Europe's Top 5 Medical Device Companies to Watch in 2023.pdf

January
Issue 04
2023
Palliare
Taking Healthcare to New Heights
Companies to
Medical
Europe's Top
Watch in 2023
Industry Insights
Understanding The
Aspects That Empower
Innova ons In Europe’s
Medical Devices
Key Approaching Measures
Transforma on Approaching
In Leading Medical
Device Companies

Be er Health and
a better way of life.

Editor’s
Note
ow patients receive care, has been shifted
Hfrom hospitals to the comfort of their homes.
Today, a rising number of people prefer to
maintain their sense of autonomy and independence
by taking greater responsibility for their health, rather
than handing it over to doctors. Technological
advancements such as the use of medical devices
today are proving to support these health-conscious
individuals in their journey of health. For instance,
instead of waiting long hours at the doctor’s clinic,
patients could keep track of their diseases such as
diabetes or hypertension which enables them to make
lifestyle choices accordingly.
Some assistive medical devices are in use for a long
time, such as dosing cups for the administration of
medications, ﬁrst aid equipment such as
thermometers, heating pads, and prosthetic devices
such as artiﬁcial arms or legs, and other related. But
recently, newer medical devices are starting to migrate
there.
SHIFTING THE
DYNAMICS OF CARE

They are presenting newer opportunities for both
healthcare professionals as well as consumers to
deliver and seek health in a safe, usable, and cost-
effective manner.
The growing sophistication of medical equipment has
significantly improved the health of the individual and
society. It has improved individual survivability in the
face of disease or injury, greatly enhancing patients'
life through an accurate diagnosis and therapeutic
results. But it is not the only benefit that the
advancement has brought. With the climbing costs of
healthcare facilities as well as the lack of enough
healthcare staff who can attend to every minute
concern of the patient, the medical devices act has
eased the tension and improved healthcare sustainably
for both the patients and healthcare providers. In the
following edition of Insights Care, “Europe's Top 5
Medical Device Companies to Watch in 2023,” we
present you those companies who have lifted
healthcare to a whole another level, through their
innovative services within the medical device
industry. If you are enthusiastic about medical
devices, then the following companies will not only
inspire you but also provide you with meaningful
insights that have led them to the position they are in
today.
We hope you have an insightful read!
Abhishek Joshi

Cover
Sto Taking Healthcare to New Heights
08
PALLIARE
C O

Articles
20
28
16
24
32
Transforming Eye-tracking
through Artificial Intelligence
DIVE MEDICAL
Novelties Ensuring the Quality of Life
MOWOOT
Leading with Precision, Care
and Confidence
INJEQ
N T E N T S
Industry Insights
Understanding the Aspects that Empower
Innova ons in Europe’s Medical Devices
Transforma on Approaching
In Leading Medical Device Companies

Editor-in-Chief
Pooja Bansal
Senior Editor
Anish Miller
Managing Editor
Abhishek Joshi
Assisting Editors
Saloni Agrawal
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
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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January, 2023
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Brief
Featuring
Company
Bredent UK Ltd
Bredent.co.uk
Stephen Denman
MD
Bredent UK Ltd. supply the dental market with
products from a single German manufacturer bredent
GmbH & Co located in Senden, south Germany.
DIVE-Medical
Dive-medical.com
Marta Ortin
CTO & Co-founder
DIVE Medical company has been dedicated to
enable precise and objective exploration of the
visual functions not only in children but in all non-
collaborative patients.
Injeq
Injeq.com
Maarit Forsten
Clinical Application
Manager
Injeq is a company that founded a solution to to make
lumbar punctures safer and more precise through its
Injeq IQ-Tip®, a spinal needle that detects gives out an
audio alarm to the physician after detecting spinal ﬂuid.
Palliare
Palliare.com
John O’Dea
CEO
Palliare, a company that is innovating in the
insufﬂation space, is working toward creating a safer
operating environment that provides better
physician control and patient outcomes
Companies to
Medical
Europe's Top
Watch in 2023
MOWOOT
Mowoot.com
Dr Markus Wilhelms
CEO and Co-founder
The company is known for its medical device
MOWOOT, which is a non-laxative solution against
chronic constipation.

Palliare
Taking Healthcare to New Heights
Palliare's vision is to
become the world technology
leader in advanced
insu ation by innovating to
meet the needs of minimally
invasive procedures.

mproving patient care with new technologies is critical
Ito continue to improve procedural outcomes and
patient quality of care. In recent years, there has been
significant evolution in many spaces within the medical
field that have benefited both patient outcomes as well as
providers’ ability to deliver top care.
Many of these advancements have come with a greater
focus on integrating technology into medicine.
Palliare, a company that is innovating in the insufflation
space, is working toward creating a safer operating
environment that provides better physician control and
patient outcomes.
We had the opportunity to speak with Palliare CEO John
O’Dea to learn more about this cutting-edge company and
the man behind its vision.
The Company’s Inception and Efforts
Palliare is an organization that has been a highlighted name
in the healthcare sector. CEO John O’Dea has a legacy and
reputation for being a leader in creating solutions to
challenges that medical professionals face during surgical
and endoscopic procedures.
Before Palliare, John founded a company called Crospon,
which operated in the endoscopy space and was later
acquired by Medtronic (NYSE: MDT) in 2017. During this
period, he spent ample time observing advanced endoscopic
procedures. In the last two decades, he observed the shift in
endoscopy from being purely diagnostic to providing
surgical treatments.
Insufflation, where gases are injected into the surgical
cavity, had been left untouched and was not being evolved
to meet the needs of these more complex and longer
endoscopic and laparoscopic.
Regarding this concern, John says, “In the same period, we
have seen the evolution of laparoscopic surgery to robotic
surgery. Similarly, insufflators have only started to evolve to
meet the emerging needs of these procedures — particularly
concerning managing smoke evacuation and leaks from
trocars.”
From this observation, an opportunity was born to innovate
in the insufflator space and provide a safer environment and
better control for physicians conducting these cases. The
company created a compact insufflator tailored to the
evolving needs of endoscopic, laparoscopic, and robotic
surgery.
An engineer by trade, John spent his early career working
for Puritan Bennett, where he designed ICU ventilators.
Later, in 1998, he Co-founded Caradyne, which developed
non-invasive ventilation products for ER and NICU
settings. The company was acquired in 2004 by Respironics
(NASDAQ: RESP).
In 2007, he founded Crospon, which developed a novel
diagnostic product called EndoFLIP. This device assesses
sphincter performance and motility in the gastrointestinal
tract. This company was acquired by Medtronic in 2017
(NYSE: MDT).
John shares, “In 2018, a year after Medtronic acquired
Crospon, I founded Palliare. We received FDA clearance
for its flagship insufflator device, EVA15, in 2020. We offer
two leading solutions: the EVA15 and the EndoTrap, and
our vision is to continue to evolve the EVA platform to bring
more innovations in surgical and endoscopic insufflation to
market.”
Products, Services, and Their Impacts
The EVA15 insufflator and smoke evacuation system
provides best-in-class laparoscopic, robotic, and surgical
endoscopic insufflation. It meets AORN guidelines on
surgical smoke evacuation, which is important to support
the safety of the OR and endoscopy suite staff and adhere to
a recent legislative drive to ban surgical smoke in the OR.
During the pandemic, John’s well-known legacy of
innovation brought him and Palliare a new opportunity. He
shares, “In 2020, during the COVID-19 crisis, we were
selected by the European Commission to design devices to
reduce potentially contaminated gases emitting from the
patient during surgery and endoscopy. The project, called
PORSAV (Protecting OR Staff From Aerosolized Virus), was
completed in July 2022. Two devices, EndoTrap and
LeakTrap, were developed by the project consortium for
which Palliare was the technical lead.”
EndoTrap was born during COVID-19 but continues to
have a strong role beyond it. The device is designed to
Europe’s Top 5 Medical Device Companies to Watch in 2023

improve staff safety by reducing exposure to airborne
particles during upper endoscopy and bronchoscopy
procedures. A protective barrier is created around the
patient’s nose, mouth, and endoscope using a single-port
anesthesia mask and viral filter, along with the EndoTrap,
which consists of a T-piece, a valve, and a protective sleeve.
EndoTrap is intended to be used during high-risk
bronchoscopy and upper GI endoscopy procedures.
The company’s main product, EVA15, is an insufflator with
a built-in smoke evacuation system. Any surgical smoke
removed from the patient is filtered through an ultra-low
particulate (ULPA) filter, which can trap particles down to
0.04um in diameter. This is important to protect OR staff
from smoke produced during these procedures.
A key aspect of the EVA15
design is that when smoke is
evacuated from the surgical cavity,
fresh gas is injected into the cavity
so that the surgeon experiences
no collapse or reduced visibility.
Pressure is sampled 100 times per
second so that the response to
evacuation is almost instantaneous
and there is no perceived change in
the pressure.

While talking about the EVA15, John adds, “A key aspect
of the EVA15 design is that when smoke is evacuated from
the surgical cavity, fresh gas is injected into the cavity so
that the surgeon experiences no collapse or reduced
visibility. Pressure is sampled 100 times per second so that
the response to evacuation is almost instantaneous and
there is no perceived change in the pressure.”
Envisioning the Future
In the coming years, Palliare is focused on moving the
insufflation field forward with exciting developments in
intelligent insufflation, such as advisory capabilities to
guide surgeons to the optimum insufflation pressure, thus
reducing the risks associated with hyper-insufflation.
Stating the primary goal of Palliare, John says, “We will be
exploring these techniques with the anesthesiologist
community, not only for the perioperative phase of a
procedure but also with a focus on exploring whether or not
smart insufflation can reduce postoperative pain for
patients. The company has a lot of exciting innovation goals
that will make procedures safer for the medical community
and help improve patient outcomes.”
The company is seeking to bring to market the world’s first
bi-level insufflator to allow insufflation pressures to be
quickly changed intra-procedurally, a feature of central
importance in new, emerging endoscopic surgery
procedures.
Challenging and Changing the Scenario
There is a strong legislative agenda, particularly in the U.S.,
to ban surgical smoke in the operating room. Many
insufflators can’t keep the pressure consistent when gas is
extracted by standalone smoke evacuation. As a result,
surgeons experience a compromised surgical field due to
decreased visibility when the gas is removed.
This technical issue has caused major concern in the OR.
Everyone agrees surgical smoke is dangerous, but so is
forcing surgeons to operate with sub-optimal visibility
during a procedure.
A newer insufflation technology, like EVA15, eliminates
this compromise and facilitates both a safer environment for
the surgical staff with proper smoke removal and a safer
procedural environment for the physician and patient.
It does this by consistently delivering the correct pressure,
thus keeping clear visibility during the procedure.
John adds, “We have worked with AORN to produce an
accredited CE course, Understanding the Challenges of
Laparoscopic Insufflation, to educate the OR community on
how the smoke evacuation and insufflation systems can be
designed to operate to meet the needs of all staff in the
OR.”
Promising Safety
Many smoke evacuators operate continuously, regardless of
whether or not smoke is being generated. This leads to
continuous CO2 being pumped into the OR.
As Palliare looks to the future, it is seeking to make this a
safer environment for all involved. John adds, “We are
working on the way to have a surgical robot or energy
system inform the insufflator when it needs to turn on and
off smoke evacuation to reduce the unnecessary CO2
produced and emitted during a procedure.”
Using Emerging Technologies
“As the company’s founder, it is my focus to continuously
develop, innovate, and advance the insufflation space,”
John says. As an example, Palliare believes that insufflators
should have a layer of communication with other
We o er two leading
solutions: the EVA15 and the
EndoTrap, and our vision is
to continue to evolve the EVA
platform to bring more
innovations in surgical and
endoscopic insu ation to the
market.

instruments in the OR and has embedded an API in the
EVA15. This allows manufacturers of laparoscopic,
endoscopic, and robotic systems to remotely control the
insuﬄator.
Words of Wisdom
Palliare has always had the interests of people–both the
patients and the clinicians delivering the care–at heart.
John’s best advice to any medical technology or device
developer is to be “needs-driven” instead of “technology-
driven.”
He shares “We are excited to have recently obtained a U.S.
patent for energy-activated smoke evacuation in continuous
pressure insuﬄators. This is important because it means that
CO2 waste is reduced, and less gas is needlessly evacuated
from the surgical cavity. With most competitors, smoke
evacuation is continuously activated for the entire
procedure.”
Over the past decade, there has been
li le innovation in insu ation
technologies designed to inject gas into
the surgical cavity. In particular this
technology has not evolved to meet the
needs of more complex, longer
endoscopic procedures.
Similar to how we saw laparoscopic
insulation needing to evolve to
address the needs of laparoscopic
robotic surgery, we see a need to
move forward insu ation technology
in the emerging fields of endoscopic
and robotic endoluminal surgery. We
are now working with a number of
emerging leaders in both the
laparoscopic and endoluminal
robotic surgery spaces.

Stay in touch.
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January | 2023 (16)

DI E-Medical
V
In the current times, early detection of visual problems
in infants, children below the age of three, and patients
with neurocognitive disorder remain a significant
challenge. The standard visual tests are majorly designed
for adult patients with normal cognitive development. It is
hardly possible to use the same tests in younger children or
patients with developmental issues.
For this reason, the DIVE Medical Device has been
developed to enable precise and objective exploration of the
visual functions not only in children but in all non-
collaborative patients.
With a mission to provide universal, affordable, and
effective means to prevent vision impairment, DIVE
Medical's Chief Technology Officer and Co-founder,
Marta Ortin, believes in the vision of ensuring early vision
diagnosis and treatment.
In an interview with Insights Care, Marta talks about DIVE
and how the device is helping doctors in the early diagnosis
and treatment of visual problems in small children and
babies.
Below are the excerpts from the interview:
Please tell us about DIVE Medical in detail.
DIVE began as a collaborative research project between
ophthalmologists and opticians from the Aragon Health
Research Institute and engineers from the University of
Zaragoza (Spain). When we presented our results at
congresses, professionals in the field expressed a lot of
interest in our project.
They often told us that they would like to be able to use our
device in their practice and that they thought it was
something useful that could benefit many people.
Encouraged by the good reception, we started this
entrepreneurial adventure and found the company DIVE
Medical in early 2020.
From then on, several of the people who had worked in the
research of the device within the institutions joined the
company, in which we are already seven employees.
Please give us a brief overview of your journey in the
healthcare niche, highlighting the USPs of DIVE
Medical.
DIVE is a device that allows us to explore the visual
function of any patient, even those with whom doctors
cannot communicate (infants, young children, or people
with neurocognitive problems) and who are more difficult
to examine (such as patients with low vision).
It is a great challenge for professionals to explore these
patients, and the results they can obtain are often subjective
and inaccurate.
DIVE is able to perform a complete visual examination of
these patients and provide objective and accurate measures
of their visual function. In this way, we help make an earlier
and more reliable diagnosis and facilitate the follow-up of
pathologies and visual therapies.
What are the core values upon which DIVE Medical is
built? What is its vision and mission?
Our vision is to grow DIVE to become the national and
international standard for exploring the visual function in
all patients and become a reference in visual test
development. Our mission is to universalize eye care by
offering new technologies that allow the early detection,
diagnosis, and follow-up of visual pathologies in all types
of patients. Our values are integrity, effectiveness,
accountability, collective talent, and the pursuit of
excellence.
What is your opinion on the necessity for the healthcare
industry to leverage the emerging trends of technology
concerning fulfilling your client's requirements in the
healthcare industry?
The introduction of technology in the healthcare industry
brings tremendous potential applications. In particular, in
January | 2023 (17)

the ophthalmology field in which we work, without using
technology, it is very challenging to explore certain patients
(including babies, patients with neurocognitive disorders, or
the elderly population), with results being very subjective
and non-repeatable, and with some visual functions being
impossible to measure.
By introducing technology, these challenges can be
overcome. In particular, DIVE has a screen on which we
display stimuli designed to evaluate different aspects of the
visual function. In addition, we incorporate eye-tracking
technology, which allows us to know the point on the
screen where the patient is looking at any given moment,
and deep learning for an automatized analysis of the
outcomes.
What was your inspiration and commitment behind
developing innovative healthcare products to improve
people's lives?
We started working on this project to solve the need the
ophthalmologists of our research team had every day during
their clinical practice. As soon as we started working on the
development of DIVE, we were able to see the impact of
our work in a very close and immediate way. Our biggest
motivation is DIVE's tangible beneficial impact on many
patients; this is the most gratifying thing for us.
As an established industry leader, what would be your
advice to the budding entrepreneurs and enthusiasts
aspiring to venture into the healthcare industry?
I would tell them to have a clear objective and high
motivation. This is a complex sector that constitutes many
paperwork requirements and a prolonged entry process. In
turn, it is very rewarding to see how something you have
worked on for years helps improve the lives of people.
What are your future goals, and how do you envision
further strengthening the stronghold of DIVE Medical
in the healthcare sector?
We are currently focusing on applying our technology for
visual exploration, but it has already opened up a lot of
exciting opportunities. Besides incorporating new tests into
our existing DIVE device, we are also planning on
developing visual therapy exercises and systems for the
automatic early detection of neurological pathologies that
affect vision, such as Parkinson's, Alzheimer's, or autism.
Please give us a few testimonials of your
clients/customers and a list of awards/recognitions that
accurately highlight DIVE Medical's position as a
booming company in the healthcare sector.
Testimonials from ophthalmologists with whom we ran a
research project:
"DIVE is a tool that puts technology at the service of
clinical needs. It provides the ophthalmologist with very
valuable information because it is capable of analyzing and
quantifying visual functions as it had never been achieved
before. It is especially useful for pediatric ophthalmology,
where explorations can be difficult. DIVE captures
children's attention from the beginning, and their
collaboration is much better."
- Teresa Pérez Roche. Pediatric Ophthalmologist.
Hospital Universitario Miguel Servet, Zaragoza (Spain).
"It is a very useful device for decision making. Experience
and the subjective impression of the specialist are often
needed to make a diagnosis. DIVE facilitates decision-
making since it provides objective and quantitative data. It
is also useful for patient follow-up, allowing to see their
evolution and transmit the results. DIVE makes the office
visits easier."
- Sandra de Fernando. Ophthalmologist. Hospital
Universitario Cruces, Bilbao (Spain).
"Interesting device for a deeper analysis of ocular and
saccadic movements. In children with neurological
problems, it is [traditionally] more complicated to evaluate
this function. Exploring contrast sensitivity and color
perception is also very interesting for children whose
diagnosis is more complex. Traditional tests are more
boring, but through games [in DIVE] it is more enjoyable
for children. Good experience with children that have
syndromes or neurological problems. Useful for young
children, with whom doubts arise when making a
diagnosis."
- Marta Galdós. Ophthalmologist. Hospital Universitario
Cruces, Bilbao (Spain).
January | 2023 (18)

he implementation of digital health strategies
Tand services has undergone a considerable
revolution as a result of the paradigm shift
from provider-centered healthcare to patient-centered
healthcare. Each nation's healthcare regulatory
agencies play a crucial role in creating the best
systems, strategies, and procedures to optimize care
delivery and provide patients with the best possible
treatment.
The majority of Western European nations currently
have policies or strategies that outline the goals of
eHealth implementation, the objectives of eHealth,
and a future road map for expanding and introducing
additional healthcare services. Next-generation health
informatics solutions are being introduced in nations
with more developed healthcare ICT infrastructure,
such as the United Kingdom, Germany, the
Netherlands, Sweden, Denmark, Norway, and Finland,
to enhance patient-centered treatment.
Understanding the
ASPECTSthat
EmpowerInnovations
in Europe’sMEDICAL
DEVICES
January | 2023 (20)

Industry Insights
January | 2023 (21)

Below are some of the aspects that have empowered
innovations in Europe’s Medical Device Industry.
Healthcare Cloud Technologies
More products are being supplied through remotely
hosted deployments rather than on-premise dedicated server
models as the medical software market evolves. As a result
of this inescapable transition to cloud-based digital health
services, most providers will no longer need to maintain
expensive and unsafe data centers. The industry is
anticipated to grow over the next two to three years as
providers in Western Europe migrate to cloud-based care
management systems like hospital information systems
(HIS), ambulatory care management systems, patient
management systems (PMS), electronic medical/health
records (EMR/EHR), and electronic prescribing. A few
providers also provide hybrid cloud models with benefits
including remote backup, disaster recovery, high resource
availability, and security and support for mobile devices.
Healthcare System Integration and Interoperability
Services
Western Europe is predicted to experience brisk expansion
in the market for healthcare systems integration. Many
applications, including medical record systems, medical
device integration, laboratory integration, radiology
integration, hospitals and clinics integration, telehealth
portals, home health, and other applications, heavily rely on
integration and interoperability services. Fast healthcare
Interoperability Resource (FHIR) and SMART on FHIR,
the organization's next-generation standard frameworks that
make use of the most recent Web standards and place a
strong emphasis on implementations, have emerged to
address the challenges of clinical and administrative data
interoperability in the real world.
Medical Device Data Integration Into Care Delivery
Process
In high acuity care units, the integration of medical device
data with patient medical records improves patient
monitoring and surveillance. Device connectivity has the
ability to decrease human error while boosting operational
effectiveness, which is advantageous to both patients and
clinicians. Along with device integration, other services like
clinical alarms based on Early Warning Scores (EWS),
predictive analytics, virtual critical care units, and warning
systems for emergency response teams can assist doctors
practise preventive care and enhance results.In high acuity
care units, the integration of medical device data with
patient medical records improves patient monitoring and
surveillance. Device connectivity has the ability to decrease
human error while boosting operational effectiveness,
which is advantageous to both patients and clinicians.
mHealth & Healthcare Mobility
Bring-your-own-device (BYOD) and bring-your-own-
application (BYOA) solutions are becoming more and more
popular in the healthcare industry as a result of the
convergence of mobile solutions and healthcare
technologies. The growth of this industry is primarily
attributable to the increased adoption of smartphones,
connected medical devices, health wearables, mHealth apps
for the management of chronic diseases, and robust 3G and
4G network penetration that provides uninterruptible
connectivity for digital healthcare services.
Conclusion
The healthcare industry in Western Europe has long been
regarded as being unreachable or less desirable as a target
for IT advancements. This is unquestionably no longer the
case, and the future in the evolving healthcare industry
holds many wonderful possibilities for fresh chances. The
installation of a safe and inter-institutional networked
infrastructure by providers seeking to improve healthcare
delivery is the main driver of the enormous development
seen in the European healthcare IT sector. By gradually
replacing legacy and non-interoperable healthcare IT
systems with systems that support open standards-based
data interchange, the aim is to further reduce administrative
expenses, avoid human errors, optimize the use of medical
data, and improve the quality of services.
The best strategy to ensure that Western European countries
supply high-quality healthcare to their citizens is to
encourage eHealth advances of medical devices in the
healthcare industry. The health systems can benefit from
increased patient empowerment, workflow optimization
through digital means, a more competent workforce, more
effective and sustainable health and care systems, and
responsive governmental administrations.
-Anish Miller
January | 2023 (22)

Leading with Precision, Care
and Confidence
ealthcare advancements that were mere ideas
Hdecades ago are coming to fruition, proving to be
much more valuable to saving human lives and
enhancing the quality of life. Medical devices have been a
vital part of these advancements and can enable technology
for its applications to help a better cause, thus is the story of
Injeq.
Injeq was founded when a group of experts in the fields of
technology and medicine saw that blind punctures were
problematic as they introduced leukemia cells from the
blood to the central nervous system. The company found a
solution through a medical need: to make lumbar punctures
safer and more precise. Its Injeq IQ-Tip® is a spinal
needle that facilitates lumber punctures. It gives out an
audio alarm to the physician when the needle tip detects
spinal fluid based on bioimpedance detection. In a
conversation with Maarit Forsten, the Clinical
Application Manager of Injeq, she talks more in depth
about the organization’s clinically proven product.
Below are the highlights of the interview:
Please brief us about your company and what ideas and
developments led to its inception in the medical device
niche.
Injeq was founded based on the problems of blind
punctures, i.e., punctures during which the doctor
performing the procedure cannot see where the tip of the
needle is. Until now, the advancement of the needle was
based on the haptic feeling in their fingertips and
knowledge of the human anatomy. For instance, avoiding
nerves and finding cavities like the spinal cavity for
cerebrospinal fluid have been based on the professional
experience of the medical practitioners so far.
What are your key products and services? How are you
revolutionizing the market with them?
We are manufacturing bioimpedance spectroscopy-based
needles with tissue recognition. Our current solution is a
spinal needle that recognizes cerebrospinal fluid on the
needle tip. For the last 100 years, nothing particularly new
has happened with spinal needles. Now we have this
innovative needle that, after detecting cerebrospinal fluid,
gives an alarm to the physician performing the lumbar
puncture. This has turned out to be very efficient in
avoiding the typical and sometimes critical complications
related to lumbar punctures.
Please brief us on the company’s professional milestones
so far.
The problem of blind punctures and tissue recognition was
found by Professor Ritta Seppänen -Kaijansinkko based on
all the patient injury reports she had received while working
in this patient injury board.
Europe's Top 5 Medical Device Companies to Watch in 2023
January | 2023 (24)

How has technology aided your goal of innovating in the
medical device industry? What are your key adaptations
of technology in your company?
Our current main solution is cerebrospinal ﬂuid detection
for challenging and, eventually, for all lumbar punctures.
Generally, this innovation has the potential to improve the
safety of all blind punctures and decrease the incidence of
related complications, this way reducing the overall health
care costs also remarkably.
What are the challenges that you have faced till now?
How have you infused your leadership skills to turn
them into opportunities for your company as well as for
the industry?
The ﬁrst challenge was to get CE approval for Injeq’s
medical device, which represents the highest risk class 3
January | 2023 (25)
Until now, the advancement of the
needle was based on the haptic
feeling in their fingertips and
knowledge of the human anatomy.
But now we have this innovative
needle, the Injeq IQ-Tip®, that, after
detecting cerebrospinal fluid, gives
an alarm to the physician
performing the lumbar puncture.
This innovation has the potential to
improve the safety of all blind
punctures and decrease the
incidence of related complications,
reducing the overall cost of health
care in the process.

according to the new Medical Device Regulation. CE mark
was gained in December 2021. After this marketing
approval, the first distributor contracts were signed, and the
sales to the biggest European markets were aimed to start.
The next challenge was the price of our device, which in the
beginning was ten times more expensive compared to the
conventional way of making lumbar punctures. However,
by improving our manufacturing processes we were able to
remarkably reduce the initial prices (almost half of the
original). In addition, we have good clinical evidence of the
benefits achieved with Injeq IQ Tip system.
As an experienced leader, what would be your advice to
budding entrepreneurs wishing to enter this industry?
First, consult the clinical world about what they need,
which means—do not make the innovation first and then go
to market, but vice versa. Second, choose the lowest
possible risk group for your medical device; choose the
indication area not having contact with the central nervous
system, heart, or big blood vessels, which automatically
makes your device class 3. Third, choose the materials and
manufacturing processes so that there are no risky materials
like nickel or processed chemicals that cause allergies, toxic
reactions, or other harm to the user or patient. Lastly, listen
to the feedback all the way through.
What are the future goals of your company? How do
you envision scaling up its growth and operations in
2022 and beyond?
We are planning to find other beneficial application areas
for bioimpedance-based tissue recognition. The goal is to
make the earlier passive needles active to improve safety,
efficiency, and patient experience and reduce overall
healthcare costs.
January | 2023 (26)

January | 2023 (28)

ompanies in the medical device business (also
Cknown as MedTech), which is under increasing price
pressure from healthcare providers and contending
with declining returns from mature technologies, must now
look for novel methods to boost their bottom lines. For
medical equipment to continue to be cost-competitive in the
future, supply chains must be digitalized.
Business executives continue to express increasing concern
about the tough price competition and downstream pressure
in the MedTech sector. Less expensive technology, value-
and outcome-based payment methods, and stricter regulatory
procedures are demanded by payers, providers, and
governments. Additionally, in a time of rising out-of-pocket
(OOP) expenses, patients have evolved into value-conscious
shoppers. Patients are increasingly price sensitive and prone
to skipping treatment when faced with high deductibles,
even while they are willing to pay out of pocket for high-
quality premium services. Prices for MedTech devices have
fallen further in the face of these challenges. These players
must not only oﬀer exceptional features but also outstanding
value to patients and providers while minimising expenses in
order to counteract dropping pricing.
Below are the transforming approaches adopted within the
leading medical device companies.
Thinking Big, Starting Small, and Acting Fast
We advise a "dream large, start small, act quickly" strategy
because disruptive digital medical devices and digital supply
Transformation
APPROACHINGin
Leading Medical
DeviceCompanies
January | 2023 (29)

networks may have broad repercussions. The first stage is to
create a future-state image of a supply chain that is
optimised from suppliers to providers to patients. In order
to reduce the risks and show early success to stakeholders,
start with small adjustments. In order to gain swift victories,
medtech companies should focus on issues that have the
potential to unleash value at several stages. Building on
early achievements, businesses can continue to create DSNs
in areas where doing so makes both strategic and
economical sense.
Developing New Workforce Skills and Capabilities
To effectively utilise DSN's potential, MedTech businesses
must schedule time and resources, train their workforces,
and train themselves. In general, rather of concentrating on
department-specific operations, the workforce should
become more tech-savvy and able to handle multiple duties.
There are three reasons why it's crucial for the workforce to
be knowledgeable about digital solutions:
• The users of digital solutions must be able to derive
value from them as consumers of the underlying
technology.
• The workforce needs to be educated on the tools and
processes being deployed, the order of new
technologies to be adopted, and their expected impact
as customers of digital solutions.
• Teams need to be ready for a changed working
relationship with IT as they implement digital solutions
since individual teams may replace IT as the principal
owners of technology.
Adopting Agile Systems for DNS development and
Deployment
To achieve significant change across the business, MedTech
organizations must adopt an agile strategy to DSN
development and deployment. With this method,
requirements can be developed incrementally rather than all
at once. Adopters can modify development based on
constantly changing aims with enhanced confidence in the
initiative's ultimate success thanks to adopters' agility in
refining and modifying.
Conclusion
MedTech companies can concentrate on new technologies
and frameworks as a way of fending off threats and
favourably impacting their bottom line, despite the
difficulties that may appear insurmountable. Using digital
supply networks (DSNs) to improve operational efficiency
and give their customers more value would be a good start.
Some of the areas where MedTech companies can seek
benefits when adopting digital technolgies involve:
Inventory management, Logistics and distribution, device
maintenance, Product development, and warehouse
operations.
Companies may increase supply chain visibility, lower
maintenance and R&D costs, boost customer happiness,
and enhance patient experiences by implementing
digitalization in these areas.
-Anish Miller
January | 2023 (30)

Novelties Ensuring the Quality of Life
Dr Markus Wilhelms
CEO and Co-founder
January | 2023 (32)

The future of healthcare is shaping up in front of our
very eyes with advances in digital healthcare
technology and nanotechnology. This rests in
working hand-in-hand with technology, and healthcare
workers have to embrace emerging healthcare technologies
to stay relevant in the coming years.
In medicine and healthcare, digital technology could help
transform unsustainable healthcare systems into sustainable
ones, equalize the relationship between medical
professionals and patients, and provide cheaper, faster,
more effective solutions for diseases. Technologies could
simply lead to healthier individuals living in healthier
communities.
Leveraging the latest advancements, MOWOOT, a growth-
stage medical device company has developed a medical
device that stimulates the large intestine in a non-invasive
way. It is also marketing a novel, purely physical, non-drug,
and non-invasive solution to chronic intestinal transit
disorders, such as neurogenic bowel disorders (NBD),
opioid-induced constipation (OIC) or chronic idiopathic
constipation (CIC).
Under the proficient leadership of Dr Markus Wilhelms,
CEO and Co-founder, MOWOOT has received the 'FDA
Breakthrough Device Designation' for the critical impact on
patients' quality of life, which opens the door to the large
US market.
In an interview with Insights Care, Dr Markus Wilhelms
sheds light on the innovations empowered by MOWOOT in
the healthcare industry.
Dr Wilhelms, please tell us about MOWOOT, its USPs
and what makes it a successful company in the
healthcare sector.
The multidisciplinary founder team of MOWOOT met in
2013 in the dHealth Barcelona program for 'needs-driven
innovation,' a European version of Stanford University's
Biodesign program.
Applying innovation methodologies like design-thinking
and based on over 500 patient interviews, the team
developed a solution to a significant unmet need in bowel
management in collaboration with leading neuro-
rehabilitation hospital Institut Guttmann and constituted the
company in November 2014. The MOWOOT device is now
already available in several European markets and is even
recommended in various clinical guidelines.
What are the core values upon which MOWOOT is
built, and What is its vision and mission?
Since the beginning, the MOWOOT team has been guided
by direct contact with patients and caregivers to develop
and market our solution to solve an unmet need and
improve the quality of life in patients with intestinal transit
disorders.
What is your opinion on the necessity for the healthcare
industry to leverage the emerging trends of technology
to fulfil your client's requirements in the healthcare
industry?
Firstly, I'd state understanding the unmet need, including all
relevant stakeholders, and finding the simplest possible
solution is crucial. Simplicity is elegance. Innovation does
not necessarily need to be complicated. However, if a
simple and elegant approach includes an 'emerging trend,'
then go for it.
What was your inspiration and commitment behind
developing innovative healthcare products to improve
people's lives?
Our founder team consists of four people with different
professional backgrounds. What we have in common is that
we want to have a positive impact on the patients and also
on society.
MOWOOT team has
been guided by direct
contact with patients
and caregivers to develop
and market our solution to
solve an unmet need and
improve the quality of life
in patients with intestinal
transit disorders.
Europe's Top 5 Medical Device Companies to Watch in 2023
January | 2023 (33)

We firmly believe that to do so, to really reach as many
people as possible, you not only need to have an innovative
product but also implement it into a viable business model.
Innovating in healthcare is one of the most difficult types of
entrepreneurship, but we accepted the challenge!
As an established industry leader, what would be your
advice to the budding entrepreneurs and enthusiasts
aspiring to venture into the healthcare industry?
First, start with understanding the unmet need and its
environment/stakeholders and do lots of interviews to learn
about this. You will have to develop a quantifiable value
proposition for your solution, taking all stakeholders' needs
into account (including payors, regulators, etc.) Apply the
"scientific method" to business creation: build > measure >
learn (repeat)
Nowadays, there are very well-developed tools available to
guide novice entrepreneurs in their healthcare adventure,
for example, the GAITS system by CIMIT in Boston. I
wish we would have had access to this type of tool when we
started—highly recommended!
What are your future goals, and how do you envision
further strengthening the stronghold of MOWOOT in
the healthcare sector?
We plan to enter the public healthcare reimbursement in
several EU markets regarding business development.
Moreover, market entry in the USA is the next natural step
for MOWOOT. Regarding products, we are working on a
pediatric version of our device to answer a market pulled by
many parents and caregivers who contacted us.
Please give us a list of awards/recognitions that
accurately highlight your organization's position in the
market.
Among 23 companies, in an extraordinary all-digital
Redefining Early-Stage Investments -RESI- conference
edition, MOWOOT was voted as the 'Best Medical Device
Company' of the event and achieved second place in the
overall rating of the most voted company.
MOWOOT received the seal of approval "Impact Business"
for start-ups with social impact after a thorough analysis by
the Ship2B foundation in the framework of their
Tech4Health acceleration program.
MOWOOT is the winner of the Best Overall Company
st
Award (1 place) as the company with the most votes of all
three categories (MedTech, biotech and digital health) of
the European Health Catapult at the EIT Health Summit in
London.
European Health Catapult is an acceleration program and
start-up competition. It awards the best-of-the-best
innovation concepts from MedTech, biotech, and digital
health across Europe. MOWOOT is the winner of the
st
Audience Award (1 place) in the MedTech category of the
European Health Catapult at the EIT Health Summit in
London.
MOWOOT also achieved second place in the Healthcare
Professional Jury awards in the MedTech category of the
European Health Catapult at the EIT Health Summit in
London.
January | 2023 (34)

Europe's Top 5 Medical Device Companies to Watch in 2023.pdf

Europe's Top 5 Medical Device Companies to Watch in 2023.pdf

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Europe's Top 5 Medical Device Companies to Watch in 2023.pdf