Medtech and the Internet of Medical Things - How connected medical devices are transforming health care

 
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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.
Medtech and the Internet of Medical Things| How connected medical devices are transforming health care

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                                    Karen Taylor                                       John Haughey
Partner                                        Director                                           Lead partner
Monitor Deloitte                               Centre for Health Solutions                        UK and North West Europe

                                                                                                                                               01
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                While the IoMT has the potential to help alleviate some of the cost,
500,000 different types of medical devices, including wearable              access and care coordination challenges facing health care, the
external medical devices (skin patches, insulin pumps and blood             generation of data points through millions of connected medical
glucose monitors), implanted medical devices (pacemakers and                devices will have little impact unless data can be turned into
implantable cardioverter defibrillator devices) and stationary medical      actionable insight.
devices (home monitoring devices, connected imaging devices and
scanning machines). Most patient interactions with the health care          More specifically, connected medical devices are a key enabler
system involve the use of medical equipment and devices.                    across the six predictions in our report The future awakens: Life
                                                                            sciences and health care predictions 2022. The extent to which the
Like most other industries, the health care sector is increasingly          predictions are realised is heavily dependent on the continued
realising the transformative nature of IoT technologies, as advances        innovation and adoption of connected medical devices at scale.
in computing and processing power, wireless technology and
miniaturisation drive innovation in connected medical device                MarketsandMarkets valued the IoMT market at $41.2 billion in
development. Connectivity enhancement can be applied to                     2017 and expects it to rise to $158.1 billion in 2022. The connected
most categories of medical devices. The rise in the numbers of              medical devices segment (helping to diagnose, monitor and treat
connected medical devices, together with advances in the systems            patients) of the IoMT is expected to rise from $14.9 billion in 2017 to
and software that support the capture and transmission of medical           $52.2 billion by 2022.
grade data, connectivity technologies and services, have created
the Internet of Medical Things (IoMT).                                      The rise of the IoMT comes at a time when health care is becoming
                                                                            increasingly expensive, with global health care spending expected
The IoMT brings together the digital and physical worlds to improve         to grow 4.2 per cent per year, from $7.1 trillion in 2015 to $8.7
the speed and accuracy of diagnosis and treatments, and monitor             trillion by 2020, largely due to a growing and ageing population,
and modify patient behaviour and health status in real time. It also        with more people living longer but with multiple comorbidities.
improves health care organisations’ operational productivity and            As a result, without radical transformation, health care in many
effectiveness by streamlining clinical processes, information and           countries risks becoming increasingly unaffordable.
work flows.
                                                                            The medtech industry has an important role to play in helping
Connectivity between sensors and devices aids real-time patient             to reduce costs, improve the quality and efficiency of care and
care, even from remote locations, while improving communication             support the shift to value-based care (VBC). However, the industry
within and between medical facilities. The large volume of data             also faces a number of systemic challenges and opportunities that
generated creates opportunities for new models of care and                  need to be addressed for the full value of the IoMT to be realised.
supports the delivery of 4P medicine – medicine that is predictive,         These include:
preventive, personalised and participatory.
                                                                            •• Developing an in-depth understanding of end users – as
The IoMT brings together people (patients, caregivers and                      more providers adopt VBC models, the speed of adoption and
clinicians), data (patient or performance data), processes (care               integration of connected medical devices will increase. Data and
delivery and patient support) and enablers (connected medical                  insights on patients and processes is key to VBC. Challenges
devices and mobile applications) to deliver improved patient                   include the extent to which an organisation’s IT infrastructure
outcomes efficiently.                                                          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

02
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               •• Successfully navigating regulatory change – managing the raft
 business models and scenarios that demonstrate how their new                of regulatory change occurring, particularly in relation to the new
 and existing devices not only improve patient outcomes but also             European and US regulations is imperative for both developing
 create value for key health care stakeholders.                              connected medical devices and the success of the IoMT.
                                                                             Managing the impact of regulatory change requires medtech
•• Developing new funding, business and operating models                     companies to take a proactive and well-planned approach. If an
   – as health care organisations focus more on improving quality            innovation model is to be sustained, companies need to build
   and reducing the costs of providing care, they require medtech            engagement with regulators into their innovation model and
   companies to demonstrate greater evidence on the added                    involve clinicians and patients in product design.
   value of both new and enhanced products. We commissioned
   a survey that found that medtech companies are having mixed            •• Attracting digital talent and building digital capability – there
   results in demonstrating the value of their connected medical             is increasing concern among key stakeholders that a growing
   devices, although some are engaged in providing services rather           skills gap will delay the deployment of IoMT solutions and
   than just products. Different types of innovation will require            constrain market growth. If medtech companies are to remain
   different business models, and progress will depend on both the           competitive they need to develop a new, digital-first skill set,
   innovators themselves working in new ways to take on risks and            including employing data scientists and multidisciplinary talent
   rewards, and the evolution of existing payment systems by both            from creative and scientific backgrounds. Accessing this talent will
   public and private payers.                                                require more resourceful recruitment and retention strategies,
                                                                             including collaborations and partnerships with a diverse range
•• Understanding interoperability requirements –                             of existing and emerging players, especially academia, data-first
   interoperability is arguably the biggest challenge for medtech,           tech companies and innovative new start-ups.
   including complying with various national and international
   standards and protocols around the exchange and use of data.           •• Maintaining trust in a digital age – global technology companies
   There are also technical challenges such as creating an integrated        and other new entrants into the health care ecosystem are
   governance framework and obtaining consent for access to                  becoming more involved in the connected medical device industry,
   health care data. For interoperability to work effectively, the           and traditional medical device companies are becoming more
   direction of travel should be towards open platforms, based               involved in data management and analytics. Consequently, as
   on open data standards. This will enable payers, providers                medtech companies develop strategies and services based on
   and technology vendors to come together to make data more                 the generation and transmission of patient data, they need to
   available to each another.                                                ensure they demonstrate clearly to patients, the public and health
                                                                             care professionals that the data are being protected and used
•• Maintaining cybersecurity – cybersecurity issues are pervasive            responsibly. Medtech companies need to develop key principles
   across medtech, as the increasing numbers and capability of               of data management and consent that give patients control over
   connected medical devices present additional risks for data               their own data, including the right not to share.
   security. The scale and cost of breaches is often significant and
   far reaching. Although four-fifths of our survey respondents           •• Improving the adoption of medical technology at scale
   considered they were reasonably well prepared to deal with                – a key challenge for medtech is ensuring that health care
   the cybersecurity of their devices, other research suggests               organisations, clinicians and patients understand the added-
   many stakeholders do not have a strong understanding of such              value of connected medical devices and use them at scale to
   risks, how to prevent them and what to do once a risk has been            drive better economics and patient outcomes. Difficulties include
   identified. Regulators acknowledge that cybersecurity threats             the lack of governance standards and sufficient, robust evidence
   cannot be completely eliminated, and stakeholders need to work            that demonstrate that connected medical devices are more cost-
   together and adopt a more proactive approach to managing                  effective, and how they can help drive the VBC agenda.
   risks. Medtech companies need to adopt a ‘security by design’             This includes ensuring that the devices are intuitive and easy to
   approach and establish real-time monitoring, cyber threat                 use and, where necessary, providing training and support to staff
   modeling and analysis, threat mitigation and remediation.                 to embed the skills needed to optimise the use of the technology.

                                                                                                                                                03
Medtech and the Internet of Medical Things| How connected medical devices are transforming health care

Creating an effective IoMT at scale requires collaboration and              •• Applying advanced analytics to the data generated from
partnership working between patients, providers, payers, pharma,               connected medical devices to provide critical insights and
academia and other medtech manufacturers. Our research                         empower better decision-making – mining, managing and
identified multiple case studies that demonstrate medtech’s                    analysing a vast array of data from medical grade wearables,
important role in the IoMT and the conditions that lead to the                 connected imaging devices and monitoring devices is a key part
adoption of connected products and services. The key enablers                  of deriving value from the IoMT. The insights generated by linking
driving the IoMT and the transformation of health care include:                connected medical device and health data sets can play a key
                                                                               role in aiding health systems to reduce costs and improve quality,
•• Collaboration between health care providers and medtech                     identify populations at risk, connect with consumers and better
   is key to the effective deployment of the IoMT – integrating                understand performance.
   connected medical devices into established care pathways is
   challenging and requires significant cooperation across the              •• Medtech services that demonstrate improvements in patient
   IoMT ecosystem. Collaboration strategies such as partnerships               outcomes and reduce health care costs – medtech companies
   and joint ventures help ensure the effective transmission,                  are utilising the increasing sophistication of connected medical
   aggregation, analysis and management of data from connected                 devices, improved interoperability across health care organisations
   devices. These collaborations allow all stakeholders to improve             and advances in analytics to develop service orientated solutions
   their understanding of patient needs and deliver more                       that provide the tenants of VBC. These services include managed
   proactive cost-effective care. Our survey respondents ranked                catheterisation laboratories and transformations from a product
   collaborations with health care providers as the most important             manufacturer to a health care provider helping improve patient
   for the development of their respective businesses models,                  outcomes and reducing the costs of health care.
   followed by collaborations with health care payers and other
   medtech companies.                                                       How will the IoMT evolve to impact care?
                                                                            The health care and life sciences industries are in transition from
•• Connected medical devices benefit patients, providers and                reactive and largely episodic models of care that are proving
   payers – partnerships with health care providers allow medtech           increasingly costly and inefficient to operate, to care models
   companies to understand the clinical context in which devices            that are proactive, digitally-enabled and deliver better value for
   are used. Medical devices are almost always designed for a               patients. Medtech companies and the IoMT can capitalise on
   specific application. Adding connectivity to a device allows data        the possibilities presented by these changes to help to connect
   to be generated on a patient’s condition and the effectiveness           patients, providers and payers and enable them all to become
   of the health care providers operations. Being able to quantify,         more patient centric, productive and cost effective.
   contextualise and communicate these interactions allows the
   medtech industry to provide solutions that deliver value to all          These disruptive technologies are changing ways of working across
   health care stakeholders.                                                the whole IoMT ecosystem. Big data, AI, mobile applications, 3D
                                                                            printing, advanced sensors and other technologies will continue to
•• Joining the dots between connected medical devices and                   create new opportunities for medtech companies. Voice technology
   health care IT systems – a number of large medtech companies             is being adopted faster than any previous technology from chatbots
   have developed connected ecosystems that act as a common                 to doctor visits, to home health care. At the same time, large
   platform to share, aggregate, and view data to drive both                technology companies are using their vast reach and expertise to
   clinical and operational value. Linking disparate sets of data           create an interoperable electronic health record that can integrate
   that sit within health care organisations is central to achieving        data from a variety of sources and enable real-time access. Although
   connectivity at scale.                                                   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.

04
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                           Other companies are utilising IoMT capabilities to aggregate data
above trends to develop service-orientated solutions that support                       and offer consultative services and predictive analytics, including
VBC. Often these services align closely with the therapeutic                            opening up health data to organisations that have typically found
expertise and specialised products of the organisation enabling                         it difficult to gain access to data outside of their own organisation.
medtech to maintain high quality patient outcomes while reducing                        These and other developments provide clear opportunities for
costs compared to similar services run by traditional health care                       medtech to transition from a provider of innovative products to an
providers.                                                                              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

                                                             Medtech as an innovative product supplier

                           Clinical advantage                           Broader value creation                         Operating leverage

                         Can meaningful clinical                    Can differential value be created                Can innovation be adopted
                      advantage be demonstrated?                            for the system?                                 at scale?
Company transition

                                                                       Key capabilities required

                     Deep understanding of care delivery                Outcomes measurement and                  Stakeholder engagement, collabora-
                      models and how care is delivered                 end-to-end evidence including              tion and partnerships to understand
                       across patient populations; and                 partnerships for data creation,            the needs of patients, providers and
                       developing rules and capability                capture sharing and analytics to            payers in order to generate the next
                           around patient consent                    enable real-world evidence-based                   generation of innovation
                                                                    approaches to improve care delivery

                      Contracting and payment models                   Complementary services and                      Product innovation based on
                      that take in to account the value                   solutions that enhance                      real-world evidence on patient
                       added from clinical innovation                  product offerings and support               outcomes and build engagement with
                                                                          patients’ and providers                   regulators into innovation models

                                      Medtech as an insightful partner for patients and health care, rewarded for
                                                         improving health care performance

                                                                                                                                                              05
Medtech and the Internet of Medical Things| How connected medical devices are transforming health care

Health care is facing numerous challenges

      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          Decreased costs

                                                                                                           Enhanced           Improved      Improved
                                                                                                            patient            patient    diagnosis and
                                                                                                          experience          outcomes      treatment

                                                                                                                  Remote
                                                                                                                                    Improved disease
                                                                                                               monitoring of
                                                                                                                                      management
                                                                                                              chronic diseases

Significant IoMT market growth predicted

              The overall IoMT market is expected to grow from $41 billion in 2017 to $158 billion by 2022

                           60                                                                                                     2017

                           50                                                                                                     2022
            $USD billion

                                                 52             49
                           40
                           30
                                                                                         28                              29
                           20
                           10     15
                                                      10                        9                         7
                            0
                                       Medical        Systems and                Technology                   Services
                                       devices          software

                                                                                                              Europe
                                                                                                              from $12 billion
                           North America                                                                      to $44 billion
                           from $13 billion
                           to $45 billion

                                                                                                                 Asia-Pacific
                                   South America                                                                 from $11 billion
                                   from $2 billion                                                               to $51 billion
                                   to $9 billion                    Middle East & Africa
                                                                    from $2 billion to $9 billion

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Medtech and the Internet of Medical Things| How connected medical devices are transforming health care

Is medtech ready for the IoMT?

…our survey of 237 respondents working in medtech companies developing
connected medical devices revealed that:

               10%
                                                                                                         71%
                                                                                        believe that health care providers and

                   51%                                To a large extent
                                                                                         clinicians are not ready to utilise data
                                                                                      generated from connected medical devices.
                 of medtech
                                                      To a limited extent
                companies are
              implementing new                        Not at all
   39%         business models
                                                                                                       67%
                                                                                        believe that the regulatory framework
                                                                                        will not catch up with what is possible
                                                                                               today for another 5 years.

                                                   Medtech is transforming from an
                                                   innovative product supplier…

                               31%                                          39%                                      43%
                       are implementing new                        are adopting a value-based                 are using Real World
                    funding models for data as a                     approach to pricing to a              Evidence to drive business
                      service to a large extent                           large extent                     decisions 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

                                                                                                                                                  07
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           The large volume of data created, along
of the internet and have shaped technology           with the devices themselves, IT systems
and society for the past 30 years (see               and software, connectivity technologies
Figure 1). IoT technologies are increasingly         and services, are combining to create the
benefiting the health care sector, as                Internet of Medical Things (IoMT).
advances in computing power, wireless
technology and miniaturisation are driving
innovation in connected medical device
development.

Figure 1: Technological and cultural changes enabling the development of the Internet of Things

       1990

                       Human-to-human
                       · Fixed telephony
                       · Text messages

                               Internet of Content
                               · Email
                               · Static webpages

                                                 Internet of Services
                                                 · Smart IT platforms
                                                 · E-commerce

                                                                             Internet of People              Internet of Things
                                                                             · High speed mobile broadband   · Smart devices and objects
                                                                             · Smart phones and tablets      · Connectivity between devices
                                                                                                             · Automation of tasks

                                                                                                                                    2018

Source: Deloitte LLP, 2018

08
Medtech and the Internet of Medical Things| How connected medical devices are transforming health care

The development of connected                      and test kits, patient management                  The medical technology
medical devices                                   software, and software that is used as a
The medical technology (medtech) industry         component in a medical device.                     (medtech) industry designs
designs and manufactures a wide range                                                                and manufactures a wide
of medical products that help to diagnose,        IoT technologies are increasingly benefiting
monitor, and treat diseases and health            the health care sector, as advances in             range of medical products
conditions. There are more than 500,000           computing power, wireless technology and           that help to diagnose,
medical technologies currently available,         miniaturisation drive innovation and the
which all share a common purpose – having         development of connected medical devices.          monitor, and treat diseases
a beneficial impact on people’s health and        Connectivity enhancement can apply across          and health conditions.
quality of life.                                  all 21 categories of medical devices.

Medical devices fall within 21 categories         The creation of the IoMT ecosystem
of medtech products, as determined by             The rise of the IoMT is being fueled by
the Global Medical Devices Nomenclature           an increase in the number of connected
(GMDN) Agency (see Appendix).1 They               medical devices that are able to generate,
represent a hugely varied product group,          collect, analyse or transmit health data or
ranging from simple, disposable supplies          images and connect to health care provider
such as plasters and syringes, through to         networks, transmitting data to either a
surgical implements, monitoring devices           cloud repository or internal servers.
and imaging machines. They also include           Figure 2 shows the main stakeholders in
medical laboratory diagnostic instruments         the IoMT ecosystem.

Figure 2: The IoMT ecosystem

                  Connectivity providers                                                             Medical device providers

                    Original                                                                                   Systems and
                 equipment                                                                                     software
               manufacturers                                                                                   providers

                                                                                                    System integrators
                                  End users                                                         and service providers

Source: MarketsandMarkets, 2017

                                                                                                                                                  09
Medtech and the Internet of Medical Things| How connected medical devices are transforming health care

The IoMT bridges both the digital and                  Importantly, the IoMT generates intelligent      The methodology for this report
physical worlds and can monitor and                    and measurable information to help               The methodology for this report includes
modify patient behaviour in real time to               improve the speed and accuracy of                a detailed literature review, market insights
manage chronic conditions such as asthma,              diagnostics and target treatments more           provided by research companies Yole
diabetes and high blood pressure. IoMT                 efficiently and effectively. It enables remote   Développement and MarketsandMarkets,
technology can also streamline various                 clinical monitoring, chronic disease and         an online survey conducted by
clinical processes and information flows               medication management and preventive             Research2Guidance, structured interviews
and bring together people (patients,                   care, and it supports people who require         with senior executives from a number of
caregivers, and clinicians), data (patient or          assistance with daily living, like the elderly   large medtech companies and insights
performance data), processes (care delivery            and disabled, to live independent lives for as   provided by Deloitte colleagues working
and monitoring) and enablers (medical                  long as possible. It also has the potential to   across the medtech and health care
devices and mobile applications) to improve            lower costs, improve efficiency and deliver      industries.
health care delivery.                                  better patient outcomes (see Figure 3).
                                                                                                        The growth of the IoMT market
Figure 3: The seven main ways the IoMT impacts health care                                              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
                                   Improved                Decreased                                    in 2017 to $158.1 billion by 2022.2 This
                                     drug                    costs                                      growth is due to the rapid digitisation of
                                  management
                                                                                                        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.

                          Enhanced                                   Improved                           In 2017, North America accounted for the
                            patient                                diagnosis and
                                                                                                        largest share of the IoMT market ($13.3
                          experience            Improved             treatment
                                                                                                        billion or 33 per cent of the total market)
                                                 patient
                                                                                                        followed by Europe ($12.4 billion), Asia-
                                                outcomes
                                                                                                        Pacific ($11.0 billion), the Middle East and
                                                                                                        Africa ($2.4 billion) and South America
                                                                                                        ($2.1 billion). The IoMT market in Asia-
                                   Remote                 Improved
                                                                                                        Pacific is projected to grow at the highest
                                   monitoring              disease                                      rate, at a CAGR of 34.3 per cent during the
                                   of chronic            management                                     forecast period, due largely to the level of
                                    diseases
                                                                                                        unmet need and the increasing number of
                                                                                                        hospitals and surgical centres being built in
                                                                                                        this region.3

Source: Adapted from The Internet-of-Things: A revolutionary tool for the health care industry,
Inside Magazine, Deloitte LLP, 2017

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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)                     Estimates of the size of the current and
                                                                                                      forecast market value for connected
       Market segmentation by component              Market segmentation by application               medical devices vary significantly depending
                                                                                                      on the criteria used. For the purposes of
                                                                     $2.3
                  $7.3                                                                                this report we use estimates from market
                                                              $5.0
                                                                                 $12.9                research firm MarketsandMarkets. They
                                    $14.9
                                                                                                      categorise connected medical devices into
                                                       $5.7                                           three groups:
          $9.3
                                                                                                      •• stationary medical devices – include
                                                              $6.6           $8.8                        X-ray and mammography devices, CT and
                         $9.8
                                                                                                         MRI scanners, ultrasound machines and
                                                                                                         nuclear imaging devices that measure
   Medical devices
                         Systems and
                                                     Telemedicine
                                                                            Clinical operations and      physiological parameters. These relatively
                         software                                           workflow management
                                                                                                         high capital cost, high-tech devices, which
   Connectivity                                      Medication             Connected                    transmit images wirelessly to clinicians,
                         Services
   technology                                        management             imaging                      are generally deployed by hospitals,
                                                     Inpatient                                           clinics and diagnostics centres with the
                                                                            Others
                                                     monitoring                                          images incorporated into the patient’s
                                                                                                         Electronic Health Record (EHR). In vitro
Source: MarketsandMarkets, 2017
                                                                                                         diagnostic devices (IVD) are also included
                                                The market for connected medical                         in this category. Stationary medical
The increasing numbers of                       devices                                                  devices are critical to diagnosis and
                                                The ability of the IoMT to help reduce                   increasingly are integrated with other
connected medical devices                       the cost of care while improving its                     health care applications to overlay patient
and rising adoption of                          effectiveness is driven by the evolution of              data and imaging to facilitate faster and
                                                artificial intelligence (AI), particularly the           more precise decision-making
smartphones are expected                        rise of machine learning technologies.
to fuel the growth of the                       Increasing investment for health care                 •• implanted medical devices – include
                                                IoMT solutions are driving market growth.                hip replacements, pacemakers and
market still further.                           The increasing numbers of connected                      defibrillators that monitor and treat
                                                medical devices and rising adoption of                   cardiac conditions, nerve stimulators,
                                                smartphones are expected to fuel the                     bladder stimulators, diaphragm
                                                growth of the market still further. Potential            stimulators and a variety of biosensors
                                                constraints to this estimated growth                     to process different signals. Patients
                                                include the extent to which health care                  who require constant monitoring often
                                                organisations, clinicians and patients are               receive implanted medical devices, which
                                                willing to deploy IoMT solutions and a lack              are intended to remain in the human
                                                of governance standards.                                 body and are implanted following surgical
                                                                                                         or medical intervention, or are clinically
                                                                                                         inserted into a natural orifice

                                                                                                                                                 11
Medtech and the Internet of Medical Things| How connected medical devices are transforming health care

•• wearable external medical devices               The remaining components of the IoMT               •• connectivity technology – connectivity
   – include insulin pumps for diabetes            ecosystem                                             technologies are the enablers of the
   monitoring, skin patches, cardioverter-         The other three key components of the                 IoMT ecosystem, connecting people
   defibrillators and other devices, including     IoMT ecosystem are:                                   and devices to the internet. Wireless
   smartwatches and activity trackers that                                                               technologies such as Wi-Fi, Bluetooth low
   produce data that are monitored by              •• systems and software – IoMT systems                energy (BLE), near field communication
   clinicians. Wearable external medical              and software primarily focus on reducing           (NFC), Zigbee, cellular and satellite
   devices are used to monitor patients               the delivery time and cost of projects             technologies are primarily used in health
   while in hospital and post-discharge, as           through device management and                      care. Factors that facilitate seamless
   well as on-going monitoring of patients            integration, information security, data            wireless connections are interoperability
   with chronic conditions or frailty.                collection and data analytics. Systems             between wireless standards, low energy
   Wearables used only for fitness tracking           and software include remote device                 consumption, and range extension. The
   or self-monitoring are not included.               management, network bandwidth                      market for connectivity technology was
                                                      management, data analytics, applications           $9.3 billion in 2017 and is expected to
The market for these connected medical                security and network security solutions.           increase to $28 billion in 2022
devices was $14.9 billion in 2017 and is              The market for systems and software was
expected to increase to $52.2 billion in              $9.8 billion in 2017 and is expected to         •• services – IoMT services include system
2022 (see Figure 5).4                                 increase to $48.3 billion in 2022                  integration services, professional
                                                                                                         services and support and maintenance
                                                                                                         services. Service providers are providing
Figure 5: The market for connected medical devices is predicted to grow from
                                                                                                         personalised and optimised services that
$14.9 billion in 2017 to $52.2 billion in 2022
                                                                                                         offer predictable and better business
                                                                                                         outcomes for health care organisations,
                                                           2017                   2022
                                                                                                         which allow these organisations to
                                                                                                         manage the entire life cycle of the IoMT
                                                                                                         in health care solutions. The market for
                  Stationary medical devices                                    $17.0bn                  services was $7.3 billion in 2017 and is
                                                          $5.7bn                                         expected to increase to $29 billion in 2022.

                                                                                $18.9bn
                  Implanted medical devices
                                                          $5.1bn

                  Wearable external
                                                                                $16.3bn
                  medical devices
                                                          $4.1bn

                                                         $14.9bn                $52.2bn
                                          Total

Source: MarketsandMarkets, 2017

12
Medtech and the Internet of Medical Things| How connected medical devices are transforming health care

How medtech can help health care                    (e.g. using connectivity to track equipment        Increasingly, companies are developing
organisations tackle current health                 patient and staff workflow), improve access        products that enter the market with
care challenges                                     to and speed of diagnosis ( e.g. advanced          the capability of internet connectivity.
Health care is increasingly expensive, with         point of care diagnostics), deliver more           The same devices that companies have
global health care spending expected to             targeted precision treatments, improve             been producing for years are now able to
grow 4.2 per cent per year, from $7.1 trillion      medication adherence (e.g. apps, smart             connect to other networks and systems
in 2015 to $8.7 trillion by 2020.5 Among G7         pills and pill boxes) and support virtual          and generate data that provides a huge
countries, expenditure on health care as            patient monitoring (e.g. sensors placed            benefit for health care professionals in
a percentage of gross domestic product              under the patient’s mattress or within             terms of delivering insight into outcomes,
(GDP) increased from 10.8 per cent in 2010          a chair and patches that continuously              patient health and effectiveness of care
to 11.4 per cent in 2016.6 Indeed, health           measure vital signs). IoMT solutions               delivery. The challenge for medtech is
care in many countries risks becoming               can help reduce health care costs by               demonstrating to payers and providers the
unaffordable, as governments and other              reducing hospital re-admissions, lowering          added cost-benefits of these enhanced or
payers find their budgets increasingly              medication non-adherence, and increasing           new connected products, and ensuring
constrained at a time when the challenges           wellness management using connected                that clinicians and patients are convinced
they face are growing significantly, driven by:     smart devices and wearables to collect and         of the benefits and ease of use.
                                                    analyse medical data. Connected medical
•• unrelenting demand pressures from a              devices can also engage and empower                Wearable medical devices and home health
   growing and ageing population – 8.5 per          patients and their carers to improve self-         monitoring devices are becoming more
   cent of the global population (617 million       management. MarketsandMarkets expect               prevalent among patients of all ages. These
   people) are aged 65 and over, with the           that potential savings from deploying IoT in       devices allow vital data to be transmitted
   total expected to double by 2050 to              health care could be as much as $63 billion        from a patient’s home directly to hospital
   1.6 billion people7                              globally.11 Case examples of some of the           and other health care staff, resulting in
                                                    savings that can be generated are included         real-time monitoring of a patient’s health.
•• increasing public expectations for more          throughout the report.                             Utilising these types of devices could
   personalised, equitable and convenient                                                              result in considerable cost reductions
   services                                         Drivers of connected medical device                and operational efficiency improvements.
                                                    development                                        Similarly, advances in sensor technology
•• advances in new treatments and                   The medtech industry is characterised by           are making the creation of data much
   technologies – prescription drug sales           a constant flow of innovation based on a           easier. Early stage examples of sensors
   are expected to rise by 5.5 per cent a           high level of research and development             embedded in novel ways include adding
   year (2016-2022) to $1.06 trillion by 2022,8     (R&D) and close co-operation with                  them to pill bottles and hospital beds.
   while medtech sales are expected to              users. Medtech companies constantly                Globally in 2016, the number of patients
   increase by 5.1 per cent a year (2016-           update their technology to improve                 being monitored remotely grew by 44
   2022) to $522 billion by 20229                   their engagement and interactions with             per cent to 7.1 million and is projected to
                                                    patients and health care providers, with           exceed 50 million by 2021.14
•• a mismatch between the demand for and            products often upgraded or replaced every
   supply of adequate numbers and types             18-24 months.12 In 2017, 13,090 medtech            However, the generation of data points
   of staff – staff are the largest cost driver     patents were filed globally – the most of          through millions of connected sensors will
   of health care, accounting for between           any category of products, and a 6.2 per            have little impact unless the data can be
   60 and 70 per cent of health care running        cent increase from 2016. Across Europe,            turned into insight and utilised effectively
   costs.10                                         this trend was even more pronounced, as            in the clinical workflow. Currently, the
                                                    medtech patent filings increased by 7.1 per        limiting factor is the ability to aggregate
The medtech industry is well placed to              cent from 2016.13                                  data. Companies are addressing this by
help alleviate some of the cost, access                                                                working to increase interoperability and aid
and care coordination challenges facing                                                                data aggregation, but its complexity means
health care. Medical devices can help staff                                                            progress has often been slow.
to work more effectively and productively

                                                                                                                                                    13
Medtech and the Internet of Medical Things| How connected medical devices are transforming health care

Medtech companies who participated                 Over half of respondents from small                Again, this is likely due to the difference in
in our survey are increasing their focus           companies said all their products are              product portfolios between the companies.
on connected medical devices                       connected, compared to around a                    For example, our interviews with large
In April 2018, we commissioned market              quarter in medium-size companies and               medtech companies highlighted that
research firm Research2Guidance to                 a third in large companies. This is likely         significant investments in emerging IoMT
conduct a survey of medical device                 because larger companies surveyed have             technologies are being made.15
companies with connected medical                   significantly larger product portfolios with a
devices. Of the 237 respondents, 73 per            number of well-established non-connected
cent were from small companies (less than          device offerings.
250 employees); 15 per cent from medium-
size companies (251 to 5,000 employees);           Across our survey respondents, the
and 12 per cent from large companies               average percentage of their overall R&D
(six per cent had more than 50,000                 budget allocated to the development
employees). See our separate methodology           of connected medical devices was
paper for full details.                            estimated to be 34 per cent; all expected
                                                   this percentage to grow, with the overall
Survey respondents on average estimated            average in five years’ time increasing to 42
that 48 per cent of their current portfolio        per cent (see Figure 6). Smaller companies
of products are connected medical devices          surveyed are currently allocating a
able to generate data today and expect the         significantly higher percentage of their R&D
percentage to increase to 68 per cent in           budget to the development of connected
five years’ time (see Figure 6).                   devices (43 per cent), compared with their
                                                   medium – and large-sized counterparts
                                                   (both ten per cent).

“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 intention of medical device companies
the percentage of devices that are produced, as well as an increase in R&D budget                         to invest increasing proportions of their
                                                                                                          R&D budget in connected devices, systems
Estimated percentage of connected medical devices today and in five years’ time                            and software is supported by our literature
                       Today                                             5 years                          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.
                                                               32%

           52%                        48%
                                                                                                          Smaller companies
                                                                                                          surveyed are currently
                                                                                    68%
                                                                                                          allocating a significantly
                                                                                                          higher percentage of
             Other                  Connected                  Other                  Connected
                                                                                                          their R&D budget to
                                                                                                          the development of
Estimated R&D budget allocation towards the development of connected medical technologies
today and in five years’ time                                                                              connected devices.
                       Today                                             5 years

                                    34%
                                                                                       42%

                                                             58%
             66%

             Other                  Connected                  Other                  Connected

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

                                                                                                                                                      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        Participants in a Deloitte US survey of 20
model focuses on volume of care, where             Health system CEOs say that the transition                      Deloitte’s view:
providers are compensated by the number            to VBC is happening, but at a slower rate                       Medtech companies
of tests, visits or procedures performed.          than initially anticipated. Many of the                         need to develop a
In a value-based care (VBC) model,                 CEOs report that they are developing and
                                                                                                          deeper understanding of the
hospitals and health care providers are            expanding innovative delivery and payment
compensated based on measures such as              models.16 A successful value-based                     end-user and their emerging
patient outcomes and satisfaction.                 payments strategy requires payer/provider              needs, and create new
                                                   collaboration, sharing of patients’ health             business models and scenarios
Today, a number of governments and other           data, and IT and analytical support. As                that demonstrate how their
health care payers are expecting providers         more providers adopt VBC models, the rate              new and existing devices not
to adopt new VBC payment models that               of adoption and integration of connected
                                                                                                          only improve patient outcomes
shift a higher level of responsibility and         medical devices will also increase. While the
risk from payers to providers. Medtech             IoMT can provide these data and insights               but also create value for key
companies have an important role to play           to help improve patient care and the overall           health care stakeholders.
in supporting this shift, including providing      cost-effectiveness of provider operations,
robust, reliable data and information to           challenges include the extent to which
providers (and payers) on the downstream           provider organisations’ IT infrastructures
value that their devices, including                are able to handle or process the
connected products, provide. Indeed, the           connections and data, and whether
data and insights provided by connected            clinicians and patients can be convinced of
medical devices can help providers                 the safety and effectiveness of the devices.
improve cost, quality and productivity of          Medtech companies will need to address a
care delivery, and support better patient          number of systemic challenges if they are
engagement.                                        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

16
Medtech and the Internet of Medical Things| How connected medical devices are transforming health care

Developing new funding, business and            Figure 7: Medtech companies are implementing new business models and ways
operating models                                of working
Health care organisations looking to
reduce their expenditure on services are          Implementing new business
                                                                                   10%           39%                                51%
taking a number of measures to lower the                            models
costs of equipment and devices, such as
forming group purchasing organisations,           Implementing new operating
                                                                     models        10%             46%                              45%
consolidating purchasing to a small range
of trusted products and changing the
                                                       Adopting a value-based
way medical devices are reimbursed.                       approach to pricing
                                                                                    17%                  44%                        39%
These factors are changing fundamentally
the way in which medtech companies                 Implementing new funding
                                                   models for data as a service      22%                       47%                        31%
commercialise their products, leading
companies to develop new funding and
                                                                              0%           20%             40%           60%            80%          100%
business models for their connected
                                                                                                    Percentage of survey participants
medical devices and software.
                                                    Not at all       To a limited extent      To a large extent
Our survey of connected medical device
                                                Note. The figures from our research survey relate to medtech companies with connected medical devices
companies found mixed results in the            and are not representative of the medtech industry as a whole. Due to rounding the figures may not total
success they are having in developing new       100 per cent.
business models. While 90 per cent of           Source: Deloitte research commissioned from Research2Guidance, 2018
our surveyed companies said they were
implementing new business models, 51 per        A significant challenge for medtech is                 These start with comprehensively defining
cent were doing so ‘to a large extent’ versus   whether, and if so how quickly, these new              the categories where a medical technology
39 per cent ‘to a limited extent’. Similarly,   business and operating models will be                  can have impact, as considered from the
most respondents are implementing               able to increase revenue and profitability.            perspective of the different stakeholders
new operating models, although this was         Furthermore, new entrants are disrupting               (ranging from the patient and their family
split evenly between 45 per cent ‘to a          the sector, which will require incumbents              and caregivers, through to individual
large extent’ and 45 per cent ‘to a limited     to take significant portfolio decisions                clinicians, provider institutions, commercial
extent’. The majority of companies are          (including divestitures of lower margin                payers, and government bodies).
also adopting a value-based approach            segments) and adopt new channels of care
to pricing, with a lower percentage             (e.g. telemedicine and remote monitoring).
implementing new funding models for data                                                               These factors are changing
as a service (see Figure 7).                    In 2017, Deloitte Consulting LLP and                   fundamentally the
                                                AdvaMed, in collaboration with taskforces
                                                of member companies representing
                                                                                                       way in which medtech
                                                medical device and diagnostic companies,               companies commercialise
                                                developed an approach to help
                                                stakeholders more effectively assess
                                                                                                       their products, leading
                                                the value of medical technologies. At the              companies to develop
                                                heart of the recommendations are a set
                                                of core principles to guide the assessment
                                                                                                       new funding and business
                                                process.                                               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

                 Clinical                            Non-clinical                             Care delivery                               Public/
                 impact                             patient impact                            revenue and                               population
                                                                                               cost impact                                impact

      The extent of clinical utility and   The impact on non-medical benefits           The impact of the technology on        The impact of the technology to the
     health outcomes associated with       for the patient (or caregiver): patient   revenues and costs for the provider,       health care system at large and
       medical technology offering           experience and patient economics         payer, and provider-sponsored plan       employers or the public as a whole
                                                (such as out-of-pocket costs)        via bonuses or penalties associated
                                                                                      with care quality metrics, as well as
                                                                                     the impact on clinical workflow and
                                                                                          other sources of operating
                                                                                                  efficiency

Source: Deloitte Consulting LLP and AdvaMed, 2017

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                                        Deloitte’s view:
of the new and emerging business models in Part 3.                                                                              While some new
                                                                                                                                reimbursement
There is also a large spectrum of innovation types, from engineering driven incremental
                                                                                                                       models are already in use,
innovations that mostly result in enhanced products aimed at identifying improvements
to stay competitive – which are unlikely to attract additional payments – to concepts like                             most focus more on prevention
human centred design that clearly create additional value for the health care system and                               and longer-term cost avoidance
which require new reimbursement models (see Case study 1). 1819                                                        that traditional reimbursement
                                                                                                                       mechanisms were not built
                                                                                                                       to reward. It is likely to take
                Case study 1. Medtronic’s outcomes-                                                                    several years for the health
                based reimbursement model with                                                                         care system to evolve to
                two large insurance companies                                                                          be able to truly reward
                                                                                                                       innovation. The different types
     Medtronic reached agreements with two large American health insurers to employ                                    of innovation will require
     an outcomes-based reimbursement model for patients opting in to use the                                           different business models, and
     Medtronic insulin pump systems. One such agreement utilised Medtronic’s new
                                                                                                                       progress will depend on both
     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 innovators themselves
     the patient automatically when required. The outcomes-based reimbursement                                         working in new ways to take on
     model enables a risk sharing approach by both the payer and manufacturer                                          risks and rewards, and the
     that links reimbursement of these new devices to improved A1C (glycated                                           evolution of existing payment
     haemoglobin) levels in the patient.18,19                                                                          systems by both public and
                                                                                                                       private payers.

18
Medtech and the Internet of Medical Things| How connected medical devices are transforming health care

Addressing interoperability                    Figure 9: Barriers to and benefits of interoperability
Health systems and equipment increasingly
connect over wired and wireless networks.
Interoperability describes the extent to
which systems and devices can exchange                                     Privacy and
                                                                       security challenges
and interpret shared data. It also allows                                associated with                           Lack of adoption of
for the authorised use of data and the                                 widespread health                            standards-based
                                                                           information                                EHR systems
exchange of medical data to facilitate
                                                                            exchange
decision-supported patient centric care
                                                                                             Lack of incentives
and reduce medical errors.
                                                                                                 to develop
                                                                                             interoperability in
Interoperability in health care is extremely                                                 the private sector
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
                                                                                        Interoperability
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                                                    Benefits
who ‘owns’ the data and can drive direct or
indirect commercial benefit from it?
                                                                                                                        Consented sharing of
                                                                                                                        patient information

There are serious                                  Increased patient/physician
                                                                  engagement
barriers to achieving
interoperability that                                                                                                   Safer transitions of care
medtech companies
need to understand.                                          Increased efficiency

                                                                                                                        Improved continuity and
                                                                                                                        consistency of care

                                                                      Lower costs

                                                                                Improved patient outcomes

                                                Source: Deloitte LLP, 2018

                                                                                                                                                    19
Medtech and the Internet of Medical Things| How connected medical devices are transforming health care

Hospitals often use hundreds of                    The increasing deployment of value-based           The Act made health care providers
customisations to make EHRs user-friendly          care models means collaboration between            accountable for keeping protected
and have multiple connecting systems               payers and providers will be a necessity.          health information (PHI) confidential, and
that increase the complexity of sharing            Although new regulations are attempting to         infringements invite hefty fines and potential
information. Connected medical devices             introduce new standards, these standards           jail terms for those who fail to comply.20
introduce even more data sources,                  are not always implemented in the same
challenging providers still further, especially    way within and between organisations,              There are also a number of technical and
in finding ways to store, share, and use           impacting the chances of interoperability.         organisational challenges that need to
patient-generated data from wearable                                                                  be overcome if interoperability is to be
health technology and smartphones.                 A number of our interviewees noted                 implemented effectively (see Figure 10).
Indeed, many health systems still lack             that the Health Insurance Portability              However, recognising the importance
interfaces that can gather and interact            and Accountability Act (HIPAA) that the            of interoperability is crucial for all
with emerging technology. Payment and              US Congress passed in 1996 proved                  professionals working in the health care
behavioral information is also likely to be        to be a barrier to the development of              industry and for all medtech companies
a future application that will require more        interoperability.                                  wishing to optimise the use of their
sophisticated layers of interoperability.                                                             connected devices.

Figure 10: Key actions life sciences and health care stakeholders should consider when tackling the interoperability challenge

                                       Working towards a unified and technology friendly platform for
                                    sharing clinical data (open Application Programming Interfaces (APIs))

                                                                                                          Implementing uniform messaging
                                                                                                          standards for health care data
             Developing a consensus on
                                                                                                          (e.g. HL7 and increasingly the Fast
           standards for interoperability
                                                                                                          Healthcare Interoperability
                                                                                                          Resource (FHIR))

          Creating an integrated
         governance framework                                                                                     Obtaining consented access
         among stakeholders to                                                                                    to data across stakeholders
          improve data integrity

                                                         Interoperable medical devices,
                                                              systems and services

Source: Deloitte LLP, 2018

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