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Digital Healthcare: A Giant Transformation from Mini Technology

Overview

Contents

As part of our Digital Healthcare series, we have been looking at developments in remote monitoring systems. Such systems can focus on disease prevention, patient monitoring during and after treatment, and lifestyle awareness.

5 Evolution of biosensor technology in remote monitoring: from wearables to injectables

In post-treatment monitoring, physicians’ roles have moved from ‘dogmatic’ to a next-generation, patientempowered approach. In today’s world, patients wear devices that help them detect and monitor abnormalities in their bodies and it has been the developments in biosensor technology that have steered this revolution. Biosensing devices are now affordable and commonplace.

6 We have come a long way: innovative technologies define a new era in product development

While the benefits of remote and patient-empowered monitoring are now proven, making things smaller, convenient and non-invasive is where drug manufacturers, technology leaders and

start-ups are placing much of their focus and resource. Biosensor miniaturization has become a market of its own, it is fast-growing and attracting investment. With this, however, come new industry challenges. From managing data privacy to overcoming adoption and implementation barriers, there are multiple constraints to be addressed. In this report, we make an assessment on the evolution of biosensor technology, including the benefits and considerations for healthcare systems. We also look at what the future has to offer for patient monitoring and disease prevention.

9 The biosensing pipeline 10 Challenges and considerations 13 Our conclusion 14 You may also be interested in

Digital Healthcare: A Giant Transformation from Mini Technology | Q2 2015 | 3

Evolution of biosensor technology in remote monitoring: from wearables to injectables Key milestones

2006 v

Nike and Apple developed fitness trackers to monitor data such as time, burned calories and distance. From 2007, other companies such as Fitbit, Jawbone and Garmin Vivofit, started entering the wearable space.

2012 v

An ingestible sensor was developed by Proteus Digital Health which was approved by FDA in the same year. Companies such as Google and other research teams began developing ‘smart’ pills to detect disease markers or indicators.

2013 v

A team in EPFL in Switzerland developed an implantable device to monitor critical biomarkers in the blood. Technology giants such as Medtronic developed implantable sensors, with other advances boosting growth in miniaturization, including the development of e-patches.

2015 v

Rhythm Solutions announced the development of an injectable sensor for real-time detection of cardiac arrhythmias. Injectable nanosensors are now being researched worldwide. There is hope that with enhanced technology access this could be the answer to various incurable diseases.


We have come a long way: innovative technologies define a new era in product development Ingestibles

Implantables

As briefly described in the first of our Digital Healthcare series, Proteus Digital Health pioneered adherence to medicine intake with ingestible sensors. This technology has now received CE mark in Europe and FDA clearance in the US, with its application fast expanding into disease prevention, treatment and post-treatment monitoring. Delivered as encapsulated microscopic particles, these nano magnets reach a person’s circulation in search for physiological abnormalities. Other examples include:

Cancer-Detecting pill by Google • Small magnetic particles are packaged and ingested as a capsule. • Once released into the bloodstream the particles travel in search of malignant cues, at which point a signal is sent out to an external device.

• The pill is still in development and company sources estimate it will be approximately ten years before the product can be applied in routine practice.

CorTemp by HQ Inc. • The ingestible sensor remotely tracks and reports temperature as it travels through the digestive tract. The signals are passed to a data recorder which is worn on the outside of the body.

• The device is FDA approved for single use but monitoring can be extended by administering another sensor once the initial pill has been depleted.

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In 2014, the global biosensor market was estimated at USD 12.96 billion, but it is expected to reach USD 22.55 billion by 2020, with a CAGR of 9.7% calculated for this period 2014-2020 – Deloitte.

Designed to be implanted under the skin, these sensors can derive power from a patch on the surface to closely monitor health biomarkers. Examples include:

Implantable biosensor from EPFL Integrated Systems Laboratory • The sensor can measure pH, temperature and concentration of molecules that are indicators of glucose, lactase and cholesterol levels.

• The sensor has been successfully tested in mice, with human trials set to complete within the next three to five years.

In the last quarter of 2014, investment in biosensors saw an increase of 259% compared with the same period in 2013 – PwC.

Implantable biosensor from Raland Therapeutics • This biosensor can • For example, a doctor would • The technology is currently monitor the body’s be able to monitor levels of being considered for human cellular responses to the toxicity in a cancer patient clinical trials. environment, offering strong following chemotherapy, potential for monitoring thereby providing an response to treatment. assessment on treatment response.

Reveal LINQ insertable cardiac monitor from Medtronic • This sensor is placed in the • With a lifespan of up to chest area under the skin. three years, the sensor It is currently the smallest detects and records heart monitor on the market. abnormal heart rhythms and

has been used primarily in people who experience unexplained fainting.


The biosensing pipeline

Electronic Patches Like a semi-permanent tattoo, these soft and thin stick-on patches are flexible, can stretch like your skin and carry sophisticated technology for remote patient monitoring. Examples include:

Electronic patch from University of Illinois and Northwestern University • The technology offers general health monitoring and potential in the clinical

setting for tests such as electrocardiograms and electroencephalograms.

• The sensor can send realtime data wirelessly to a smartphone or a computer.

The appetite for innovation around miniaturized biosensors continues to grow. Pioneers understand the significant healthcare and cost implications, particularly for burdensome conditions such as diabetes and cancer. The following is a taste for what the application of biosensor technology might look like and how some of today’s challenges could be tackled in the future.

Electronic tattoo from University of California • The sensor is designed to • So far, the technology is continuously monitor lactate being considered for fitness levels, a by-product of and performance tracking, sweat. but its applications are

endless – the technology could eventually generate enough electricity to run devices like heart monitors.

HealthPatch from VitalConnect • A clinical-grade sensor fitted to a disposable and adhesive patch that can be placed on the chest

and used to monitor vital health metrics such as heart rate, respiratory rate, temperature, etc.

• Biometric data and vital signs are wirelessly sent to the HCP and/or the patient via Bluetooth.

Injectables

Implantable birth control Researchers at MIT are developing an implantable chip that generates small amounts of contraceptive hormone from within a woman’s body for up to 16 years. Cyber pills that talk to your doctor A British research team is developing a ‘cyber’ pill that enables ‘texting’ the doctor directly from inside the body for treatment monitoring. Smart dust A team from the University of Michigan is developing nano antennas, smaller than a grain of sand. These can organize themselves inside the body into ‘as-needed’ networks to power internal processes and act concertedly against diseases like cancer. Smart pens that can draw biosensors on the skin A team at the University of California is developing enzymatic ‘ink’ which can be used to draw biosensors on the skin to monitor blood glucose levels.

This technology has been labelled “the future of health monitoring.” It is designed to reach and function from inside the body. One example is:

Injectable nano sensors that alert at first signs of a heart attack • Following injection, the sensors reside in circulation and travel in the bloodstream. • When encountered with important changes in

the blood, such as those resulting from alterations to the arterial lining of the heart and shedding of cells, an alert is emitted to a remote source, as a first sign of a heart condition.

8 | Digital Healthcare: A Giant Transformation from Mini Technology | Q2 2015

• The technology has the potential to detect other conditions like cancer and is currently awaiting FDA approval.

Implantable 3D smart organs A team of biochemists at MIT is developing 3D printed tissues and organs using DNA scaffolds. Brain-computer interface A team at Brown University is developing miniature electrodes to be implanted in the brain that can control external devices. This has a likely application in the area of prosthetics.


Challenges and considerations There is no doubt that with the emergence of miniaturized biosensors, the concept of patient and treatment monitoring will be transformed. From the time that a patient walks into a hospital, to their time back at home, data will be continually transmitted to both the patient and the Healthcare Practitioner (HCP). While conceptually this is very attractive, systems and infrastructure need to operate efficiently. For this, new industry challenges and considerations require attention.

Adoption of new technologies and development of a new skillset •

A new array of up-to-date • competencies is needed for healthcare systems and HCPs to operate effectively in this environment. This includes training and education around data integration, clinical interpretation, handling of new technologies and even defining new relationships between physicians and patients.

Resource and investment is required to implement new systems and working flows, educate end-users and generate awareness. Education is key to the uptake of these new technologies.

Data privacy and security •

The issues around data privacy and security are questions for both the consumer and the manufacturer. Who owns and • who has access to medical data is one of many concerns, though patients must also remain conscious of a new

“Technology is completely changing the game… Monitoring physiological parameters... is now done at home by the patient. That raises a huge need for education for patients to understand how to interpret the medical information they’re getting from these devices”. – Lee Hartwell, Nobel Prize winner.

acquired responsibility to hold and share personal information.

of new treatment algorithms based on real-time data records requires technical expertise, must be strictly adhered to and developed in collaboration with physicians and professional associations.

HCPs and manufacturers must embrace new security acts as governed by HIPAA privacy rules. Similarly, development

Engaging the end-user and facilitating use of the technology •

Patients must believe in and lose the ‘fear’ of new technologies. The end goal is to empower patients with interpretation of their own medical information.

•

To achieve this, convenience is paramount. Declines in

the use of wearable devices have been reported, with user rate dropping by up to 50% within the first 18 months of purchase. User experience should be a core focus for manufacturers along with the launch of new technologies.

•

The search for the most reliable way to provide accurate data to the patient and build their trust in that measure continues. A company that can successfully achieve this would likely be a strong leader in the market.

•

Interoperability is vital and implementation of sophisticated yet user-friendly softwares and working flows will help in gaining acceptance from both patients and HCPs.

Data management and interoperability •

Over time, datasets generated • will be very large. Physiological data has to be meaningful and actionable for the end-user and functionality has to focus on integrating data into new clinical workflows.

Development of algorithms should enable the provision of clinically meaningful data. But parallel to this, EHRs will have to evolve into a more comprehensive and integrated solution that hosts data from multiple disparate sources.


Our conclusion The potential that biosensors hold in remote monitoring is vast – they can detect, record and transmit important information in real-time about physiology, environment, function and lifestyle. This translates into remarkable health benefits that range from disease prevention to early detection, treatment and post-treatment management. But great progress brings new challenges. Problems will no longer stem from a lack of information or inaccuracy of data, but rather an overload of highly significant data. Industry’s efforts need to shift towards creating an ecosystem that promotes patient empowerment over their medical information, HCP education and the establishment of new working models that can effectively draw credibility from the

medical community. Equally, technological integration that enables interoperability, will be key. Members from the medical profession as well as experts in data security, treatment guideline development, economics and reimbursement, will play key roles towards the deployment of a revolutionary biosensor-driven and patientcentered healthcare framework.


You may also be interested in

If you are • Looking to stay up to date • In the quest for new with changes in the clinical, insights from the medical regulatory and commercial community on digital and environments. other healthcare topics.

Our Digital Healthcare Report: An Era of Evolution & Revolution Click here to read it.

Digital Healthcare:

A Change Healthcare Challenges in Industry Dynamics of Today

An Era of Evolution & Revolution

M&A activity has been abundant, from Google, to Bayer, to Intel. Acquisitions of digital enterprises and partnerships The greater complexity of medical practice, with Chronic disease burden Disruption technologya giants are enabling business models evolve,is severe progressively ageing population and to a rising means unleashingdemand the potential of healthcare. is not current only an era Chronic of for better healthcare,It mean diseases are the main opportunity disruption,systems but alsomust one of opportunity, growth and innovation. cause of death across the EU: become smarter. To this end, an evolution towards improving Partnerships Acquisitions Investments services and reducing costs has begun, with novel andMedtronic more efficient toindata Google partners acquiresapproaches GE invests healthtracking IT with Novartishandling, Corventis communication, patient To commercialise To enable the GE plans to invest and care now underway. a smart contact lens that monitors blood glucose from tears, recorded on a mobile device.

Vantage Health partners with Nasa To commercialise a screening sensor for lung cancer that can also be connected to a smart phone device.

launch of a waterproof, wireless heart monitoring patch to detect cardiac arrhythmias.

St. Jude Medical acquires Cardiomems To launch a device that monitors heart failure with the potential to reduce hospital admissions.

USD 2Bn in health IT over the next five years to address operational and efficiency challenges faced by healthcare organisations.

Bayer invests in mobile health apps Bayer launched its own accelerator for health apps, Grants4Apps, which selects innovative projects to improve healthcare and pharmaceutical processes.

cancer, diabetes, for mental and respiratory disorders account companies 1 for 86% of deaths.

to create and Disease management innovate is costly

In the EU, up to 80% of all healthcare spend goes to chronic disease management – that is more than EUR 700Bn every year.2

Patient numbers will increase The number of patients is set to increase – in cancer alone, the absolute number of patients per year will increase over 40% in the next 15 years.3

• Seeking a fresh perspective • Seeking insightful research on your competitors, their support for your daily and tactics and strategies. complex business activities. Transforming thefor A New Platform Patient GrowthLifecycle & Opportunity Digital innovations are transforming patient care, offering unprecedented and cost efficiencies. The market potential of treatment digital healthcare In section, we gained will review a few examples of how is this strong and has traction from all cutting-edge innovations technology to date haveand revolutionised angles – entrepreneurs, each stage giants, of the patient lifecycle. healthcare all willing to invest and reinvent the system.

The Digital intersection advances betweenfor IT, promise pharma and processes healthcare to become is creating a more platform for effective, growth and less prone opportunity to errors and more affordable

Venture funding of digital health continues to outpace traditional healthcare sectors, including software, biotech, and medical devices. As of mid-2014, it had already surpassed the total funding reported for 2013.

Venture investment in digital health

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Digital health investment has increased over the years but exploded in 2014 with a reported USD 2.3Bn successfully raised by June of that year.

USD 2.29Bn (YTD Jun 2014)

0.60 USD 1.97Bn USD 1.45Bn

(YTD Dec 2013)

(YTD Dec 2012)

0.30

USD 0.88Bn (YTD Dec 2011)

0 Indexed data based on Rock Health 2014 Midyear Report

1. Tackling chronic diseases in the EU, EurActiv Special Report, April 2014 6 | Digital Healthcare: An Era of Evolution & Revolution | Q1 2015 2. EU Summit on Chronic Diseases, Brussels, Belgium, April 2014 3. Popescu et al. Annals of Oncology 2014

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Our Pre-treatment close up on Screening & Diagnositics Click here to read it.

Digital Healthcare: Pre-treatment: Screening & Diagnostics Healthcare is now preventive and more precise

key drivers Evidence-based knowledge and the rise in screening and diagnostic programs Emergence of innovative and faster biomarker discovery platforms

Better technologies for clinical data access and information

processing

Increased support from government and regulators to drive personalized medicine

Greater medical demand to assist a progressively aging population

Focusing on oncology as an area of great change New cancer cases (Global)

Recurring

risk of cancer recurrence

14 | Digital Healthcare: A Giant Transformation from Mini Technology | Q2 2015 14.1 mm

23.6 mm

risk of second primary tumor

Copyright © 2015 by Grail Research No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means — electronic, mechanical, photocopying, recording, or otherwise — without the permission of Grail Research. This document provides an outline of a presentation and is incomplete without the accompanying oral commentary and discussion. COMPANY CONFIDENTIAL