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 06
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 ($2.1 billion). The IoMT market in Asia- Remote Improved Pacific is projected to grow at the highest monitoring disease rate, at a CAGR of 34.3 per cent during the of chronic management forecast period, due largely to the level of diseases unmet need and the increasing number of hospitals and surgical centres being built in this region.3 Source: Adapted from The Internet-of-Things: A revolutionary tool for the health care industry, Inside Magazine, Deloitte LLP, 2017 10
Medtech and the Internet of Medical Things| How connected medical devices are transforming health care Figure 4: IoMT market segmentation by component and application, 2017 ($ 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 20
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