The Outlook for Wearable Health Tech in Managing Chronic Disease

May 2016

A FirstWord ExpertViews Dossier Report

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The Outlook for Wearable Health Tech in Managing Chronic Disease

Published May 2016© Copyright 2016 Doctor’s Guide Publishing Limited

All rights reserved. No part of this publication may be reproduced or used in any form or by any means graphic, electronic or mechanical, including photocopying, recording, taping or storage in information retrieval systems without the express permission of the publisher.

This report contains information from numerous sources that Doctor’s Guide Publishing Limited believes to be reliable but for which accuracy cannot be guaranteed. Doctor’s Guide Publishing Limited does not accept responsibility for any loss incurred by any person who acts or who fails to act as a result of information published in this document. Any views and opinions expressed by third parties and reproduced in this document are not necessarily the views and opinions of Doctor’s Guide Publishing Limited. Any views and opinions expressed by individuals and reproduced in this document are not necessarily the views and opinions of their employers.

Cover image: © WavebreakMediaMicro/missbobbit | AdobeStock

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ContentsExecutive summary .............................................................................................................................. 1

Research Objectives and Methodology .................................................................................3

Key questions answered in the report ....................................................................................4

The evolution of wearable technologies in the health and consumer markets ......................................................................................................................5

Health, fitness wearables evolving towards ‘medical grade’ devices ....................................8

Wearable technologies popularised by shift towards patient‑centric healthcare ............10

Pharma lags behind general healthcare, tech companies in developing wearable technologies ......................................................................................................................................... 11

Wearable tech holds promise of enhancing clinical adherence and generating insights for personalised programmes ..........................................................14

The importance of differentiating between consumer‑grade and medical‑grade wearable technologies ......................................................................................................................15

Potential to improve adherence to treatment currently driving pharma interest in creating health wearables ...........................................................................................................19

Aligning patient and pharma perspectives of ‘relevant’ monitoring parameters ............... 21

The down-line influence of wearable tech for payers, consumers .......................................23

Future benefits: altering disease progression ............................................................................24

Collaborations between pharma and tech companies ...........................................................25

The role of wearable devices in chronic disease management .......................... 27

Contribution of variables assessed to date .................................................................................29

Patient satisfaction and improved healthcare behaviours ......................................................30

Remote care with ‘ambient monitoring’ ....................................................................................... 31

Potential for future use of wearable devices in chronic disease management ................33

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Using wearable devices to aid clinical decision making ..........................................................36

Incorporating general fitness and activity levels into a public health context ......................................................................................................................38

Leveraging wearable device data for clinical trial support ......................................................39

The potential for wearable technologies at point‑of‑diagnosis .............................................. 41

Rehabilitation – hospital based and home based, remote patient monitoring ..................43

Use of wearables for long‑term patient support and adaptation ...........................................44

Challenges of developing wearable devices ....................................................................45

Challenge I: Managing the data derived from use of wearable devices ............................. 47

Challenge II: Weighing consumer‑grade wearables compared to medical‑grade devices ................................................................................................................48

Challenge III: Data management, processing and analytics necessary to draw value from wearable technologies ................................................................................50

Challenge IV: Pharma leadership needs to get on board with collaborative health solutions .................................................................................................56

Challenge V: Partnering with tech companies and public bodies ........................................ 57

Challenge VI: Managing patient expectations ............................................................................59

Challenge VII: Working with regulatory bodies .......................................................................... 61

Market landscape for wearable devices ..............................................................................62

Opportunities for pharma in the wearable technologies market space abound, but uptake is dependent on patient attitudes, motivation ......................................................63

Senior population, chronic condition monitoring are obvious entry points into the marketplace ..........................................................................................................................65

Market potentially exists for wearable technologies that can guide physician decision making, demonstrate treatment efficacy .................................................66

Pharma can steer creation, adoption of next‑generation medical wearables ...................66

Partnerships will be key to expanding pharma’s involvement in wearables .....................68

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Research Objectives and MethodologyThis report charts the evolution of wearable devices and outlines key development considerations for pharmaceutical companies in supporting and developing wearable devices to improve long term outcomes for patients that enhance traditional pharmacotherapies and improve compliance to treatment. An overview of the sector’s use of wearables is provided, in addition to examples of the determination of non‑pharma companies’ inclusion on the use of wearables to secure healthcare data and customer loyalty.

The research methodology used to compile this report included a wide‑ranging review of available literature on, and media coverage of, the wearable devices market worldwide, followed by in‑depth interviews with experts in the field. Information was obtained from publicly available sources of information and from previously published FirstWord reports and analysis.

ContributorsThe following experts have kindly contributed their insight to this report through interviews:

nEsther Broer, International Brand Manager at ARIAD Pharmaceuticals

nMark Field, Senior Vice President, Business Lead, Early Research & Development, Grunenthal Group

nKai Gait, Global Multichannel Marketing Director, GlaxoSmithKline

nHelen Harrison, European Digital Manager, Eli Lilly

nBernard Levy, Director of Early Commercial Strategy at Novartis Oncology

nKevin Loth, Vice President of Corporate Affairs and Policy, EMA, at Celgene

nIrina Osovskaya, Digital Manager at Janssen UK & Ireland

nErik Janssen, Vice President Global New Patient Solutions Neurology at UCB

nJon Stamford, Co‑Founder, Parkinson’s Movement

nEmma Sutcliffe, Consultant Director, Patient Engagement, Grunenthal Group.

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Key questions answered in the reportKey questions that were asked during the course of the research included:

1) What are the current feelings, attitudes and challenges about the impact of wearable tech within different types of healthcare organisations?

2) Do pharmaceutical companies believe that the increasing popularity and demand for wearable tech is from patients, healthcare providers (HCPs) or other stakeholders?

3) How has the demand for wearables affected how the pharmaceutical industry interacts with stakeholders?

4) Who are the key decision makers as it pertains to the decision to invest in wearable tech?

5) What will be the impact of patient‑generated data from wearable tech?

6) Which of the wearable tech categories has the greatest value in healthcare – Sensors, Implants or biometric feedback systems?

7) Which of the chronic disease areas will benefit most from the use of wearable tech?

8) Describe the best case studies of wearables in healthcare and how a pharmaceutical company should approach the development of a wearable.

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Leveraging wearable device data for clinical trial supportInevitably, companies with the reach, relevance and committed consumer loyalty like Apple and Google will leverage their technology and marketing prowess to alter the ways that clinical trials are conducted. Unsurprisingly, therefore, the US National Institutes of Health confirmed that as of the end of 2015, 299 clinical trials have built wearable devices into their protocols. The benefits to the industry postulated from using wearables as part of this transformation include:

nLower development costs

nImproved patient recruitment and monitoring

nLower therapy costs.

Accordingly, the pharmaceutical industry has started to incorporate medical grade wearables to augment and support patients participating in clinical trial programmes. In 2015, Novartis created an app for use with the Apple phone to help patients with impaired vision improve their activities of daily living. Although this is not a clinical trial application, it demonstrates and was heralded as the clear intention of a ‘big pharma’ to pilot and step into wearables.

In 2015, the media speculated that Google intended to establish a wristband health tracker designed specifically for use in clinical trials.26 This was a clear differentiation from consumer‑focused rivals at Apple and Fitbit. Google will need to have the capacity to reassure clinical trial sponsors and physicians about the reliability of the data gathered by the device, as well as demonstrate the value of additional features, such as the ability to track light exposure, noise level and other environmental metrics. The results of trials of the device are scheduled to be published in 2016, from which the company plans to file for regulatory approval in various markets.

The prospect of such a device is equal measures appealing and alarming to the industry as they know they must invigorate traditional R&D with innovative approaches whilst remaining sedulous to clinical trial protocol as errors could jeopardise not only the regulatory process, but also patient safety. Helen Harrison,

26 Google steps up wearables plan with clinical trial‑focused wristband (June 2015). Retrieved from: https://www.fiercebiotechit.com/story/google-steps-wearables-plan-clinical-trial-focused-wristband/2015-06-25

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Challenge IV: Pharma leadership needs to get on board with collaborative health solutionsFor many pharma companies, the transition from being a creator of medicines to a collaborator in health solutions is one which has to first be fleshed out internally. Erik Janssen describes the initial phases of development at UCB: “there’s a lot of scepticism, of course, because you’re bringing something in which is not known and not familiar within the organisation. So what we try to do is build enough insight and knowledge and expertise around what it can do and what it can’t do, but also what it can deliver in the future. We’re putting in the infrastructure to manage the data and also the data scientists we are recruiting, and then of course also you need to build databases up. So with databases you will make a difference, and it’s also not that by collecting just clinical data – it’s the aspect of real raw evidence. It started as unclear for us, but we knew that of all these wearables and technologies we had to persevere – to strive for better outcomes for patients, especially in neurology. We had to challenge ourselves with searching questions: how can we accept – as an ecosystem not as pharma companies but everybody, the patients, the payers, the physicians and the pharma companies – that the response rate of drugs in neurology is less than 50 percent. So 50 percent of the patients are getting drugs that just don’t work. That’s unacceptable. We started to envisage that over time, technology will help us to permit better phenotyping, genotyping, building data around patients to really go almost at an individual level, that’s of course the ultimate dream. But if we can have all the data from individual patients, it does not need to be owned by a pharma company, but as we collaboratively work to find the right solution for that individual patient, that’s what the future will be. So I think technology will really be a major driver to get to that point. So I see wearables for a pharma company as a means to get to better treatment for patients, but also it needs to happen in a collaborative way with all the different stakeholders in the eco system. Pharma cannot own that. That’s not our role.”

Esther Broer, International Brand Manager at ARIAD Pharmaceuticals, agrees that an internal leader and pioneer is essential. Esther explains, “I think there is an appetite for [wearables]. However, it’s not implemented. Our European Head is quite interested in all the wearable technology as an application for our business. However, there is nobody assigned to take care of these kind of things. Therefore, it’s my feeling that therefore it’s not happening. If there’s not somebody who is

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