st and medical
device execu ve with a broad understanding of
clinical development and commercializa on.
Mary Canty
Director of Research
Garwood
Medical Devices
LLC garwoodmedical.com
Mary is an experienced scien st in the medical
device industry with exper se in prosthe c joint
infec ons and electrochemistry.
Company

Maria
Nyakern
Empowering the MedTech Sector with
Efficient Clinical Research
I felt inspired to be part
of setting up and coordinating
clinical trials to answer critical
scientific questions and get
proof that the new treatment
works and is safe.

Story
Maria Nyakern
Founder
AKRN Scientific
Consulting S.L.

he current tide of the digital revolution is directed
Tby technology, guiding every sector and carving a
world filled with better opportunities. Amongst
many, the healthcare segment is also flourished with a
cluster of advantages that are technology-mediated.
In this list, the first beneficiary is the MedTech sector. This
particular healthcare segment has been booming and is
expected to rise with a CAGR of 5.5 percent by 2029. This
development has provided multiple innovations with the
resilient endeavors of visionary leaders. In contemporary
times, healthcare visionary leaders are enhancing the fruits
of research and facilitating the needed direction in order to
strengthen the medical sector in a better way.
Infusing expertise, creativity, and innovation in the
MedTech segment is an inspiring healthcare leader—Maria
Nyakern. She is the Founder of AKRN Scientific
Consulting S.L. She has clubbed her childhood passion of
becoming a doctor and her interest in clinical research to
shower the medical community with a trustworthy platform.
Along her journey, she has also been successful in
providing clinical and regulatory services for Medical
Device and diagnostic manufacturing companies.
Maria strongly believes that working in clinical research
enables the Doctors and healthcare community to evaluate
their practice objectively and be involved in advancing the
medical discipline. Furthering ahead, she is found inspiring
fellow women professionals of the field to rise above and
gift the care sector with quality skills and expertise.
Let us dive further into her leadership tale and learn how it
is transforming the MedTech industry!
An Inspiring Tale
As a child, Maria wanted to be a doctor, but in her late
teens, she became more interested in science, technology,
engineering, and maths (STEM). She loved reading
biographies about great scientists and scientific discoveries
and was inspired by female scientists like Rosalind
Franklin, Emilie du Chatelet, and Lise Meitner.
Her interest in medical research awakened during her last
year of undergraduate studies in molecular biology at
Stockholm University in Sweden. She took a course in
advanced cell biology led by Professor Uno Lindberg, who
later became a very enlightening supervisor during her final
degree project and motivated her to pursue a research
career, followed by her doctoral studies.
She exclaims, “That was an exciting time in my life!”
After finishing her doctoral studies in Stockholm in 2003,
Dr Nyakern spent a few years pursuing academic research
in Bologna, Italy. Later, in 2006 she moved to Brussels and
started to work in clinical research at a global medical
device company.
Expressing her research interest, she says, “I was fascinated
by the world of clinical research and realized how it is
necessary to develop new treatments for different diseases
and conditions that occur in humans. Applied clinical
research is the foundation of evidence-based medical
practice. I felt inspired to be part of setting up and
coordinating clinical trials to answer critical scientific
questions and get proof that the new treatment works and is
safe.”
Over the following years, she was immersed in the world of
clinical investigations and understood the scientific
standards that are required to protect patients and produce
reliable scientific results. Enlightening further, she informs,
“The clinical investigation is one of the last steps of a long
and often quite tedious research and development process.
Understanding the connectivity of R&D and clinical
research inspired me to pursue science, technology, and
engineering.”
Hence, she encourages everyone to think broadly about
what research actually is.
She puts, “Those who work in healthcare often feel that
they are asked to help others in need. Some of the benefits
come from knowing that you are contributing to the science
and the art of medicine and that you have the tools to
question and test different approaches objectively. Everyone
has a role in supporting research—many will contribute to
research, and some will be research leaders.”
For her being in healthcare is not just a career – it’s a
calling!
Spearheading Dream into Reality
After working in academic research in Sweden and Italy, Dr
Nyakern did spend about ten years at different global
medical device companies and startups located in Europe.
Later, she founded AKRN Scientific Consulting (AKRN).
5 Most Empowering Women Leaders in MedTech Industry in 2022

I worked with all the hired
staff and focused on setting
up a milieu that promoted and
facilitated the reasoning skills
required to solve given
problems successfully.
Along the way, she got to know the work of several
outstanding women pioneers, some running their own
research labs or startups and some working with the
corporate industry. She notes, “This was incredibly
inspiring, and I knew that one day, I wanted to start a
women-owned business that could promote the excellent
work of like-minded women professionals of the MedTech
industry.”
Therefore, in 2017, when Maria established herself as a
clinical consultant in Madrid, she started facilitating
opportunities for other talented scientists, especially female
scientists, and initiated to establish a life-science consulting
business based on the ethics and values she consistently
applied in her own profession as a clinical research
scientist.
Hence, AKRN Scientific Consulting was born.
Apart from the extensive experience that Maria brought
with her, she feels that being a female leader introduced a
more empathetic and nurturing perspective to AKRN. This
helped her in the decision-making that drove diverse
perceptions, contributing to opinions that made a
well-rounded outcome.
Maria made specific efforts to develop good female leaders
as she feels that they are not only strong mentors but also
often pillars of the community. She shares, “For women,
the leadership journey is not linear, and we must deal with
obstacles along the way, and I really believe in helping
women who want to achieve more.”
As her career and life progressed, she was motivated by an
aspiration to provide problem-based learning opportunities
to talented professionals of AKRN. She says, “I wanted to
make learning approachable, engaging, and fun, and I think
I have been successful in this. I established a training
program that consciously worked on providing various
opportunities to continue and develop the employee’s
critical thinking skills that are so valuable for
problem-solving and planning, and holistically executing
clinical research.”

As an entrepreneur, you also
need courage and tenacity to
provide arguments about why
someone should invest in you
and your business idea.
Expressing further, she adds, “I worked with all the hired
staff and focused on setting up a milieu that promoted and
facilitated the reasoning skills required to solve given
problems successfully.”
Maria has also set up training programs that educate young
scientists to enter the rewarding world of medical device
clinical research. Her scientific training gave her the perfect
terrain to develop resilience and not give up. Maria notes
that she has seldom found a clear route in life. Instead, she
had to forge her own way most of the time. She started in
science, continued into clinical research, and developed
enthusiastically into an entrepreneur and business leader.
Maria’s inspiring story reflects a famous
philosophy—When life offers you an opportunity, do not
turn it down. Reminiscing about her journey, she says, “I
always took any opportunity that came my way with both
hands. It has been a very intense decade with long nights,
missed holidays, and sacrifices along the way, but I believe
you must do what grabs your interest.”
Maria is an inspiring leader, and she is steadily seeking to
drive the field of clinical research consulting services
forward. She says, “I am entirely convinced that the future
lies with young talent. And I hope I can be part of shaping it
in the way I believe is right.”
Dr Nyakern has put these values into her brainchild –
AKRN, since its inception. The company has experienced
fast and steady organic growth, both in employees, clients,
and projects, and has been able to establish itself in the
European market quickly. Maria, with her innovative
leadership skills, has demonstrated to the AKRN’s potential
clients that Maria’s company possesses the skills and
insights that are useful at every stage of the project
development cycle.
Under Dr Nyakern’s guidance and experience, AKRN was
acquired by a US-based global medical device
company—CRO NAMSA in the year 2022. It is interesting
to note that the acquisition occurred even before the
completion of five years of its foundation. Such has been
the impact of Maria’s leadership. This acquisition will
allow NAMSA to expand its expertise and ability to meet
the growing demand for safe, efficient clinical development
and commercialization services for medical devices.
About AKRN
AKRN is a medical device CRO with specific expertise in
European medical device law that develops and conducts
clinical investigations and performance studies in
compliance with the requirements outlined in the medical
The European Association of Economy and
Competitiveness awarded Maria Nyakern with the
Isaac Peral National Prize for Research, Science, and
Innovation 2022 to recognize the research work
carried out by AKRN.
The European Association and its jury recognized the
success of AKRN as a medical device CRO and Dr
Nyakern'scapacity for "entrepreneurial leadership
within the European framework."

device regulations EU MDR 2017/745 and EU IVDR
2017/746.
She informs, “We have an excellent track record of meeting
short turnaround times, which is extremely important for
medical device startups during the development phase.”
This helps AKRN to facilitate its services when one needs
to reach critical clinical milestones that can demonstrate a
new technology’s value and guarantee the subsequent
financing round. The AKRN team has specific competence
in devices in the cardiovascular therapeutic space and aims
to be the most experienced and knowledgeable European
CRO in this field today.
Diverse Offerings
The core of AKRN's business has been to set up and
manage medical device clinical investigations according to
Good Clinical Practice (GCP) for medical devices and the
ISO standard 14155:2020. Maria's medical and clinical
research background has ensured that clinical trials are set
up and executed according to good clinical practice and has
always been the cornerstone of her leadership.
As a parcel of their basket of service offerings, her team
also supports manufacturers with several important
regulatory and technical documents, including Clinical
Evaluation Reports (CER), Performance Evaluation Reports
(PER), Summary of Safety and Clinical Performance
(SSCP), and more.
Along with its top offerings, AKRN consultants help
companies transition their device development from the
medical device and IVD directives (MDD and IVDD) to the
recent European regulations EU MDR 2017/745 and EU
IVDR 2017/746. Also, they provide guidance on
implementing a medical device quality management system
as per to ISO 13485:2016.
Optimizing Regulatory Services for Clients
AKRN's services are grounded in medicine and science and
assist its MedTech clients and partners in moving from
medical discovery into clinical development,
commercialization, and post-market follow-up.
Its multidisciplinary team comprises research specialists
and clinical professionals having higher scientific
knowledge obtained from Ph.D., Pharm.D., and Masters in
Clinical Research programs. Such strength of its high level
of scientific and clinical expertise helps the company to
optimize and offer services in a cost-conscious and diligent
manner that are highly valued by AKRN's clients.
AKRN experience covers a wide range of medical device
therapeutic areas, including neuroscience and
cardiovascular devices. Additionally, the organization is
highly fluent in more than ten European languages, which is
very important to master when working in a European
setting and with competent national authorities and ethics
committees.
This multidisciplinary team is also able to offer a single
point of contact, with the benefit of strong senior
management support, which facilitates working with SMEs
and MedTech partners that need both “boots on the ground”
and executive strategy and support. She proudly says, “Our
team has proven to have solid knowledge in the clinical
research industry, with specific insights and expertise in the
European MedTech setting that can help our clients meet
their goals. “That, combined with a genuine passion for
medical device technology and supporting small and
emerging MedTech manufacturers and startups!”

For women, the leadership
journey is not linear, and we
must deal with obstacles along
the way, and I really believe in
helping women who want to
achieve more.
She feels that her clients and partners view her organization
as trusted and valued advisors in clinical investigations,
regulatory development, and CE-mark strategic consulting.
Women and the Medtech Industry
On a broader spectrum, gender inequality is not a MedTech-
specific challenge. The female ratio of CEOs and founders
in startup verticals in medicine and technology is less than
20%, which is in line with most other startup sectors. In
contrast, as per the World Health Organization, women
account for 70% of the global health and social care
workforce.
She opines that gender inequality leads to a severe lack of
focus on women’s health issues in medical research. So, it
is clear that the industry needs to innovate for women and
needs more innovation by women in healthcare.
Maria mentions that supporting emerging female leaders is
the key, particularly while the world still has few role
models. Education, Coaching and Mentoring, and having
allies is critical, and the industry must highlight how
‘female’ leadership can complement the traditional, more
male leadership.
Maria shares, “As a business owner and entrepreneur, I’ve
had the opportunity to support women’s growth and
persuade them to take chances and try new roles. I feel
humbled to see how well my audience has responded and its
impact, ushering more women into the medical device
industry. Because as important as it is to have a pipeline
and role models, we also need allies that encourage you to
strive for more and say, Of course, it should be Me!”
She is personally inspired by the capacity and leadership
shown by the talented women in her organization. AKRN
has many young female role models within the company.
All across AKRN and NAMSA, women in leadership
positions are a living testament to the many ways women
are lighting the way.

An Advice to Excel
In the interview interaction, Maria opinionated on the
significance of providing entrepreneurs with funding,
coaching, mentoring, and business support to develop their
ideas.
She says, “As an entrepreneur, you also need courage and
tenacity to provide arguments about why someone should
invest in you and your business idea.”
Maria is also a defender of being “Humbitious,” a term
coined by the executive coach and distinguished Trinity
University professor Dr. Amer Kaissi that speaks about
finding the right match between being humble and
ambitious. She brings to notice the way in which Dr. Kaissi
shatters the common myths about leadership being an ego-
driven game and talks about the power of low-ego and
high-drive leadership.
Her advice to people is to reach out to others for help and
not be afraid or ashamed to connect with those business
leaders who inspire them. She says, “Send them an email,
connect with them on LinkedIn, or ask a mutual contact for
an introduction. Good leaders are always willing to give
you their time and guide you to succeed.”
Dr Nyakern is passionate about supporting budding
entrepreneurs and making the path easier for others. She
delivers a powerful message that says, “My leadership
story started as a young girl without industry connections,
mentors, or allies. All I had was a powerful desire to
achieve and prove myself. My tenacity and courage helped
me get to where I am today.”
Path for the Future
By partnering with NAMSA, AKRN aspires to continue
increasing its presence globally and in Europe. With the
expanded expertise of the combined organizations, they
believe that the organization will serve as the world's
leading CRO for cardiovascular research services.
Maria proceeds to inform that the acquisition of AKRN by
NAMSA will increase their global scale and will help them
serve MedTech clients across 19 locations throughout
APAC, Europe, North America, and South America.
As the worldwide leader in the medical device testing
industry since 1967, NAMSA's complete continuum
development services help clients overcome development
hurdles, mitigate concerns and streamline
commercialization efforts.
Highlighting the importance of changing dynamics of
healthcare worldwide, Dr Nyakern explains, “As we
prepare for future health challenges, we know there will be
no single solution or answer. That’s why we must keep
building our team today, with people from all backgrounds
and experiences — including, but not limited to, brilliant
women — so that the innovation reflects all of us and a
healthier future with more robust health systems and a
renewed and refocused cross-sector collective of new
leaders.”
“At AKRN, now a part of NAMSA, we will continue
working to be the first and most trusted MedTech CRO in
Spain, Europe, and beyond,” concludes
Dr Maria Nyakern.

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Digital Health
www.insightscare.com
November | 2022 18

Telehealth
OVID-19 is a big term in today’s world. Since the
Cpandemic, if people have experienced something
good, it is the delivery of healthcare, and health
information services via remote technologies.
Before the pandemic started visiting a doctor, a hospital or a
clinic was a hectic task to do which involved longer waiting
time and delayed appointments. The efficiency,
effectiveness and cost associated with telehealth were
rewarded with disbelief by providers and patients alike.
However, the pandemic and the lockdown have pointed out
telehealth as an essential and good innovation to have,
especially in the crisis.
Post-pandemic, we can experience telehealth resulting in
virtual check-ups and remote diagnosis with effective
measures to treat the patients with the best methods
possible. During the pandemic, many people started to use
these services to fulfil their medical needs. In the process,
people discovered that telehealth is providing far more
amenities compared to video visits between patients and
healthcare providers.
We can assume the numerous advantages of telehealth for
both patients and healthcare providers post-pandemic.
and its Scopein the
Post-Pandemic
WORLD
www.insightscare.com
November | 2022 19

Ÿ Convenience and comfort
One obvious advantage of telehealth is the comfort and
convenience of having a medical visit without physically
travelling to the doctor’s office or clinic.
Telehealth visits will easily fit into patients’ busy schedules.
As the patients will have an option to meet their health
experts or physician using any electronic gadget such as
phone, tablet, laptop, or computer, patients can access or
schedule an appointment whenever they will have free time.
In addition, those patients who are injured or in the stage of
recovery will not have to travel to the clinic or hospital for
their check-up as telemedicine will allow these patients to
stay in a safe and comfortable environment.
Ÿ Suitability of care
With telehealth, the patients will easily receive the care
when they will need it and they will not have to wait for an
appointment. In emergency cases, telehealth will allow the
patients to receive care immediately, and help them until
they will reach the hospital.
One of the advantages of telehealth we will experience soon
that is: telemedicine will be accessible on weekends and
holidays, especially when healthcare and clinics are closed.
Telehealth will offer us an alternative source of immediate
care.
Ÿ Controlling the spread of infections
Telehealth is currently an excellent way to help and control
the diseases that cause infections and illness, recent
example is COVID-19. Telehealth protects both healthcare
professionals and patients by holding patient-clinical
meetings at a distance, making it the most effective way to
control the spread of infections.
Experts already assume that telehealth will soon come up
with enhanced methods to control the spread of infections
and treat the patients with additional precise medication
required with advanced technology.
Ÿ Telehealth will provide a better assessment
It will be an advantage for some specialists to treat the
patients in their home environment when they will be
assessing their condition. Observing the surroundings will
provide the doctors with the data that will help to
understand the patient’s condition.
As per the experts’ prediction, neurologists and physical
therapists will find it easier to observe the patient’s ability
to navigate their home environment while undergoing
treatment.
Ÿ Telehealth will be responsible for family connections
It will be helpful for the patient to have a family member
with them when they will be undergoing treatment or a
consultation with their doctor. A family member will be
able to help the patients to answer the questions or
additional information.
In addition, a family member will be able to keep and
maintain a record of valuable information from the visits.
Ÿ Efficient cost-saving and management
Telehealth visits will not require patients to travel, and it
will help in lowering the secondary expenses. Telemedicine
will offer time and cost-saving by decreasing transportation
costs, reducing the need for childcare, and reducing time
away from work.
Analysis from the research indicates that patients who will
use telehealth will spend less time in the hospital and that is
going to reduce the associated cost of the additional
hospital bills and other expenses related to hospital
medication.
Eventually, telehealth will contribute towards reducing the
overhead medical costs, as healthcare providers will pay
less amount of money towards their facility’s additional
expenses.
By using telehealth in medical practices, even doctors can
make medical appointments easier, more convenient, and
less expensive for many of their patients.
The bottom line
Telehealth has been an invaluable tool, especially during the
COVID-19 pandemic. It has offered numerous advantages,
both in treating the patients suffering from COVID-19 and
treating patients with unrelated conditions from a distance,
contributing its services to prevent the spread of the disease.
However, looking at the advantages of telehealth we can
experience now, it can be assumed that these services will
contribute more efficiently and will continue to apply in the
post-pandemic world.
-Anish Miller
www.insightscare.com
November | 2022 20

Bridging Healthcare with Technology Leadership
houlder pain. Arm weakness. Elbow joint deficiency.
SUpper extremity disabilities are not only major
afflictions for patients but can physically burden
therapists and challenge the productivity of clinics.
As a result, technological inventions have come to the
forefront, including assistive technology. The use of
assistive technology for upper limbs is a rapidly growing
area, and has led to improvements in chronically impaired
patients’ ability to function.
It also has the potential to reduce long-term costs. One
study co-funded by the U.S. Department of Veterans Affairs
and the Rehabilitation Research and Development Service
demonstrated clinical benefits for robotics-assisted therapy
and showed lower total costs of care when factoring in
therapy and downstream healthcare costs.
With the demand for such innovations estimated to reach
$3.5 billion in 2026, leaders like Angie Conley are
mesmerizing the world with their share of inventions in the
field to fulfill this rising demand.
Her thoughtful efforts to provide relief for shoulder and arm
injuries in the comfort of one’s home led to the creation of
Abilitech. The company facilitates the rehabilitation needs
of people with the Abilitech Assist Device, which is an at-
home device that regularly aids activities of daily living.
Under Angie’s leadership, Abilitech Medical has won
numerous awards, and she is also named as an inventor on
two patents. As the CEO of the company, she believes in
the discipline established by inculcating mission, vision,
and core values. She places the organization’s mission to
restore independence to people who live with
neuromuscular weakness and its core values of people,
impact, innovation, and results at the heart of Abilitech.
This has enabled them to be renowned as what their
customers call – A Wheelchair for the Arms.
Through the interview highlights below, let us delve deeper
into her journey of shaping the MedTech device industry
with Abilitech!
Angie, could you brief us about your inspiration behind
venturing into the MedTech industry?
I have always been attracted to helping other people. My
father was a physician, and my mother was an educator
who set good examples of loving their work and serving
their community. They always told me to find what I love,
to do that well, and the rest will fall into place.
In 2015, I saw a video of a 3D-printed exoskeleton that
helped children move their arms for the first time. The
social impact of that device was captivating. I looked
further into the technology and learned of the enormous
unmet need.
When people lose the use of their legs, the basic standard of
care is to get a wheelchair. And when people lose an arm,
they get a prosthetic arm. Until Abilitech, there were no
good commercial solutions to help people who have weak
or injured arms.
My medical device background at Medtronic provided the
business acumen and relationships to build a first-class team
and a product that I am passionate about!
Please tell us about your journey in the industry,
highlighting your contribution to Abilitech’s success.
When I founded Abilitech, I was guided by strong input
from clinical experts interested in seeing a portable assistive
technology become commercially available for patients
who had lost the function of their arms due to stroke and
other neuromuscular conditions. They believed that moving
with intention and repetition would help these individuals
gain strength.
5 Most Empowering Women Leaders in MedTech Industry in 2022
www.insightscare.com
November | 2022 22

Angie Conley
Chief Executive O cer
Abilitech Medical, Inc.

They maintained that an at-home device, regularly aiding
activities of daily living, could help with rehabilitation.
Reimbursement considerations and the need for large
clinical studies shaped our commercial product strategy to
focus on the activities of daily living because we could
demonstrate patient-specific outcomes within minutes. It
also allowed us to focus the resources on a small market,
learn about our device, and expand from there.
We have worked with key centers of excellence to better
understand different populations with our Abilitech Assist
device and refine who we can help, and determine how our
technology needs to evolve to help more people and new
indications.
Could you elaborate upon the core values on which the
company is built, and what is the mission of the
organization?
I cannot overstate the importance of emphasizing the
mission, vision, and values to drive the company. I saw this
work very effectively at Medtronic, and it always brought
great meaning to my work. At Abilitech, we also use our
mission, vision, and values as our north star.
Startups are hard. They require long hours, can have limited
resources, and the job market is extremely competitive. Our
mission (to restore independence to people who live with
neuromuscular weakness) and our values (people, impact,
innovation, results) are worn proudly and are not just some
corporate speak.
A highlight of my work is our weekly team meeting, where
It is important to create a
culture where employees feel
safe to try new things.
Experienced leadership can
help to translate the learning
from failures into future
success.
www.insightscare.com
November | 2022 24

I get to hear employees share how they are realizing our
mission and values in their individual job duties. These
guideposts help us stay motivated and focus on what’s
important. They have become a tangible way through which
we have recruited and retained the top industrial talent.
Tell us more about the services and the immersive
benefits that make your company stand out from the
competition.
We target patients with a manual muscle test of two or
greater in the shoulder and elbow, and it’s thrilling to see
our Abilitech Assist device help many of these individuals
in performing daily tasks that they couldn’t otherwise have
accomplished. Many patients call us the “Wheelchair for
the arms” and say that they feel like their arms are floating
in the water. To make the technology available in their
home environments is the icing on the cake.
There are no other commercial devices used in the home
that can support both the shoulder and elbow and adjust for
different weighted objects, whether that’s a spoon, cell
phone, or 12-oz. glass of water. Assistance at the shoulder
helps people lift their arms with controlled movement
repeatedly, to accomplish activities of daily living.
Please elaborate on the technological developments and
the patented technologies that the company incorporates
when catering to the dynamic needs of the MedTech
Industry.
We have a robust intellectual property portfolio with the
freedom to operate analysis. Central to our IP is the ability
to dynamically adjust for different weights and to have both
a shoulder and elbow assist.
What are the biggest challenges that you have faced,
and the most important lessons that you have learned in
your professional journey so far?
The two major headwinds we have faced in recent years are
COVID and the very complex reimbursement terrain in the
U.S.
Physician and clinician fatigue is very real in this
pandemic-affected environment, and the people we work
with are immunocompromised. In a very short amount of
time, we flipped our sales model to market direct to patients
and built out a tele-evaluation assessment program.
Additionally, the U.S. reimbursement is ever-changing, and
there is a shift from fee-for-service to models considering
the overall cost of care, such as Medicare Advantage.
Ultimately, this should be a good thing for Abilitech when
considering the potential to reduce other medical costs, help
people live longer and more independently in their homes,
delay or avoid the expense of skilled nursing homes, and in
some cases, return to work.
Being an experienced leader, what is your intuitive
advice for the budding youngsters venturing into the
MedTech industry?
Embrace your organization’s mission, vision and values
early on to help guide you through important decisions.
Seek teams with delicate balances of complementary skills,
experience, potential and personalities. You need some
leaders who know how to get things done, and in medical
device, it is essential that you do things right the first time.
But lateral thinking is important, too. Experience from one
field with a new application can lead to great creativity.
Make sure you understand reimbursement and how your
organization gets paid best. This drives so many decisions,
impacting product design, clinical studies, sales channels
and strategy, and more.
The learning mindset is important. Developing a new
technology is not easy and you are bound to make mistakes.
Failure can also be a way of learning, especially when it
happens at an early stage of the development process.
It is important to create a culture where employees feel safe
to try new things. Experienced leadership can help to
translate the learning from failures into future success.
Lastly, spend time in customer discovery. Look at all your
stakeholders and understand the value proposition to them.
Study the competitive landscape and learn what has
historically worked and where the pitfalls have occurred.
It’s more efficient to be a fast follower!
www.insightscare.com
November | 2022 25

n most parts of the world, parents love their sons more
Ithan daughters, they seem to have the perception that
more investments should be put into the males because
of course, they would carry on the family name and legacy.
Even in marriages, where the woman has no respect nor
value unless she gives birth to a son. The preference of the
male child over the females has also contributed largely to
menace of gender inequality, decline in girl child education,
and socioeconomic disparities.
This ideology is propagated by certain cultural beliefs,
illiteracy, societal restrictions, religion and emotional
desires, male dominance as only ones in charge of family
income, perceived weakness that females can't attain certain
positions, amongst many others.
I grew up in a family of seven (Parents, three sisters, and a
brother). I’m the last child with my twin sister, and was told
mum wanted a second son, but oh well, she had two more
girls and twins at that, how funny. My parents actually
didn't obviously make a preference over my only brother,
maybe to protect “our feelings” or not. However, we got
equal education, resources, and support. This may have
worked for me, but not for others. I once had a friend whose
case was the reverse, it affected her upbringing, damaged
her self-esteem, and created a barrier to discovering her true
self and abilities. It hindered her ability to explore, to crown
it all; she got married early- this is a story of a million
I am Nancy Udenka, founder of Teenage Mom Initiative
and I celebrate the International Day of the Girl Child.
A Physiologist, Medical doctor (in view) at Shenyang
Medical College, MPH (one of my goals) Health scholar
and an adent Mental Health advocate on a mission to
acquire prominent leadership skills in emergency
responses, and first-hand experience in research and
operations.
I hold Bachelor's Degree in Physiology, General from
Anambra State University. Community Volunteer on
Health at Nigerian Red Cross Society. Certified by
LinkedIn in Customer Experience Leadership, and
Customer Service: Managing Customer Expectations,
and Customer Service: Problem Solving and
Troubleshooting. And Customer Service Representative
Certificate by Alison.
A philanthropist and exponent towards mental health
among teenage mothers.
Ÿ Founder, TEM Initiative
Ÿ Content creator @Youtube
Ÿ Public speaker
Ÿ Co-founder NANPAT MD Limited
You will find Nancy where they are talking about; The
United Nations Sustainable Development Group
initiatives, Venereal Health, Public Speaking, Teen
Mental Health, and Reproductive Health.
www.insightscare.com
November | 2022 26

Nancy (Chinelo) Udenka
Founder
Teenage Moms Initiate (TMI)

others. In Africa, especially in the western part, research has
proven records of a high prevalence of child marriage prior
to her physical and/or emotional growth. Not ignoring the
fact, they get pregnant and have to experience child labor,
and risk of complications during delivery, overall negative
impact on their mental wellness, and sexual and
reproductive health.
The future of the girl child as an endangered species
amongst her male counterparts and sadly, even her fellow
counterparts, must be protected at all costs. It’s high time
we stopped distributing sweets only when a baby boy is
born and frowning when a girl is born. Time to put a halt to
uttering coated sarcasm “this is a rare thing for a girl to
achieve” when a change in a chain of cycles is encountered.
It shouldn’t be considered a deviance that a daughter can do
the job of a son.
The Girl Child Time To Rule Her World Is Now or
Never
Now the narrative is changing, no longer shall our voices
go unheard. Every girl has the right to attain greatness and
harness her full potential, there should be no limitations as
to what level she should stop.
Gone are….
Days when the girl child isn't recognized:
Days when the girl child shouldn't be educated:
Days when the girl child shouldn't be in power:
Days when the girl child is voiceless:
Days when the girl child's roles were only limited to
marriage and childbearing:
Days when the girl child future ends in the kitchen:
Days when the girl child isn't allowed to dream big:
We must instead look on the bright side and embrace this
beautiful astonishment, that is, the power of a girl child.
Ÿ We, the daughters are stronger than the world thinks.
Ÿ Stronger than our parents think.
Ÿ Even much stronger than we think of ourselves.
Ÿ We shouldn't let criticism stop us from reaching the
top, and allow nobody to make us feel inferior without
our own consent.
I’m excited as to the adverse change going on in the lives of
girls, campaigns bursting out to promote girl child
education to let her dream big and fly without limitations.
There is great need for a strategic alliance among
individuals, educational bodies, private entities, as well as
national and international bodies, to properly tackle this
issue. Social media platforms can serve as aid for
promotions, campaigns to create awareness and raise a call
of action.
“With adversity, however, comes resourcefulness, creativity,
tenacity, and resilience. The world’s 600 million adolescent
girls have shown time and time again that given the skills
and the opportunities, they can be the changemakers
driving progress in their communities, building back
stronger for all, including women, boys and men.
Girls are ready for a decade of acceleration forward. It is
time for us all to stand accountable – with and for girls –
and to invest in a future that believes in their agency,
leadership and potential.” (UNITED NATIONS)
I’m very passionate about teen girls, with focus on their
mental health, sexual and reproductive health. Both of these
areas are de-emphasized and not well addressed. Parents
shy away from proper conversation about sex, educative
institutions doesn't promote abstinence and the environment
doesn't preach about preventive measures as it should. This
has led to increase in teenage pregnancies, school drop out
of teen girls, socioeconomic inequalities, increased poverty
amongst other negative impacts.
I am an advocate of the United Nations SDG 3.7 target plan
with more focus on the indicator 3.7.2 Adolescent birth rate
(aged 10–14 years; aged 15–19 years) per 1,000 women in
that age group, as well as SDG 5.3 target plan, emphasis on
the Indicator 5.3.1 Proportion of women aged 20–24 years
who were married or in a union before age 15 and before
age 18.
Through my organization TEMI, we’ll keep striving to
encourage workshops, campaigns, outreaches and open
discussions to tackle this menace. You too can be part of
this movement by engaging in community development
programs, empowering young girls, volunteering, and
donations.
www.insightscare.com
November | 2022 28

igital technology has transformed
Dalmost every industry sector, including
Education, Retail, Banking,
Manufacturing, IT, Communications,
logistics, healthcare, hospitality, etc.
The Healthcare industry, which was traditionally
operating, got a big boost from digital
transformation. This sector needed the most modern
and superfast systems at all levels due to the gravity
of importance at any given stage.
Primarily as we consider the basic points of
operations, mainly R&D, consultation, diagnostic
and pathological procedures, medication,
treatments, hospitalization, monitoring, and
Transformations in
Digital
HEALTHCARE
Look
OUT
for in
to
www.insightscare.com
November | 2022 30

analysis; digital technology has been created as a multi-
disciplinary concept integrating all the vital work procedures
in a single line to be easily connected, reviewed, and
enhanced in the main objective of the process.
Technology has penetrated all functional sections of the
healthcare industry in many ways.
Dynamic Resource gateway: Having opened the vast
internet resource and accessibility to multiple global research
laboratories, doctors and clinical scientists are better
equipped with searching for necessary medical knowledge
resources. It has helped in recruiting the medical staff,
sourcing visiting consultants, and connecting with numerous
diagnostic centres and blood banks.
Strengthening the Research and development. The
scientists in various domains of medical research use modern
technologies of AI, Augmented reality, data assimilation, and
processing.
Facilitating clinical research and support. This involves
designing and developing epidemiological service trials,
developing and customization in the process of collection
and management of clinical data, and further analysis.
Monitoring the quality of healthcare. The entire process,
right from patient enrolment to the quick data collection,
periodical diagnosis and related treatments, monitoring of
changes in the results, creating an analysis of the treatment
with the doctor's opinion, have all improved the quality of
the treatment. Precise diagnosis coupled with the right and
timely medication or treatment results in recovery in the
minimum time period.
Real-time tracking: Inventory tracking, storage, and
management are crucial functions for any medical facility.
All the essential drugs, medicines, vaccines, consumables,
accessories, medical aids, blood units, plasma, etc., need to
be stored in sufficient quantity. This includes the availability
of Doctors and ambulance services.
Streamlining the entire process. The entire process is
unified in a central system that helps in easy tracking,
coordination, updates, reports, analysis, surveys, and
analytical study.
Global Connect: Enabling the role, opinion, and
consultation of multiple Doctors, researchers, and joint
consultation on critical procedures.
Quick and easy communication. Digital technology has
made entire communication easy, smooth, and seamless.
Regardless of the location of the consulting physicians,
diagnostic centres, and other facilities, all things can be
Embracing Innovations
easily connected under one system without the need to move
the patient.
Round-the-clock assistance: 24X7 and 365 days dedicated
functions have boosted in saving the lives of patients in
accidents or other medical emergencies. Quick, timely
medical support has steadily controlled the death rate.
Remote consultation: Modern integrated software platforms
connect the patients easily to the doctors through audio or
video calls facilitating the data sharing for clear
communication and patient experience.
Smart projection: Modern tools in software systems that
read, identify, and analyse in their built-in frameworks; help
in the creation of smart, accurate, and logical projections.
Close monitoring in various stages of pregnancy in the foetal
development and response to the expected growth
parameters and also in the sectors of fertility solutions,
oncology, and cosmetic surgeries.
Real-time consultation: Virtual meeting platforms have
helped in Audio-visual interactions for real-time
consultation.
Data Science: Data management and analytics in important
complex case studies have strengthened the decision-making
process helping in various stages.
Wearable technology: Modern devices like heart monitors,
pacemakers, hearing aids, automated wheelchairs have made
the treatment and the life after treatment easier.
Robotic applications: A better control, accuracy, speed, and
reliability has been established in certain niche areas of
healthcare which are active assistance in complex surgeries,
disinfection, and sanitization, supply-analysis-delivery
operations, patient care with symptom analysis, assistance,
etc.
The Journey Ahead
The role of digital technology has miraculously elevated the
quality, accuracy, and speed of the procedures resulting in
faster recovery and well-being of the patients. We can gladly
look up to the phenomenal advancements and the magnitude
of its efficacy that has transformed human lives into a
blessed lifestyle.
www.insightscare.com
November | 2022 31

hat if questions were not asked? What if the
Wexisting challenges were not solved? And what if
the world still believed in the facts bestowed
through the loops of hierarchical levels?
Can’t imagine a world like that right?
That’s more of a reason to thank the leaders, who stepped
up, questioned the problems, and solved them innovatively
to present an easy-going path for all in the future.
In this list of such exemplary leaders, we at InsightsCare
crossed paths with Mabel Gimeno who is transforming the
lives of many patients who are diagnosed with vision-
related challenges. Though she comes from an educational
background in the Arts field, she has effectively utilized her
innovative leadership skills to intricately design solutions
for early vision care. She presented these solutions to the
healthcare world when she cofounded DIVE Medical with
Victoria Pueyo and made a big jump in the MedTech sector
in 2020.
As the CEO and Co-founder of this startup, a pioneer in
early vision care with eye-tracking and artificial intelligence
technologies, she is currently immersed in its commercial
launch.
Through the interview highlights below, let us indulge in
her contributions in changing the MedTech sector with her
innovative and visionary leadership!
Mabel, kindly brief us about yourself and motivate us
with the inspiring tale of your professional journey so
far.
I have a degree in BA and an MBA from IESE. After
starting my career in marketing departments in FMCG
companies that belonged to P&G or Danone, I have spent
20+ years in management positions in SMEs, reaching the
General Management of Araven, a B2B company selling in
more than 40 countries.
After taking the leap into entrepreneurship by creating my
own innovation food consultancy, I made a big jump to the
MedTech sector in 2020 and co-founded DIVE Medical
together with a group of researchers from the University of
Zaragoza and the Health Research Institute of Aragon, in
Spain.
As the CEO of this startup, a pioneer in early vision care
with eye-tracking and artificial intelligence technologies, I
am currently immersed in its commercial launch.
What has been your source of motivation and
inspiration in your in achieving your career milestones
and becoming a successful leader in the MedTech
industry, especially as a woman leader?
My curiosity and love for big challenges determined my
interest in a career related to marketing and innovation,
where I achieved relevant milestones in building new strong
brand positionings and launching successful new products.
Transforming the Methods for Early
Eyecare with Innovative Tech Solutions
WHAT WORKS BEST FOR
ME IS TO WALK EVERY
MORNING FOR AT LEAST
HALF AN HOUR. IT HELPS
ME ORGANIZE MY BUSY
MIND AND WHEN I START
MY DAY EVERYTHING
FLOWS BETTER.
www.insightscare.com
November | 2022 32

Mabel Gimeno
CEO and Co-founder
Devices for an Integral Visual Examination

I gradually moved to smaller companies and different
sectors where building things from scratch, working in
multidisciplinary teams, and finding ways to develop
successful business models in international environments
became my motto. I am now applying all my business
knowledge to the MedTech sector with the support of
partners with extensive experience in accessing private and
public health customers.
In this case, the impact we can have on millions of patients
with low vision adds extra motivation, since I have
experienced what a late detection of a vision problem can
have on a child with my youngest child.
Please tell us about DIVE Medical and what were the
ideas and developments that led to its inception.
DIVE Medical S.L, is a MedTech company that offers a
proprietary technology based on eye tracking and artificial
intelligence for screening and complete examination of
visual function in a fast and accurate objective manner. It
caters even to patients with cooperation problems such as
preverbal children and people with cognitive problems or
elderly people.
We live in a world where more than 1 billion people live
with low vision worldwide, one third of the 810 million
children with vision problems are not detected early and 25
percent of children have vision-related learning disabilities.
In this world, Victoria Pueyo, a pediatric ophthalmologist in
a tertiary care hospital in Spain and co-founder of DIVE,
was faced every day with patients with whom it was very
difficult to get objective data on how their vision was in the
past and to make good decisions. These are the most
vulnerable patients, babies, or those who present
cooperation problems in visual examinations due to
neurocognitive causes. And she knew that technology can
be of great help to them.
Her meeting with computer engineers was critical to start a
project and after 6 years of research, DIVE Medical was
founded as a spin-off of the University of Zaragoza in
February 2020, and that is when I joined the project for its
commercial launch.
Currently I lead a multidisciplinary team of 13 people,
made up of healthcare professionals, engineers and business
and marketing profiles.
What are the products and services that your company
offers and how is it impacting the demographic
concerned?
Our technology has two main fields of application with two
different software modules in a unique device:
Ÿ In examinations of visual function by vision
specialists, ophthalmologists and optometrists,
providing objective metrics not dependent on the
examiner for diagnosis and monitoring the effectiveness
of treatments.
Ÿ In visual screening performed in primary care
providing an immediate indication of the need or not for
referral to a specialist. By applying AI to the metrics
obtained, the screening can be performed by personnel
with minimal training.
We are able to explore children from six months of age and
people with neurocognitive diseases with a greater
accuracy.
www.insightscare.com
November | 2022 34

How does your company ensure maximum care for
nonverbal patients too? How is it revolutionizing the
sector?
The team has been really obsessed from the beginning of
the project to make our technology capable of reliably
testing the most vulnerable groups, the patients that cannot
provide feedback on what they see.
It has been essential to make clinical trials in five countries,
Spain, Mexico, China, Vietnam, Russia and Hong Kong,
with patients from six months of age, affected by a large
number of visual pathologies, and also with disabled
patients.
We have recently submitted a patent covering the methods
and processes to validate the eye tracking data for
performing different tests.
In what ways are you adopting emerging technologies to
upgrade your deliveries? What has been the success and
impact of eye tracking and Artificial intelligence
technologies that you are currently using in your
operations?
Since our software relies on these technologies their
contribution has been the key, but in order to reliably screen
such difficult patients we have developed very deep
methods and processes.
These allow us to really have reliable data for patients who
are uncooperative or have limited visual function.
Moreover, as AI experts we have been able to elevate the
potential of eye tracking technology and respond to the
needs of a collapsed and under-resourced healthcare sector.
Being a leader comes with greater responsibilities. How
do you manage the stress behind them and what do you
do to practice a healthy work-life balanced lifestyle?
What works best for me is to walk every morning for at
least half an hour. It helps me organize my busy mind and
when I start my day everything flows better. I also walk
throughout the day as much as I can and take Pilates
classes.
I eat healthy and try to have lunch or dinner with my
husband and my three teenager children. Sharing with them
is also very important for my balance. On weekends,
besides having fun with friends, I try to do as much as I can
of my two passions: going to concerts and hiking in nature.
What would be your advice to aspiring entrepreneurs
wishing to enter this industry?
Coming from other sectors I have to say that the healthcare
sector is particularly challenging due to regulations, the
need for strong clinical evidence, reluctance to change...so
“be patient” is my first advice.
I would recommend to start contacting the healthcare
ecosystem (accelerators, start-ups, advisors) as early as
possible to avoid any mistakes that cost time and money.
And last, but most important, don’t dare to start selling
from day one, even if you only have a first concept.
What are the future goals of DIVE Medical? How do
you envision upscaling its operations and reach in 2022
and beyond?
In November 2022 we will reach a major milestone, with
the MDR CE marking of our first product. Our goals are to
position our brand among ophthalmologists in Europe and
then expand to other geographies such as America and Asia
with the best distributors in each country.
In terms of R&D, we will gradually incorporate new tests to
become a more comprehensive solution that will appeal the
vast majority of eye care professionals.
Please share any clientele, awards, and recognitions.
We already have some devices booked and will close our
first sales in Spain by the end of 2022.
We were selected in 2020 as one of three healthcare
companies to invest in by Banco Sabadell. We have also
received different grants from the Spanish Ministry of
Innovation and recently received the Seal of Excellence
from the European Union.
We have been recognized with the Emprendedores XXI
and GooDs awards among others.
And, we have been selected to participate in
entrepreneurship programs of first level institutions, EIT
Health, Ship2B, Rafael del Pino Foundation and MIT Sloan
School of Management and ESADE with experts from
Silicon Valley.
5 Most Empowering Women Leaders in MedTech Industry in 2022
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November | 2022 35