Notes |
Medtech and the Internet
of Medical Things
How connected medical devices
are transforming health care
July 2018
Contents
Foreword 01
Executive summary 02
Part 1. Connectivity is transforming the medtech industry 08
Part 2. Challenges and opportunities for medtech 16
Part 3. Connected medical devices are transforming care 31
Part 4. The future for medtech and the IoMT 40
Appendix: Nomenclature and medical device classifications
used in the report 47
Endnotes 48
Contacts 52
Deloitte Centre for Health Solutions
The Deloitte Centre for Health Solutions is the research arm of Deloitte LLP’s Life Sciences and Health Care practices. Our goal is to identify emerging trends, challenges,
opportunities and examples of good practice, based on primary and secondary research and rigorous analysis.
The UK Centre’s team of researchers seeks to be a trusted source of relevant, timely and reliable insights that encourage collaboration across the health value chain,
connecting the public and private sectors, health providers and purchasers, patients and suppliers. Our aim is to bring you unique perspectives to support you in the role
you play in driving better health outcomes, sustaining a strong health economy and enhancing the reputation of our industry.
In this publication, references to Deloitte are references to Deloitte LLP, the UK affiliate of Deloitte NWE LLP, a member firm of Deloitte Touche Tohmatsu Limited.
Foreword
Welcome to the Deloitte Centre for Health Solutions’ report Medtech and the Internet of
Medical Things: How connected medical devices are transforming health care.
Patient interactions with the health care system often involve interactions with equipment and devices – from syringes and bandages,
blood pressure monitors and pregnancy testing kits, to surgical instruments, pacemakers, artificial joints, and MRI and CT scanners. The
medical technology (medtech) industry designs and manufactures a wide range of products to diagnose, monitor, and treat patients and is
instrumental in helping health care organisations achieve better patient outcomes, lower health care costs, improved efficiency and new
ways of engaging and empowering patients.
Major advances in wireless technology, miniaturisation and computing power are driving innovation in medtech, leading to the
development of an increasing number of connected medical devices that are able to generate, collect, analyse and transmit data. The
data, along with the devices themselves, are creating the Internet of Medical Things (IoMT) – a connected infrastructure of medical
devices, software applications and health systems and services. The IoMT is rapidly transforming medtech’s role and relationships within
health care. More specifically, connectivity between sensors and devices is enabling health care organisations to streamline their clinical
operations and workflow management, and improve patient care, even from remote locations. Provided medtech companies can convince
clinicians and patients of the value and benefits of connected medical devices, the pace and scale of health care transformation will be
exponential.
New regulations, digitisation, data analytics, artificial intelligence, automation and the development of value-based health care represent
some of the numerous challenges as well as opportunities facing the medtech industry. Consequently, medtech companies from start-ups
to corporates are reinventing themselves to remain competitive. New strategies are needed to harness data provided by digitally-enabled
products and make their business and operating models relevant and sustainable. This will help companies develop evidence of better
health outcomes at reasonable cost to obtain price reimbursement and gain market access. For some medtech companies this means
shifting from a product-based model to a value-based system driven by software-based services and solutions.
Connected medical devices will have a profound impact on patients, clinicians and the life sciences industry. Our report focuses on how
the IoMT is transforming medtech’s role in health care and the impact of the increased use of connected medical devices on medtech
companies’ business and operating models. It outlines how medtech companies can get digital transformation right – whether through
adapting their existing business models, inventing new ones or both. The industry’s future will depend on its ability to demonstrate to
providers and payers how connected medical devices contribute to the new value-based paradigm.
Hanno Ronte
Partner
Monitor Deloitte
Karen Taylor
Director
Centre for Health Solutions
John Haughey
Lead partner
UK and North West Europe
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Executive summary
A series of technological and cultural revolutions are allowing technology and
people to be better connected to one another, leading to the development of the
Internet of Things (IoT) – a network of connected, smart devices and objects that can
communicate with each other and automate key tasks.
Medical technology (medtech) companies manufacture more than
500,000 different types of medical devices, including wearable
external medical devices (skin patches, insulin pumps and blood
glucose monitors), implanted medical devices (pacemakers and
implantable cardioverter defibrillator devices) and stationary medical
devices (home monitoring devices, connected imaging devices and
scanning machines). Most patient interactions with the health care
system involve the use of medical equipment and devices.
Like most other industries, the health care sector is increasingly
realising the transformative nature of IoT technologies, as advances
in computing and processing power, wireless technology and
miniaturisation drive innovation in connected medical device
development. Connectivity enhancement can be applied to
most categories of medical devices. The rise in the numbers of
connected medical devices, together with advances in the systems
and software that support the capture and transmission of medical
grade data, connectivity technologies and services, have created
the Internet of Medical Things (IoMT).
The IoMT brings together the digital and physical worlds to improve
the speed and accuracy of diagnosis and treatments, and monitor
and modify patient behaviour and health status in real time. It also
improves health care organisations’ operational productivity and
effectiveness by streamlining clinical processes, information and
work flows.
Connectivity between sensors and devices aids real-time patient
care, even from remote locations, while improving communication
within and between medical facilities. The large volume of data
generated creates opportunities for new models of care and
supports the delivery of 4P medicine – medicine that is predictive,
preventive, personalised and participatory.
The IoMT brings together people (patients, caregivers and
clinicians), data (patient or performance data), processes (care
delivery and patient support) and enablers (connected medical
devices and mobile applications) to deliver improved patient
outcomes efficiently.
While the IoMT has the potential to help alleviate some of the cost,
access and care coordination challenges facing health care, the
generation of data points through millions of connected medical
devices will have little impact unless data can be turned into
actionable insight.
More specifically, connected medical devices are a key enabler
across the six predictions in our report The future awakens: Life
sciences and health care predictions 2022. The extent to which the
predictions are realised is heavily dependent on the continued
innovation and adoption of connected medical devices at scale.
MarketsandMarkets valued the IoMT market at $41.2 billion in
2017 and expects it to rise to $158.1 billion in 2022. The connected
medical devices segment (helping to diagnose, monitor and treat
patients) of the IoMT is expected to rise from $14.9 billion in 2017 to
$52.2 billion by 2022.
The rise of the IoMT comes at a time when health care is becoming
increasingly expensive, with global health care spending expected
to grow 4.2 per cent per year, from $7.1 trillion in 2015 to $8.7
trillion by 2020, largely due to a growing and ageing population,
with more people living longer but with multiple comorbidities.
As a result, without radical transformation, health care in many
countries risks becoming increasingly unaffordable.
The medtech industry has an important role to play in helping
to reduce costs, improve the quality and efficiency of care and
support the shift to value-based care (VBC). However, the industry
also faces a number of systemic challenges and opportunities that
need to be addressed for the full value of the IoMT to be realised.
These include:
• Developing an in-depth understanding of end users – as
more providers adopt VBC models, the speed of adoption and
integration of connected medical devices will increase. Data and
insights on patients and processes is key to VBC. Challenges
include the extent to which an organisation’s IT infrastructure
is able to handle or process the connections and data, and
whether clinicians and patients can be convinced of the safety
and effectiveness of the devices. Medtech companies need
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
to develop a deep understanding of the end-user and create
business models and scenarios that demonstrate how their new
and existing devices not only improve patient outcomes but also
create value for key health care stakeholders.
• Developing new funding, business and operating models
– as health care organisations focus more on improving quality
and reducing the costs of providing care, they require medtech
companies to demonstrate greater evidence on the added
value of both new and enhanced products. We commissioned
a survey that found that medtech companies are having mixed
results in demonstrating the value of their connected medical
devices, although some are engaged in providing services rather
than just products. Different types of innovation will require
different business models, and progress will depend on both the
innovators themselves working in new ways to take on risks and
rewards, and the evolution of existing payment systems by both
public and private payers.
• Understanding interoperability requirements –
interoperability is arguably the biggest challenge for medtech,
including complying with various national and international
standards and protocols around the exchange and use of data.
There are also technical challenges such as creating an integrated
governance framework and obtaining consent for access to
health care data. For interoperability to work effectively, the
direction of travel should be towards open platforms, based
on open data standards. This will enable payers, providers
and technology vendors to come together to make data more
available to each another.
• Maintaining cybersecurity – cybersecurity issues are pervasive
across medtech, as the increasing numbers and capability of
connected medical devices present additional risks for data
security. The scale and cost of breaches is often significant and
far reaching. Although four-fifths of our survey respondents
considered they were reasonably well prepared to deal with
the cybersecurity of their devices, other research suggests
many stakeholders do not have a strong understanding of such
risks, how to prevent them and what to do once a risk has been
identified. Regulators acknowledge that cybersecurity threats
cannot be completely eliminated, and stakeholders need to work
together and adopt a more proactive approach to managing
risks. Medtech companies need to adopt a ‘security by design’
approach and establish real-time monitoring, cyber threat
modeling and analysis, threat mitigation and remediation.
• Successfully navigating regulatory change – managing the raft
of regulatory change occurring, particularly in relation to the new
European and US regulations is imperative for both developing
connected medical devices and the success of the IoMT.
Managing the impact of regulatory change requires medtech
companies to take a proactive and well-planned approach. If an
innovation model is to be sustained, companies need to build
engagement with regulators into their innovation model and
involve clinicians and patients in product design.
• Attracting digital talent and building digital capability – there
is increasing concern among key stakeholders that a growing
skills gap will delay the deployment of IoMT solutions and
constrain market growth. If medtech companies are to remain
competitive they need to develop a new, digital-first skill set,
including employing data scientists and multidisciplinary talent
from creative and scientific backgrounds. Accessing this talent will
require more resourceful recruitment and retention strategies,
including collaborations and partnerships with a diverse range
of existing and emerging players, especially academia, data-first
tech companies and innovative new start-ups.
• Maintaining trust in a digital age – global technology companies
and other new entrants into the health care ecosystem are
becoming more involved in the connected medical device industry,
and traditional medical device companies are becoming more
involved in data management and analytics. Consequently, as
medtech companies develop strategies and services based on
the generation and transmission of patient data, they need to
ensure they demonstrate clearly to patients, the public and health
care professionals that the data are being protected and used
responsibly. Medtech companies need to develop key principles
of data management and consent that give patients control over
their own data, including the right not to share.
• Improving the adoption of medical technology at scale
– a key challenge for medtech is ensuring that health care
organisations, clinicians and patients understand the addedvalue of connected medical devices and use them at scale to
drive better economics and patient outcomes. Difficulties include
the lack of governance standards and sufficient, robust evidence
that demonstrate that connected medical devices are more costeffective, and how they can help drive the VBC agenda.
This includes ensuring that the devices are intuitive and easy to
use and, where necessary, providing training and support to staff
to embed the skills needed to optimise the use of the technology.
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Creating an effective IoMT at scale requires collaboration and
partnership working between patients, providers, payers, pharma,
academia and other medtech manufacturers. Our research
identified multiple case studies that demonstrate medtech’s
important role in the IoMT and the conditions that lead to the
adoption of connected products and services. The key enablers
driving the IoMT and the transformation of health care include:
• Collaboration between health care providers and medtech
is key to the effective deployment of the IoMT – integrating
connected medical devices into established care pathways is
challenging and requires significant cooperation across the
IoMT ecosystem. Collaboration strategies such as partnerships
and joint ventures help ensure the effective transmission,
aggregation, analysis and management of data from connected
devices. These collaborations allow all stakeholders to improve
their understanding of patient needs and deliver more
proactive cost-effective care. Our survey respondents ranked
collaborations with health care providers as the most important
for the development of their respective businesses models,
followed by collaborations with health care payers and other
medtech companies.
• Connected medical devices benefit patients, providers and
payers – partnerships with health care providers allow medtech
companies to understand the clinical context in which devices
are used. Medical devices are almost always designed for a
specific application. Adding connectivity to a device allows data
to be generated on a patient’s condition and the effectiveness
of the health care providers operations. Being able to quantify,
contextualise and communicate these interactions allows the
medtech industry to provide solutions that deliver value to all
health care stakeholders.
• Joining the dots between connected medical devices and
health care IT systems – a number of large medtech companies
have developed connected ecosystems that act as a common
platform to share, aggregate, and view data to drive both
clinical and operational value. Linking disparate sets of data
that sit within health care organisations is central to achieving
connectivity at scale.
• Applying advanced analytics to the data generated from
connected medical devices to provide critical insights and
empower better decision-making – mining, managing and
analysing a vast array of data from medical grade wearables,
connected imaging devices and monitoring devices is a key part
of deriving value from the IoMT. The insights generated by linking
connected medical device and health data sets can play a key
role in aiding health systems to reduce costs and improve quality,
identify populations at risk, connect with consumers and better
understand performance.
• Medtech services that demonstrate improvements in patient
outcomes and reduce health care costs – medtech companies
are utilising the increasing sophistication of connected medical
devices, improved interoperability across health care organisations
and advances in analytics to develop service orientated solutions
that provide the tenants of VBC. These services include managed
catheterisation laboratories and transformations from a product
manufacturer to a health care provider helping improve patient
outcomes and reducing the costs of health care.
How will the IoMT evolve to impact care?
The health care and life sciences industries are in transition from
reactive and largely episodic models of care that are proving
increasingly costly and inefficient to operate, to care models
that are proactive, digitally-enabled and deliver better value for
patients. Medtech companies and the IoMT can capitalise on
the possibilities presented by these changes to help to connect
patients, providers and payers and enable them all to become
more patient centric, productive and cost effective.
These disruptive technologies are changing ways of working across
the whole IoMT ecosystem. Big data, AI, mobile applications, 3D
printing, advanced sensors and other technologies will continue to
create new opportunities for medtech companies. Voice technology
is being adopted faster than any previous technology from chatbots
to doctor visits, to home health care. At the same time, large
technology companies are using their vast reach and expertise to
create an interoperable electronic health record that can integrate
data from a variety of sources and enable real-time access. Although
robotics and automation will inevitably replace some jobs, they
will also add new ones that blend employee skill sets and the
development of transferable skills.
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
A growing number of medtech companies are capitalising on the
above trends to develop service-orientated solutions that support
VBC. Often these services align closely with the therapeutic
expertise and specialised products of the organisation enabling
medtech to maintain high quality patient outcomes while reducing
costs compared to similar services run by traditional health care
providers.
Other companies are utilising IoMT capabilities to aggregate data
and offer consultative services and predictive analytics, including
opening up health data to organisations that have typically found
it difficult to gain access to data outside of their own organisation.
These and other developments provide clear opportunities for
medtech to transition from a provider of innovative products to an
insightful partner in health care (see Figure below).
Connected medical devices are helping medtech companies move from innovative product suppliers to insightful partners
in health care Company transition
Medtech as an innovative product supplier
Medtech as an insightful partner for patients and health care, rewarded for
improving health care performance
Key capabilities required
Deep understanding of care delivery
models and how care is delivered
across patient populations; and
developing rules and capability
around patient consent
Outcomes measurement and
end-to-end evidence including
partnerships for data creation,
capture sharing and analytics to
enable real-world evidence-based
approaches to improve care delivery
Stakeholder engagement, collaboration and partnerships to understand
the needs of patients, providers and
payers in order to generate the next
generation of innovation
Complementary services and
solutions that enhance
product offerings and support
patients’ and providers
Product innovation based on
real-world evidence on patient
outcomes and build engagement with
regulators into innovation models
Contracting and payment models
that take in to account the value
added from clinical innovation
Clinical advantage
Can meaningful clinical
advantage be demonstrated?
Broader value creation
Can differential value be created
for the system?
Operating leverage
Can innovation be adopted
at scale?
05
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Health care is facing numerous challenges
Significant IoMT market growth predicted
Global healthcare spending is expected to grow from
$7.1 trillion in 2015 to $8.7 trillion by 2020
The percentage of people aged
65 and over
is expected to double by 2050 The benefits of the IoMT
Improved drug
management
Enhanced
patient
experience
Remote
monitoring of
chronic diseases
Improved
patient
outcomes
Decreased costs
Improved
diagnosis and
treatment
Improved disease
management
The overall IoMT market is expected to grow from $41 billion in 2017 to $158 billion by 2022
Medical
devices
$USD billion
Systems and
software
2017
2022
Technology Services
0
10
20
30
40
50
60
15
52
10
49
9
28
7
29
South America
from $2 billion
to $9 billion Middle East & Africa
from $2 billion to $9 billion
Asia-Pacific
from $11 billion
to $51 billion
North America
from $13 billion
to $45 billion
Europe
from $12 billion
to $44 billion
06
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Is medtech ready for the IoMT?
To a large extent
To a limited extent
Not at all
Medtech is transforming from an
innovative product supplier…
43%
are using Real World
Evidence to drive business
decisions to a large extent
39%
are adopting a value-based
approach to pricing to a
large extent
31%
are implementing new
funding models for data as a
service to a large extent
… to an insightful partner
for patients and health care, rewarded
for improving health care performance
The above percentages are taken from our survey of 237 respondents from connected medical
device companies
…our survey of 237 respondents working in medtech companies developing
connected medical devices revealed that:
51%
39%
10%
of medtech
companies are
implementing new
business models
71%
67%
believe that health care providers and
clinicians are not ready to utilise data
generated from connected medical devices.
believe that the regulatory framework
will not catch up with what is possible
today for another 5 years.
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Part 1. Connectivity is transforming the
medtech industry
A series of technological and cultural revolutions are allowing technology and people
to be better connected to one another, leading to the development of a network of
connected, smart devices and objects that can communicate with each other and
automate key tasks. This is known as the Internet of Things (IoT).
These revolutions began with the invention
of the internet and have shaped technology
and society for the past 30 years (see
Figure 1). IoT technologies are increasingly
benefiting the health care sector, as
advances in computing power, wireless
technology and miniaturisation are driving
innovation in connected medical device
development.
The large volume of data created, along
with the devices themselves, IT systems
and software, connectivity technologies
and services, are combining to create the
Internet of Medical Things (IoMT).
Figure 1: Technological and cultural changes enabling the development of the Internet of Things
Source: Deloitte LLP, 2018
1990
2018
Human-to-human
· Fixed telephony
· Text messages
Internet of Services
· Smart IT platforms
· E-commerce
Internet of Things
· Smart devices and objects
· Connectivity between devices
· Automation of tasks
Internet of Content
· Email
· Static webpages
Internet of People
· High speed mobile broadband
· Smart phones and tablets
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
The development of connected
medical devices
The medical technology (medtech) industry
designs and manufactures a wide range
of medical products that help to diagnose,
monitor, and treat diseases and health
conditions. There are more than 500,000
medical technologies currently available,
which all share a common purpose – having
a beneficial impact on people’s health and
quality of life.
Medical devices fall within 21 categories
of medtech products, as determined by
the Global Medical Devices Nomenclature
(GMDN) Agency (see Appendix).1
They
represent a hugely varied product group,
ranging from simple, disposable supplies
such as plasters and syringes, through to
surgical implements, monitoring devices
and imaging machines. They also include
medical laboratory diagnostic instruments
and test kits, patient management
software, and software that is used as a
component in a medical device.
IoT technologies are increasingly benefiting
the health care sector, as advances in
computing power, wireless technology and
miniaturisation drive innovation and the
development of connected medical devices.
Connectivity enhancement can apply across
all 21 categories of medical devices.
The creation of the IoMT ecosystem
The rise of the IoMT is being fueled by
an increase in the number of connected
medical devices that are able to generate,
collect, analyse or transmit health data or
images and connect to health care provider
networks, transmitting data to either a
cloud repository or internal servers.
Figure 2 shows the main stakeholders in
the IoMT ecosystem.
The medical technology
(medtech) industry designs
and manufactures a wide
range of medical products
that help to diagnose,
monitor, and treat diseases
and health conditions.
Figure 2: The IoMT ecosystem
Source: MarketsandMarkets, 2017
Medical device providers
Systems and
software
providers
System integrators
End users and service providers
Original
equipment
manufacturers
Connectivity providers
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
The IoMT bridges both the digital and
physical worlds and can monitor and
modify patient behaviour in real time to
manage chronic conditions such as asthma,
diabetes and high blood pressure. IoMT
technology can also streamline various
clinical processes and information flows
and bring together people (patients,
caregivers, and clinicians), data (patient or
performance data), processes (care delivery
and monitoring) and enablers (medical
devices and mobile applications) to improve
health care delivery.
Importantly, the IoMT generates intelligent
and measurable information to help
improve the speed and accuracy of
diagnostics and target treatments more
efficiently and effectively. It enables remote
clinical monitoring, chronic disease and
medication management and preventive
care, and it supports people who require
assistance with daily living, like the elderly
and disabled, to live independent lives for as
long as possible. It also has the potential to
lower costs, improve efficiency and deliver
better patient outcomes (see Figure 3).
Figure 3: The seven main ways the IoMT impacts health care
Source: Adapted from The Internet-of-Things: A revolutionary tool for the health care industry,
Inside Magazine, Deloitte LLP, 2017
The methodology for this report
The methodology for this report includes
a detailed literature review, market insights
provided by research companies Yole
Développement and MarketsandMarkets,
an online survey conducted by
Research2Guidance, structured interviews
with senior executives from a number of
large medtech companies and insights
provided by Deloitte colleagues working
across the medtech and health care
industries.
The growth of the IoMT market
The IoMT market, which can be viewed
through either a component or an
application lens (see Figure 4), is expected
to grow at a compound annual growth rate
(CAGR) of 30.8 per cent, from $41.2 billion
in 2017 to $158.1 billion by 2022.2
This
growth is due to the rapid digitisation of
health care systems to aid efficient patient
care, the rise in the demand for mobile
health care technologies and an increase
in demand from an ageing population and
people suffering from chronic diseases.
In 2017, North America accounted for the
largest share of the IoMT market ($13.3
billion or 33 per cent of the total market)
followed by Europe ($12.4 billion), AsiaPacific ($11.0 billion), the Middle East and
Africa ($2.4 billion) and South America
($2.1 billion). The IoMT market in AsiaPacific is projected to grow at the highest
rate, at a CAGR of 34.3 per cent during the
forecast period, due largely to the level of
unmet need and the increasing number of
hospitals and surgical centres being built in
this region.3
Improved
drug
management
Enhanced
patient
experience
Remote
monitoring
of chronic
diseases
Improved
patient
outcomes
Decreased
costs
Improved
diagnosis and
treatment
Improved
disease
management
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Figure 4: IoMT market segmentation by component and application, 2017 ($ billion)
Source: MarketsandMarkets, 2017
Market segmentation by component
Medical devices
Market segmentation by application
Connectivity
technology
Systems and
software Telemedicine
Medication
management
Connected
imaging
Inpatient
monitoring Others
Clinical operations and
workflow management
Services
$14.9
$12.9 $5.0
$8.8 $6.6
$9.8
$7.3
$9.3
$5.7
$2.3
The increasing numbers of
connected medical devices
and rising adoption of
smartphones are expected
to fuel the growth of the
market still further.
The market for connected medical
devices
The ability of the IoMT to help reduce
the cost of care while improving its
effectiveness is driven by the evolution of
artificial intelligence (AI), particularly the
rise of machine learning technologies.
Increasing investment for health care
IoMT solutions are driving market growth.
The increasing numbers of connected
medical devices and rising adoption of
smartphones are expected to fuel the
growth of the market still further. Potential
constraints to this estimated growth
include the extent to which health care
organisations, clinicians and patients are
willing to deploy IoMT solutions and a lack
of governance standards.
Estimates of the size of the current and
forecast market value for connected
medical devices vary significantly depending
on the criteria used.For the purposes of
this report we use estimates from market
research firm MarketsandMarkets. They
categorise connected medical devices into
three groups:
• stationary medical devices – include
X-ray and mammography devices, CT and
MRI scanners, ultrasound machines and
nuclear imaging devices that measure
physiological parameters. These relatively
high capital cost, high-tech devices, which
transmit images wirelessly to clinicians,
are generally deployed by hospitals,
clinics and diagnostics centres with the
images incorporated into the patient’s
Electronic Health Record (EHR). In vitro
diagnostic devices (IVD) are also included
in this category. Stationary medical
devices are critical to diagnosis and
increasingly are integrated with other
health care applications to overlay patient
data and imaging to facilitate faster and
more precise decision-making
• implanted medical devices – include
hip replacements, pacemakers and
defibrillators that monitor and treat
cardiac conditions, nerve stimulators,
bladder stimulators, diaphragm
stimulators and a variety of biosensors
to process different signals. Patients
who require constant monitoring often
receive implanted medical devices, which
are intended to remain in the human
body and are implanted following surgical
or medical intervention, or are clinically
inserted into a natural orifice
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
• wearable external medical devices
– include insulin pumps for diabetes
monitoring, skin patches, cardioverterdefibrillators and other devices, including
smartwatches and activity trackers that
produce data that are monitored by
clinicians. Wearable external medical
devices are used to monitor patients
while in hospital and post-discharge, as
well as on-going monitoring of patients
with chronic conditions or frailty.
Wearables used only for fitness tracking
or self-monitoring are not included.
The market for these connected medical
devices was $14.9 billion in 2017 and is
expected to increase to $52.2 billion in
2022 (see Figure 5).4
Figure 5: The market for connected medical devices is predicted to grow from
$14.9 billion in 2017 to $52.2 billion in 2022
2017
$5.7bn
$5.1bn
$4.1bn
$17.0bn
$18.9bn
$16.3bn
2022
Source: MarketsandMarkets, 2017
Stationary medical devices
Implanted medical devices
Wearable external
medical devices
Total $14.9bn $52.2bn
The remaining components of the IoMT
ecosystem
The other three key components of the
IoMT ecosystem are:
• systems and software – IoMT systems
and software primarily focus on reducing
the delivery time and cost of projects
through device management and
integration, information security, data
collection and data analytics. Systems
and software include remote device
management, network bandwidth
management, data analytics, applications
security and network security solutions.
The market for systems and software was
$9.8 billion in 2017 and is expected to
increase to $48.3 billion in 2022
• connectivity technology – connectivity
technologies are the enablers of the
IoMT ecosystem, connecting people
and devices to the internet. Wireless
technologies such as Wi-Fi, Bluetooth low
energy (BLE), near field communication
(NFC), Zigbee, cellular and satellite
technologies are primarily used in health
care. Factors that facilitate seamless
wireless connections are interoperability
between wireless standards, low energy
consumption, and range extension. The
market for connectivity technology was
$9.3 billion in 2017 and is expected to
increase to $28 billion in 2022
• services – IoMT services include system
integration services, professional
services and support and maintenance
services. Service providers are providing
personalised and optimised services that
offer predictable and better business
outcomes for health care organisations,
which allow these organisations to
manage the entire life cycle of the IoMT
in health care solutions. The market for
services was $7.3 billion in 2017 and is
expected to increase to $29 billion in 2022.
12
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
How medtech can help health care
organisations tackle current health
care challenges
Health care is increasingly expensive, with
global health care spending expected to
grow 4.2 per cent per year, from $7.1 trillion
in 2015 to $8.7 trillion by 2020.5
Among G7
countries, expenditure on health care as
a percentage of gross domestic product
(GDP) increased from 10.8 per cent in 2010
to 11.4 per cent in 2016.6
Indeed, health
care in many countries risks becoming
unaffordable, as governments and other
payers find their budgets increasingly
constrained at a time when the challenges
they face are growing significantly, driven by:
• unrelenting demand pressures from a
growing and ageing population – 8.5 per
cent of the global population (617 million
people) are aged 65 and over, with the
total expected to double by 2050 to
1.6 billion people7
• increasing public expectations for more
personalised, equitable and convenient
services
• advances in new treatments and
technologies – prescription drug sales
are expected to rise by 5.5 per cent a
year (2016-2022) to $1.06 trillion by 2022,8
while medtech sales are expected to
increase by 5.1 per cent a year (2016-
2022) to $522 billion by 20229
• a mismatch between the demand for and
supply of adequate numbers and types
of staff – staff are the largest cost driver
of health care, accounting for between
60 and 70 per cent of health care running
costs.10
The medtech industry is well placed to
help alleviate some of the cost, access
and care coordination challenges facing
health care. Medical devices can help staff
to work more effectively and productively
(e.g. using connectivity to track equipment
patient and staff workflow), improve access
to and speed of diagnosis ( e.g. advanced
point of care diagnostics), deliver more
targeted precision treatments, improve
medication adherence (e.g. apps, smart
pills and pill boxes) and support virtual
patient monitoring (e.g. sensors placed
under the patient’s mattress or within
a chair and patches that continuously
measure vital signs). IoMT solutions
can help reduce health care costs by
reducing hospital re-admissions, lowering
medication non-adherence, and increasing
wellness management using connected
smart devices and wearables to collect and
analyse medical data. Connected medical
devices can also engage and empower
patients and their carers to improve selfmanagement. MarketsandMarkets expect
that potential savings from deploying IoT in
health care could be as much as $63 billion
globally.11 Case examples of some of the
savings that can be generated are included
throughout the report.
Drivers of connected medical device
development
The medtech industry is characterised by
a constant flow of innovation based on a
high level of research and development
(R&D) and close co-operation with
users. Medtech companies constantly
update their technology to improve
their engagement and interactions with
patients and health care providers, with
products often upgraded or replaced every
18-24 months.12 In 2017, 13,090 medtech
patents were filed globally – the most of
any category of products, and a 6.2 per
cent increase from 2016. Across Europe,
this trend was even more pronounced, as
medtech patent filings increased by 7.1 per
cent from 2016.13
Increasingly, companies are developing
products that enter the market with
the capability of internet connectivity.
The same devices that companies have
been producing for years are now able to
connect to other networks and systems
and generate data that provides a huge
benefit for health care professionals in
terms of delivering insight into outcomes,
patient health and effectiveness of care
delivery. The challenge for medtech is
demonstrating to payers and providers the
added cost-benefits of these enhanced or
new connected products, and ensuring
that clinicians and patients are convinced
of the benefits and ease of use.
Wearable medical devices and home health
monitoring devices are becoming more
prevalent among patients of all ages. These
devices allow vital data to be transmitted
from a patient’s home directly to hospital
and other health care staff, resulting in
real-time monitoring of a patient’s health.
Utilising these types of devices could
result in considerable cost reductions
and operational efficiency improvements.
Similarly, advances in sensor technology
are making the creation of data much
easier. Early stage examples of sensors
embedded in novel ways include adding
them to pill bottles and hospital beds.
Globally in 2016, the number of patients
being monitored remotely grew by 44
per cent to 7.1 million and is projected to
exceed 50 million by 2021.14
However, the generation of data points
through millions of connected sensors will
have little impact unless the data can be
turned into insight and utilised effectively
in the clinical workflow. Currently, the
limiting factor is the ability to aggregate
data. Companies are addressing this by
working to increase interoperability and aid
data aggregation, but its complexity means
progress has often been slow.
13
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Medtech companies who participated
in our survey are increasing their focus
on connected medical devices
In April 2018, we commissioned market
research firm Research2Guidance to
conduct a survey of medical device
companies with connected medical
devices. Of the 237 respondents, 73 per
cent were from small companies (less than
250 employees); 15 per cent from mediumsize companies (251 to 5,000 employees);
and 12 per cent from large companies
(six per cent had more than 50,000
employees). See our separate methodology
paper for full details.
Survey respondents on average estimated
that 48 per cent of their current portfolio
of products are connected medical devices
able to generate data today and expect the
percentage to increase to 68 per cent in
five years’ time (see Figure 6).
Over half of respondents from small
companies said all their products are
connected, compared to around a
quarter in medium-size companies and
a third in large companies. This is likely
because larger companies surveyed have
significantly larger product portfolios with a
number of well-established non-connected
device offerings.
Across our survey respondents, the
average percentage of their overall R&D
budget allocated to the development
of connected medical devices was
estimated to be 34 per cent; all expected
this percentage to grow, with the overall
average in five years’ time increasing to 42
per cent (see Figure 6). Smaller companies
surveyed are currently allocating a
significantly higher percentage of their R&D
budget to the development of connected
devices (43 per cent), compared with their
medium – and large-sized counterparts
(both ten per cent).
Again, this is likely due to the difference in
product portfolios between the companies.
For example, our interviews with large
medtech companies highlighted that
significant investments in emerging IoMT
technologies are being made.15
“Being a large company, we need to gain flexibility and agility in order to compete with new
entrants and mainly with automated tech. Therefore, we are pivoting our business models
and operations, that today requires ‘high touch’.”
R&D Manager, Medtech company
14
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Figure 6: Connected medical device manufacturers are anticipating an increase in
the percentage of devices that are produced, as well as an increase in R&D budget
Note. The figures from our research survey relate to medtech companies with connected medical devices
and are not representative of the medtech industry as a whole. Due to rounding the figures may not total
100 per cent.
Source: Deloitte research commissioned from Research2Guidance, 2018
Estimated percentage of connected medical devices today and in five years’ time
Today 5 years
Other Other
52% 48%
68%
32%
Estimated R&D budget allocation towards the development of connected medical technologies
today and in five years’ time
Today 5 years
Other Other
34%
66%
42%
58%
Connected Connected
Connected Connected
The intention of medical device companies
to invest increasing proportions of their
R&D budget in connected devices, systems
and software is supported by our literature
review and from our structured interviews,
with one global company now investing
60 per cent of its R&D budget into systems
and software development.
Smaller companies
surveyed are currently
allocating a significantly
higher percentage of
their R&D budget to
the development of
connected devices.
15
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Part 2. Challenges and opportunities for
medtech
Cost, staffing and demographic challenges, combined with the exponential rate
of technological change and advances in medical science are forcing a shift in the
conventional model of health care provision towards value-based care.
The traditional fee-for-service health care
model focuses on volume of care, where
providers are compensated by the number
of tests, visits or procedures performed.
In a value-based care (VBC) model,
hospitals and health care providers are
compensated based on measures such as
patient outcomes and satisfaction.
Today, a number of governments and other
health care payers are expecting providers
to adopt new VBC payment models that
shift a higher level of responsibility and
risk from payers to providers. Medtech
companies have an important role to play
in supporting this shift, including providing
robust, reliable data and information to
providers (and payers) on the downstream
value that their devices, including
connected products, provide. Indeed, the
data and insights provided by connected
medical devices can help providers
improve cost, quality and productivity of
care delivery, and support better patient
engagement.
Participants in a Deloitte US survey of 20
Health system CEOs say that the transition
to VBC is happening, but at a slower rate
than initially anticipated. Many of the
CEOs report that they are developing and
expanding innovative delivery and payment
models.16 A successful value-based
payments strategy requires payer/provider
collaboration, sharing of patients’ health
data, and IT and analytical support. As
more providers adopt VBC models, the rate
of adoption and integration of connected
medical devices will also increase. While the
IoMT can provide these data and insights
to help improve patient care and the overall
cost-effectiveness of provider operations,
challenges include the extent to which
provider organisations’ IT infrastructures
are able to handle or process the
connections and data, and whether
clinicians and patients can be convinced of
the safety and effectiveness of the devices.
Medtech companies will need to address a
number of systemic challenges if they are
to optimise their role in the IoMT.
“The industry must have more close relationships with the ‘real’ health care system and
health care providers, namely doctors and nurses. Without the partnership of the medical
world all smart devices will stay only ‘nice-to-have devices’ instead of really connected
devices.”
CxO, Medtech company
Deloitte’s view:
Medtech companies
need to develop a
deeper understanding of the
end-user and their emerging
needs, and create new
business models and scenarios
that demonstrate how their
new and existing devices not
only improve patient outcomes
but also create value for key
health care stakeholders.
16
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Developing new funding, business and
operating models
Health care organisations looking to
reduce their expenditure on services are
taking a number of measures to lower the
costs of equipment and devices, such as
forming group purchasing organisations,
consolidating purchasing to a small range
of trusted products and changing the
way medical devices are reimbursed.
These factors are changing fundamentally
the way in which medtech companies
commercialise their products, leading
companies to develop new funding and
business models for their connected
medical devices and software.
Our survey of connected medical device
companies found mixed results in the
success they are having in developing new
business models. While 90 per cent of
our surveyed companies said they were
implementing new business models, 51 per
cent were doing so ‘to a large extent’ versus
39 per cent ‘to a limited extent’. Similarly,
most respondents are implementing
new operating models, although this was
split evenly between 45 per cent ‘to a
large extent’ and 45 per cent ‘to a limited
extent’. The majority of companies are
also adopting a value-based approach
to pricing, with a lower percentage
implementing new funding models for data
as a service (see Figure 7).
Figure 7: Medtech companies are implementing new business models and ways
of working
Note. The figures from our research survey relate to medtech companies with connected medical devices
and are not representative of the medtech industry as a whole. Due to rounding the figures may not total
100 per cent.
Source: Deloitte research commissioned from Research2Guidance, 2018
0% 20% 40% 60% 80% 100%
Not at all
Implementing new business
models
Implementing new operating
models
Adopting a value-based
approach to pricing
Implementing new funding
models for data as a service
To a limited extent To a large extent
Percentage of survey participants
10% 39% 51%
10% 46% 45%
17% 44% 39%
22% 47% 31%
A significant challenge for medtech is
whether, and if so how quickly, these new
business and operating models will be
able to increase revenue and profitability.
Furthermore, new entrants are disrupting
the sector, which will require incumbents
to take significant portfolio decisions
(including divestitures of lower margin
segments) and adopt new channels of care
(e.g. telemedicine and remote monitoring).
In 2017, Deloitte Consulting LLP and
AdvaMed, in collaboration with taskforces
of member companies representing
medical device and diagnostic companies,
developed an approach to help
stakeholders more effectively assess
the value of medical technologies. At the
heart of the recommendations are a set
of core principles to guide the assessment
process.
These start with comprehensively defining
the categories where a medical technology
can have impact, as considered from the
perspective of the different stakeholders
(ranging from the patient and their family
and caregivers, through to individual
clinicians, provider institutions, commercial
payers, and government bodies).
These factors are changing
fundamentally the
way in which medtech
companies commercialise
their products, leading
companies to develop
new funding and business
models for their connected
medical devices and
software.
17
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Figure 8: A value framework for innovation in health care
Source: Deloitte Consulting LLP and AdvaMed, 2017
The extent of clinical utility and
health outcomes associated with
medical technology offering
The impact on non-medical benefits
for the patient (or caregiver): patient
experience and patient economics
(such as out-of-pocket costs)
The impact of the technology on
revenues and costs for the provider,
payer, and provider-sponsored plan
via bonuses or penalties associated
with care quality metrics, as well as
the impact on clinical workflow and
other sources of operating
efficiency
The impact of the technology to the
health care system at large and
employers or the public as a whole
Clinical
impact
Non-clinical
patient impact
Care delivery
revenue and
cost impact
Public/
population
impact
Figure 8 describes the four main categories of value drivers which are a core consideration
in deciding the appropriate business model to adopt.17 We explore some specific examples
of the new and emerging business models in Part 3.
There is also a large spectrum of innovation types, from engineering driven incremental
innovations that mostly result in enhanced products aimed at identifying improvements
to stay competitive – which are unlikely to attract additional payments – to concepts like
human centred design that clearly create additional value for the health care system and
which require new reimbursement models (see Case study 1). 1819
Deloitte’s view:
While some new
reimbursement
models are already in use,
most focus more on prevention
and longer-term cost avoidance
that traditional reimbursement
mechanisms were not built
to reward. It is likely to take
several years for the health
care system to evolve to
be able to truly reward
innovation. The different types
of innovation will require
different business models, and
progress will depend on both
the innovators themselves
working in new ways to take on
risks and rewards, and the
evolution of existing payment
systems by both public and
private payers.
Case study 1. Medtronic’s outcomesbased reimbursement model with
two large insurance companies
Medtronic reached agreements with two large American health insurers to employ
an outcomes-based reimbursement model for patients opting in to use the
Medtronic insulin pump systems. One such agreement utilised Medtronic’s new
insulin pump, the MiniMedTM 670G, a hybrid closed loop system that leverages
a continuous glucose monitoring sensor to instruct the pump to deliver insulin to
the patient automatically when required. The outcomes-based reimbursement
model enables a risk sharing approach by both the payer and manufacturer
that links reimbursement of these new devices to improved A1C (glycated
haemoglobin) levels in the patient.18,19
18
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Addressing interoperability
Health systems and equipment increasingly
connect over wired and wireless networks.
Interoperability describes the extent to
which systems and devices can exchange
and interpret shared data. It also allows
for the authorised use of data and the
exchange of medical data to facilitate
decision-supported patient centric care
and reduce medical errors.
Interoperability in health care is extremely
complex and relies on being able to
establish connectivity and communication
between devices and IT systems, and
between data and workflows while
enabling secure and transparent data
exchange through consensus standards
and protocols. However, there are serious
barriers to achieving interoperability that
medtech companies need to understand if
they are to ensure the effective deployment
of their connected devices and realise the
benefits of interoperability (see Figure 9).
A key question that needs to be resolved is
who ‘owns’ the data and can drive direct or
indirect commercial benefit from it?
There are serious
barriers to achieving
interoperability that
medtech companies
need to understand.
Figure 9: Barriers to and benefits of interoperability
Interoperability
Benefits
Improved patient outcomes
Source: Deloitte LLP, 2018
Privacy and
security challenges
associated with
widespread health
information
exchange
Lack of incentives
to develop
interoperability in
the private sector
Lack of adoption of
standards-based
EHR systems
Consented sharing of
patient information
Safer transitions of care
Increased efficiency
Improved continuity and
consistency of care
Lower costs
Increased patient/physician
engagement
19
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Hospitals often use hundreds of
customisations to make EHRs user-friendly
and have multiple connecting systems
that increase the complexity of sharing
information. Connected medical devices
introduce even more data sources,
challenging providers still further, especially
in finding ways to store, share, and use
patient-generated data from wearable
health technology and smartphones.
Indeed, many health systems still lack
interfaces that can gather and interact
with emerging technology. Payment and
behavioral information is also likely to be
a future application that will require more
sophisticated layers of interoperability.
The increasing deployment of value-based
care models means collaboration between
payers and providers will be a necessity.
Although new regulations are attempting to
introduce new standards, these standards
are not always implemented in the same
way within and between organisations,
impacting the chances of interoperability.
A number of our interviewees noted
that the Health Insurance Portability
and Accountability Act (HIPAA) that the
US Congress passed in 1996 proved
to be a barrier to the development of
interoperability.
The Act made health care providers
accountable for keeping protected
health information (PHI) confidential, and
infringements invite hefty fines and potential
jail terms for those who fail to comply.20
There are also a number of technical and
organisational challenges that need to
be overcome if interoperability is to be
implemented effectively (see Figure 10).
However, recognising the importance
of interoperability is crucial for all
professionals working in the health care
industry and for all medtech companies
wishing to optimise the use of their
connected devices.
Figure 10: Key actions life sciences and health care stakeholders should consider when tackling the interoperability challenge
Interoperable medical devices,
systems and services
Obtaining consented access
to data across stakeholders
Implementing uniform messaging
standards for health care data
(e.g. HL7 and increasingly the Fast
Healthcare Interoperability
Resource (FHIR))
Developing a consensus on
standards for interoperability
Creating an integrated
governance framework
among stakeholders to
improve data integrity
Working towards a unified and technology friendly platform for
sharing clinical data (open Application Programming Interfaces (APIs))
Source: Deloitte LLP, 2018
20
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Although interoperability is clearly a
challenge, the results of our survey
suggest that the majority of respondents
from companies that have developed
connected medical devices feel they are
well prepared to face this challenge – 76
per cent of respondents believe they are
‘reasonably well’ or ‘very well’ prepared to
develop interoperable connected medical
devices (and software systems). Again, this
high degree of confidence may be due to
the fact that these companies are actively
dealing with interoperability challenges.
Nevertheless, interoperability is a
shared responsibility, and findings from
our interviews with medtech leaders
indicated that the challenge in developing
interoperability is dependent on being able
to collaborate with health care providers.
Our survey results support this finding,
with only 43 per cent of respondents
indicating that they are collaborating
with health care providers on connected
medical devices ‘to a large extent’.
The Office of the National Coordinator
for Health Information Technology laid
out a vision for achieving interoperable
health IT that supports a “broad scale
learning health system” by 2024.21 It
noted that while there has been some
progress in establishing standards and
services to support health information
exchange and interoperability, electronic
health information is rarely shared across
organisational, vendor and geographic
boundaries. Electronic health information
is also not sufficiently standardised to
allow seamless interoperability, due to
inconsistently expressed vocabulary,
structure, and format, thereby limiting
the potential uses of the information to
improve health and care. Learning lessons
of previous and current health information
exchange infrastructure to improve
interoperability is a priority.
Widespread interoperability across varying
systems can only be achieved through
reliance upon standard technology
interfaces that establish clear rules for
communicating. Currently, some of these
technology standards are ‘open,’ others
are ‘restricted’ or ‘closed,’ meaning they
don’t achieve the highest possible level
of interoperability. This creates different
environments for stakeholders:
• with open standards, any vendor of
communications equipment or services
can implement all standards necessary to
interoperate with other vendors. In turn,
consumers of these products can choose
the product that meets their needs
and switch at will without fear of losing
functionality or control of their data
• with closed standards, there are
restrictions on which vendors can
implement the standard, which in turn
impact consumer choice and market
competition. These restrictions can
be a lack of access to a democratic
standardisation process, onerous licensing
terms, or proprietary technical ‘hooks’.
APIs that allow disparate applications
to connect will be an important tool for
increasing health data exchange, preventing
information blocking and fostering
interoperability of health information.
Moreover, well-managed API exchanges
usually include authentication, authorisation,
encryption and signatures to ensure secure
connections. Furthermore, as cloud-based
platforms advance the use and functionality
of EHRs, they have the potential to solve the
interoperability problem between different
EHR systems. Not only do cloud software
systems tend to work better with other cloud
software, they are also more scalable than
their server-based counterparts and can
increase data accessibility while providing a
stable and flexible environment for managing
information securely.
“We don’t support
interoperability in the open
source sense, but certainly
in the connecting to make
services more seamless.”
CxO, Medtech company
Deloitte’s view:
Interoperability is
arguably the biggest
challenge to health care’s
ambition for a patient-centred,
digitally-enabled, health care
ecosystem. If the challenge is
to be addressed, open
platforms, based on open data
standards is the direction of
travel that needs to be followed
to enable payers, providers,
and technology vendors to
finally come together to make
data more available to one
another.
21
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Maintaining cybersecurity
The increasing interconnectivity of IoMTenabled devices collecting and sharing
patient data significantly increases the
number of potential vulnerabilities within a
system. As medical devices are connected
to home networks, public Wi-Fi or cellular
networks to transmit information back
to the hospital’s network, information
becomes more prone to hacking and
compromises the privacy of the individuals
concerned.
Protecting patients from cyber threats
represents a new and ever evolving
challenge for both medtech and health care
organisations alike. The increasing capability
and usage of connected medical devices can
also serve as additional points of failure for
data security. Over the last ten years, there
have been a number of incidents revealing
the security vulnerabilities of connected
medical devices.22
As more health care applications and
platforms move to the cloud, data
has more value than nearly any other
commodity, and hospitals, doctor’s
offices, pharmacies and other health care
facilities store an abundance of valuable
data, making them prime targets. Health
care-provider networks are constantly
under attack by ransomware, hacks and
other threats. Although new technologies
and government initiatives to improve
cybersecurity are on the rise, the value of
patient data is increasing as well, and with
it, the amount of cybercrime.
Recently, numerous large data breaches
have occurred, with as many as 79 million
people affected in one such health care
breach.23 Moreover, the cost of such
data breaches are significant and often
far-reaching. The Ponemon Institute
estimated the cost per capita of a data
breach in health care in 2017 as the highest
compared to 17 other industries.24
The Ponemon research was based on a
survey of both connected device makers
and health care providers to determine
if both groups are aligned regarding the
need to address risks to medical devices.
It found a lack of alignment about current
risks and a serious disconnect between the
perceptions of device manufacturers and
providers about the state of medical device
security which could prevent collaboration
in achieving greater security. The research
estimated that 67 per cent of device
makers believe an attack on one or more
medical devices they have built is likely,
with 56 per cent of providers believing such
an attack is likely. Despite the likelihood
of an attack, only 17 per cent of device
makers and 15 per cent of providers are
taking significant steps to prevent attacks.
Accountability for the security of medical
devices manufactured or used is lacking.
While 41 per cent of providers believe they
are primarily responsible for the security
of medical devices, almost one-third of
both device makers and providers say
no one person or function is primarily
responsible.25
Fixing security flaws often requires
software patches that are reactive to the
threat rather than proactive. Once a flaw
is identified, implementing changes across
a large number of devices, IT systems and
stakeholders is difficult to do and requires
a concerted effort among all stakeholders
to rectify the flaw, often making connected
medical devices the weakest links within
health care networks.26 Moreover,
research indicates that key stakeholders
do not have a strong understanding
of the cybersecurity risks within their
organisation, how to prevent them and
what to do once a risk has been identified.
Preparation is critical in staying connected
and protected. However, even with a fully
staffed IT department, most healthcare
organisations need to identify a cloudbased IT-solutions partner or cloud service
provider (CSP) that offers the most up-todate infrastructure on which to support
its network and establish cloud service
agreements and service level agreements
(SLAs).27
Interestingly, respondents to our survey
of connected medical devices indicated
that they consider their organisation
‘reasonably well’ or ‘very well’ prepared
to deal with the challenges of maintaining
device cybersecurity (see Figure 11).
Moreover, our survey results also indicated
that larger companies felt better prepared
than smaller companies – possibly as
larger companies have more resources
to dedicate towards maintaining the
cybersecurity of their products.
“In the increasingly connected world of devices, mobility, and cloud, the need for better
intelligence has led to the increase in adoption of IoT health care software and services.”
CEO, IoT and Cloud provider company
22
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
The increase in publicity about cyberattacks and preparation for the EU General
Data Protection Regulation (GDPR) may
have increased the importance given to
tackling this risk.
Figure 11: Preparedness of medtech
companies towards maintaining the
cybersecurity of connected medical
devices
Note. The figures from our research survey
relate to medtech companies with connected
medical devices and are not representative of
the medtech industry as a whole. Due to
rounding the figures may not total 100 per cent.
Source: Deloitte research commissioned from
Research2Guidance, 2018
0%
20%
40%
60%
80%
100%
37%
44%
12%
2%
4%
Don’t know
Not very well Reasonably well
Percentage of survey participants
Very well
Not at all
The FDA (US Food and Drug Administration)
acknowledges that because cybersecurity
threats cannot be completely eliminated,
manufacturers, hospitals and facilities
must work to manage them to balance
protecting patient safety and promoting
the development of innovative technologies
and improved device performance.28 Many
countries are beginning to address this
emerging risk with regulatory policies,
such as the FDA’s Pre and Postmarket
Management of Cybersecurity Medical
Devices,29,30 which provide manufacturers
with some clarity on how to handle
ever evolving issues in cybersecurity.
Additionally, industry groups such as the
Association for the Advancement of Medical
Instrumentation (AAMI) have released
security risk management guidance for
connected medical devices. Following
several years of development, the European
Commission (EC) produced new rules in 2017
to ensure the safety of medical devices in the
future. The new regulations aim to increase
security and regulatory certainty and take
into account the latest developments in the
sector including medical software, apps and
cybersecurity practices.31
Looking to the future, both the FDA and
the European Union Agency for Network
and Information Security (ENISA) have
provided guidance on the implementation
and security considerations required for
interoperable medical devices.32,33
“[My] company has put increased resources into cybersecurity, in addition to the mitigations
designed into the products even though we haven’t had any issues thus far.”
Regulatory/Quality/Compliance Manager, Medtech company
Deloitte’s view:
Given the scale of
potential security
issues affecting connected
medical devices, all
stakeholders managing and
utilising the data generated
from connected medical
devices need to take a more
proactive and collaborative
approach to identify and
resolve security issues. Medical
device manufacturers need to
adopt a ‘security by design’
approach where a device is
designed from the ground up
to be secure instead of adding
security features after it has
been delivered and deployed.
To mitigate cybersecurity risks,
organisations will need to avoid
disconnected governance and
establish real-time monitoring,
cyber threat modeling and
analysis, threat mitigation and
remediation. AI and machine
learning can help medtech and
health care organisations
anticipate emerging cyber
threats.
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Successfully navigating regulatory
change
Over the past few decades the regulation
of the safety of medical devices has
remained relatively unchanged. For
the majority of devices, the only formal
evidence required was the CE marking.
However, in Europe, the 2011 silicone
breast implant scandal and product
recall of the metal-on-metal hip implant
highlighted serious weaknesses in the then
regulatory system and strengthened the
case for modernisation.34
Moreover, as medical devices become
ever more sophisticated and innovative,
regulations in most countries have failed
to keep pace with scientific and technical
developments. The increasing use of
digital technologies has exacerbated
this situation. As a result, concerns over
the safety of medical devices and data
security have led regulators to put in
place, or plan to put in place, legislation
and protocols that aid in the management
and implementation of medical device
safety, accountability, cybersecurity and
interoperability (see Figure 12).35 The
industry expects obtaining CE marking
will be more challenging following the new
regulations.
For the majority of devices,
the only formal evidence
required was the CE
marking.
Figure 12: Timeline of key regulatory changes impacting medical devices
Source: Deloitte LLP, 2018
FDA (2014): Content of pre-market
submissions for Management of
Cybersecurity in Medical Devices.
EU (2016): International Organization
for Standardization (ISO 13485:2016).
FDA draft (2016): Post-market
Management of Cybersecurity in
Medical Devices.
FDA (2017): Design considerations
and Pre-market Submission
Recommendations for Interoperable
Medical Devices.
Medical Device Single Audit Program
(MDSAP) (2017): Adopted by regulators
in the US, Canada, Japan, Brazil, and
Australia.
EU (2022): In Vitro Diagnostics Medical
Devices Regulation (IVDR) fully applied.
EU (2017): European Union Agency
for Network and Information Security:
Baseline Security Recommendations
for IOT.
EU (2018): General Data Protection
Regulation (GPDR).
EU (2020): Regulations for medical
devices (MDR) fully applied.
24
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Medtech companies are currently facing
a triple hit on medical device regulatory
compliance. New regulations from
the European Union, Canada, and the
United States are being implemented
simultaneously, which will impact all
companies wishing to do business in
these geographies.36 In particular, the
regulatory landscape in Europe will change
significantly over the next five years, as new
EU regulations are fully enacted.
The EU Medical Devices Regulation and
In Vitro Diagnostic Medical Devices
Regulation
In June 2016, new legislation was agreed
by all EU member countries to adopt the
Medical Devices Regulation (MDR). Similarly,
in April 2017 the In Vitro Diagnostic
Medical Devices Regulation (IVDR) was
approved. The new rules apply in full after
a transitional period – spring 2020 for
MDR and spring 2022 for IVDR. The aim
is to establish a modern and more robust
EU legislative framework to ensure better
protection of public health and patient
safety and affect all companies wanting to
do business in the EU (see Figure 13).
37,38
However, industry representatives
frequently raise concerns that regulators
find themselves slow to react to trends that
could significantly improve the operations
of both medical technology and health care
organisations. In our survey, 66 per cent
of respondents either ‘agree’ or ‘strongly
agree’ that the regulatory framework will
not catch up with what is possible today
for another five years – a finding echoed
by most of our interviewees. However,
proactive steps are being undertaken
by regulators, particularly the FDA to
catch up with trends within the industry,
including recommendations for pre-market
submission of interoperable medical
devices, published in 2017.39
The General Data Protection
Regulation
The General Data Protection Regulation
(GDPR) is intended to strengthen and unify
data protection for all individuals within the
EU and from 25 May 2018 is automatically
applicable across all member states. It also
applies to any company that does business
with, or has customers in, EU member
states.
While GDPR is seen as a roadblock by some
in the medtech industry, it also presents
an opportunity to ensure that connected
medical devices are more secure and
private as a result. At present, many
citizens in Europe have limited electronic
access to data about their own health. The
data is often untraceable and scattered
in different places, which may impact
adversely on diagnosis, treatment and
follow-up. The enactment of the GDPR is
intended to ensure that citizens will now
have secure access to a comprehensive
electronic record of their health data, have
control of these data and are able to share
their health data securely with authorised
parties (for medical treatment, preventive
services, research or for any other purpose
they deem appropriate).
Figure 13: Key changes as a result of the EU MDR
Source: Deloitte LLP, 2018
Expansion of product
scope for regulated
medical devices and
device reclassification
according to risk, contact
duration and invasiveness
Systematic clinical
evaluation of Class IIa
and Class IIb medical
devices
Implementation of unique
device identification for
full compliance and
traceability
More rigorous
post-marketing
surveillance
More stringent clinical
evidence and
documentation of class
III and implantable
medical devices
Increased transparency
of a products clinical
and safety data will be
available to the public
via EudaMed
Identification of person
responsible for
regulatory compliance
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
This should be irrespective of where
the data is located and in line with data
protection legislation. The regulation also
aims to ensure that unauthorised access is
prevented.
Industry opinion on regulatory change
Despite concern among industry
professionals about new regulations,
around four-fifths of our survey
respondents indicated that their
organisation is well prepared to deal
with MDR and GDPR (see Figure 14).
This is possibly due to the length of time
regulators have allowed organisations to
transition over to the new regulations.
Figure 14: The preparedness of connected medical device manufacturers towards
the implementation of industry specific and wider regulatory changes
Note. The figures from our research survey relate to medtech companies with connected medical devices
and are not representative of the medtech industry as a whole. Due to rounding the figures may not total
100 per cent.
Source: Deloitte research commissioned from Research2Guidance, 2018
Preparedness to comply with industry
regulatory changes (e.g. MDR)
Don’t know
Preparedness to comply with wider
regulatory changes (e.g. GDPR)
Not at all Not very well Reasonably well Very well
5% 1% 6% 1%
39% 36%
12%
18%
40%
43%
Deloitte’s view:
Recent and ongoing
regulatory changes
will impact every medtech
company that currently sells or
sponsors products in the
European Union (EU).
Managing the impact of
regulatory change requires
a proactive and well-planned
approach. If medtech
companies are to create a
sustainable innovation model,
they need to build engagement
with regulators into their
innovation models and involve
clinicians and patients in
product design. Medtech
companies should consider
establishing cross-functional
steering committees to
integrate R&D with commercial,
manufacturing and market
access. Meanwhile, the FDA’s
initiatives to develop a more
collaborative approach to
innovation may have lessons
for other regulators to follow.
While GDPR is seen as a
roadblock by some in the
medtech industry, it also
presents an opportunity
to ensure that connected
medical devices are more
secure and private as
a result.
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Attracting digital talent and building
digital capability
There is a growing concern across the
health ecosystem about the lack of skills
to deploy IoMT solutions and the risk
that this will constrain market growth.
Medtech’s workforce has traditionally
been focused on electrical and mechanical
engineering and product development
supported by large traditional sales forces.
Today it also requires a high level of skills
in digital, advanced data analytics and
machine learning, and a workforce that
is educated and flexible. Data scientists
with advanced degrees and training in
maths, statistics and/or computer science
and experience in data mining and data
visualisation are much sought after skills.
Regulatory changes and growing economic
pressures across the IoMT ecosystem have
also created a demand for new skills and
capabilities to manage the path from R&D
to market, to ensure that new devices gain
commercial market access.
However, there is growing evidence of
an emerging skills shortage affecting the
medtech industry. Research undertaken
as part of the development of the UK’s
Life Sciences Strategy in 2017 identified
a growing skills gap as one of the greatest
challenges for the UK’s medtech industry.40
Although 79 per cent of our survey
respondents believe that their company
is ‘very well’ or ‘reasonably well’ prepared
to build digital capability within their
organisation, only 22 per cent of all
respondents selected ‘recruiting top digital
talent’ as one of their top three priorities
for better utilising the data generated from
connected medical devices. This may be
because the companies in our survey are
already producing connected medical
devices and have invested in the requisite
skills.
While mergers and acquisitions can help
larger companies acquire the digital
talent that will be needed, partnerships
and collaborations with traditional and
non-traditional players can also form
part of an organisation’s skills and talent
strategy. Companies will also need to
invest in developing an innovative, flexible
digital culture in order to recruit and
retain the digital talent needed to build
the data-centred services that will drive
value for patients, providers and their own
organisations in the future.
Similarly, while the health care sector is
expected to benefit immensely from IoMT
technologies, the lack of skills to deploy
IoMT solutions could also constrain market
growth.41 The addition of IoMT devices
makes network management more difficult
for health care IT teams as they deal with
increased complexity. In our survey, 70 per
cent of respondents agreed that health
care providers and clinicians are not
ready to utilise the data generated from
connected medical devices.
Deloitte’s view:
If medtech companies
are to remain
competitive, they need to
develop a new, digital-first skill
set including digitally savvy
skills and multidisciplinary
talent from creative and
scientific backgrounds.
Accessing this talent will
require more resourceful
recruitment and retention
strategies, including
collaborations and
partnerships with a diverse
range of existing and emerging
players, especially academia,
engineering companies,
data-first tech companies and
innovative new start-ups.
“I think we’re well suited [to manage and utilise the large
amount of data generated from connected medical devices].
[We] went outside the industry and recruited Silicon Valley
executives [for] big data [analytics] to help our executive
team a few years ago.”
Executive VP – Quality and Regulatory Affairs, Medtech company
“Traditionally, medtech R&D is driven by mechanical and
electrical engineers and related processes. IoMT related
R&D focusing on software and sensors requires a different
mindset and collaboration approaches with partners. This
means a cultural shift for the R&D teams that needs to be
managed actively.”
Global Head of R&D, Medtech company
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Maintaining trust in a digital age
A willingness for patients to be prepared
to share data is critical to the long-term
success of connected medical devices. For
this to happen, patients need to have trust
in how their data will be used.
While 80 per cent of respondents from our
survey believe that their company is either
‘reasonably well’ or ‘very well’ prepared
to obtain patient trust and willingness to
share data, this contrasts with the findings
from many patient surveys. However, the
interactions medtech companies have
with patients move beyond apps and
web portals, as many connected devices
collect and send data on a patient’s wellbeing autonomously. Research has shown
that vulnerabilities in connected medical
devices are commonplace, and medtech
companies and health care organisations
are not as proactive as they need to be in
tackling these challenges.42
As large technology companies become
more involved in developing connected
medical devices, and traditional medical
device companies become more involved
in data management and analytics,
underlying trust issues that often occur
between consumers and companies may
emerge. In 2018, high-profile breaches
involving large technology companies
have brought concerns regarding the use
and management of personal data to the
forefront of public debate. A report by
the Wellcome Trust notes that consumers
distrust organisations that look to
profit from health data.43 Therefore, it is
imperative that medtech learns lessons
from other industries and manages
privacy and security risks proactively as its
business and operating models evolve.
“The health care system is not fully ready for IoT, [and] has a lot of catching up to do. [It] does
not have the technical capabilities, nor the professional technical manpower to handle and
manage the technology. Technology is moving at a faster pace than the health care system
and the regulatory system.”
CxO, Medtech company
Deloitte’s view:
Medtech companies
need to earn the trust
of providers and patients by
developing strong privacy and
security arrangements (e.g.
data encryption and
authentication mechanisms),
adopting key principles of data
minimisation, data protection
by design, and data protection
by default, and giving patients
control over their own data,
including the right not to share,
as well as enabling the patient
to see who is using data and
for what purposes. Embedded
blockchain-like technology can
provide a real-time mechanism
to track how data collected by
connected devices is
processed, when it is used and
for what purposes.
“There is always something you don’t know around
managing and using data. Exposure to more use cases will
definitely help us.”
CxO, Medtech company
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Improving the adoption of medical
technology at scale
The main barrier to adoption of connected
medical technologies involves acceptance
by health care systems as a whole, as well
as by individual health care professionals.
Health care systems are struggling to
recruit and retain the technical capabilities
to deal with new technologies, with
the pace of change in developing new
technologies outpacing that of health care
systems and regulations. Confidence in
connected technologies is another barrier
to the full scale adoption of connected
medical technologies, with staff reluctance
to engage with technology due, in part,
to the scale, pace and proliferation of
technology development and a lack of
education and training in deploying them in
a clinical setting.
The 2016 edition of Philips’ annual Future
Health Index lists the top ten perceived
barriers to connected technology adoption
from health care professionals (see
Figure 15).44 The report notes that the
investments required to encourage the
adoption of connected technology are
a concern across all countries, and are
shared by the patient and health care
professional populations.
“Patients will become more aware of [their] rights, [which] will impact how organisations
create governance around ownership of data. It will depend on the age profile of patients
– the younger generation might be happy for data to flow, [whereas the] older generation
might not.”
Global IOT Partner Manager, Technology Company
Half of health care professionals and patients believe connected care technology would
increase the cost of health care overall, and there were worries about the resources needed
for associated needs, such as training and data security.
Figure 15: Top ten perceived barriers to adoption of connected technology*
Source: Philips Future Health Index, 2016
*Respondents were asked to select their top three perceived barriers to adoption.
Cost of devices
Privacy concerns/data security
Health system bureaucracy
Training for patients to use new
systems/technologies
Trust in accuracy of data collected
by the devices
Attitude of patients to adopt new
systems/technologies
Government health-related
regulation/policy
Awareness of devices
Attitudes of health care professionals
to adopt new systems/technologies
Training for health care
professionals to interpret/use data
from new systems/technologies
46%
29%
25%
24%
22%
22%
19%
19%
19%
16%
0% 10% 20% 30% 40% 50%
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
In England, Academic Health Science
Networks (AHSNs) were established in 2013
to help the UK government’s efforts to
develop and spread adoption of innovation
across the NHS. AHSNs are a network of
15 different regional organisations with the
goal of improving health and generating
economic growth. The role of AHSNs is
to connect the NHS to academia, local
authorities, the third sector and industry,
in order to identify and drive the adoption
and spread of health innovations across
large populations (see Case study 2).
Each AHSN works across a distinct
geography serving a different population
in each region while sharing the same
priorities, including promoting economic
growth, diffusing innovation, improving
patient safety, improving quality and
reducing variation and putting research
into practice.45
4647
Case study 2. AHSN’s promotion of
the adoption of new technologies
(GDm-health)
The AHSN network has promoted the adoption of GDm-health™ – a smartphone
app that allows the remote monitoring, management and communication
between pregnant women with gestational diabetes and health care providers.
Gestational diabetes mellitus (GDm) affects roughly ten per cent of pregnant
women, with an estimated 100,000 women across England impacted annually.
Careful monitoring of blood glucose (BG) levels is essential for the successful
management of the patients’ condition.46 The system is comprised of the GDmhealth app, which is used with a blood glucose meter by the patient to send realtime patient-annotated BG results via Bluetooth or NFC (near field communication)
to a clinical web-dashboard for the care team to see.47 The web-dashboard
enables health care professionals to prioritise care to women most in need and
to manage patients in real time through text messages and to communicate with
other staff involved in their care. The app makes it possible for women to receive
feedback from their care team on their glucose levels and guidance to alter their
diet or medication accordingly.
The Oxford Academic Health Science Network (Oxford AHSN) played a key role in
establishing the proof of concept, as well as helping to find an industry partner to
further test, develop and commercialise the GDm-health system. By March 2017,
almost 2,000 women had taken part in the regional pilot, with the results showing
a reduction in unnecessary clinic visits by 25 per cent, as well as better glucose
control. The system is now being rolled out to other regions and is part of a fiveyear strategic research agreement between Drayson Health, the University of
Oxford and Oxford University Hospitals NHS Foundation Trust starting in July 2017.
Deloitte’s view:
Medtech companies
need to be able to
provide robust and reliable
evidence to health care
organisations on how
technological advancements
and the data generated by
connected devices improve the
efficiency and cost-effectiveness
of care delivery. This includes
ensuring that the devices are
more intuitive and easy to use,
and, where necessary,
providing training and support
to staff to embed the skills
necessary to optimise the use
of the technology and realise
the cost-benefits of adoption.
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Part 3. Connected medical devices are
transforming care
Creating the IoMT at scale requires close collaboration with patients, providers, payers,
pharma and other medtech manufacturers. Our research identified multiple ways
in which medtech is working towards building the IoMT, deriving value from it and
transforming health care.
Collaboration between health care
providers and medtech is a core
component of the IoMT
Integrating connected medical devices into
established care pathways is challenging
and requires significant cooperation
from multiple stakeholders to work
successfully. Cross-industry collaborations
are key in bridging gaps in expertise and
creating solutions that deliver clinical,
operational and financial value. Most
medtech companies in the IoMT market
are adopting collaboration strategies
such as partnerships and joint ventures
to increase their market presence and
share risk. These collaborations can be
used to support a number of aspects
of the IoMT ecosystem, including the
transmission, aggregation, analytics and
management of data from connected
medical devices. Health care providers, and
in particular their EHRs, provide the central
repository for data from multiple devices.
For collaborations to be effective, health
care providers need to grant medtech
companies access to these data, under
agreed and approved circumstances,
including, where relevant, patient consent
on how this data can be used.
Our survey respondents ranked
collaborations with health care providers
(68 per cent) as the most important for
the development of their respective
businesses, followed by collaboration
with health care payers (45 per cent), and
other medtech companies (42 per cent).
A total of 87 per cent of respondents either
agreed or strongly agreed that realising the
benefits of connected medical devices and
delivering value and efficiency can only be
delivered through collaboration with health
care providers (see Figure 16). In practice,
connected medical device companies
indicated slightly greater success in
collaborating with patients than they have
Figure 16: Collaborations with health care providers
Note. The figures from our research survey relate to medtech companies with connected medical devices
and are not representative of the medtech industry as a whole. Due to rounding the figures may not total
100 per cent.
Source: Deloitte research commissioned from Research2Guidance, 2018
Strongly agree
Percentage of survey participants
Realising the benefit from connected medical
devices requires close collaboration with health
care providers
Connected medical devices will be central to delivering
value and efficiency for health care providers
Health care providers and clinicians are not ready
to utilise data generated from connected
medical devices
Strongly disagree Disagree Neutral Agree
0% 20% 40% 60% 80% 100%
52%
50%
26%
35%
37%
45%
10%
10%
11% 17%
Figure 17: The extent to which medtech organisations are collaborating with
patients and health care providers in response to connected medical devices
Note. The figures from our research survey relate to medtech companies with connected medical devices
and are not representative of the medtech industry as a whole. Due to rounding the figures may not total
100 per cent.
Source: Deloitte research commissioned from Research2Guidance, 2018
Not at all
Working more closely with providers
Working more closely with patients
Supporting providers to improve productivity
To a limited extent To a large extent
0% 20% 40% 60% 80% 100%
51%
43%
40%
13%
13%
13%
43%
37%
48%
Percentage of survey participants
with health care providers (see Figure 17),
highlighting that both medtech and health
care providers need more constructive
dialogue when developing and integrating
connected devices into clinical practice.
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
A better understanding of provider
needs will allow medtech and other key
stakeholders to develop the industry
intersections required to support a
connected medical device ecosystem,
from the collaborations needed to support
interoperability to the technologies
required for advanced analytics. Figure
18 highlights the multiple and often
complex intersections between the
relevant stakeholders in the connected
medical device ecosystem. Although a
number of organisations are leading the
way in utilising collaboration, there is a
need to develop a clear understanding
of the points at which they occur, their
governance, accountability and influence
on how the IoMT operates. Optimising
these collaborations will enable medtech to
be pivotal in driving developments in VBC.
Figure 18: Connected medical device collaborations can occur at multiple
intersections and across industries
Patients
Providers
(hospitals/clinics/
carers)
Analytics platforms
Connected
medical devices
Health care provider collaborations
Payer collaborations
Medtech collaborations
Tech company collaborations
Communications
services (cellular/Wi-Fi)
Payers
Note. Arrows indicate points at which data from connected devices can be transferred
Source: Deloitte LLP, 2018
A better understanding
of provider needs will allow
medtech and other key
stakeholders to develop
the industry intersections
required to support a
connected medical device
ecosystem.
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Digitally connected medical devices are benefiting both patients and hospital providers
Medical devices are almost always designed for a specific application. Adding connectivity to a device allows data to be generated related
to a patient’s wellbeing and a device’s operations, which can then be used to improve performance and outcomes (see Figure 19).
Figure 19: Collaboration can benefit both patients and providers
Patients
Providers
…which other devices their
device can link with
And how this information
can be used to drive
improvements in …
· patient outcomes
· operational efficiency
· financial performance
· product design
…what analytics are useful in
relation to the therapy being used
to treat a patient
…which teams input into the
clinical care of patients
…the clinical context in which
devices are used
Source: Deloitte LLP, 2018
A number of medtech companies are implementing solutions that wrap their connected device offerings around patient monitoring and
services that allow providers to understand key health metrics of their patient population. Some of these connected solutions are linked to
the therapies developed by the company, such as implantable cardiovascular devices (see Case study 3).4849
Case study 3. Medtronic CareLink
The Medtronic CareLink network is an internet-based remote monitoring system compatible with 99.9 per cent of Medtronic
devices. The Medtronic CareLink Network service allows Medtronic implantable cardiac devices to be remotely monitored
through a network that is accessible to a clinician at all times. Data is collected from a person’s implanted cardiac device
and stored on the Medtronic CareLink Clinician website. This website provides secure internet access to data received from
implantable pacemakers, implantable cardioverter defibrillators, cardiac resynchronisation therapy with pacing devices, cardiac
resynchronisation therapy with defibrillator devices, and implantable loop recorders. Clinicians can also receive CareAlert
notifications, which are generated in response to clinical events, to identify potential device problems before they become
more serious. The CareLink network service may reduce the need for the person to attend face-to-face follow-up appointments
with their clinician.48 Evidence from the operation of CareLink for patients with heart failure suggests that it decreases the time
from the detection of a clinical event to a clinical decision, and it decreases the number of emergency visits and overall health
care use in people with heart failure compared to standard face-to-face follow-up.49
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Other connected solutions are delivering
better patient outcomes and aiding health
care providers to improve operational and
financial performance (see Case study 4).
These connected medical devices are
proving increasingly crucial to the health
care providers that have adopted them.5051
Case study 4. UK NHS utilising Bruin
Biometrics’ connected medical
technology to improve patient outcomes
and workforce productivity
Pressure ulcers (PU), are an area of localised damage to the skin and underlying
tissue and are a prevalent medical problem that can result in pain, disfigurement,
infection and death.50 The prevalence of PUs in nursing homes across Europe
ranges from 18 to 23 per cent and can be up to 57 per cent in some critical care
units. However, with early detection, around 80 per cent of PUs are preventable.
Bruin Biometrics’ hand-held skin tissue assessment device – the SEM scanner™ –
detects early, pressure-induced tissue damage, including PUs. The device detects
changes in the sub-epidermal moisture (SEM), which has been found to indicate
tissue damage three to ten days prior to visual skin damage or PU formation. The
device has been used successfully in 13 participating NHS hospitals. Analysis of the
outcomes for over 1,200 patients indicated that:
• over 50 per cent of hospitals achieved no new bedsores during the evaluation
• hospitals observed reductions in bed sores of up to 90 per cent
• nursing managers reported improved productivity and the release of nursing
time, as well as significant cost savings related to reduced length of patient stay
and treatment costs
• one hospital estimated that it could save £600,000 and 1,420 nursing hours
annually if the technology was rolled out across the hospital.51
Other connected
solutions are delivering
better patient outcomes
and aiding health care
providers to improve
operational and financial
performance.
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Joining the dots between connected
medical devices and health
care IT systems will enable the
transformation of health care
operations
As discussed in Part 2, achieving
connectivity at scale requires
interoperability – devices, systems and
organisations communicating through
a common language, with the ability to
link disparate sets of data that sit within
health care organisations. A total of 88 per
cent of our survey respondents agreed
that optimising the value from connected
medical devices requires data sets to be
linked to one another. However, there is no
consensus on what the best method is to
achieve large scale interoperability, with a
range of solutions emerging.
Connected ecosystems are often designed
to support the companies’ own devices,
or they do not integrate well into existing
systems used by health care providers,
leading to pockets of interoperability within
a health care organisation that is unable
to share information with other medical
specialties within the same organisation.
A number of large medtech companies,
however, have developed connected
ecosystems that act as a common platform
to share and view data (see Case study 5).
Medtech companies are increasingly turning
to collaboration to achieve interoperability
that can work across an organisation and
incorporate devices made by third parties.
Some collaborations look to incorporate
third party devices into their own digital
ecosystem, integrating data from across
a wide range of devices into their own
solution, or they look to harmonise systems
and data sharing among an organisation’s
own systems (see Case study 6).
525354
Case study 5. Philips HealthSuite
connects devices and services around
a common platform
Phillips HealthSuite is an open, secure platform of services, capabilities and
tools purpose-built for healthcare. It allows medical devices to share data in
a secure, unified and open platform that collects, compiles and analyses clinical
and operational data from a wide range of devices and sources. This data can
then be accessed by clinicians, patients and carers remotely through mobile and
desktop applications that can provide real-time patient data. The technology
delivers precise, predictive, and personalised insights and can be used to enable
telemedicine, remote monitoring, genomics analytics and precision diagnostics,
and help drive behaviour change, and improve the operations of health care
providers and help consumers with personalised services that help them
improve their health and wellbeing. Currently, it is estimated that the Philips
HealthSuite stores over 15 petabytes of data gathered from hundreds of millions
imaging studies, medical records and patient inputs. Philips recently announced
HealthSuite Insights, an industry-first service that delivers healthcare-specific
tools and technologies to address the full process of building, maintaining,
deploying and scaling AI solutions. Through HealthSuite’s open platform, Philips
has collaborated with research institutions to develop new solutions for patients
living with chronic long-term illnesses. In one such example, Phillips worked with
a University Medical Center to develop an integrated solution that uses a wearable
sensor that can be placed on the chest of a COPD (chronic obstructive pulmonary
disease) patient once they have been discharged from hospital. The sensor collects
data on metrics such as physical and respiratory activity and heart rate, and it
allows both individuals and clinicians to track the health of the patient.52
Case study 6. Qualcomm Life
connecting the dots for health care
and medtech companies
Qualcomm Life specialises in providing connectivity solutions to health care and life
sciences organisations. Its product, Capsule, is capable of collecting and analysing
data from hundreds of types of medical devices and integrating it into patient EHRs.
Over 2200 hospitals have implemented its solutions to automate the collection and
transfer of vital signs to the hospital’s EHR system, a task usually done manually by
nurses which can save up to 30% of nursing time. A study was made in one hospital in
France, and by avoiding manual collection and transcribing data into the EHR system,
the unit was able to save more than 164 hours annually, allowing nurses more time
to care for patients, while also increasing the data collection from patients by 54 per
cent.53 Qualcomm Life has also collaborated with Philips to enhance medical device
connectivity through its 2net Platform for its Healthsuite Platform.54
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Applying advanced analytics to the data
generated from connected medical
devices to provide critical insights and
empower better decision-making
Patient data provides insights into a health
condition and the success of treatment, as
well as insights on the efficiency of services
delivered by health care providers. Mining,
managing and analysing a vast array of data
from medical grade wearables, imaging
and monitoring devices play a key part in
realising the value in the IoMT. The increasing
connectivity between devices and data
has led medtech companies to develop
advanced analytical capabilities that are
able to uncover hidden patterns and trends
in information. This in turn is generating
actionable insights and enabling self-learning
systems to sense, predict, infer and conceive
alternatives that may not otherwise be
obvious. Analysis of these large data sets
can also aid in improving the productivity of
medtechs’ R&D and Commercial operations.
The insights derived from linking connected
medical devices and health data sets
have a key role in aiding health systems
to reduce costs, improve quality, identify
populations at risk, connect with consumers
and better understand performance.55
These capabilities are essential components
for the successful implementation of
VBC. Some of these advanced analytical
capabilities are derived from collaborations
with large technology companies that
provide analytics platforms able to run large
data analytics across a variety of connected
devices and other data sources (see Case
study 7).56
Case study 7. Dexcom and Verily
collaborate for advanced analytics
in health care
Dexcom – a developer of continuous glucose monitoring (CGM) systems, entered
into a collaboration with Verily Life Sciences (formerly Google Life Sciences) in
August 2015 to develop miniature CGM systems to help people with type II diabetes
manage their condition. The partnership aims to create the next generation of
CGM products and will incorporate Verily’s miniaturised electronics platform and
Dexcom’s sensor technology. Ultimately, the partnership is focused on minimising
the cost and size of CGM body-worn components and providing connectivity to
enable more people to control their diabetes with timely, actionable information.
Verily is developing miniature sensor electronics on an adhesive patch to make
continuous monitoring less burdensome. The design of the patch allows continuous
subcutaneous monitoring of the interstitial fluid, which may be less disruptive
for those needing to measure their blood glucose levels. The patch has wireless
connectivity to allow secure data sharing and continuous tracking of glucose levels.
Dexcom’s G6 CGM was given FDA approval in March 2018, which eliminates the need
to calibrate the device with blood drawn from the finger. Instead, the sensors sit
under the skin and read the interstitial fluid and send information to a smartphone
or smartwatch. This new generation of devices may also offer up a wealth of
information that can be taken advantage of through big data analytics.56
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
A total of 64 per cent of our survey
respondents indicated that developing
a stronger analytical capability to manage
and interpret data was one of their
organisation’s top three priorities.
Forty-seven per cent also highlighted
that linking data with other patient data
sets (such as genomics and electronic
medical records) was a top three priority.
Consequently, medtech companies are
forging strategic partnerships with each
other to collect, analyse and interpret data
to provide insights to health care providers
(see Case study 8).5758
The transformation of medtech
business models
While the medtech industry clearly
understands the value of utilising the
data generated from their connected
medical devices to improve both clinical
and operational performance, only 54 per
cent of our survey respondents agreed
that they were either ‘reasonably well’
or ‘well’ prepared to monetise this data.
Moreover, most companies in the industry
are still at an early stage in the process of
understanding its role beyond supplying
products to health care providers and
patients.
Case study 8. GE and Roche
Diagnostics working together to
provide clinical insights in oncology
GE Healthcare and Roche Diagnostics entered into a strategic, long-term
partnership in January 2018 to develop and co-market digital clinical decision
support solutions.57 The initial focus of the collaboration is on products that
accelerate and improve personalised treatment options for cancer and critical
care patients. The two companies aim to develop dashboards that bring together
data generated by the companies’ capabilities in-vitro and in-vivo diagnostics to
aid decision-making among oncology and critical care teams. The dashboards will
utilise GE Healthcare’s imaging and monitoring data, and Roche’s biomarker, tissue
pathology and genomics data as well as data from third party in-vivo and in-vitro
solutions (company and product agnostic). The industry-first platform will use
advanced analytics to provide workflow solutions and apps that support clinical
decision-making. For example, oncology teams employing numerous specialists
will have a comprehensive data dashboard available for review and collaborate and
align on treatment decisions for cancer patients at each disease stage. Additionally,
within the critical care setting, the integration of data from a patient’s hospital
monitoring equipment with biomarker, tissue pathology, genomic and sequencing
data will allow physicians to identify, and even predict severe complications before
they arise.58
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
A number of medtech companies are already
utilising the increasing sophistication of
connected medical devices, interoperability
across health care organisations and the
implementation of advanced analytics to
develop service-orientated solutions that
support VBC. Often these implementations
align closely with the therapeutic expertise
of the organisation and the products they
produce. Fifty-one per cent of our survey
respondents agreed that their company
will be a data business and not a product
business in the future. Some medtech
companies are using their knowledge of
a specific therapeutic area and data from
the IoMT to develop managed services for
high volume and high cost services such as
catheterisation laboratories (cath labs) – see
Case study 9.59 606162
Some companies are utilising their IoMT
ecosystems to aggregate data and offer
consultative services and predictive
analytics. Such collaborations are opening
up health data to organisations that have
typically found it difficult to gain access
to data outside of their own organisation,
such as smaller medtech companies.63
These large and growing aggregated
data sets are beginning to empower
decision-making based on use of real-world
evidence (RWE). Indeed, 88 per cent of
survey respondents indicated that they are
using RWE to drive business decisions.
Case study 9. Medtronic Integrated
Health Solutions’ Cath Labs managed
services
In 2013, Medtronic formed Integrated Health Solutions (IHS) – a business focused on
developing long-term partnerships with hospitals, health systems, physicians and
payers to develop tailored services and solutions to improve clinical, operational
and financial outcomes.60 The services include the development, management,
modernisation and optimisation of cath labs, with the objective of helping hospital
cardiology departments to: improve patient outcomes, enhance operational
performance, contain and manage costs. Medtronic’s Cath Labs managed services
(CLMS) is vendor independent and manages all aspects of a cath lab (regardless
of the products used within them).61 Currently, Medtronic IHS has 170 ongoing
long-term partnerships in 24 countries across Europe (such as the UK, Italy and the
Netherlands ) and the Middle East, delivering value to health care organisations and
supporting the delivery of high quality care more cost effectively. For example – the
Maastricht University Medical Centre in the Netherlands Medtronic IHS realised:
• $2.5 million in savings in one year
• a 90 per cent reduction in patient admission time
• a 33 per cent reduction in the length of stay for cardiac resynchronisation therapy
patients
• a 37 per cent reduction of cancelled procedures through better planning and
scheduling
• a 43 per cent reduction in staff overtime.62
IHS Managed Services offer also covers other care settings beyond the CathLab,
such as Operating rooms and ICUs.
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Other medtech companies have
transformed their underlying business
models to deliver high quality patient
outcomes while reducing costs of similar
services run by traditional health care
providers (see Case study 10).64656667
Case study 10. From manufacturer
to service provider – the transformation
of Fresenius
Fresenius Medical Care has transformed itself from a supplier and manufacturer
of renal products to a company that now operates one of the largest dialysis
services in the world, providing both the equipment and delivery of the service. The
organisation has served 322,253 patients, delivered 48 million treatments per year,
and has 114,831 employees in Q1 2018.64 Globally, Fresenius Medical Care accounted
for 10 per cent of the total patients treated and 35 per cent of the total dialysis
products in the market in 2017, while also operating the largest number of dialysis
clinics (3,790 in Q1 2018).65
In the US, Fresenius Medical care has used its extensive network of equipment,
clinics and specialist staff to create 24 out of the 37 End Stage Renal Disease (ESRD)
Seamless Care Organisations (ESCOs). ESCOs are designed to allow dialysis clinics,
nephrologists and health care providers to communicate and work together to
improve and individualise the care patients with ESRD receive.66 Results running
from October 2015 through to December 2016 indicate improvements in patient
outcomes and reduction in costs. These include:
• a nine per cent decrease in hospitalisation rates for these patients
• more than $43 million in gross savings
• an average 5.4 per cent reduction in expenditures per patient.67
“We strongly believe that the health care ecosystem is inevitably evolving to a model that
closes the value chain in health care delivery. This requires payers to shift from a legacy
transaction-oriented, claim adjudication business model to a new, analytics-based, shared
risk provider compensation model.”
CxO – Medtech company
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Part 4. The future for medtech and the IoMT
Cost-effective and purposefully-designed, technology-enabled health care solutions
can improve the well-being of millions of people and radically change the way services
are delivered to patients.
Digitisation is helping to improve the
continuity of care, promote improved
health and prevent disease. It is driving
the reform of health systems and their
transition to new models of patient-centred
care, enabling the shift from hospitalcentred systems to more communitybased and integrated care organisations.
Digital tools have the potential to enable
better use of health data in research and
innovation to support personalised health
care, better health interventions and health
and wellness services.
These drivers of patient centricity and
digitisation are not only important for the
medtech industry but are also crucial for
the future of the pharma industry, as is
highlighted in our 2017 report, Pharma and
the connected patient.68
A future where data is secure, aggregated
and easily analysed will be a key enabler
for the digital transformation of health care
and the health and well-being of people
on an individual, national, and global
scale. Connected medical devices and the
IoMT are pivotal to these shifts to new
models (VBC, RWE and population health
management (PHM)).
Medtech will enable digital health
The health care and life sciences industries
are moving away from traditional reactive
and largely episodic models of care that are
proving increasingly costly and inefficient to
operate, to care models that are proactive,
digitally-enabled and deliver better care
and value for patients. VBC, RWE and
PHM are pivotal to the future operation of
health care providers and payers. Medtech
companies and the IoMT can capitalise
on the possibilities presented by these
changes, to help to connect patients,
providers and payers to enable them to
become more patient centric, productive
and cost effective (see Figure 20).
Figure 20: The interconnected IoMT health ecosystem
Primary care services Secondary care services
Patients Payers
Life sciences companies
IoMT Cloud
Source: Deloitte LLP, 2018
E-prescriptions
Smart diagnostic
tools
Smart PoC
testing
Telemedicine
Smart pill
bottles
Genomics
data Vital signs
monitoring
Smart beds
Patient
education
Smart
patient
monitoring
tools
E-physio
Remote
monitoring
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
More specifically, as we move closer towards the predictions made in our November 2017
report, The future awakens: Life sciences and health care predictions 2022 (see Figure 21), the
current boundaries between the IoMT and consumer IoT will start to blur, giving rise to new
opportunities for medtech companies.69
Figure 21: Six predictions for 2022 – both evolutionary and revolutionary
The quantified self is alive and well: The genome generation is more
informed and engaged in managing their own health
The culture in health care is transformed by digital technologies:
Smart health care is delivering more cost-effective patient-centred care
The life sciences industry is industrialised: Advanced cognitive
technologies have improved the productivity, speed and compliance
of core processes
Data is the new health care currency: Artificial intelligence and
real-world evidence are unlocking value in health data
The future of medicine is here and now: Exponential advances in
life-extending and precision therapies are improving outcomes
New entrants are disrupting health care: The boundaries between
stakeholders have become increasingly blurred
Source: Deloitte LLP, 2018
Medtech technologies are a key enabler
across all six predictions with numerous
examples in each ‘Evidence in 2017’
section. The use cases include:
• consumers using health and fitness
technologies to make informed decisions
about their lifestyle choices, treatments
and the care they receive and biometric
data sharing between doctors and
patients
• the rise of the smart hospital, virtual
rehabilitation in orthopaedics and Mercy
Virtual Care Center monitoring patients
across 40 ICUs and providing telehealth
services to people in their own home
across seven US states
• DeepMind Health establishing strict
rules to improve the safety and security
of health data and AI enabled diagnostic
technology and tech giants moving into
health care
• the increasing numbers of connected
smart phone devices cleared for use by
the FDA and point-of-care technology
enabled services providing populationbased health management and hospitalto-home enterprise telehealth services.70
These and other digital health solutions,
and the increasing ease with which they
can be accessed, will drive growth across
the medtech industry. Customers will not
only include health care providers, but also
consumers and payers. Large consumer
tech companies will continue to blur the
boundaries between stakeholders, pushing
both medtech and health care companies
to change their traditional business
models. Payers and consumers will tend to
prefer companies that help them improve
their lives and treatment outcomes in a
cost-effective way.
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Many of the case studies in this report
illustrate how some companies are already
utilising the ubiquity of digital technology,
such as remote monitoring, to aid in better
post-operative and longer-term care
for patients. These examples are likely
to proliferate as tech companies make
effective use of their digital expertise to
develop ecosystems that bring together
a plethora of medical device data on which
advanced analytics can be run. Further
progress in these digital initiatives will
continue to transform health care and blur
the lines between industries (see Case
study 11). 7172
Case study 11. Apple electronic
health record
In early 2018, Apple Inc. updated its Health app, debuting a feature for U.S.
customers to see their health records right on their iPhone®. The Apple® Health
app allows patients to aggregate health records data from a variety of participating
healthcare institutions, including information on allergies, conditions, immunisations,
lab results, medications, procedures and vital signs. Apple Inc.’s health record feature
is built on Fast Healthcare Interoperability Resources (FHIR) and incorporates the
latest technologies in authentication, encryption and privacy. As of June 2018, more
than 500 U.S hospitals and clinics are supporting health records on iPhone® for
their patients.71 hospitals and clinics are supporting health records on iPhone® for
their patients. It was estimated that 728 million iPhones® were in use in 2017, and
therefore the potential reach of Apple Inc.’s Health app is vast.72
Disruptive technologies will
revolutionise medtech and the
delivery of health care
Technology itself will become a treatment,
as evidenced by the new generation of
mobile apps increasingly appearing in
treatment guidelines – initiatives like
point-of-care testing to improve the
diagnosis of sepsis,73 tests to differentiate
between bacterial and viral infections to
reduce over-prescribing of antibiotics74
and the FDA’s call for medtech to help find
alternative treatments to the opioid crisis.75
Mobile digital technology will also enable
telehealth communication that brings
providers and patients together at
substantially lower costs than traditional
consultations. Innovation in sensor
technologies will lead to clinical grade
wearables able to increase the quality and
value of the data they provide, and could
spur further growth in the wearables
market.
Big data, AI, mobile applications, 3D
printing, robotics, advanced sensors,
big data and the IoMT are leading to
a fourth industrial revolution which will
continue to create new opportunities
for medtech companies (see Figure 22).
These technologies can improve patient
outcomes, the economics of health care,
enable PHM, and drive beneficial changes
during each stage of the patient journey.
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Figure 22: Disruptive technologies can improve the pulse of health care
Genomics is improving our understanding of health
conditions, providing patients with more information
on their health risks, making health care more
personalised and therapies more accurate
Additive manufacturing
(3D printing) is significantly reducing
the costs of medical implants and
surgical tools, and can enable
hospitals to create tools on site
Blockchain can improve
the privacy of sharing data
across a large network of
users and provide an
immutable record of data
transactions
Telemedicine enhanced 5G
technologies will enable high
resolution connections to remote
areas and can also empower remote
surgery through the use of robotics
Smart sensors and materials of
increasing sophistication can allow
products and materials to alter their
behaviour based on external
conditions such as pH, temperature,
electric fields and bacteria
Robotics is providing
surgeons with new and
more accurate tools for
complex surgeries. It is also
making health care
operations, such as the
delivery of medical goods
throughout a hospital more
efficient and less costly
Advanced digital imaging is
creating visual representations of
internal human anatomy, with
pre-, peri-, and post-operative
digital images used to obtain a
more accurate picture of internal
patient anatomy
Advanced technologies can improve:
· patient outcomes
· health care related costs
· access to health care
· the accuracy of medicines
· the manufacturing of products
· the privacy and security of patient data
Source: Deloitte LLP, 2018
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Without a doubt, disruptive technologies
are changing how we gather medical
information and how we interact with
medical professionals and caregivers.
Robotics, AI, genomics and the wearable
sensor industry will replace existing jobs,
but they will also add new ones focused
on blending employee skill sets and
developing transferable skills.
AI will improve the efficiency and costeffectiveness of diagnostics
Over the next two to three years, examples
of AI use in everyday health care settings
will become a reality, with radiology fueling
much of this change, albeit the demand for
real-time data analysis is much wider. AI will
be integrated into the clinical workflow in
existing tools like EHR and Picture Archiving
Centres (PACs), empowering practitioners
with just-in-time data. Images and data will
be automatically routed to AI engines in
order for clinically relevant information to
be extracted in real time. Instead of wading
through thousands of images or documents,
the most important and relevant pieces
of information will be identified by AI –
whether it’s textual information or image
data pinpointing a nodule, tumor or simply
something that changed in a scan. Advanced
PACs that act as AI algorithm-routing
engines will assist radiologists by sifting
through massive amounts of data with great
precision.76
Another example where AI is set to
transform diagnostics is pathology,
where AI can help laboratories to reduce
unwarranted variations in performance.
Pathologists will be much less likely to miss
things because the computer algorithms
will help them find them, radically changing
how laboratories work. Advancements
in AI could make pathology a fully-digital
discipline.77
A 2016 Frost & Sullivan report suggested
that AI has the potential to improve health
outcomes by 30 to 40 per cent – not by
replacing the decision-making of health
care professionals, but by giving them new
insights into vast amounts of data.78
The adoption of voice-enabled devices
will improve clinician and patient
engagement
Voice technology is being adopted faster
than any previous technology. A 2018
Google survey found 53 per cent of
people said it already ‘feels natural’ talking
to a voice-activated device. One-in-six
Americans now own a smart speaker, an
increase of 128 per cent since January 2017
and, by 2020, 75 per cent of households
are expected to have some kind of voice
activated speaker, giving 258 million
Americans direct access to voice assistants
on a daily basis.79 Voice-driven technology
presents many opportunities for medtech
companies to connect health care
organisations with patients and caregivers
like never before.
Several hospitals and health systems have
embraced Amazon’s app-like approach to
the world of voice assistants, for example:
• Northwell Health created an Amazon
Alexa skill that offers wait times and
direction to nearby hospitals and urgent
care locations80
• Boston Children’s built KidsMD, a voiceenabled symptom checker that parents
can use to get answers to medication
dosing questions or questions about
symptoms their child is experiencing81
• Libertana Home Health Care has
been using Alexa voice assistants to
support health care at home, to check
in on patients and remind them to
take medication or about upcoming
appointments.82
Voice technology is rapidly evolving.
AI will continue to expand the ways voice
technology can be used to improve the
patient experience, from chatbots, to
doctor visits, to home health care. By
2020, its predicted that 50 per cent of all
searches will be voice activated, which
means that health care will need to
optimise their websites and make sure
their digital content is voice-search friendly
to take advantage of longer phrase, spoken
queries. Moreover, medtech and health
care organisations will need to develop an
understanding of the landscape of voice
technology and how they can integrate this
into meaningful voice strategies.83
The expanding role of medtech in
improving the management of clinical
trials
The IoMT is also aiding clinical trials,
allowing information to be shared between
patients, providers and regulators involved
in the trial. A number of technology
companies have entered this arena working
with pharma to develop cutting edge
biotechnology to provide solutions that
allow trial investigators to design digitallyenabled trials and gather data from a
patient remotely (see Case study 12).
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Overcoming disparity in the quality
of data is one of the key barriers to
medtech adoption
A key challenge for medtech and health
care organisations alike is the disparity
in quality of data held on patient EHRs.84
To overcome this challenge and provide a
more cohesive data profile around patients,
large technology companies are using
their vast reach and expertise to create
a continuous EHR that can integrate data
from a variety of sources and enable realtime access as well as using AI technologies
to aid in the analysis of large longitudinal
datasets (see Case study 13).858687
Medtech’s bright future as the key
enabler in the transformation of
health care
Continuing to solve the challenges
identified in this report and supporting
innovation will put the medtech industry
at the forefront of digitisation and the
delivery of high quality and affordable
health care as the global population
continues to age. Moreover, embracing
disruptive technologies such as AI, robotics,
blockchain and genomics will further
enhance patients’ access to medicines,
improve diagnosis, care and treatment.
Linking the rapidly advancing IoMT and
the wider IoT with disruptive technologies
will position medtech companies as key
enablers of 4P medicine (medicine that
is predictive, preventive, personalised
and participatory), VBC, RWE and PHM.
Going forward, there are some significant
implications for all stakeholders in the
IoMT ecosystem that need to be tackled
forthwith (see Figure 23).
Case study 12. Otsuka Pharmaceuticals
and Proteus Digital Health partner
for digital medicines
In a partnership with Otsuka Pharmaceutical, Proteus Digital Health developed
the world’s first Digital Medicine, a drug/device product that combines Otsuka’s
ABILIFY® (aripiprazole) for serious mental illness with Proteus’s ingestible sensor
in a single tablet to record ingestion digitally and, with patient consent, share
information with their health care professionals and caregivers. Proteus Discover
comprises a small wearable sensor patch, ingestible sensors, a mobile app and a
provider portal for medication effectiveness to help physicians improve treatment
results. The company has also entered into partnerships with leaders from other
industries such as Oracle and Novartis. These strategies have helped the company
enhance customer experience and satisfaction.85
Case study 13. IBM Watson
collaborations with medtech companies
IBM Watson Health has been collaborating with Medtronic since 2015 to develop
a cognitive app that aids in the detection of important patterns and trends for
diabetes patients. The collaboration led to development of the app ‘Sugar.IQ’, which
uses real-time CGM data available from Guardian Connect CGM system. It uses IBM
Watson’s cognitive computing power to identify hidden patterns in diabetes data.
The app is used to uncover behaviours influencing glucose levels and send relevant
insights to users. It also allows users to inquire about how specific foods impact
their glucose levels, and the mobile app is able to track food to deliver meal-related
insights to help users better control their condition.86
Sweden-based Elekta announced a collaboration with IBM Watson in early 2018 in
which Watson for Oncology will be paired with Elekta’s digital cancer care solutions
as a clinical decision support tool.87 Elekta provides radiation therapy, radiosurgery,
related equipment and clinical management for the treatment of cancer and brain
conditions. The collaboration positions Elekta as the first radiation therapy company
to offer capabilities that combine conventional health information systems with
AI and cognitive cloud computing. Watson for Oncology is able to summarise key
medical attributes of patients as well as provide information to oncologists to help
them deliver effective treatment options. Watson for Oncology also provides a large
collection of medical literature and insights about different treatment options for
physicians to consider.
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Figure 23: Actions for IoMT stakeholders that will benefit patients
Actions for medtech Actions for providers Actions for payers
• examine the level of connectivity of the
devices in your portfolio and develop a
business intelligence strategy including
determining what data would be useful
to collect
• pursue data integration as a strategic
function that aligns to business
objectives
• ensure products are built on open
standards that are widely accepted by
the industry (for example FHIR) and can
accept or utilise APIs
• be generous in sharing data, including
bartering data sharing for broader
access to other health data sets
• build interoperability into all
connected medtech products based
on understanding the IT systems of
customers and the medtech company
• hire people who understand the new
and emerging technologies and can
think about business models differently
• develop a deep understanding, not just
of providers and payers, but immerse
the business in understanding how the
patient will use and experience devices
and any restrictions patients may place
on the use of their data
• focus on recruiting, up-skilling and
retaining a workforce that is digitally
skilled
• collaborate early with regulators on
innovation
• understand what data assets are
available and whether they are
accessible and interoperable
• recruit the right skills to analyse data
and build actionable reports
• have clear systems and processes for
obtaining patients consent to the use of
their data
• adopt industry endorsed standards
( such as FHIR) to improve
interoperability
• adopt a clear business intelligence
strategy and define how the IT systems
can receive and integrate data from
multiple sources and how it can be
shared
• prioritise P4 medicine and an
integrated PHM approach to care
delivery and determine which
connected medical devices will best
support these initiatives
• assess the relevance of VBC business
models and determine which would
best meet your circumstances and
what technology would generate the
outcomes data required to meet the
expectations of consumer–driven
health care
• explore what data types and sources
can shed new light on patient
outcomes and the value of treatments
and interactions
• develop a range of evidence-based
value-based payment contracts to
match to providers
Source: Deloitte LLP, 2018
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Appendix: Nomenclature and medical device
classifications used in the report
The Global Medical Device
Nomenclature (GMDN)
The GMDN is a list of generic names used
to identify all medical device products
that are used for diagnosis, prevention,
monitoring, treatment or alleviation of
disease or injury. The GMDN provides
health authorities/regulators, health care
providers, conformity assessment bodies
and others with a single generic naming
system that can be used to exchange
medical device information and support
patient safety. The GMDN is used for:
• data exchange between manufacturers,
regulators and health care authorities
• exchange of post-market vigilance
information
• supporting inventory control in hospitals
• purchasing and supply chain
management.
The GMDN is recommended by the
International Medical Device Regulators
Forum (IMDRF), is used by over 70 national
medical device regulators to support their
activity and is managed by the GMDN
Agency. Table 1 lists the 21 categories of
medical devices and provides examples of
devices in each category.88
Table 1: Classification of medical technologies as determined by the GMDN
Code Classification Example
01 Anaesthesia and respiratory devices Oxygen mask, gas delivery unit, anaesthesia breathing
circuit
02 Body fluid and tissue management
devices
Haemodialysis devices and heart-lung machines
03 Body tissue manipulation devices Liposuction devices
04 Cardiovascular devices Cardiac stents and pacemakers
05 Complementary therapy devices Acupuncture needles/devices, bio-energy mapping
systems/software, magnets, moxibustion devices,
suction cups
06 Dental devices Dentistry tools, alloys, resins, floss, brushes
07 Disability-assistive products Wheelchairs, walking frames, hearing aids
08 Ear/Nose/Throat (ENT) devices ENT microscopes and workstations
09 Endoscopic devices Gastroscopes, laryngoscopes
10 Gastro-urological devices Specialised urology catheters
11 General hospital devices Hospital beds
12 Healthcare facility products and
adaptions
Gas delivery systems
13 In vitro diagnostic medical devices (IVDs) Pregnancy test, genetic test, glucose strip
14 Laboratory instruments and
equipment
Most IVD which are not reagents
15 Neurological devices Implantable neurostimulators and CSF drainage
catheters
16 Obstetrical/Gynaecological devices Delivery forceps and vaginal speculums
17 Ophthalmic devices Spectacles, contact lenses, intraocular lenses
18 Orthopaedic devices Hip or knee joint replacement devices
19 Physical therapy devices Heat therapy products
20 Plastic surgery and cosmetic devices Breast implants
21 Radiological devices CT scanners
Definition of connected medical devices
A connected medical device is one which is able to generate, collect, analyse or transmit
data or images, and can connect to health care provider networks and transmit data to
either a cloud repository or internal servers in order to prevent, diagnose or treat diseases.
For the purposes of this report medical devices should have received or be in the process
of receiving regulatory approval (e.g. FDA, CE). Devices for wellbeing and fitness are not
included. All of the device classifications above have the potential to be connected medical
devices due the increased capability and use of hardware such as embedded sensors and
software, powered by IoT technology, with connectivity provided by faster cellular network
(3G and 4G), WiFi, Bluetooth Low Energy (BLE), Zigbee, Near Field Communication (NFC)
and Satellites.
47
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Endnotes
1 GMDN Database. GMDN Agency, 2018. See also: https://www.gmdnagency.
org/About/Database
2 IOT Healthcare Market – Global Forecast to 2022, MarketsandMarkets,
2017. See also: https://www.marketsandmarkets.com/PressReleases/iothealthcare.asp
3 Ibid.
4 Ibid.
5 2015 Global health care outlook: Common goals, competing priorities.
Deloitte, 2015. See also: https://www2.deloitte.com/content/dam/Deloitte/
global/Documents/Life-Sciences-Health-Care/gx-lshc-2015-health-careoutlook-global.pdf
6 Health expenditure and financing, OECD, 2018. See also: http://stats.oecd.
org/index.aspx?DataSetCode=HEALTH_STAT
7 He W et al. An aging world: 2015. US Census Bureau, International
Population Reports, p95/16-1, 2016. See also: https://www.census.gov/
content/dam/Census/library/publications/2016/demo/p95-16-1.pdf
8 EvaluatePharma, World Preview 2017, Outlook to 2022. Evaluate Ltd, 2017.
See also: http://info.evaluategroup.com/rs/607-YGS-364/images/WP17.pdf
9 EvaluateMedTech World Preview 2017, Outlook to 2022. Evaluate Ltd. 2017.
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10 Time to care: Securing a future for the hospital workforce in Europe. Deloitte
LLP, 2017. See also: https://www2.deloitte.com/uk/en/pages/life-sciencesand-healthcare/articles/time-to-care.html
11 IOT Healthcare Market – Global Forecast to 2022, MarketsandMarkets,
2017. See also: https://www.marketsandmarkets.com/PressReleases/iothealthcare.asp
12 Medical-device development – are you missing out on R&D tax credits?
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ie/2016/09/06/medical-device-research-tax-credit/
13 Annual report 2017. European Patent Office, 2017. See also: https://www.
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14 Fagerberg J and Frick A. mHealth and home monitoring. Berg Insight. See
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15 Deloitte Centre for Health Solutions research and interviews, 2018.
16 Deloitte 2017 Survey of US Health System CEOs: Moving forward in an
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17 Value-based care and medical technology: Assessing the value of medtech
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18 Medtronic announces outcomes-based agreement with Aetna for type 1
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19 Leveraging value-based healthcare partnerships to transform care,
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20 Are HIPAA and interoperability at odds? Medical Economics, 10 April
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21 Connecting Health and Care for the Nation: A Shared Nationwide
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22 Burns AJ et al. A brief chronology of medical device security.
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23 Top 10 biggest healthcare data breaches of all time, Digital Guardian, 2018.
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24 Ponemon Institute’s 2017 cost of data breach study: Global overview.
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25 Ibid.
26 Medical devices and the Internet of Things: A three-layer defence against
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html
27 Impact of cloud computing on healthcare version 2.0. Clouds Computer
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28 Cybersecurity. US Food and Drug Administration, 2018. See also: https://
www.fda.gov/MedicalDevices/DigitalHealth/ucm373213.htm
29 Content of premarket submissions for management of cybersecurity in
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www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/
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30 Postmarket management of cybersecurity in medical devices. US Food
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31 Medical devices and the Internet of Things: A three-layer defence against
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html
32 Design consideration and pre-market submission recommendations
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33 Baseline security recommendations for IoT. ENISA, 2017. See also: https://
www.enisa.europa.eu/publications/baseline-security-recommendations-foriot
34 Regulation of medical implants in the EU and UK, House of Commons,
2012. See also: https://publications.parliament.uk/pa/cm201213/cmselect/
cmsctech/163/163.pdft
48
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
35 Overview of Device Regulation, FDA, 2018, See also: https://www.fda.gov/
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36 Medical device regulatory changes affect the bottom line: Planning for
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37 Regulatory framework. European Commission, 2018. See also: https://
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38 Preparing for the future: The new European Union medical devices
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39 Design consideration and pre-market submission recommendations
for interoperable medical devices. US Food and Drug Administration,
2017. See also: https://www.fda.gov/downloads/MedicalDevices/
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40 Life sciences industrial strategy: A report to the Government from the life
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41 The future is here: The future of work. Deloitte 2018. See also: https://www2.
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42 Medical device security: An industry under attack and unprepared to
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43 The one-way mirror: Public attitudes to commercial access to health data.
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44 The capacity to care: Measuring perceptions of accessibility and integration
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45 About Academic Health Science Networks. The AHSN Network, 2017.
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46 Better monitoring and fewer hospital visits for women who develop
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47 Craig J and Shore J. RX137 Digital health evidence: Case studies. York Health
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48 CareLink remote monitoring network: Heart failure. Medtronic, 2018. See
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49 CareLink network service for remote monitoring of people with cardiac
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chapter/technology-overview
50 About pressure ulcers. Bruin Biometrics, 2018.
See also: http://www.bruinbiometrics.com/en/sem/pressure-ulcers-dtis
51 NHS hospitals report ulcer reduction with scanner, Nursing Times, 2016. See
also: https://www.nursingtimes.net/news/hospital/nhs-hospitals-reportulcer-reduction-with-scanner/7014456.article
52 New solutions for a chronic condition. Philips, 7 June 2018. See also: https://
www.philips.co.uk/healthcare/innovation/about-health-suite/case-studieshealth-suite
53 Hospital Improves Care with Automated Data Collection and System
Integration, Microsoft, 2014. See also: https://customers.microsoft.com/
en-us/story/hospital-improves-care-with-automated-data-collection
54 Philips and Qualcomm announce strategic collaboration to advance
personalized connected health care, Phillips, 2016. See also: https://
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55 Health system analytics: The missing key to unlock value-based care.
Deloitte, 2015. See also: https://www2.deloitte.com/us/en/pages/lifesciences-and-health-care/articles/health-system-analytics.html
56 Miniaturized CGM. Verily Life Sciences LLC, 2018. See also: https://verily.
com/projects/sensors/miniaturized-gcm/
57 Roche and GE enter partnership to develop integrated digital diagnostics
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58 Ibid.
59 Integrated health solutions. Medtronic, 2018. See also: http://www.
medtronic.com/us-en/healthcare-professionals/services/integrated-healthsolutions.html
60 Ibid.
61 2016 European Managed Services for Cath Labs Market Leadership Award.
Frost & Sullivan, 2016. See also: http://www.medtronic.com/content/dam/
medtronic-com/uk-en/misc/documents/medtronic_award_write_up.pdf
62 Integrated health solutions. Medtronic, 2018. See also: https://www.
medtronic.com/uk-en/healthcare-professionals/integrated-healthsolutions.html
63 Siemens Healthineers Digital Ecosystem. Siemens Medical Solutions,
2018. See also: https://usa.healthcare.siemens.com/healthineers-digitalecosystem/digital-ecosystem#
64 We care about kidneys. Fresenius, 2018. See also: https://www.
freseniusmedicalcare.com/en/home/
65 Fresenius Medical Care: A 2017 success story not to be missed. Seeking
Alpha, 2017. See alsohttps://seekingalpha.com/article/4099783-freseniusmedical-care-2017-success-story-missed
66 A better way to coordinate healthcare for renal patients. Fresenius Seamless
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67 Fresenius Medical Care achieves improved health outcomes and savings
in demonstration program in the United States. Fresenius, 2017.
See also: https://www.fresenius.com/6217
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Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
68 Pharma and the connected patient: how digital technology is enabling
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69 The future awakens: Life Sciences and Health care Predictions 2022.
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html
70 Ibid.
71 Empower your patients with health records on iPhone. Apple, 2018.
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72 Celebrating 10 years of iPhones. 63% of all iPhones ever sold are still in
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73 Rooney KD and Schilling UM. Point-of-care testing in the overcrowded
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75 Monegain B. FDA launches innovation challenge to help stem opioid crisis.
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76 The future is here: The future of work is poised to bring better jobs and
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77 Sharma G and Carter A. Artificial Intelligence and the Pathologist: Future
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78 From $600 million to $6 billion, artificial intelligence systems poised for
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79 Tree O. Understanding voice technology and how it can impact healthcare.
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80 Lemieux C. How Northwell Health is reimagining healthcare part 2:
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81 Comstock J. Boston Children’s Hospital launches KidsMD, an app for
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82 Wicklund E. How One Home Health Provider Turned Alexa Into an mHealth
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86 Hlabangane S. IBM Watson-powered Sugar.IQ app goes live. eHealth News,
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87 Elekta taps IBM Watson Health to bring AI to comprehensive oncology
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html?id=3B834965FF709CE1
88 GMDN Database. GMDN Agency, 2018. See also: https://www.gmdnagency.
org/About/Database
50
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Notes
51
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
Contacts
John Haughey
UK and NWE Life Sciences and
Health Care Leader
+44 20 7303 7472
jhaughey@deloitte.co.uk
Michael Dohrmann
Partner, Monitor Deloitte
+49 89 29036 7638
mdohrmann@deloitte.de
Hanno Ronte
Partner, Monitor Deloitte
+44 20 7007 2540
hronte@deloitte.co.uk
Glenn Snyder
Medical Technology Segment Leader
+1 415 699 4469
gsnyder@deloitte.com
Emma Bairstow
Partner, UK Medical Technology Leader
+44 1293 76 1211
ebairstow@deloitte.co.uk
Pedro Arboleda
Managing Director, Monitor Deloitte
+1 617 437 3802
parboleda@deloitte.com
Mike Standing
EMEA Life Sciences and Health Care Leader
+44 20 7007 3178
mstanding@deloitte.co.uk
Chris Park
Partner, Strategy Deloitte
+1 617 437 2215
chrpark@deloitte.com
Helena Lisachuk
Director Deloitte Digital IoT Global Lead
+31 (0)88 288 2286
helisachuk@deloitte.nl
Contacts
Authors
Karen Taylor
Director, UK Centre for Health Solutions
+44 20 7007 3680
kartaylor@deloitte.co.uk
Amen Sanghera
Analyst, UK Centre for Health Solutions
+44 20 7007 4559
asanghera@deloitte.co.uk
Mark Steedman
Manager, UK Centre for Health Solutions
+44 20 7007 8857
msteedman@deloitte.co.uk
Matthew Thaxter
Analyst, UK Centre for Health Solutions
+44 20 7007 7975
mthaxter@deloitte.co.uk
Acknowledgements
Pratik Avhad of the Deloitte Centre
for Health Solutions and Rui Zhou of
Deloitte Consulting Canada. Special thanks
to the valuable contributions provided
by Deloitte practitioners and teams from
across the world.
Contact information
To learn more about the Deloitte
UK Centre for Health Solutions, its
projects and events, please visit:
www.deloitte.co.uk/centreforhealthsolutions
Deloitte UK Centre for Health Solutions
Stonecutter Court
1 Stonecutter Street
London EC4A 4TR
52
Medtech and the Internet of Medical Things | How connected medical devices are transforming health care
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