The Journal of mHealth Vol 1 Issue 4 (August 2014)

WHAT’S INSIDE

NEWS, REVIEWS, CLINICAL DATA, mHEALTH APPLICATIONS

The

Journal of mHealth The Global Voice of mHealth

August 2014 | Volume 1 Issue 4

SPECIAL REPORT Powering Future Medical Devices

Your Integrated Health...

Available Right Now! ARTICLES

AWARDS

NEWS

Mobile Medical Applications Roadshow: 10 Lessons for Developers

Rolex Awards for Enterprise Recognise mHealth Innovators

Mobile Ultrasound Project Delivers Success in Morocco

Some things just... ...stand out from the crowd

Global Digital Health 250 The most innovative companies in the field of digital health For more information please contact us at thejournalofmhealth@simedics.org

Editor's Comments

Welcome It is amazing how often discussions relating to mobile and digital health among consumers and healthcare professionals alike often begin, or end, with the phrase ‘in the future...’ “In the future - care will be administered using this technology”, or “in the future I will be able to monitor my health using such a device.” I tend to find this outlook rather blinded. Yes, there is huge potential for growth in the use of mobile and digital solutions to administer and deliver care over the next decade, but the fact is that there are already so many solutions available, right now, that can allow us to connect with our health in new and innovative ways. Meaning that the path towards “your integrated care” has already been well and truly taken!

In this issue we focus on just a few of the many success stories, where mHealth is already delivering tangible results, benefits, and measurable returns on investment.

As part of our feature article (“Your Integrated Health...Available Right Now!” on page 4) we consider the ways in which the consumer market for health & wellness solutions has exploded in recent years, providing a vast choice of devices, applications, and solutions that can allow us all to easily engage with so many aspects of our daily health, using technology.

This issue also includes a special report, authored by The Journal of mHealth, that considers the implications of Powering Future Medical Devices. Considering the many different technologies that are emerging in this field, this 16-page special feature takes an in-depth look at the ways in which technology is changing how medical devices can be powered and the impact that this is likely to have on designs of new medical innovations. (The full report can be found on page 33).

Finally, we are very pleased to be able to include an article that is the result of a collaboration with the mHealth Regulatory Coalition, which considers the top ten lessons for mHealth developers learned from their recent Mobile Medical Applications Roadshow, that has run at various locations throughout 2014. This is an insightful and essential read for anyone involved with the development of mHealth solutions!

We hope you enjoy reading!

Matthew Driver Editor

Published by Simedics Limited www.simedics.org Editor: Matthew Driver Design: Jennifer Edwards For editorial, research and paper submissions, and advertising opportunities please contact: Matthew Driver matthew@simedics.org +44 (0) 1756 709605 Subscribe at www.thejournalofmhealth.com The editor welcomes contributions for The Journal of mHealth. Submissions can be sent to the Editor by email, images and graphics should be submitted in high resolution format.

The opinions expressed in this publication are not necessarily shared by the editors nor publishers. Although the highest level of care has been taken to ensure accuracy the publishers do not accept any liability for omissions or errors or claims made by contributors or advertisers, neither do we accept liability for damage or loss of unsolicited contributions. The publishers excercise the right to alter and edit any material supplied. This publication is protected by copyright and may not be reproduced in part or in full without specific written permission of the publishers.

ISSN 2055-270X © 2014 Simedics Limited

The Journal of mHealth

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Table of Contents

In This Issue 4

Your Integrated Health...Available Right Now! During an average day we test-drive a diverse array of health and wellbeing technologies, with the aim of demonstrating just how easy it can be to monitor and navigate your health, using readily available technologies.

26

MMA Roadshow: 10 Lessons for Developers The top ten lessons for mHealth developers learned from the recent Mobile Medical Applications Roadshow, provides practical advice on how to manage mHealth application development under FDA regulation.

33

SPECIAL REPORT: Powering Future Medical Devices This 16-page special feature takes an in-depth look at the ways in which technology is changing how medical devices can be powered and the impact that this is likely to have on designs of new medical innovations.

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August 2014

Table of Contents

Industry News 10

Smartphone Immunoassay Allows Point-of-Care Salivary Cortisol Tests

11

Mobile Health Services can Save the UK NHS from Collapse, say Experts

12

SPECIAL

REPORT 34

Mobile Health Monitoring: The Problems with Battery Life

Nexus6 Gets FDA Clearance for Smartphone-Connected Inhaler

36

Innovation Driving Improvements in Battery Function

13

80% of Smartphone Users Want Healthcare Alerts

38

Beyond the Battery: Harvesting Energy to Power Medical Devices

13

Up to €197,500 for Developing Cross-border mHealth Solutions

44

New Thermoelectric Generator Could Power Wearables in the Future

14

EarlySense Chair Sensor Receives FDA Clearance

45

15

Device Allows Wheelchair Users to Steer Using Their Eyes

Innovative Method to Transfer Energy to Medical Chips Deep in the Body

47

Energy Harvesting Materials for Wearables and Smart-Textiles Targeted by Ground-breaking European Study

15

Could Wireless be a Viable Alternative to Wearables?

16

Novartis Joins With Google to Develop Contact Lens to Monitor Blood Sugar

47

Superelastic Battery Research

17

Google X’s New Project Will Try to Map the Healthy Human Body

29

Using mHealth to Battle HAIs and Superbugs

30

Developing a Pro-active Answer to Healthcare: What are the Next Steps for Self-care in the Digital Age?

18

Using Video to Promote Patient Empowerment and Sustainability in Kidney Care

20

Achieving Digital Success in Healthcare

31

International Digital Health and Care Congress

21

Rolex Awards for Enterprise Recognise mHealth Innovators

49

23

Mobile Ultrasound Project Delivers Success in Morocco

Innovative Initiative Opens Door to Wealth of FDA’s Publicly Available Data

50

Upcoming Events

50

Advertisers Index

25

The Future of Health is Happening Now

The Journal of mHealth

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Your Integrated Health...Available Right Now!

Your Integrated Health

By Matthew Driver

Available Right Now!

Predictions for how we will interact with our health using digital solutions have been proposed for years, and to many this idea, of fusing digital and mobile systems within our daily lives, in order to enhance our health and well being, is more science fiction than reality. However, despite the digital health market still being in its relative infancy, the fact is that the technology and digital solutions necessary to allow us to monitor, navigate, and improve our health are actually, in the large part, already available.

In the consumer health sector, in particular, the advances that have occurred in recent years have provided a complete range of products, devices, applications, and software solutions that can all be easily integrated within daily life, in order to actively manage what is becoming ‘your integrated health’. In this article during an average day in the life of our editor we test-drive a diverse array of health and wellbeing technologies, with the aim of demonstrating just how easy it can be to monitor and navigate your health, using readily available technology.

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One of the main difficulties with personal digital healthcare is that given the wide variety of devices, solutions, and applications that are available, it can be hard to keep track of all the data that is produced. Each device, wearable tracker or monitor usually comes with its own smartphone application and cloud storage system that collects and analyses the data. In time, as you begin to use a range of these services, interacting with each becomes time-consuming, repetitive, confusing, and ultimately discouraging.

A solution that keeps track of all this data becomes very useful in mak-

August 2014

ing sense of your overall health. For this exercise we have used the dacadoo Health Score. This device agnostic solution allows you to track and benchmark your health and well-being in an easy and fun way. The dacadoo Health Score is a number from 1 (low) to 1,000 (high) and based on who you are, how you feel and how you live your life. This type of digital health solution encourages you to remain active and engaged by using personal feedback, rewards, social interactions and gaming features. When tracked over time, it offers a good directional indicator of how your health and wellbeing is evolving.

Using the Health Score in combination with a whole variety of monitoring and tracking devices I found it incredibly easy to immerse digital health into my [Matthew Driver - Editor] daily life... … I am silently woken at 7am by a gentle vibration from the Fitbit One device strapped to my wrist. Already this wearable tracker will have synced my sleep data with my dacadoo application via bluetooth. The device is easily transferred from the wrist strap to a clip on my waistband and it is ready to provide constant telemetry throughout the day. During the daytime, it tracks steps, distance,

calories burned, and stairs climbed, and during the night it measures sleep quality, which in turn provides a detailed indication of my sleep patterns, and stress levels. I check the dacadoo application from my tablet and I am instantly able to access detailed graphs and statistics relating to the quality of sleep from the previous night. I am notified that my daily step count, and quality of sleep, tracked using the Fitbit One device and recorded as part of my overall Health Score, were below average, and I receive some suggestions to help me improve that over the course of the day. I have been using the dacadoo solution’s stress tracker which uses voice stress analysis, questionnaires and an overnight heart rate variability measurement to determine my relative stress levels. I see from the results that these levels are currently elevated and I resolve to ask my doctor about this later that day, and to try and increase my exercise activities in a hope that this may improve the situation.

As part of my daily health regime I can track key vital statistics, and so I set about taking a number of quick readings. Using a wireless blood pressure cuff from digital health specialists Withings, I can quickly gain a daily blood pressure reading and have the data instantly transmitted, synced, and recorded by dacadoo. At the request of my doctor I also choose to use the one-click share function in the cuff ’s dedicated smartphone application to transfer these readings to my physician. This will allow him to review the measurements in advance of my appointment. At this time, I also use a Pulse 02 wearable/smartwatch device also from Withings to record heart rate and blood oxygen levels. Finally, I step onto a wire-

Your Integrated Health...Available Right Now! less body-analyser set of scales, which instantly measure my weight, body composition, heart rate again and even air quality, the data is recorded wirelessly and available instantly for analysis.

In addition to the regular measurements, the dacadoo solution contains other vital body statistics including height, waist circumference, cholesterol and glucose levels. These were inputted when I setup the solution using test results from my doctor, however, if I wanted to monitor something like glucose more frequently, then there is a wide array of different technologies that can be used for point-of-care testing, which would deliver accurate monitoring of these levels. These include subcutaneous wireless implants, smartphone peripherals, standalone devices, and in the future (as we have seen recently from Google) even contact lenses.

There are a full range of sleep analysers, activity trackers, and vital sign monitors currently available, which are becoming more sophisticated and accurate with each new variant. By having a device agnostic data capture and analysis solution like the Health Score, the data is all collected in one location which helps improve the user experience of interacting with these types of devices. All of these measurements help form the basis of my ongoing Health Score and by tracking them I gain a valuable realtime insight into my relative health at any given time.

At 8.30am I get a reminder on my smartphone via text message, informing me that I have a doctors appointment booked for the afternoon.

Text messaging, as a healthcare technology, is a relatively simple solution that has produced significant improvements in services across a range of medical and healthcare use cases. Simple text message reminders for appointments, medication adherence, health & wellness encouragement, and post-treatment support can dramatically improve patient adherence, and enhance service provision. It is also a technology that is widely supported across many different areas of the community, and therefore easy and costeffective to deploy.

The 8.30am appointment reminder is closely followed by another text message

that tells me that I have missed taking my regular medication. This reminder has been automatically initiated by the pill bottle, which sits on the kitchen counter. Developed by Adheretech the bottle knows when doses are due and if the bottle has been opened at the correct time. Failure to remember to take a dose results in the system initiating a prompt via phone call or text message.

The device, which is an FDA-registered Class I medical device and is HIPAAcompliant, is one of a number of similar adherence technologies, which are striving to improve the way in which patients interact with their medications. I now remember to take the required dose of medication, and begin to input nutritional information relating to my breakfast into my dacadoo application, which analyses this information and uses it to further inform my Health Score.

All of this may seem like a lot of additional work and unnecessary effort, but the truth is that it barely takes more than a few minutes each day to record many of these measurements. In fact the very nature of these consumer-led digital health devices means that considerable work and expertise has gone into developing and designing intuitive and understandable user experiences. Data is collected rapidly, often via automated methods, and devices are seamlessly integrated, in order to allow simple transfers of information, and subsequent storage and analysis of collated data. All technical operation and calculation is performed in the back-end elements of solutions, leaving users presented with easy to understand graphical representations, or dashboards, illustrating current and historic data.

Before I leave the house I receive a notification from another smartphone application, this time the service in question is delivered by a company called Cue. The notification is from a part of the application called FluMap which tracks and monitors influenza outbreaks. Although not in an at-risk category, I have been feeling a little under the weather recently so I utilise the Cue point-of-care digital testing device to instantly determine whether I may be suffering from the infection. We have featured Cue previously in The Journal of mHealth, as a device which is part of the growing number of available point-of-care, athome, testing solutions, which are allowing people to independently conduct molecular level tests, that would have previously only been available via traditional healthcare services.

Cue enables you to connect to your health at the molecular level. You can track 5 key health molecules: Inflammation, vitamin D, fertility, influenza, and testosterone in just minutes, at home.

You simply use one of the five tracking cartridges with the device, collect a sample (either blood or saliva) using the sample wand, and slide it into the cartridge. The system detects the presence of the sample wand, and automatically starts the analysis. After a few minutes, it delivers the information wirelessly to my smartphone.

I take the test, and it comes back negative. I now know, without even talking to a doctor, that this is not the problem, and more than likely the symptoms are related to the earlier detected stress and disturbed sleep pattern. I resolve to go Continued on page 6

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Your Integrated Health...Available Right Now! Continued from page 5

to the gym and take some daily exercise which will more than likely improve my overall feelings of well being.

I put on a Samsung Gear 2 smartwatch and use it to check in with the news feed from dacadoo and I am updated that a number of friends have already completed pretty impressive exercise challenges for that day, which provides further incentive to increase my activity levels. This social health element is a key part of the dacadoo solution, and one which is being utilised effectively within this, and many other digital health offerings. By engaging someone on a social level it instantly creates a sense of community and develops an effective support and encouragement network.

It also means that you can just as easily compete against a friend in another country, as you could against someone at your own sports centre, and receive rewards and incentives for successful engagement.

2014 has been the year for launches of smart watches like the Gear 2 from Samsung, with many large global technology companies, including Apple and Google, announcing intentions to introduce watches, centred around the grow-

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ing demand for consumer-centric health & wellness monitoring. The components of the watches themselves, in many cases lend themselves directly to enhancing biometric data collection, and solution providers are quickly adapting their systems to operate with these new devices.

The sophistication of the monitoring components is developing rapidly, meaning that in the not so distant future, these will be able to monitor many more biological responses/levels. The determination to deliver a platform for integrated healthcare tracking and monitoring, can be seen by the commitment of companies like Apple and Samsung to develop dedicated healthcare divisions centred around these products. This competition seems to, in part, being fuelled by the desire for smartphone device/software providers to tie users into proprietary platforms that capture and store individual health data, thus increasing consumer brand loyalty.

Getting into the car the onboard e-health module will have already synced with dacadoo to obtain my current health score data. This information is stored in tandem with a basic electronic medical record within a dedicated onboard unit. In case of an accident the system will automatically call the emergency services for assistance, and provide first-responders with key information about the location of the vehicle and medical information of the occupants. This process is still in the concept stages, but in Europe the Automatic Emergency Call system (eCall) is already in place to contact emergency services in case of an accident and similar systems operate in the USA. A number of major car manufacturers are already testing the ability to transmit additional t e l e m e t r y, to enable f i r s t responders to

receive medical information in a standardised format prior to arriving onscene.

Before setting off, I access my health score again using the, android enabled, in-car entertainment system, and have it bring up a list of my recent activities along with a list of suggested challenges that I may wish to participate in. These challenges are part of the social element of the application, and they enable me to join, or compete against, other users in combined activities, something that can significantly improve motivation, as well as making the exercise more fun. I select an intriguing running challenge, that involves running the distance of the German Nurburgring Grand Prix track, and see that I will be joining 127 other users on the same challenge.

Although not currently available, my car itself will, in the not so distant future, be also able to directly contribute to my health monitoring. Seatbelts which monitor heart rate and wake drivers up if they sense they are falling asleep behind the wheel, have already been developed by scientists. The new devices can spot when breathing and heart rate slows and issue a warning alarm to pull over to prevent motorists from causing accidents through nodding off. The new system – dubbed HARKEN - also takes a second reading from a special seat cover.

Arriving at the gym, I am easily able to share my current health score via email with the customer services department.

This will be logged and monitored as part of my membership, and the gym then rewards me based upon positive improvements in my health score, or successful completion of challenges. This type of interactive, incentive based, service is becoming available at a growing range of fitness and sport centres, and provides both a unique way for them to interact with their customers, as well as providing positive incentive to encourage people to exercise more regularly.

Beyond individuals, this type of solution is also being utilised by public health service providers, as a means of enabling people across the wider community to improve their health and well-being using a fun and social method of motivation.

An example, is the Move More project in Sheffield UK, which is trying to use wearable health trackers to collectively

Your Integrated Health...Available Right Now! engage whole communities to engage in more physical activity and exercise.

As part of my workout warm-up I clip the Withings Pulse O2 activity monitor onto a wristband and quickly take a heart rate reading and measure my blood oxygen level - this is an estimation of your blood’s oxygen saturation (SpO2), and it is a useful way to assess the overall efficiency of respiratory function. This is automatically uploaded to dacadoo via bluetooth. Checking the application I see that other people have successfully completed the recently accepted challenge, and I am further motivated to try and complete it myself. By wearing an activity tracker it allows me to monitor and record my heart rate etc in real time as I exercise.

Although the activity trackers currently on the market are relatively unobtrusive and ergonomically designed, there is already a move towards creating even more discreet monitoring devices. MC10, for example, have already demonstrated a flexible, wearable patch, not much bigger than a band-aid, that will be capable of monitoring vital signs continuously.

These have application far beyond just exercise and fitness, wearable trackers are rapidly becoming a common method of remotely monitoring patients with a whole range of chronic medical conditions.

The gym itself is fully equipped with networked exercise machines that record my workout, store it online and allow me to share the results. The equipment features technology from Preva a cloudbased solution that automatically tracks exercise workouts without the need for cumbersome USB devices or keys. Preva allows you to track your fitness progress at the gym with on-console software or on-the-go with the Preva Mobile appli-

cation, and it also means that I can instantly access my fitness history at any gym around the world that uses the networked equipment. From my account, I am able to export the collected data, meaning that all of my workouts are recorded in one central location. This makes it really easy to upload the data to dacadoo and use it to impact my health score.

Taking to the treadmill, I accompany the workout with music generated using another unique smartphone application, this time from a service called BioBeats.

This innovative solution blends healthcare with entertainment, by creating music that is dynamically generated from your individual heartbeat. Merging data from the heartbeat with real time feedback through music delivers a unique synergistic interaction with your own body. The music changes to reflect the data driven by your own bio-feedback.

The BioBeats technology provides a tool from which you can learn directly from your biometric data and adapt to help you live a more engaging, healthier life.

Data from the heartbeat is just the start.

BioBeats is in the process of developing upgrades to the system that will interface across a range of biometric data-sources allowing you to gain a greater overall picture of your health and wellness by drawing on numerous data points.

Having exhausted myself on the treadmill I see that I have managed (only just!) to complete the running challenge I set earlier. I instantly share this with other users and via twitter. A couple of congratulatory notifications and a digital badge for the successful achievement help reinforce my feeling of accomplishment and well-being.

Gamification of healthcare is a concept which is being successfully incorporated into many digital health and well-being solutions as a means of increasing motivation and encouraging engagement.

For example, part of the dacadoo solution is called the Health Navigator. This uses behaviour design and motivation principles from the so-called Self-Determination Theory (SDT), which focuses on intrinsic motivation. The three principles of this are: Autonomy, meaning you choose the goals and participate in activities on your own volition; Competence, which focuses on setting realistic goals - progress towards these goals gen-

erates a sense of accomplishment, which is further boosted with peer recognition and positive feedback; and, Relatedness, friends and groups with similar interests make you more committed towards reaching those goals. All of these combined are directly incorporated into the solution to help provide an interactive experience which encourages regular participation.

Engagement is an important element of the digital health continuum, and one which must be embedded in solutions in order to encourage continual effective use. Returning home, I log-in to another digital solution that is using innovative methods to engage with users, and to radically change the culture in which we interact with our healthcare provision. This time the solution is a patient management platform that is provided directly by my local doctors surgery.

This gives me a unique way to manage my own care, with the help and support of healthcare professionals. The system, called Vitrucare - developed by UK based Dynamic Health Systems - is a dedicated web-based platform that allows me to measure, monitor, and regulate my own personal care, and allows me to upload readings directly to a shared platform managed by my own general practitioner.

The system has already been wirelessly propagated using the range of biometric readings taken earlier in the day. All of the data is visualised in my personal dashboard using graphical realtime repContinued on page 8

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Your Integrated Health...Available Right Now! Continued from page 7

resentations. Using a pre-agreed care plan that encourages personal responsibility for self-monitoring and proactive care, the Vitrucare system seamlessly links my data with the practice management system of my personal GP, who can see results, monitor progress, and directly interact with me via the system, thus preventing unnecessary appointments and interventions. From the dashboard I can see that I am meeting my target for exercise, but falling short on my goal to reduce the levels of saturated fat in my diet. Taking note, I set a similar target in my dacadoo application to help me work towards this goal.

Patient management platforms, such as Vitrucare, are available from a variety of providers, and are becoming more commonplace across a range of healthcare providers. They are also radically changing the patient-doctor relationship by encouraging and empowering people to take personal responsibility for changing their own health. This in turn means that doctors are encouraged to become less reactive and more proactive in the way they manage their patients. By giving people the ability to share data (from personal digital health solutions, monitors, trackers, and devices) with their healthcare provider you actively empower them to take personal responsibility for their own health issues and increase accountability within your personal health ecosystem.

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I am reminded again of my pending doctors appointment, so I take a seat on the couch, put my feet up and grab my smartphone. I quickly log-in to the video consultation service, and await my appointment time with the doctor. I see from the notes that the doctor has already reviewed all of my recorded measurements, seen my progress towards my personal care plan, and has been updated by the remote-conferencing system of my current concerns, regarding stress and symptoms. I am alerted to the fact that I have been prescribed a range of digital solutions, including; an update to my personal-care plan, as well as some recommended low-fat recipes, for my diet application, that should help reduce the levels of saturated fat intake. All of this before I have even been seen by the doctor. The application beeps to let me know that it is my turn, and I simply use the video conferencing function to

August 2014

consult with the doctor from the comfort of my own home. Following the consult, I am prescribed a dedicated stress application that will help teach me some simple techniques to recognise and treat the signs of stressful behaviour and before I can even log-out of the consultation application, I receive an email with a download link. The doctor also informs me that from the daily measurements it can be seen that, in general, I am making good progress towards my care plan goals.

Come the evening I receive a number of notifications from dacadoo, via the application on the Samsung Smartwatch, congratulating me on my activity throughout the day and making some suggestions for things that I may want to consider going forward. This prompts me to check my personal dashboard, on the tablet, and I can see that my Health Score has improved slightly over the day.

This has in turn improved my ranking against friends, which is very satisfying!

I write a few fun comments relating to activities that friends have completed during the day, and finally change the settings on my nutrition coach to help remind me to stick to the prescribed diet.

I record a voice sample for the stress tracker, and log-out.

Falling asleep, the rise and fall of my breathing, my heart rate are all silently recorded, and so the cycle begins again!

Although this was a hypothetical day used to illustrate how someone can take

significant steps to interact directly with their health in a proactive way, using digital and mobile solutions, I found that it took very little conscious action in order to incorporate these devices and systems into my regular routine.

The majority of the solutions automate actions, and prompt interaction only when necessary, meaning that there is very little disturbance to daily-life. In fact by simply making a few very simple changes to incorporate digital solutions, the technology quickly begins to enhance the relationship with your own personal health. Overtime this empowers you as the individual to make better informed choices about the way you live.

It also demonstrates that the solutions to make these changes are readily available right now and that as demand for personal health tracking becomes more widespread these devices and solutions are going to become integral to the way we live our lives – NOW and not just in the future!

We would like to take this opportunity to thank dacadoo for assisting us in conducting this exercise, and for making the Health Score available for us to help demonstrate this undertaking. If you are interested in finding out more about the dacadoo solution, please visit: www.dacadoo.com. n

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INDUSTRY NEWS News and Information for Digital Health Professionals

Smartphone Immunoassay Allows Point-of-Care Salivary Cortisol Tests According to a recent announcement the ability to conduct point-of-care stress tests could soon be available using a smartphone.

areas, use the smartphone test to help diagnose disorders involving excessive cortisol or depletion of the hormone, and to allow cortisol levels to be monitored easily over time.

With a simple tube, some software and a saliva sample, people and their doctors can measure levels of the stress hormone cortisol.

They’d also like the public to monitor their own cortisol levels whenever they want. So they designed their device to be inexpensive to manufacture, and easy to use on all cell phones, all platforms and all form factors.

Measuring levels of the stress hormone cortisol within a saliva sample using a laboratory immunoassay or mass spectroscopy requires instrumentation and technical personnel and is unable to deliver timely results. According to research presented at ICE/ENDO 2014, the joint meeting of the International Society of Endocrinology and the Endocrine Society in Chicago, researchers outlined a smartphone-based quantitative salivary cortisol immunoassay that provides results in 5 minutes and can be performed at the point-of-care.

“We have designed a method by which anyone with a smartphone will be able to measure their salivary cortisol level quickly, easily and inexpensively,” said lead investigator Dr. Joel Ehrenkranz, director of diabetes and endocrinology at Intermountain Healthcare in Murray, Utah.

While a commercial lab in the United States may charge up to $50 to run a quantitative salivary cortisol test and take up to a week to provide the results, the smartphone test will cost under $5 and give results in less than about 10 minutes, states Ehrenkranz.

“Parts of the United States and the rest of the world that lack facilities to measure cortisol will now be able to perform this essential diagnostic test,” he said. “Also, measuring salivary cortisol with this technology will provide a way for individuals to monitor their personal biometric stress levels easily and inexpensively.”

Ehrenkranz and his research team would like to see healthcare providers around the world, especially in low-resource

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August 2014

It consists of a case, a light pipe, and a lens, it uses no battery power and it’s unbreakable and reusable, they say.

For the developing world, it needs to be inexpensive, Ehrenkranz said, and it costs only about $1 to make.

Project collaborator Dr. Randall Polson, senior optical engineer in the College of Engineering at the University of Utah in Salt Lake City, wrote in an email, “We are trying to make sure a skilled 8th-grader – a 12-year-old – can get accurate results.”

“The measurement system’s smartphone and reader act as a photo studio. . . . The complex and difficult processes are put into the strip chemistry and embedded into the smartphone application, so if you have a charged phone and a test kit you can get accurate results without complicated infrastructure and highly trained technicians,” Polson wrote.

To take the test, a person puts a straw-like saliva collector under the tongue, and capillary action wicks the saliva to an assay strip in a cassette that’s inserted into a reader; the reader aligns a lens and light diffuser with a smartphone’s camera and flash. A few minutes later, the smartphone image analysis app quantifies the cortisol value. This immunochromatographic quantitative salivary cortisol technology can measure cortisol with a detection limit and dynamic range sufficient to diagnose adrenal insufficiency, hypercortisolism, and monitor physiologic variations in cortisol concentration.

Continued on page 12

Industry News

Mobile Health Services can Save the UK NHS from Collapse, say Experts Mobile health services, provided through smart-phones, tablets or laptops, are the way to save the NHS from collapsing under the growing number of patients with long-term conditions, say experts.

“Electronic or mHealth is not hype – it is the future of health care. Implemented properly it could save the NHS. Unless we change, it is almost inevitable that the NHS will fail in the face of people living longer with more and more chronic illnesses,” warned Professor Shahid Ali, a family doctor and Professor of Digital Health at Salford University.

The comments came at a packed meeting at the British Library in London, organised by the healthcare division of communications agency Porter Novelli, alongside sister agencies Paradigm Communications and Kiosk. Guests from major pharmaceutical companies, medical charities, NHS bodies and private health organisations debated the question: “is mHealth hope or hype?”

Professor Ali said that rather than overloading GPs with extra work, electronic health systems would reduce the workload by cutting routine appointments and unnecessary follow-ups; leaving more time for the seriously ill.

At his practice, patients use an internet service called VitruCare through which they can set goals, action plans and trackers to self-manage their conditions. They can input health data from their homes, via computers or mobile phones, for example, blood pressure which can be seen by their clinician in the practice.

“This enables the clinician to manage by exception – if patients are well, we don’t need to see them. If you manage by exception you completely change the game because you can focus your resources where needed to improve health outcomes. The current medical model just doesn’t work for long-term illnesses,” said Professor Ali. He added: “Give patients control.

Patients are responsible if you treat them

as individuals. Enabling patients to take control empowers them, and means they become active participants in their health rather than passive recipients, becoming less dependent and reducing the frequency of contact. Patients are the biggest advocates of electronic health, as they want to take control of their own conditions – it is the cultural change and clinical practices which are the barriers to wider use.”

do. They are the biggest growth sector for this technology.”

Other speakers at the meeting included Tony Kane, independent mHealth consultant and former head of mHealth at Vodafone Global Enterprise; Said Dajani, Head of Digital at Diabetes UK, Technology Theorist and Author, Tom Chatfield and Bleddyn Rees, Head of Healthcare at international law firm Wragge Lawrence Graham & Co and non-executive director at the European Connected Health Alliance.

“The need for technology to encourage people with diabetes to manage their own condition is of the utmost importance to the whole UK, not just to people with diabetes. Diabetes costs the NHS a huge amount of money and unless something changes this will increase to an unsustainable level. New technology offers the prospect of helping people better manage their diabetes, as well as for other chronic conditions,” he said.

Tony Kane said it was a misconception that mHealth was all about personal apps, given that two-thirds of them were discarded after less than ten uses.

Instead, mHealth is about the creation of services that are aligned to the everyday needs of patients, clinicians and payers. He said it was a myth that older people could not cope with the technology of mHealth. “Old people do get it and they make it work. Older generations don’t get bored like young people

Mary Smiddy, UK Head of Health and Wellness for Porter Novelli, said the meeting was the first in a series that the group was planning looking at how mHealth can potentially help transform the delivery of healthcare services. “The successful implementation and adoption of mHealth relies on a diverse range of stakeholders with competing agendas, communicating in one, unified, voice,” she said. n

Said Dajani said some 50,000 people with diabetes were now using a tracker app developed by Diabetes UK to monitor their blood glucose levels, and more than half a million members of the British public took an online test to see if they were at risk of developing Type 2 diabetes.

The Journal of mHealth

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Industry News

Nexus6 Gets FDA Clearance for Smartphone-Connected Inhaler Touch is the latest generation in Nexus6’s Smartinhaler [line of devices]. With each new generation our Smartinhalers get smaller, easier to use, and incorporate more sensors that generate higher quality data, and higher levels of medication adherence. The SmartTouch supersedes our SmartTrack device, which is proven in clinical trials to double preventative medication adherence levels.”

New Zealand-based medical device company Nexus6 has received FDA clearance for its smartphone-connected inhaler, SmartTouch, as a class II medical device. The new SmartTouch device has been cleared as a prescribable Metered Dose Inhaler (MDI) with a handful of intended uses: in clinical trials; in clinical practice, and for patient self-management.

In all cases the device is used to help track usage, but it does not sense or report on the remaining amount of medication in the device and it does not offer a dose counting feature. The SmartTouch inhaler records the date and time the inhaler is used, which is then both stored on the device itself and transmitted wirelessly to the patient’s smartphone, tablet, or PC. As the device’s name suggests, it sports a tiny, touch screen display too.

“Nexus6 was established in 2001 and has been dedicated to developing Smartinhaler technology ever since,” Garth Sutherland, Chief Executive Officer of Nexus6 said in a statement. “The Smart-

While there aren’t many, there is a growing number of smart inhalers in the market today. Perhaps the best known is Propeller Health, which uses GPSconnected inhalers to collect data about where and when patients have attacks.

In May Propeller, formerly Asthmapolis, received FDA clearance for a new iteration of its platform that includes a new smart inhaler and is geared for patients with either asthma or COPD. The new platform helps users to prevent so-called “asthma attacks” or similar lung inflammation symptoms caused

by COPD. The Propeller Metered-Dose Inhaler, which is Bluetooth Low Energyenabled, measures a patient’s use of their rescue inhaler. That data is automatically compared to a patient’s baseline and to general clinical guidelines, and the app can alert care teams if an attack seems likely. In addition to its previously existing coaching program focused on how to manage the disease, recognize symptoms and avoid triggers, the system will

Continued from page 10

Dr. Ehrenkranz said the first screening test for hypercortisolism is salivary cortisol, and that 3 percent of people with type 2 diabetes actually have Cushing’s disease - of which excess cortisol would be a sign - but they don’t get screened because their doctors don’t have access to the technology.

It will also help individuals, Ehrenkranz said. As an example, he cited the 10 percent of people with depression who have psychotic depression, with cortisol levels that rise before

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August 2014

now be able to coach users on how to use their inhaler properly.

In April Biopharmaceutical company Opko Health acquired Israeli smart inhaler company Inspiro Medical for a sum in “the low eight figures”, with the aim of using Inspiro’s Inspiromatic technology to develop an app-connected inhaler that will be bundled with a forthcoming new drug for asthma, COPD, and cystic fibrosis.

The Inspiro inhaler has features that make it easier to use, including an active powder de-agglomerator to ease inhalation and a microcontroller that better times the delivery of inhaled drugs.

A connected app could be used to give near realtime feedback and instruction on proper use of the inhaler as well as to access data from sensors contained in the inhaler and to send that data to physicians, caretakers, or parents. The inhaler performed better than the gold standard in a small trial last year, according to the company.

For more information visit: www.smartinhaler.com. Taken from original article featured on MobiHealthNews n

the onset of psychosis. Using this device, people at risk for psychotic depression will be able to check their salivary cortisol level every day and take steps to avoid a psychotic break.

The Ministry of Public Health of Thailand plans to introduce the cortisol test later this year, as a consumer product to monitor individuals’ stress, Ehrenkranz said. His team is collecting clinical data to submit to the FDA to gain approval to market the test as a class 2 medical device, which they hope will be granted in 2015. n

Industry News

80% of Smartphone Users Want Healthcare Alerts The percentage of smartphone owners wanting healthcare alerts or notifications on their mobile devices has reached a new all-time high.

A recently published global survey by FICO shows that 80 percent of people would like the option to use their smartphones to interact with healthcare providers.

The predictive analytics and decision management software company says these organisations include government and private insurers, hospitals, pharmacies, mail-order drug companies, third party administrators and clinics.

The survey also revealed that 76 percent of people worldwide are “keen to be reminded of their medical appointments” and 69 percent would like to receive reminders to arrange appointments or to prompt them to take their medication.

“The way healthcare organisations communicate with people is changing, as individuals become more and more sophisticated about using information technology to make health-related decisions,” said Stuart Wells, FICO’s chief

product and technology officer.

“People are especially interested in mobile services that can help them manage their personal health and shop for healthcare services,” Wells adds. “The leading healthcare providers are increasingly turning to mobile technologies to meet this demand, and to engage frequently and proactively with consumers.”

The FICO survey showed that 56 percent of people worldwide trust healthcare organisations with personal data. So while e-health records have yet to take off in many countries, simple innovations around mobile alerts and information services are helping to build the trust necessary for this trend to continue.

“Mail order pharmacies are checking customer orders via mobile applications, insurers are validating policy details and medical service providers are requesting feedback on the quality of their services or managing follow-up care,” said Dr. Wells. “Privacy is critically important and consumers are required to opt-in, but given the benefits of mobile technology in the healthcare field, that doesn’t appear to be an impediment to adoption.

People are eager to have a dialog with their healthcare providers in ways that are convenient to them.”

The potential for mobile technology in healthcare ties in with another emerging trend – an increase in the use of alternative advice channels. Almost two-thirds of smartphone users want to receive medical advice through digital channels instead of visiting a doctor. In addition, 71 percent of smartphone users are open to offers of relevant healthcare services from businesses, and 53 percent are open to provider-initiated communications.

The survey looked at consumer preferences and tendencies with regards to mobile, online and in-person interactions with healthcare providers. 2,239 adult smartphone users were surveyed in the UK, Australia, Brazil, China, France, Germany, India, Italy, Japan, Korea, Mexico, Russia, Turkey and the United States.

The healthcare preferences of smartphone consumers from the US, Australia, Brazil, China and the UK can be explored in further detail at a special interactive website: www.fico.com/mobileIQ. n

Up to €197,500 for Developing Cross-border mHealth Solutions With an invitation to tender of nearly €200,000, the EU-funded DECIPHER project is challenging companies to develop a mobile solution that enables patients to gain, from anywhere in the EU, safe, 24/7 access to their prescription data, emergency data, examination results and other health information.

The DECIPHER project, along with partners in Finland, Italy, Spain and the UK, wants to find mobile solutions that will enable secure cross-border access to existing patient healthcare portals and make medical care more efficient and safe. This will especially be helpful for patients with chronic diseases or unplanned care episodes to manage their health. The new userfriendly application acquired through pre-commercial public procurement (PCP) will enable efficient and safe medical care of

mobile patients in EU member states.

Bidders are invited to tender under the pre-commercial procurement (PCP) procedure for the provision of research and development services.

DECIPHER ("Distributed European Community Individual Patient Healthcare Electronic Record") is funded under the European Commission 7th Framework Programme for research and technological development (FP7) and runs until 2016.

For more information, to express interest and find FAQs: www.decipherpcp.eu n

The Journal of mHealth

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Industry News

EarlySense Chair Sensor Receives FDA Clearance EarlySense, a company specialising in contact free monitoring solutions, have recently announced the market clearance by the US Food and Drug Administration for their chair sensor solution. The chair sensor, which continuously monitors patient’s heart rate, respiratory rate and movement, was recently evaluated at Coffee Regional Medical Center where it successfully enabled the clinical team to proactively respond to early signs of patient deterioration and to prevent patient falls.

Clinicians have long known that ambulating patients from bed to chair improves healing, reduces the risk of complications and shortens length of stay. Moving around in an upright position appears to be of most benefit in the early postoperative period and to improve lung function and reduce potential pulmonary complications. But to date there has been no automatic contact-free solution for keeping patients safe in their chairs.

Continuous patient monitoring is a key factor in recognising and promptly responding to early warning signs, and facilitates timely interventions for nonICU patients. The EarlySense Chair Sensor empowers clinical staff to provide proactive effective, timely interventions when patients are deteriorating or at risk of falling, therefore, accelerating recuperation and reducing risks.

“The chair sensor fits the workflow here very nicely”, said Sue Lane Hughes, Director of Medical/OPO Unit at Coffee Regional Medical Center. “The biggest advantage of the chair sensor is that it monitors the patient when sitting on the chair and doesn’t require any user contact. We found it to be very useful

in giving the clinical team information about their patients, no matter if they were in bed or sitting in the chair. The EarlySense System is allowing the medical staff to recognise potential adverse events prior to them becoming acute events that potentially put patients in jeopardy. The chair sensor is another tool to assist us in preventing patient falls by getting staff into patients’ rooms before they have exited the chair. Since we started using the chair sensor we have had zero patient falls from chairs.”

EarlySense assists clinicians in early detection of patient deterioration and in identifying and preventing potential adverse events such as patient falls and pressure ulcers. The company’s solutions monitor patient’s heart and respiratory rate, as well as movement, with a unique sensor that is placed under the mattress. The system was designed to address safety challenges on general care floors as well as failure to rescue of those

patients who are usually monitored by nursing staff approximately once every four to eight hours.

According to Avner Halperin, CEO of EarlySense “Medical institutions have often expressed the need for automatic sensing in chairs. Hospitals have used the EarlySense bed sensor solution to make their beds a smart, safe place for more than 100,000 patients. Hospitals have shown us that they value smart beds, now for the first time they can get ‘smart chairs’. In addition, with a chair sensor we believe that a number of other clinical environments will open up to the EarlySense System, such as Emergency Departments, Outpatient Clinics and waiting areas where concern around patients may exist and today there is no practical way to monitor patients.”

For more information visit: www.earlysense.com n

We want to hear from you The thoughts and ideas of our readers and subscribers are essential to us at The Journal of mHealth. We want to hear your opinions on the mHealth industry. Contact us at journalofmhealth@simedics.org

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August 2014

The

Journal of mHealth The Global Voice of mHealth

Industry News

Device Allows Wheelchair Users to Steer Using Their Eyes People with paralysis will soon be able to attach an inexpensive device to their wheelchair along with their laptop to allow them to navigate using just their eyes – without having to stare at any controls.

person's intentions. The finished system involves two cameras – one trained on each eye – that observe eye movements and pass that information onto a laptop computer, which works out which direction and how far into the distance a person is looking.

People who have lost the use of their limbs as a result of multiple sclerosis or spinal cord injury, for example, can usually move their eyes, as the eyes are directly connected to the brain.

Several existing technologies allow people to stare at arrows on a computer and direct the movement of a wheelchair, but these systems generally experience a considerable delay between the movement of the eyes and the chair. Similarly, the user is limited by an inability to look around while manipulating the controls.

“But then you've got the King Midas problem,” says Faisal.

"Everything he touched turned into gold, and we don't want to move everywhere we look."

Looking to overcome this problem, Aldo Faisal of Imperial College London and his colleagues have developed software that uses subtle eye movements to distinguish when a person is looking around and when they want to move.

"Current eye tracking software doesn't allow you to look around while moving," says Faisal. "And technologies that use brainwaves to control wheelchairs aren't common because it takes many months to train a person to use them, and then you need to really concentrate to move – it's not natural."

His team has observed how people move their eyes when walking around and used the data to build software that decodes a

Exactly how they solved this problem is still under wraps, he says, but it involved analysing subtle eye movement patterns to distinguish those relevant to locomotion from those we use when merely looking around. "Our software can tell the difference between looking at someone using a coffee machine, and wanting to walk over to that coffee machine," says Faisal.

The system responds within 10 milliseconds to a person's intention to move. Typically anything under about 15 or 20 milliseconds feels instantaneous, says Faisal.

The team has tested the system on people without physical disabilities and found that they were able to steer through a crowded building faster and with fewer mistakes than with current technologies that track eye movements.

The innovation is still in the development phase, but the team hopes to have the system ready for market within three years. n

Could Wireless be a Viable Alternative to Wearables?

Parents could soon be able to watch their baby’s heart rate from another room without using any kind of wearable device or special sleeping pad with a new development out of MIT that uses Wi-Fi signals to track the rise and fall of peoples’ chests.

Researchers at the Computer Science and Artificial Intelligence Laboratory (CSAIL) transmitted a low-power wireless signal through a wall and measured how long it took the signals to bounce back. Changes in the reflected signals allowed the team to measure movement, or even minute chest movements.

The CSAIL group have demonstrated that they can now detect gestures as sub-

tle as the rise and fall of a person’s chest, and from that, they can determine a person's heart rate with 99 percent accuracy.

The researchers suggest that potential uses for the research may include: Health-tracking apps, baby monitors, military and law enforcement, search and rescue scenarios or to track individual health statistics. The MIT team is now interested in expanding it so it can be used to track emotion, which is also linked to heart rate and breathing.

“It has traditionally been very difficult to capture such minute motions that occur at the rate of mere millimeters per second,” says MIT professor of electrical engineering and computer science

Dina Katabi, the paper's co-author who also directs the Wireless Center. “Being able to do so with a low-cost, accessible technology opens up the possibilities for people to be able to track their vital signs on their own.”

The team—which includes Robert Miller, a professor of electrical engineering and computer science, and graduate students Fadel Adib and Zach Kabalec—has also developed the capability to track the movements of up to four distinct individuals, which could be helpful for search-and-rescue operations (such as when emergency responders are trying to find survivors inside a burning building).

Continued on page 16

The Journal of mHealth

15

Industry News

Novartis Joins With Google to Develop Contact Lens to Monitor Blood Sugar Google have announced a partnership with the European drug maker Novartis to develop their prototype smart contact lens with the potential to monitor the wearer’s blood sugar levels.

Novartis said that Alcon, its eye care unit, had struck a deal to license so-called smart lens technology from one of Google’s research divisions. As part of the agreement, Alcon said it would look to create products from Google’s prototype smart contact lens, which uses miniature sensors and a radio antenna thinner than a human hair to track glucose levels.

Information about blood sugar levels, which is particularly useful for people with diabetes, could be uploaded to smartphone devices and used by doctors and patients to monitor the data almost in real-time, according to a statement from Google issued when the company released its prototype in January.

It is unclear how long it will take Novartis to develop the technology into actual products, though the company’s chief executive, Joseph Jimenez, said the move toward wearable health technology, like the smart lenses, was part of a broader trend to involve patients in managing their own health. Such technology has the potential to lower the cost of managing chronic disease.

“We are looking forward to working with Google to bring together their advanced technology and our extensive knowledge of biology to meet unmet medical needs,” Mr. Jimenez said in a statement.

Monitoring glucose levels through the lenses could prove to be easier and more comprehensive than current techniques, which generally require diabetics to prick their fingers for droplets of blood.

About 382 million people—one in every 19—around the world have diabetes, a class of diseases in which the body is unable to

Continued from page 15

The system works by transmitting a lowpower wireless signal and using its reflections to track moving humans. It can do so even if the humans are in closed rooms or hiding behind a wall.

As the signal is transmitted at a wall, a portion of the signal penetrates through, reflecting off a person on the other

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August 2014

deal with sugar, usually because of inadequate or no production of insulin. In the U.S., more than 29 million people, or 9.3% of the population, suffer from the disease, according to the American Diabetes Association.

Mr. Jimenez said the smart lenses may also be used can also correct vision in a manner similar to the lenses on autofocus cameras.

Novartis hopes to have a prototype available for research-anddevelopment reviews by early 2015.

Sergey Brin, a Google founder, said the company’s smart lens technology could “help improve the quality of life for millions of people.”

The push to develop medical technology comes as several of the world’s largest technology companies are looking for new areas for growth. Analysts say that the pharmaceutical and health care sectors are crucial targets as people increasingly take greater control of their own medical treatment. n

side. However, due to all the signal interference from other objects, the team had to create technology to cancel out irrelevant reflections.

In order to monitor breathing, the technology needed to be precise: The researchers created a complex metric that approximates the subject’s volume, and then observed and amplified its

changes to distinguish the breathing.

Katabi’s team is now working on higher resolution capabilities that would allow them to detect actual body silhouettes, gestures, and even emotions. (Heart rate and breathing are strong indicators of emotional extremes like fear or anger.) n

Industry News

Google X’s New Project Will Try to Map the Healthy Human Body The new project out of Google X, called Baseline Study, will collect genetic and molecular data from 175 anonymous people in an attempt to piece together an exquisitely detailed picture of what makes up a healthy human being.

Google’s researchers will be collecting a broad set of data from a range of people with varying levels of health. The project will then employ Google’s strong computing power to decode all the gathered information and reveal patterns or biomarkers.

For example, some people are more prone to osteoporosis than others.

Knowing how individuals process and break down various nutrients could help doctors to understand what makes someone less likely to develop brittle bones.

major genetic research players like Hal Barron, a former chief medical officer at Genentech.

Baseline is not the first body mapping project, there are plenty of others. But existing studies tend to focus on a particular disease or part of the body. This is also not Google’s first dance with genetic research. The company is also working on a media dubbed “anti-aging” study called Calico. The mysterious project was revealed last September and includes

Baseline is extremely broad in scope and Google wants to expand the study to include thousands of people — which raises questions about privacy. An institutional review board will preside over the human medical research data. As the study ramps up medical boards at Duke University and Stanford University will determine how the information is used.

The study has a serious opportunity to help develop better drugs and help people to be the healthiest versions of themselves — and of course to help doctors better understand the way the human body operates.

This also signifies Google's growing intentions to increase their presence within the healthcare industry, and to use their unique market position to influence the field of digital and mobile health. n

We can publish your educational white papers, case studies, and research reports in The Journal of mHealth We can work with you to develop engaging, creative, and informative content that will help educate and promote the results of your work, to a targeted audience of industry professionals.

Our readers appreciate thought-provoking white papers that educate and inform in order to expedite their decision-making process. Publishing credible, quality white papers in The Journal of mHealth will ensure that your potential clients will refer to them frequently as valued resources.

Our publishing programs all include an integrated marketing plan to ensure your content gets high exposure. Contact us for more information on our Content Publishing Programs at journalofmhealth@simedics.org.

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The Journal of mHealth

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Using Video to Promote Patient Empowerment...in Kidney Care

Using Video to Promote Patient Empowerment and Sustainability in Kidney Care In the June issue of The Journal of mHealth we featured a discussion of The Value of Video in Modern Health and Social Care Provision, in this article we report on the results of another innovative deployment where video is being used to support patients with chronic renal conditions.

The study, which is a collaborative project between the Stevenage’s Lister Hospital Renal Unit at East & North Hertfordshire NHS Trust UK and video consultation specialists v-connect, integrates video consultation services into care packages aimed at supporting kidney patients in their own homes.

The v-connect consultation technology which provides a complete video consultation solution connecting professionals, patients and carers, across NHS and local authority networks and the internet - was provided to forty patients receiving renal replacement therapy, allowing them to connect directly with the renal unit at The Lister Hospital in Stevenage (UK) using the video service. This included transplant patients, patients receiving continuous ambulatory peritoneal dialysis and home haemodialysis.

The service has been implemented to support the provision of virtual clinics into the patients home, as well as allowing patients to call into the renal unit during office hours to ask questions relating to their care and use of at-home medical technology. The use of video to support these patients assists in them becoming more confident and more able to manage their own care, and given the complexities of home haemodialysis the use of video significantly increases the level of support available to the patient.

Both patients and clinicians have reported positive outcomes as a result of the trial.

18

As well as seeing positive benefits in terms of reduced travel to and

August 2014

from hospital appointments, patients found that being able to proactively ask questions - and see their nurse or consultant over the video link - gave them greater confidence in managing their conditions.

“Traditionally the NHS has worked on a hospital based approach, where as now [using video conferencing services] we have made a significant shift towards a service that suits the patient” states Dr. Suresh Mathavakkannan, Clinical Director at The Lister Hospital. “For the patient it is no different to having a consultation at the hospital, but it takes away the hassle of coming in”.

For clinicians, the service enables an increased level of support to the patients - and an improved relationship as their patients become more empowered. Being able to ask for help when needed makes them more confident and prevents them waiting until a problem becomes acute. Being able to see their nurse or consultant provides them with a greater level of reassurance and maintains the close link that renal patients have with their clinical staff. The clinicians involved also report having a more relaxed experience with the patients, and that the ability to run clinics from several locations in the hospital is also valuable. For staff supporting these patients, the technology reduces their workload by changing the way in which care is administered. Instead of nurses spending large amounts of time in cars visiting patients at home, they are able to quickly and easily use the technology to provide support, which in turn allows them to be more proactive in the way patients are cared for.

The positive results of this deployment have been summarised in a series of videos which are available online at: www.youtube.com/channel/UChHRpJAYELfVKF2Gee0wExQ The Lister Hospital and East & North

Hertfordshire NHS Trust UK are hoping to introduce similar services, using the technology, aimed at supporting patients with other long-term conditions, where video has the potential to disrupt current pathways and open up new ways of delivering care effectively and efficiently.

Enabling People with Renal Conditions to Regain their Independence The v-connect deployment at Stevenage’s Lister Hospital Renal Unit is supported

by Devices for Dignity (D4D) Healthcare Technology Co-operative, which is a nationwide initiative funded by the NHS National Institute for Health Research to drive forward innovative new products, processes and services to help people with long-term conditions.

Fourteen percent of the UK population suffers from Chronic Kidney Disease (CKD) and this number increases markedly with age, with more than 25% of the adult population over the age of 65 suffering from the most severe stages of CKD and the associated high morbidity and mortality.

Devices for Dignity aims to support the deployment of services like the video consultation services from v-connect that help improve patient experience, aid rehabilitation, and empower patients.

A number of papers will be presented by v-connect at this years King’s Fund International Digital Health and Care Congress held in London in September, that will give a flavour of how video conferencing is impacting care delivery and bringing new combined opportunities through interoperability.

For more information on this project and all of the v-connect services visit: www.v-connect.co.uk n

Connecting care professionals

colleague

Connecting care and treatment in the home

Connecting people together in the community

Solutions that improve outcomes We can work with you to implement a network of care that enables personalisation for the cared for and integration between care providers.

v-connect provides a complete solution to implementing video communication in the remote delivery of care.

Connecting Care, Connecting Carers Connecting Care

Video connects people to each of their services giving them a single point of access to care in their home.

Connecting Carers

Using video to communicate between care providers allows better communication between carers.

v-connect.co.uk

01274 287 787

info@v-connect.co.uk

Achieving Digital Success in Healthcare

Achieving Digital Success in Healthcare

By Dr Alexander Graham Dr Alex Graham is a medical doctor by background, having trained in London before entering the business world. He is currently a founding partner at AbedGraham, a research and strategy consultancy which assists global IT corporates to navigate the clinical, organisational and commercial complexities of the UK’s National Health Service (NHS). He is also medical director of EMEA for Imprivata.

Adoption and diffusion of technology requires negotiation of many hurdles especially in the healthcare setting. Satisfying all the stakeholders that your product or service will affect is a tremendously difficult process, highlighted by the fact that inventions take on average 17 years to reach widespread diffusion in healthcare.

The key to success stories in healthcare revolve around what I feel is the holy triad of clinical, organisational and financial metrics. If one of these is not satisfied, it gives an organisation (or at least one of the board) the chance to reject the technology out of hand. If you can create something that can show a demonstrable impact on patient care, improve the working lives of the employees that will be using it and save money (preferably in cash-releasing benefits) then it will be very difficult to discard as a concept. The final stage is then of course ensuring that when deployment happens, that the maximum value is generated out of it, which is where front-line clinical engagement is the key.

In my personal experience, too many companies focus on a specific section of an ROI study and neglect one or more of the important factors just mentioned. Often the technical elements are oversold while the financial and clinical elements are neglected somewhat. Of course, this is perfectly understandable as those are the strong points historically of IT organisations.

However, a more holistic approach is required to achieve maximal adoption and diffusion within a system.

One of the more successful companies I have worked with recently has been Imprivata, leader in single sign-on and authentication software products. They have taken a product that is a fairly simple IT proposition but worked it into a comprehensive piece of clinical technology that satisfies all stakeholders concerned. The base product is single sign on which allows a dramatic reduction in the time spent logging in and out of clinical software programs. The idea is that it gives clinicians up to 45 extra minutes a day through streamlining alone. A simple piece of technology but one that has far reaching consequences for the efficiency of an organisation.

A lot of my work centres on taking well-defined and simple technologies and moulding them around the commercial metrics that exist in healthcare. The key is to dig down and analyse where your product fits in amongst the myriad financial metrics and initiatives that exist in clinical systems and start building a robust business case around them. By taking hospital and trustspecific measures and national quality and clinical metrics

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August 2014

into consideration, technologies can develop from simple software propositions to all-encompassing healthcare solutions, which will have answers to any question a board member may ask, whether clinical, organisational or financial.

Other examples that I have been watching closely are the vendors of digital dictation products such as WinScribe, G2Speech and BigHand. This is especially noticeable in the UK where I see digital dictation as one of the foremost front-line technologies to kick-start a paper-lite or paperless NHS. The basic software surrounding digital dictation is again a simple premise, but can be appropriated to numerous clinical, financial and organisational benefits. Also, at a higher level, digital dictation will often be the first transformational step for healthcare organisations who can then progress to speech recognition and higher level data analytics, driving further organisational benefits.

In the world of digital and mobile, there is much said about revolutionary new technologies like 3D printers, complex genomics and robotics. In my opinion, those will have some part to play in the future but at the moment, financially strained and time-poor healthcare organisations require sensible, proven infrastructure solutions that can reap tangible benefits across the institution. They’re not ‘sexy’ and it may not reach the wider media but solutions like these are the immediate future of digital and mobile in healthcare.

I believe success can be derived from a granular knowledge of all the stakeholders, their individual pain points and a deep understanding of the clinical and financial atmospheres they exist in.

If you can frame your product or service in terms of each of their requirements and validate it on multiple levels, then you are well set on the way to success in the healthcare market. n

Have a project you want us to cover?

Let us know the details of any projects that you would like us to cover in upcoming editions of The Journal. Send the details to journalofmhealth@simedics.org The

Journal of mHealth The Global Voice of mHealth

Rolex Awards for Enterprise Recognise mHealth Innovators

Rolex Awards for Enterprise Recognise mHealth Innovators The 2014 International Rolex Awards for Enterprise have recognised innovation in mhealth by awarding two young laureates for their ground-breaking projects, that aim to improve healthcare delivery in Third World countries.

The two are among five winners of the 2014 award. Named ‘Young Laureates’ they were chosen by an international jury from more than 1,800 nominees – all under 30 years of age – for “their leadership qualities and their ability to harness technology, in an original way, to improve the well-being of the community and the environment, as well as to advance scientific knowledge.”

The two honourees are Neeti Kailas for her work in detecting infant hearing loss among children in India, and Arthur Zang who has invented what is believed to be Africa’s first medical tablet, which will allow health-care workers in rural areas to send the results of cardiac tests to heart specialists via a mobile-phone connection.

Arthur Zang

tors to heart disease. Yet there are fewer than 50 heart specialists, most of whom are based in the cities of Douala and Yaoundé, leaving rural areas with virtually no cardiac care.

Zang’s patented touchscreen Cardio Pad could change that. He has invented a medical tablet, which will allow healthcare workers in rural areas to send the results of cardiac tests to heart specialists via a mobile-phone connection.

His company, Himore Medical, will sell the Cardio Pad as part of a complete diagnostic kit for about US$2,000, less than half the price of other, less portable, systems.

Cardiac Telemedicine Brings Hope in Cameroon The incidence of heart disease is rising in many low- and middle-income countries around the world due to wealthier lifestyles and greater longevity. Cameroon is no exception. According to Cameroon’s Society of Cardiologists, some 30 per cent of the country’s 22 million people suffer from high blood pressure, which is one of the key contributing fac-

The other components in the kit are a set of four wireless electrodes and a sensor that attaches to the patient and transmits its signals via Bluetooth to the Cardio Pad. The kit takes a digitised electrocardiogram (ECG) reading of the patient’s heart function.

The healthcare worker who takes this reading then transmits this information to a national data centre. Once the ECG is received, a cardiologist makes a diagnosis and sends it back to the centre to be relayed to the health-care worker treating the patient, along with prescription instructions.

The Cardio Pad has the potential to become a complete telemedicine tool,

allowing measurement and transmission of integrated information on a patient’s health profile, which could help diagnose many other diseases.

The idea for the Cardio Pad emerged in 2007, when Zang was finishing his degree. Interested in applying technology to medicine, he spent a lot of time in hospitals. On one hospital visit, he was watching a television programme showing an ECG being taken. “I said to myself: ‘I wonder how that works?’”

Cardiologist Professor Samuel Kingué from Yaoundé’s main hospital became a mentor, teaching Zang about the type of software needed for a portable ECG device and about how to process the data that comes from the signal.

When Zang began designing the Cardio Pad, however, financing was difficult.

“I went to the banks, but they wanted all sorts of guarantees.” So he used a 21st-century solution: he posted a video about his project on Facebook to raise funds. This led to a $20,000 grant from the Cameroon Government, which Zang used to produce 20 tablets, two of which are being tested in hospitals in Cameroon.

With his Award funds, Zang will produce 100 tablets, 10 for each of Cameroon’s provinces. “My goal is to have 500 Cardio Pads being used across Cameroon,” Continued on page 22

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Rolex Awards for Enterprise Recognise mHealth Innovators Continued from page 21

he says. He also wants to export the device to other regions such as central Africa and India. The Cardio Pads are currently produced in China. Over the next decade, Zang hopes to shift production to Cameroon, enabling his country to benefit economically as well.

The Cardio Pad is just the first step in Arthur Zang’s mission to bring better health care to his country. He aims to set up Cardioglob, an integrated nationwide network of hospitals and cardiologists, allowing comprehensive data management and cardiac services. Zang also intends to develop a family of medical devices and technologies, such as simple ultrasound equipment, for use in rural areas. And he is already planning his next invention, a beeper to allow patients to alert their doctors in medical emergencies.

Neeti Kailas

Detecting Infant Hearing Loss Neeti Kailas is a designer who wants to make a difference, improving life opportunities for hearing-impaired children by detecting infant hearing loss early on.

Her passion for design is coupled with a desire to transform healthcare in India, and she has used her skills to create a non-invasive portable device that screens newborn babies for hearing impairment.

Together with her engineer husband Nitin Sisodia, Kailas launched the Sohum Innovation Lab, and the lab’s first product is a device to screen babies for hearing loss. Kailas is personally connected to the project, through an Indian childhood friend who was born with hearing problems. “She’s had a totally different life to the rest of us, with very few opportunities,” says Kailas. Her

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friend is just one of many. Every year, some 100,000 hearing-impaired babies are born in India, but there is no routine screening countrywide to detect the condition, and the existing tests are expensive and require skilled health-care workers. Early screening is vital because, if left unaddressed, by the time the baby is six months old, a hearing impairment can impede the development of speech, language and cognition.

Kailas’s device works by measuring auditory brainstem response. Three electrodes are placed on the baby’s head to detect electrical responses generated by the brain’s auditory system when stimulated. If the brain does not respond to these aural stimuli, the child cannot hear. The device is battery-operated and non-invasive, which means babies do not need to be sedated, as some previous tests have required. Since the device is inexpensive and portable, it can be used anywhere. “Another of the device’s major advantages over other testing systems is our patented, in-built algorithm that filters out ambient noise from the test signal. This was really important for us because, if you’ve ever been to health clinics in India, you’ll know how incredibly crowded and noisy they are,” says Kailas.

The device is still a prototype, and Rolex Award funds will allow Kailas to start clinical trials later this year. Her plan is to launch the device in 2016, first focusing on institutional (hospital) births, with the aim of screening 2 per cent of such births in the first year, before scaling up

on an annually accrued basis.

If the clinical trials prove successful, Kailas and her partner will be embarking on an ambitious project that she hopes will ultimately allow every single baby born in India to be screened for hearing impairment. Kailas acknowledges that ensuring this happens in a country like India – with its complex, chaotic healthcare system – is “a tall order”, but she has devised an innovative approach to rolling out the technology through pediatricians, maternity homes, health-care workers and entrepreneurs, who will buy the devices and then charge a small fee for every test. A door-to-door service will be particularly important in rural areas, where health clinics are scarce. While it is an untested approach, Kailas is confident that it will work. “Indians don’t need much encouragement to become entrepreneurs. When the IT boom hit, for example, Internet cafés mushroomed all over the country,” she says.

Kailas’s hope is that the screening programme can be adapted to include screening for impaired vision in newborns, or for identifying high-risk pregnancies.

Talking to The Journal of mHealth Kailas describes the inspiration for the company. “Sohum Innovation lab India Pvt Ltd was founded in 2012 with the mission to make innovative technology based, product and service solutions and implement them with a self-sustaining business model to tackle daunting problems in resource-poor settings. These

Mobile Ultrasound Project Delivers Success in Morocco problems do not exist in isolation. They are complex and linked to several variables. So the solution also needs to be multi-faced, and the impact needs to be measurable. Sometimes the solution calls for a new product, an awareness campaign, or a new business model, or a service. We believe in doing immersive research to find the right problem and then creating and implementing a comprehensive and integrated solution with a self-sustaining business model.”

“The first unmet need we found, and selected to address, was that of hearing screening” continues Kailas. “In India, in the absence of hearing screening a child with hearing loss goes undetected till the age of 4 or 5. Then the parents finally realise that the baby is not talking yet. After several referrals and a lot of frustration, they finally diagnose the child with hearing impairment. By then it is too late to save speech. This is what we want to prevent. If the child had been screened at the right time, with appropri-

ate habilitation, he or she could communicate normally and go on to have equal opportunities for education and employment.”

“There are three key aspects to our solution- an awareness campaign to inform people about the critical need for timely hearing screening, a unique and novel device that performs in low resource settings, and a network of experts to ensure after-care to babies that screen positive.

We being these three aspects together with a self-sustaining business model.”

“For the device in particular, we are designing an ABR solution that can perform in the noisy settings that are prevalent in India. Here there are 26 Million babies that are born every year, and there is too little time, few skilled health care workers and the affordability is low.

The test is quick to administer and can perform even in such settings. It can be performed even by a low skilled worker, as it is easy to place the electrodes and to

tell if the baby has passed, or needs to be referred.”

Sohum hearing screening will be launched in India first to reach the millions of babies born in India each year.

There are several other low-income and low-middle-income countries, globally, that can benefit from the product and service and which have shown interest.

The company is currently in the process of developing other devices with technology innovations, that are similarly targeted at resource-poor settings.

The Rolex Awards for Enterprise support pioneering work in five areas: Applied technology, Cultural heritage, Environment, Exploration and discovery, and Science and health. Projects are assessed on their originality, potential for impact, feasibility, and, above all, on the candidates own spirit of enterprise.

For more information on these projects, visit: www.rolexawards.com. n

Mobile Ultrasound Project Delivers Success in Morocco The majority of childbearing related deaths occur in developing countries within rural areas and among poorer communities from complications that develop during pregnancy. Most of these deaths occur where ultrasound imaging during pregnancy and delivery is currently underutilised as a result of financial constraints. The healthcare solutions to prevent or manage pregnancy and childbirth complications are well known, making many maternal deaths avoidable.

Advances in ultrasound technology - smaller ultrasound imagecapturing devices, data encryption, data storage and Internet connectivity - enable ultrasound to be available in places not previously convenient or economically reasonable. The UN, WHO, UNICEF, UNFPA and others have developed initiatives to focus on addressing these underlying causes and examine possible solutions.

Maternal mortality is a priority for the Moroccan government as the population composition indicates particular vulnerability to this issue. In 2008 the Ministry of Health (MOH) developed specific actions in The Moroccan National Acceleration Plan for 2008-12 to hasten the reduction of maternal mortality. Furthermore, Morocco is one of 57 countries suffering from a severe lack of healthcare professionals and remains extremely vulnerable to their exodus to other countries. This lack of resources is exacerbated by unequal allocation of human health professionals between rural and urban areas and within the different

regions of the Kingdom.

In support of the efforts of global initiatives and, specifically, the Moroccan Ministry of Health, The Mobile Ultrasound Patrol Project was created, financed and powered by a collaboration between Trice Imaging Inc., Qualcomm Wireless Reach, SonoSite Fuji Film and Sony. To test the technical capabilities of technological options for rural Morocco, these groups provided advanced wireless communication and collaboration technology supporting connected portable ultrasound devices and subsequent remote access to state-of-the-art imaging diagnostics in Continued on page 24

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Mobile Ultrasound Project Delivers Success in Morocco Continued from page 23

3 small rural villages via mobile networking.

In all, officials said, 575 exams were conducted, with 94 revealing potential at-risk pregnancies and 158 patients flagged for a second opinion.

Qualcomm officials said the healthcare providers in Morocco were able to: »» Shorten the time for diagnostic reviews or second opinions from two weeks to less than a day; »» Reduce ultrasound costs from $80 to $2 per patient; »» Reduce the delivery of data from site to specialist from four days to two seconds; »» Shorten the wait time for a medical opinion from two weeks to less than a day; »» Improve the ability of local healthcare providers to deliver ultrasound images sufficient for diagnostic purposes from 20 percent to 92 percent; and »» Increase the number of patients seeking care at so-called “health houses,” as well as boosting the number of deliveries in those facilities and reducing the number of potentially-more-problematic at-home births.

“The results created in this collaboration are beyond what we could have dreamed,” Asa Nordgren, CEO of Trice Imaging, a partner in the project, said in a prepared statement. “This project proves that new technology can provide high quality, affordable and timely healthcare services under really tough circumstances and to people who would not normally have access to quality care.”

In their report, Nordgren and Shawn Covell, Qualcomm’s vice president of governmental affairs, highlight four elements driving disruption in ultrasound medicine. The latest ultrasound devices coming onto the market are smaller and able to connect wirelessly to the Internet via Bluetooth, Wi-Fi or cellular technologies, they point out. In addition, mobile networks are starting to overtake fixed networks in terms of speed, capacity and range, and today’s technology is also better adept at storing and encrypting data and authenticating users. Finally, led by agencies such as the United Nations and the World Health Organization, there’s an increased focus on women’s health issues around the globe.

“The Mobile Ultrasound Patrol Project showed that using wireless technology and a cloud-based system would make a significant difference in medical care in a region like rural Morocco,” the two wrote in an executive summary. “These technologies not only help the image-capturing physician or midwife to quickly make appropriate decisions; they efficiently connect health houses to second opinion expertise at regional and university hospitals, all of which saves the patient time.”

Nordgren and Covell also noted that while this project was a success, they could see a whole lot more being done with the technology.

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“We think the next step is a project focusing on proving the clinical outcome and tying the use of technology to the actual desired results, saving lives and ultimately impacting the millennium goals to contribute to lowering the global maternal death rate,” they wrote. “We think that both the technology and the workflow model should be put to a real test, implementing the next project in the top five regions on UNFPA’s list of countries that have the highest maternal death rates. Other areas of interest to consider would be breast cancer, tuberculosis and elderly care.”

More details and results from the project can be found at: www. mobileultrasoundprojects.org n

The Future of Health is Happening Now

The Future of Health is Happening Now

By Keith Nurcombe Keith Nurcombe has worked in healthcare for over twenty years spending the last few years working with businesses in the health and technology space, most recently building O2 Health where he was Managing Director until the end of 2012, since then he has been providing consultancy services to businesses.

It is so easy these days to hear the words being uttered both by payors and also by healthcare companies - “it just doesn’t work at scale and I can’t get anywhere with mHealth programs”. This generally gets followed by “I know that everybody says the market is growing and that it will be a huge opportunity but I just don’t see it”.

I think this is really sad, as there are programs out there now that are truly changing the way healthcare is being delivered and offering patients a genuinely different way to look after their own health and take responsibility for the changes that they need to make especially when managing long term conditions.

2. Does the solution deliver value for money or ROI for the payor or provider of the care?

»» Patients use their own mobile device saving them hassle and the payors investment in new technology.

3. Can the system be used easily both by patients, healthcare professionals and payors?

»» It provides a cost effective model for healthcare professionals to manage their patients with COPD and track their behavior and their motivations to manage their condition better.

4. Can the system potentially at some point be integrated easily into the local care model?

There are some great examples out there of real innovation and they don’t just rely on expensive technology or just providing a pill reminder for the patient - that’s not the future of healthcare.

I think this is about being brave, working with the right innovative payors, who do see the opportunity to change the way they are delivering healthcare and making sure that the quality of the solution that you have really answers the key questions for the healthcare market of the future:

Take the recent release of me&my COPD from Astra Zeneca and Exco inTouch. This is a program prescribed by healthcare professionals to help patients and healthcare professionals manage their existing COPD.

1. Does the solution allow patients to really take part and to take responsibility for their care and their long term conditions?

»» This provides a revolutionary self care model for the patients who use the program looking at all aspects around fitness, medication, disease information and patient motivation.

»» It allows patients to involve their carers and loved ones in helping them manage their existing COPD. »» Provides payors with potential data about how patients manage this condition and how they can better treat patients in the future as the healthcare environment continues to change.

All in all let us be positive about this– let us see the real changes that are happening, let us see healthcare changing for the future and the better rather than seeking the half empty glass that focuses on what we cannot achieve and what we cannot do. n

EXECUTIVE HEALTHCARE CONSULTING Nurcombe Consulting delivers interim senior management support, strategic business analysis, change management as well as development of plans and capability for entry into the healthcare market in the UK and globally. Experience at end to end business reviews and then implementing required changes to deliver strategic goals and change of direction for businesses. Management support at senior level within organisations to deliver change as well as day to day management of the running of the business.

Support in delivering new business opportunities into new markets in the healthcare space with considerable experience in: • • • • • • •

Pharmaceuticals OTC and Consumer brands Healthcare delivery to patients in their home Tele-health and tele-care provision Provision of staff and care for patients in their home and also in NHS and private care settings Development of private healthcare opportunities working with the NHS and other state providers Digital Health and the use and deployment of technology to support patient and health outcomes

With over twenty years experience in healthcare locally, regionally and globally this consultancy has the experience to deliver value to your business. For more information please visit www.nurcombeconsulting.com or email nurcombeconsulting@gmail.com

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MMA Roadshow: 10 Lessons for Developers

MMA Roadshow: 10 Lessons for Developers

By Bradley Merrill Thompson, Kim Tyrrell-Knott and Matthew Driver The mobile health industry is dynamic and rapidly changing. Novel technologies are being introduced that raise new questions for entrepreneurs and regulators alike. In the fall of 2013, the US Food & Drug Administration Agency (FDA) took an important first step in addressing some of these questions by publishing Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff (Final MMA Guidance). However, many questions still remain. There also has been continued discussion regarding the scope of FDA’s jurisdiction and how health information technology, including mobile apps, should be regulated, leaving many developers uncertain about how best to proceed.

The mHealth Regulatory Coalition, along with a dozen plus industry and university co-sponsors[1], organized a series of events in early 2014 to help educate industry on the Final MMA Guidance and provide practical advice on how to manage mHealth application development under FDA regulation.

The MMA Roadshow brought together FDA, healthcare and industry professionals, academics, provider organizations, and other mHealth stakeholders in a series of seminars to discuss the regulatory issues associated with bringing new mobile applications to market in the healthcare space.

Using a multi-disciplinary approach, the events provided valuable insight and different perspectives on the mHealth sector.

Business leaders, investors and regulatory experts shared best practices and lessons learned with developers and other new entrants to the FDA regulated environment.

We highlight the key takeaways from the MMA Roadshow to help developers navigate the current environment:

Align Your Business and Regulatory Strategies

The conventional approach of building a product, getting funding, and then dealing with legal and regulatory concerns

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does not work well in the FDA regulated market. Understanding the regulatory requirements and implications is critical to the business strategy for any health related product - even if the strategy is to remain unregulated.

FDA regulates based upon the manufacturer’s intended use. What you say matters.

You need to be aware of how your marketing claims affect your intended use and the classification of your application. It is important to appropriately manage your claims and intended use to achieve your goals while remaining within the appropriate regulatory classification.

Panelists warned that it could be a big mistake for companies to develop the regulatory and business/marketing strategies in separate silos.

Walk, Crawl and Run FDA regulates based on risk. Class III being the highest risk, Class II, moderate risk and Class I the lowest risk. The higher the risk of the device, the more regulatory requirements will apply. Class I devices, generally speaking, only need to comply with registration and listing and medical device reporting and implement a quality system. The requirements are incremental such that Class I requirements will apply to Class II and Class III devices as well. So the time and effort invested in implementing a quality system or medical device reporting process will benefit you as you introduce higher risk devices.

Many companies start with an unregulated or Class I device in order to get some initial revenue and gradually develop higher risk products. In the instance of a Class I device, this also allows a company to establish its quality system and become familiar with FDA requirements and build upon that foundation. Stepwise iterations in product complexity and risk can be useful in managing your development process as well.

Although 510(K) clearance requires that you demonstrate your product is substantially equivalent to a predicate (an existing

legally marketed device), that does not mean it needs to be exactly the same. A 510(K) pathway is not out of your reach because you have an innovative mobile application. Sometimes decades old predicates can be relevant and applicable to even seemingly novel medical technologies. Also, once you have a 510(K) clearance, there are strategies to streamline the 510(K) clearance process for additional claims as function evolves or you develop evidence for a new marketing claim.

Get Good Advice Early It will save you from a multitude of problems later on. If your device will be regulated, the requirements are much easier, and less costly, to implement from the beginning of development than to retroactively address. You can often phase the implementation of certain requirements based upon the stage of development to minimize the expense. Alternatively, if your device will not be regulated, that knowledge both helps you limit scope of your product and avoid unnecessary expense of complying with regulatory requirements.

(Although as we discuss below you may want to comply with certain quality system requirements).

There are a number of experts who can help and there are a lot of good resources that are free. The FDA website has a number of resources and a whole section dedicated to assisting small businesses. Anyone working in or near the FDA regulated space should read the publicly available FDA commentary and guidance.

Developers can also go directly to the FDA and ask them for assistance. Now, FDA will not act as a consultant, but they do provide helpful feedback. The FDA also launched an MMA email enquiry option simultaneously with the Final MMA Guidance which allows companies to ask questions informally via email. You need to have carefully thought through the issue and appropriately framed the questions before engaging with the Agency. You also need to make sure you are engaging the appropriate group within the Agency and be willing to live with the answer you get.

However, even with the risk of not get-

MMA Roadshow: 10 Lessons for Developers ting a favourable response, many panelists touted seeking advice directly from the FDA at an early stage as a positive and helpful endeavour.

cal device companies can use agile development techniques and there are software tools that make agile programming more documentable.

Customize Your Quality Systems and Design Controls Many of the quality system requirements reflect good business practices and activities your company may be doing today.

Most software developers have design controls and software controls. The key is to document your processes and adjust it, as necessary, to comply with the specific FDA requirements. It is important that your processes reflect how your company does business. A quality system is not one size fits all. It should be right-sized to reflect your organization and the complexity and risk of your product. Many start-up companies are tempted to adopt form policies and processes to save time or money.

While templates may be helpful, they must be customized. Otherwise, you run the risk of the policies and procedures sitting on the shelf and the company not complying with its own quality system, which could be problematic in the event of an FDA inspection.

If you are operating on a limited budget or are entering into this area without prior experience, you may want to consider leveraging a reputable contract manufacturer that has an existing FDA compliant quality system in place. Be sure to enter into a quality agreement that clearly articulates the regulatory responsibilities of each party.

If your app is currently subject to enforcement discretion. You may want to consider voluntarily adopting an FDA compliant quality system. The Final MMA Guidance strongly recommends that manufacturers of devices subject to enforcement discretion implement quality systems. In addition, the product could evolve over time and end up in a regulated classification. If that happens, you will be in a much better position to obtain clearance or approval without disruption to your business. You will also avoid unnecessary cost and effort of trying to retroactively develop the documentation needed for a submission or application if you have a quality system in place.

Leverage Free or Existing Resources There are ways to implement a quality system cost effectively and there are a number of free resources. The FDA website has extensive information on implementing a quality system. AAMI, Association for the Advancement of Medical Instrumentation, is also a good source of information.

There are also free software tools and documentation systems that you can leverage.

However, confirm the tools are FDA compliant before you commit to using them.

Despite a common misperception, medi-

Developers should consider that it might be more expensive at the onset but it will likely save money in the future. Also, remember that in addition to standard software testing, you also have to account for the fact that your product will run on a mobile device (e.g., what if the user is in a car when he/she uses your app, what about a brightly lit outside location?).

Know Your Customer and Your Market This may seem obvious but it is critical.

Who is your customer? Is your customer the hospital or the individual physicians?

Nowadays hospitals make a lot of the decisions for their employed clinicians.

So even if clinicians need it and are your end users, you need to understand whether hospitals want it and will they pay for it.

Panelists recommended that you engage with end users and all stakeholders (e.g., hospitals, physicians, patient groups, backend administrators in health care entities) to ensure that your product will serve their range of needs.

They also recommend you consider how your product will fit into the user’s workflow without being burdensome. Merely requiring physicians to open up a separate screen can impact adoption and necessitate a stronger value proposition.

You also need to assess your market early on and understand the size of the opportunity. What is the right approach? Can it be addressed via an unregulated approach? If it requires a regulated app, are the returns going to be worthwhile?

Clearly Articulate Your Value Proposition The mobile application marketplace is inundated with 99 cents and free apps. You need to differentiate yourself. Why should customers pay a premium for your regu-

lated product? Are you going to increase your customer’s efficiency, lower cost or improve outcomes? Are you solving a problem- such that the end user needs your app or do they merely want it? If it is addressing a critical need, consumers, patients and healthcare providers may be willing to pay a premium. But they may also be more willing to trust a regulated app to address their critical health need.

Conversely, if the app is a “want”, they might not be willing to pay a premium.

This needs to be factored into your regulatory strategy. This also gets back to knowing your market. The costs associated with a FDA regulated environment may make it difficult to maintain a FDA regulated product for 99 cents - unless there is a very large market for the device. In some instances, it may be better to remain unregulated. However, that requires living with the trade-offs, namely not being able to market your app for medical device purposes.

Understand What Investors Expect First and foremost, you have to be able to show an investor that they will get a good return on investment (ROI). This, of course, gets back to the value proposition demonstrating how you are solving a problem that people care about and that your target audience will buy. You need success in both the numerator (health outcomes) and denominator (economic viability).

The regulatory strategy is also a critical factor in recouping their investment.

More and more investors, even early stage investors, want to understand a company’s regulatory strategy before they will invest.

Many want to see solid data before they will put in serious money. Angel investors may be more willing to take on some additional risk but you should plan on spending some of that early stage investment in developing a clear regulatory strategy.

On the flip side, investors need to understand that a lean startup model for a medical device technology has a different scope than it does in standard information technology. If your investor does not appreciate that, you will need to do some education or look for another investor who has experience in this space.

Investors are also looking for comprehensive teams with diverse areas of expertise.

If the founding team does not have an area of expertise, partner with someone who does. Serious investors will be lookContinued on page 28

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MMA Roadshow: 10 Lessons for Developers Continued from page 27

ing for team members that have been successful before and bring credibility to your product.

All of that said, developers should not assume that investment is necessary. It gets back to your regulatory strategy. If you are developing unregulated apps, it might not be necessary to seek outside investment.

Define Your Payment Model What is your compensation model? Or will you seek reimbursement or payment from an insurer? Reimbursement for a mobile medical app is becoming more feasible, but it is challenging. Some insurers may be willing to pay because of the potential costsavings but this will require a customized and nuanced approach.

Do Not Forget Other Regulatory Considerations There are a number of other regulatory requirements that apply to mobile medical apps that must be addressed at early stages.

Data privacy and security is essential to any app involving identifiable health information.

The FCC also has a requirement for wire-

less communication devices that need to be considered. If you are launching globally, you will also need to consider the regulations in the countries in which you app can be downloaded.

The mHealth Regulatory Coalition The mHealth Regulatory Coalition was formed in 2010 with the purpose of ensuring that the regulatory environment for mHealth technologies allows for innovation while at the same time protecting patient safety. The coalition serves as a thought-leader in the mHealth ecosystem to provide expertise on which mHealth technologies should be regulated and how they should be regulated.

The coalition focuses on a number of issues relevant to the mHealth regulatory framework, including: »» Participating in the legislative process to tackle the big picture question of which agency or organisation should regulate mobile medical apps. »» Tackling the tougher questions associated with the scope of FDA regulation, including the agency’s reach into: Apps used for wellness; Low risk- generic

Want to learn about the benefits of Field Testing for Health apps & systems?

Visit www.pass.ch/fieldtesting

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IT accessories; Pharmaceutical-related apps; and, Generic software modules used as parts of medical software programs. »» Improving the regulatory environment for those apps subject to FDA oversight, including: Moderating the quality system requirements for app development; identifying a clear pathway for FDA clearance; Creating a hassle-free way to keep software up-to-date. »» Expanding these frameworks to coordinate with other regions around the world.

For more information on the mHealth Regulatory Coalition and the Mobile Medical Applications Roadshow, please visit www.mhealthregulatorycoalition.org.

1 ACT, American Telemedicine Association, Consumer Electronic Association (CEA), Continua, CTIA, Epstein, Becker & Green, GSMA, mHIMSS, National Venture Capital Association, Regulatory AffAirs Professionals Society (RAPS), Wireless Life Sciences, University of Illinois, John Hopkins University, University of California San Diego, University of Texas at Austin, Massachusetts Institute of technology (MIT), mHealth Europe Summit. n

Using mHealth to Battle HAIs and Superbugs

Using mHealth to Battle HAIs and Superbugs Mobile devices introduced into hospital settings present new challenges in the growing and costly battle to prevent hospitalacquired infections (HAIs) and suberbugs.

New Cross Hospital, part of The Royal Wolverhampton NHS Trust (UK), recently announced a milestone of one million hand hygiene observations using TeleTracking Technologies, Inc.’s automated hand hygiene sensor as part of the ‘Safe Hands’ program, in collaboration with systems provided by Centrak.

This compares to just 600 visual observations over the same time period. Safe Hands is a government-funded effort using Real-Time Locating System (RTLS) technology to improve staff compliance in order to reduce the threat of antibiotic-resistant HCAIs, which is growing globally, according to the World Health Organization (WHO).

Program Manager, Clare Nash, RN, states that over the past nine months the Trust badged nearly 4,000 employees, all inpatients, and over 1,226 assets. Finding a tagged asset now takes just 25 seconds, which means patients are given timely treatment or intervention. RTLS also ensures proper cleaning of equipment. Saving time means more planned preventative maintenance (PMM) and safe equipment, plus NHSLA compliance.

“It’s a pioneering technological system,” said Nash, and it continues to drive improvements to the hospital’s already excellent infection prevention standards. The system is “the biggest of its kind in any hospital in the world” and a “revolutionary step forward in healthcare,” she said.

The TeleTracking system also tracks the role of every badged staff member who comes in contact with an infected patient.

Nash recalled a case early in the program where an infected patient came in contact with hospital staff members, fellow patients and mobile medical assets 217 times before a diagnosis was made. “This is why it’s so hard to contain norovirus and C. diff,” she says of the number of contacts recorded. “I am so amazed at the power of this data. It shows us how important it is to get an infected patient isolated as soon as possible.”

In addition to monitoring hand hygiene enterprise-wide, the RTLS-based technology from TeleTracking locates equipment across the Trust, generates available bed status, and tracks

patients and staff locations automatically and in real time. White boards and magnets have been replaced with 42 inch computer touchscreens that show everything in real time on a floor plan graphic, from equipment, to patients, to staff members.

Every time equipment is moved, a patient leaves a ward, or a staff member washes their hands - the TeleTracking system knows. Alerts go off if a patient hasn’t been seen for more than an hour, or if a patient is in an isolated area longer than 20 minutes. Location and time data is sent back to computer touchscreens in each department.

Infection prevention and control nurses used to spend an hour or more per patient tracking patient contacts and locations to perform root cause analyses. Now they can run a report to access the information with the click of a button.

Cheryl Etches, chief nurse, added, “I now have access to so much information about patient safety and experience issues. The potential this system offers is phenomenal and can fundamentally underpin the operating framework of our organisation.”

By using the real-time locations of patients to automate bed occupancy and discharges, New Cross Hospital has a live bed state.

Nearly 75 percent of discharged patients now leave their wrist badges in a drop box before leaving the hospital, automatically triggering housekeeping to clean vacated beds. Beds are now becoming available to new patients in less than 40 minutes–which is the time it takes to notify a housekeeper and clean a room.

Originally intended exclusively to monitor hand washing, Nash says administrators soon realised the TeleTracking system’s greater potential. Data reports detail the hours of care given to individual patients, by individuals or groups of staff. This can be triangulated with patient condition, acuity, fall risk, etc. Staff judged this feature to be the most important, closely followed by patient status at a glance.

Nash says this reporting capability is supporting accurate costing for service provisions, predicting and planning for future staffing levels, and informed dialogue with Trust commissioners.

“The system also makes the hospital more efficient,” Nash said, because “there is no longer a need to walk around to see if tasks have been done.” This gives care providers more time to spend with patients.

According to the World Health Organization, an estimated 1.4 million people around the world become ill from HAIs in a given year, and yet hand hygiene compliance in hospitals is below 40 percent. In the United States alone, the Centers for Disease Control and Prevention estimates that one in every 25 patients falls prey to an HAI. Source: Teletracking Technologies Inc n

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Conference News Developing a Pro-active Answer to Healthcare: What are the Next Steps for Self-care in the Digital Age? Health experts, practitioners and community leaders came together in London in June to debate Self-Care in the Digital Age - the use of technology to empower individual healthcare - a positive but challenging issue in the light of growing pressure on the UK's National Health Service (NHS).

The conference was organised by DALLAS (Delivering Assisted Living Lifestyles At Scale), a programme developed by the UK's innovation agency, the Technology Strategy Board (TSB), it aims to transform lives of 160,000 people within four communities which currently act as demonstrators.

The event was also co-hosted by The King's Fund, an independent charity working to improve health and health care in England. The opening address was by Lord Filton, Chair of the newly ceased Centre for Ageing Better which hopes to apply evidence of what works,.

However, in his opening remarks, Filton made no pretence of knowing what the answers were: “We don’t really know how to adapt technology to ageing and self-care," he said. “There are some serious barriers.

But that’s where the TSB can step in. It’s important to have a body that has a long term attitude, as you don’t always get an answer by employing some “whizzo“ product. We need to turn things around and bring the technology into the conversation.”

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The use of the correct terminology surfaced as crucial point with several delegates pointing out that “self-care” insinuates that people need to care for themselves.

On this point, Hazel Harper, the DALLAS Assisted Living Innovation Platform Programme Manager was very keen to get the audience to contribute, to provide a better description of what was involved. She asked them to consider the questions: “Why is it not there? Why are we not doing this now?”

She also pointed out that “A challenge is that people are not interested in their own well being as a priority.”

Prior to the conference, a meeting of policy makers had also used the occasion to debate the issue and the conversation was summarised for the audience by Nick Goodwin, Chief Executive, International Foundation for Integrated Care and Senior Associate, The King's Fund, UK. Policy makers, he told the audience, were aware that the issues of surveillance and assessment were delicate ones in this context and that helping individuals become more proactive in their health needed to be a shared conversation, one that empowers people. He spoke of the danger of the appearance that: “Providers are trying to shift this onto people, but at the same time costs are

an issue so it’s a delicate balance. So the emphasis is that it’s about supported care and adds to capabilities."

There was also debate about the novelty and unexplored nature of the terrain: “When we talk of normalising the process, then the consumer market is likely to grow, bringing people into design, bringing in a cultural shift.”

The audience were very much involved in the general debate and often reminded the presenters that we shouldn't forget the users, they are the ones who can bring about the changes. As well as the fact that whatever technology is involved must have people at heart, it should be entertaining and fun, as well as easy to use, if we are to “nudge" people towards its use.

Jackie, a programme adviser and a nurse made a point which got to the rub of the problem: “Why,” she asked, “have so many sectors - banking, entertainment... managed to reframe what they’re doing and digital health hasn’t?”

The audience was also asked to provide arguments for and against digital health.

The advantages, they voted for were: »» Technology is enabling, it provides independence and gives people peace of mind

Conference News »» Convenience, interactivity »» Better levels of care, personalisation, enhanced wellbeing »» Tech can be seen as part of a broader service.

The disadvantages, they decided, were: »» Cost - how is it sustainable? Have to upgrade »» There’s a juxtaposition between intrusion and enablement. So we need to consider fear and distrust. »» Quality control, accreditation and risk perception need to be taken into account. According to one audience member: ”Don’t let the public sector invest in tech - they will buy Beta

Max, not Netflix!” »» Accountability is a factor. »» We need to consider informationoverload, literacy and accessibility Lord Filton summed up the proceedings.

“It’s not about selling technology,” he said, “It’s: how do we help ourselves?

There are two conversations: how do we help technology transform statutory care; how to enable people to better engage in a preventative way. So it’s about a consumer market accelerator.

But also: what are the impediments to consumer market adoption? That conversation needs to be had with the TSB - how do we break through these inhibitions?”

He entreated the audience to not give up or to think that it isn’t going change: “This is a persistent change,” he said.

“This issue isn’t going away. We have to maximise the technology if we are to harness the benefits.”

So, what’s next for self-care in the digital age?

The next steps are a self-care declaration in the form of a White Paper. The International Digital Health and Care Congress takes place 10-12 September 2014 and a Dallas event and webcast on February 15, 2015.

Taken from the original article at: https://connect.innovateuk.org/web/ictktn/ article-view/-/blogs/developing-a-pro-activeanswer-to-healthcare-what-are-the-next-stepsfor-self-care-in-the-digital-age- n

International Digital Health and Care Congress

For those interested in the design and application of new technologies that support improvements in health care, The King’s Fund is hosting its annual three-day digital health and care congress in September.

cerning health care technology. This is a standalone event for those involved in the research and evaluation of digital health and care programmes who may not wish to attend the full congress.

Following on from last year’s success, this highly-acclaimed event brings together international researchers, policy makers, practitioners and innovators to share experiences and showcase new designs in digital health, mobile health, telehealth and telecare.

During Thursday 11 and Friday 12 September, there will be plenary sessions and breakouts focusing on the advancements and benefits of digital health and care. These will be aimed at UK and international health and social care professionals, technology providers and commercial and third sector health and social care.

The organisers have received an unprecedented response to their call for papers and are expecting to showcase an exciting range of projects during the event. Topics will include: »» »» »» »» »»

sustaining independence as people age preventing and managing chronic illness effectively supporting people with mental health issues digitally enabling service transformation new innovations in health care technology

The congress also offers the chance to attend a pre-congress seminar on Wednesday 10 September, where attendees will explore the latest research and evaluation methodologies con-

In previous years the congress has sold out far in advance so the organisers recommend that you register soon to guarantee your place.

To find out more about the congress, the sponsorship opportunities and to register, visit www.kingsfund.org.uk/digital2014 The King's Fund is an independent charity working to improve health and health care in England. They help to shape policy and practice through research and analysis; develop individuals, teams and organisations; promote understanding of the health and social care system; and bring people together to learn, share knowledge and debate. They’re vision is that the best possible care is available to all. n

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Powering Future Medical Devices

SPECIAL REPORT: Powering Future Medical Devices

Mobile Health Monitoring: The Problems with Battery Life One of the major problems associated with all mobile healthcare devices stems from the power source and crucially the limitations of battery life. The battery is the critical element in the mobile equation, but also the one that often proves to be the greatest hindrance.

For designers, the limitations of battery life is becoming a serious problem in the delivery of many of the mobile health technologies that we are starting to see emerge. A system like Google Glass, currently only has a practical battery life of about five hours, and less when coupled with continuous data streaming, this makes this type of technology impractical for use over a full working-day. When the long working hours of healthcare professionals are taken into account then the lack of longevity becomes even more contentious.

In terms of implantable sensors and devices, the technology to engineer the miniturised components needed for the actual devices is at present becoming more available. A number of significant projects and studies are assessing the practical implications of having implanted micro-devices and micro-sensors, even at the nano-scale, within the body. One persistent problem though tends to be the reliability of miniturised power sources. In order to make these type of devices a reality they need to be powered either by tiny batteries that can be recharged using a source outside the body, or preferably they should source their own energy using adjacent collection of ambient heat, movement, or chemical transition.

Even wearable monitoring devices, where much work has gone into extending the practical use time, are often still encumbered by limited battery life.

The hope in the short-term is that innovation will provide practical solutions to these issues and there are already many developments that may provide the answer to these problems.

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Battery design Improving the actually design of batteries in order to improve capacity, duration, energy efficiency, and energy recapture, is the first step towards developing units that have the capabilities to match the ambitions of mobile healthcare devices.

One example of the changing technological landscape comes from Amprius, an American startup venture out of Stanford University, which has developed a battery which has vastly improved power density[1]. Providing up to 700 watts per litre compared to the standard 400 watts per litre, which means they last 25 percent longer between charges. It is already supplying the smartphone and tablet market, and looks set to make inroads into other industries, in the near future.

typical liquid electrolytes over time and make charging impossible. The flexible and customisable zinc anode, electrolyte, and metal oxide cathode of the battery are printed in the form of electrochemical inks. The printing process is similar to silk-screening where material is deposited in a pattern by squeezing it through a mesh over a template.

The implication of this for product designers is that instead of building the device around the power source, not only can the power source be built around the device, it can be the device.

Another start-up Imprint Energy is developing zinc, instead of lithiumbased batteries[2]. They have found that zinc is much more stable and safer than the traditional lithium construction, so batteries need much less packaging and can even be screen-printed, which also allows for extensive customisation and flexibility.

3D printing is having other influences on the way in which batteries are manufactured. A team of researchers at Harvard University, working with the University of Illinois, have recently developed a method which allows batteries to be printed using 3D printers, in a similar manner to the manufacturing methods already being employed to produce other complex circuitry components[3].

If commercialised, the process has the potential to make the fabrication process quicker and easier, whilst at the same time allowing for the manufacture of complex and advanced designs.

The technology uses a polymer electrolyte that allows zinc-based batteries to be recharged. It prevents the formation of fingers which typically bridge across

The ‘ink’ used in the process is actually a suspension of nanoparticles in a dense liquid medium like ethylene glycol.

This process is possible because of the

SPECIAL REPORT: Powering Future Medical Devices unique properties of the nanoparticle suspension. It is mostly solid as it sits in the printer ready to be applied, then begins to flow like liquid when pressure on it is increased. Once it has left the custom syringe applicator, it returns to a solid state. The research team has been able to lay down multiple layers of this ink with extreme precision at 100-nanometer accuracy. The tiny batteries being printed are about 1mm square, and could pack even higher energy density than conventional cells thanks to the intricate constructions.

This approach is much more realistic than other metal printing technologies because it doesn’t rely on high temperatures. This all happens at room temperature and works with existing industrial 3D printers that were built to work with plastics. The team hopes that future work will make this type of nanoparticle extrusion possible on consumer-level 3D printers.

It is a promising development especially for ingestible or implantable biosensors.

As wearables are designed to fit the body, many devices need to be stretchable and this goes for batteries too, research from Northwestern University and the University of Illinois details a stretchable battery capable of operating when stretched to three times its normal size[4].

The batteries will allow stretchable electronic devices to be used anywhere, including inside the human body where they could monitor anything from brain waves to heart activity, succeeding where flat, rigid batteries would fail.

Northwestern University’s Yonggang Huang and Illinois’ John A Rogers have demonstrated the battery that continues to work - powering a commercial lightemitting diode - even when stretched, folded, twisted and mounted on a human elbow. The stretchable battery can deliver power and voltage similar to a conventional lithium-ion battery of the same size, but the flexible battery can stretch up to three times its original size and still function.

As reported in the journal Nature Communications, the flexible lithium-ion battery completes the flexible electronics package with a cordless power source.

The paper introduces a set of materi-

als and design concepts for a rechargeable lithium ion battery technology that exploits thin, low modulus silicone elastomers as substrates, with a segmented design in the active materials, and unusual ‘self-similar’ interconnect structures between them. The result enables reversible levels of stretchability up to 300%. Stretchable wireless power transmission systems provide the means to charge these types of batteries, without direct physical contact.

"Batteries are particularly challenging because, unlike electronics, it is difficult to scale down their dimensions without significantly reducing performance," comments Rodgers.

"We start with a lot of battery components side by side in a very small space, and we connect them with tightly packed, long wavy lines," Huang said.

"These wires provide the flexibility.

When we stretch the battery, the wavy interconnecting lines unfurl, much like yarn unspooling. And we can stretch the device a great deal and still have a working battery."

Improved Charging The ability to charge batteries quickly, more efficiently, and wirelessly is the promise of a variety of breakthrough technologies. By eliminating a device's dependency upon a fixed point charger, and reducing the time taken for recharging, the capabilities of a device can be significantly improved.

Israeli start-up StoreDot[5] recently demonstrated the ability to charge a bioorganic battery from flat to full-charge in just 30 seconds. The system, which is currently only a prototype, uses quantum dots, a nanocrystal made of semiconductor materials that are small enough to

exhibit quantum mechanical properties.

The technology was actually spun out of research being done into Alzheimer’s disease at Tel Aviv University. That work identified the peptides (amino acids) that are now being put to work in StoreDot’s bio-organic battery.

“When the self-assembly process of these molecules can be managed, we can create nano-crystals,” comments Dr Doron Myersdorf CEO and founder of StoreDot, discussing how the technology works. “We were able to take the same peptides that participate in biological processes in our body and to create nano-crystals — these are stable, robust spheres.

“The diameter of these sphere is 2.1 nanometer. Very, very tiny. And these can be used, because they have special properties and they are robust, in a semiconductor device or in a battery or in a display. We are talking about new types of materials that can be introduced into different types of devices.”

StoreDot’s original focus for the nanocrystals was memory chips — which could write faster than traditional flash memory. It has also demonstrated an image sensor using the technology. But it has now shifted focus to what it sees as the two most promising near-term routes to commercialise the technology: fast-charging smartphone batteries, and cadmium-free displays.

At present the technology has its limitations due to its size and limited capacity, but the prototype has clearly demonstrated the potential. Dr Myersdorf suggests that a working product is at least three-years away.

Continued on page 37

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Innovation Driving Improvements in Battery Function Carbon Nanomaterials to Develop Next-generation Batteries A research team from the University of Alberta has used carbon nanomaterials to develop next-generation batteries capable of charging faster and lasting longer than today's standard lithiumion batteries.

"What we've done is develop a new electrochemistry technology that can provide high energy density and high power density for the next generation," said lead researcher Xinwei Cui, who completed his PhD in materials engineering at the University of Alberta in 2010 and is now chief technology officer at AdvEn Solutions, a technology development company that is working on the battery so it can be commercially manufactured for use in electronic devices.

The research team developed the new technology for energy storage using a process called induced fluorination.

"We tried lots of different materials. Normally carbon is used as the anode in lithium-ion batteries, but we used carbon as the cathode, and this is used to build a battery with induced fluorination," Cui explained.

The advantages of using carbon are that it is cost-effective and safe to use, and the energy output is five to eight times higher than lithium-ion batteries currently on the market. The new battery also performs better than two other future technologies: lithium-sulfur batteries, currently in the prototype stage, and lithium-air batteries, now under development. For example, the induced-fluorination technology could be used to produce cellphone batteries that would charge faster and last longer.

"Nobody knew that carbon could be used as a cathode with such a high performance. That is what's unique with our technology and what is detailed in our paper," Cui said. The team published their findings in the journal Nature Scientific Reports.

The paper was written by Cui; Jian Chen, a researcher in the National Institute for Nanotechnology; Tianfei Wang, a PhD candidate in materials engineering; and Weixing Chen, professor of chemical and materials engineering at the U of A. "It wasn't a quick process. Once we found carbon is different, we persisted for three years until we got results," Cui said.

AdvEn Solutions hopes to have a prototype by the end of 2014 and aims to develop three versions of the battery to serve different goals. One battery would have a high power output and a long life cycle, the second would have high energy for quick charging, and the third a super-high energy storage.

"We have a long way to go, but we're on the right track. It's exciting work and we want everyone to know about it and that it's very young but promising," said Cui.

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AdvEn is a growing company housed within the Department of Chemical and Materials Engineering at the University of Alberta. It aims to expand by taking on new researchers and gaining more funding. The company recently secured a partnership with the U.S.-based aerospace company Lockheed Martin to develop an advanced anode for AdvEn's high-performance carbon cathode.

Source : University of Alberta

Using Sand to Improve Battery Performance Researchers at the University of California, Riverside's Bourns College of Engineering have created a lithium ion battery that outperforms the current industry standard by three times. The key material: sand.

"This is the holy grail - a low cost, non-toxic, environmentally friendly way to produce high performance lithium ion battery anodes," said Zachary Favors, a graduate student working with Cengiz and Mihri Ozkan, both engineering professors at UC Riverside. The idea came to Favors six months ago. He was relaxing on the beach after surfing in San Clemente, Calif. when he picked up some sand, took a close look at it and saw it was made up primarily of quartz, or silicon dioxide.

His research is centered on building better lithium ion batteries, primarily for personal electronics and electric vehicles. He is focused on the anode, or negative side of the battery. Graphite is the current standard material for the anode, but as electronics have become more powerful graphite's ability to be improved has been virtually tapped out. Researchers are now focused on using silicon at the nanoscale, or billionths of a meter, level as a replacement for graphite. The problem with nanoscale silicon is that it degrades quickly and is hard to produce in large quantities. Favors set out to solve both these problems. He researched sand to find a spot in the United States where it is found with a high percentage of quartz. That took him to the Cedar Creek Reservoir, east of Dallas, where he grew up.

Sand in hand, he came back to the lab at UC Riverside and milled it down to the nanometer scale, followed by a series of purification steps changing its color from brown to bright white, similar in colour and texture to powdered sugar. After that, he ground salt and magnesium, both very common elements found dissolved in seawater into the purified quartz. The resulting powder was then heated. With the salt acting as a heat absorber, the magnesium worked to remove the oxygen from the quartz, resulting in pure silicon. The Ozkan team was pleased with how the process went. And they also encountered an added positive surprise. The pure nano-silicon formed in a very porous 3-D silicon sponge like consistency. That porosity has proved to be the key to improving the performance of the batteries built with the nano-silicon.

SPECIAL REPORT: Powering Future Medical Devices The improved performance could mean increasing the expected lifespan of silicon based electric batteries up to three times or more. The energy density is more than three times higher than that of traditional graphite based anodes, which means cell phones and tablets could last three times longer between charges.

The findings were just published in a paper, "Scalable Synthesis

of Nano-Silicon from Beach Sand for Long Cycle Life Li-ion Batteries," in the journal Nature Scientific Reports. In addition to Favors and the Ozkan's, authors were: Wei Wang, Hamed Hosseini Bay, Zafer Mutlu, Kazi Ahmed and Chueh Liu. All five are graduate students working in the Ozkan's labs.

Source: University of California, Riverside n

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An alternative to conventional batterycharging processes is the use of wireless charging solutions, which are beginning to show significant potential.

Inductive charging (also known as "wireless charging") uses an electromagnetic field to transfer energy between two objects. This is usually done with a charging station. Energy is sent through an inductive coupling to an electrical device, which can then use that energy to charge batteries or run the device.

The basis of wireless charging use an induction coil to create an alternating electromagnetic field from within a charging base station, and a second induction coil in the portable device takes power from the electromagnetic field and converts it back into electrical current to charge the battery. The two induction coils in proximity combine to form an electrical transformer. Greater distances between sender and receiver coils can be achieved when the inductive charging system uses resonant inductive coupling.

Qi (pronounced "Chee") is an interface standard developed by the Wireless Power Consortium for inductive electrical power transfer over distances of up to 4 cm (1.6 inches)[6]. The Qi system comprises a power transmission pad and a compatible receiver in a portable device.

To use the system, the mobile device is placed on top of the power transmission pad, which charges it via resonant

inductive coupling. The standard and technology have already been built into many smartphones, and is seen, by many, as the way devices will be charged in the near future. The Wireless Power Consortium was established in 2008, and is an open-membership cooperation of Asian, European, and American companies in various manufacturing industries.

Device Efficiency Apple is taking a lead here as demonstrated by their new M7 processor which minimises the battery power needed to track a smartphone user’s activity by using lower-level processing to record movement data. This means that tracking and health monitoring software applications can more easily track activity levels, via the smartphone itself, without the need for external peripherals.

Hardware and micro-chip manufacturers are also keen to improve the efficiency with which hardware elements operate at. Thus, reducing the energy requirements needed to power a whole range of devices. SuVolta and Arm Processors have both recently demonstrated new, more efficient transistor designs that allow devices to run longer with the same processing speed as comparable chips.

Improved connectivity can also provide solutions to extend battery-life. A primary example is that of Bluetooth technology. Until recently devices that relied on a Bluetooth interface to trans-

fer data from a monitoring device to a mobile phone were extremely limited by the drain they placed upon the battery of the monitoring mobile device. Apple even prohibited applications (from the App Store) that required continuous data transfer due to the significant reduction in battery life that they bought about.

With the introduction of Bluetooth Low Energy, devices can now interface with a smartphone with very little residual impact upon the power supply, meaning that a device can stream data virtually continuously without significant impact on the user’s battery.

Ambient backscatter is another exciting efficiency improvement development. It works by piggybacking on existing wireless signals to transmit without drawing on battery power. It currently only works on a limited radius (5 – 6.5 miles) and with basic info, such as a text message, but its capabilities are likely to improve.

1 http://www.amprius.com 2 http://www.imprintenergy.com 3 Sun, K., Wei, T.-S., Ahn, B. Y., Seo, J. Y., Dillon, S. J. and Lewis, J. A. 2013. 3D Printing of Interdigitated Li-Ion Microbattery Architectures. Adv. Mater., 25: 4539–4543.

4 Sheng Xu, Yihui Zhang, et al. 2013.

Stretchable batteries with self-similar serpentine interconnects and integrated wireless recharging systems. Nature Communications 4, Article number: 1543.

5 http://www.store-dot.com 6 http://www.wirelesspowerconsortium.com n

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BEYOND THE

BATTERY

Harvesting Energy to Power Medical Devices A series of articles that consider the possible options for the use of energy harvesting as viable power sources for medical devices

Device Can Harvest and Store Energy from the Mechanical Movements of a Beating Heart The heart expends half a joule of energy every time it beats. Before every contraction, the potential energy trapped in chemical bonds within cardiac muscle cells is released and converted into the mechanical power of the heartbeat. But, like all energy, that which is harnessed to power the heart is never destroyed; it just changes form as it radiates away from the organ as heat and vibrations of surrounding tissue and fluid.

Professor John Rogers of the University of Illinois at Urbana-Champaign, and his research team recently announced that they have constructed flexible energy-harvesting devices that can convert the

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movement of body parts - like the heart and lungs - into energy captured by a battery that could be used to power implantable devices like pacemakers. The devices, which are described in a paper published in PNAS, are constructed of thin ribbons of lead zirconate titanate (PZT) surrounded by flexible, biocompatible plastic, with an integrated rectifier and rechargeable battery.

When the piezoelectric material flexes due to contraction and relaxation of the organ to which it is affixed, it generates electrical energy from the movement. Because organ movements occur as pulses, the team had to include energy storage in their creation

so that electricity could be delivered continually. They accomplished this by building in a tiny chip-scale, commercially available, battery into the device.

“The heart is a great place to do mechanical energy-harvesting because it is constantly in motion. One of the challenges, though, with the heart, is that any constraint you apply to its natural motion by gluing a device onto its surface can cause all kinds of adverse reactions in the way that the heart is beating,” Rogers explained. “That requires you to engineer the device so that it’s not just flexible, but ultra-flexible, so that the action of the heart is unaltered by the

SPECIAL REPORT: Powering Future Medical Devices integration of the device onto the organ.”

The researchers grew rat smooth muscle cells on the devices to make sure they were not toxic, and measured flexibility over 20 million cycles of mechanical testing. They showed that bending and unbending of the device generated enough energy to charge a 3.8-volt battery. The team attached the devices in vivo to the hearts, diaphragms, and lungs of cows, sheep, and pigs using sutures, and determined that movement of these organs was not disrupted by the device and could be converted to voltage when the chest cavities were both open and closed. In vivo, the devices generated enough energy to power a human pacemaker.

The team found through testing that their system could deliver 0.2 microwatts per square centimeter of stable electricity over 20 million cycles. Voltage and current outputs, they write, were three to five orders of magnitude higher than previous experiments. These results, the team concluded, demonstrate that their system could power implants like pacemakers with or without batteries.

Though the successful use of energyharvesting devices in human-scale animal models represents a huge step forward, clinical use is still likely several years away.

“We know we can generate power at a

practical level. We know that these things can work on an animal model heart at the human-scale without any problems,” said Rogers, but “the evaluations up to this point have not involved long term studies.” He added that testing the longevity of the devices and their integration with the heart could reveal any deficiencies. “I don’t think we’ll see problems, but you have to go through that process to find out.”

The authors see huge potential in their device, both inside and outside the human body.

“Cardiac and lung motions, in particular, serve as inexhaustible sources of energy during the lifespan of a patient,” they write. “In addition to uses on internal organs, the same types of system can be implemented in skin-mounted configurations for health/wellness monitors or non-biomedical devices. The potential to eliminate batteries or, at least, the need to replace them frequently represents a source of motivation for continued work in these and related directions.”[1] A European consortium of researchers, led by CEA-Leti in France, is also developing a low-power cardiac pacemaker, operating at 5 µW instead of 25 µW, powered by energy generated by the patient’s heartbeats. Eliminating the battery avoids having to replace it every five to ten years. It

also means the device can be made smaller.

The team is aiming, eventually, to reduce the size of the cardiac stimulator eight-fold to less than 1 cm³. This would enable it to be implanted directly onto the epicardium, obviating the need to attach a lead into the heart through a vein. The consortium is investigating both piezoelectric and electrostatic (electrets) techniques for the mechanical to electrical conversion process, harvesting power in the 20 Hz region.

Initially, the techniques are expected to provide an output power of around 10 µW, via a power-conversion circuit.

1 C. Dagdeviren et al., 2014. “Conformal piezoelectric energy harvesting and storage from motions of the heart, lung, and diaphragm,” PNAS, doi/10.1073/pnas.1317233111. n

Future Artificial Muscles and Machines to be Fueled by Water Artificial muscles powered by bursts of electricity generated from water could lead to moving machines fueled solely by evaporating sweat.

The generators developed by MIT researchers are based on strong, flexible films that perform as actuators, or artificial muscles. These films expand when they absorb water and contract when they expel it.

Made of two organic polymers, polypyrrole and polyol-borate, these artificial muscles generate significantly more force when exposed to water than comparable actuators, which are typically made from just one kind of material. Films composed of the two polymers that are just 15-40 microns thick — about onesixth to two-fifths the width of a human hair — can lift objects 380 times heavier than themselves and transport cargo 10 times heavier than themselves.

When these films are placed on flat moist surfaces, such as sheets of wet paper, they swell and curl up. However, they dry quickly

via evaporation at room temperature — in just a few seconds when on wet paper, and in just a minute or two if they get completely soaked and then removed from water. A quick drying time helps the film absorb water again, enabling the cycle to start all over. For as long as the paper emits water vapor, the film continues to dance.

"When we made this material, we found it moved automatically on human hands," says researcher Mingming Ma, a chemist at MIT. “That was an interesting phenomenon, which we thought could lead to something.”

In order to convert this motion into electricity, the researchers next coated these artificial muscles with nine-micron-wide layContinued on page 40

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ers of a piezoelectric material, polyvinylidene difluoride, which converts this constant mechanical stress to electrical energy. As such, when the actuators flexed in response to moisture, they generated roughly three bursts of electricity every 10 seconds, with a peak voltage of about one volt.

"Potential commercial applications include large-scale watervapor power generators or small generators to power wearable

electronics," Ma says. One might imagine large-scale power generators placed above lakes or rivers, he says, and small-scale generators attached to clothing, where the mere evaporation of sweat could fuel devices such as wearable blood pressure and heart rate sensors. Even tinier generators could help power microelectrical mechanical systems (MEMS) or nanoelectronics.

Full article citation: Ma, et al. 2013. Bio-Inspired Polymer Composite Actuator and Generator Driven by Water Gradients. Science Vol. 339 no. 6116 pp. 186-189. n

Implantable Fuel Cell Could Power Neural Prosthetics to Help Regain Control of Limbs MIT engineers have developed a fuel cell that runs on the same sugar that powers human cells: glucose. This glucose fuel cell could be used to drive highly efficient brain implants of the future, which could help paralysed patients move their arms and legs again.

The fuel cell, described in the June 12 edition of the journal PLoS ONE, strips electrons from glucose molecules to create a small electric current. The researchers, led by Rahul Sarpeshkar, an associate professor of electrical engineering and computer science at MIT, fabricated the fuel cell on a silicon chip, allowing it to be integrated with other circuits that would be needed for a brain implant.

The idea of a glucose fuel cell is not new: In the 1970s, scientists showed they could power a pacemaker with a glucose fuel cell, but the idea was abandoned in favor of lithium-ion batteries, which could provide significantly more power per unit area than glucose fuel cells. These glucose fuel cells also utilised enzymes that proved to be impractical for long-term implantation in the body, since they eventually ceased to function efficiently.

The innovation of the MIT fuel cell is that it is fabricated from silicon, using the same technology used to make semiconductor electronic chips. The fuel cell has no biological components: It consists of a platinum catalyst that strips electrons from glucose, mimicking the activity of cellular enzymes that break down glucose to generate ATP, the cell’s energy currency. (Platinum has a proven record of long-term biocompatibility within the body.) So far, the fuel cell can gen-

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erate up to hundreds of microwatts— enough to power an ultra-low-power and clinically useful neural implant.

“It will be a few more years into the future before you see people with spinal-cord injuries receive such implantable systems in the context of standard medical care, but those are the sorts of devices you could envision powering from a glucose-based fuel cell,” says Benjamin Rapoport, a former graduate student in the Sarpeshkar lab and the first author on the new MIT study.

Rapoport calculated that in theory, the glucose fuel cell could get all the sugar it needs from the cerebrospinal fluid (CSF) that bathes the brain and protects it from banging into the skull. There are very few cells in the CSF, so it’s highly unlikely that an implant located there would provoke an immune response. There is also significant glucose in the CSF, which does not generally get used by the body.

Since only a small fraction of the available power is utilised by the glucose fuel cell, the impact on the brain’s function would likely be small.

Karim Oweiss, an associate professor of electrical engineering, computer science and neuroscience at Michigan State University, says the work is a good step toward developing implantable medical devices that don’t require external power sources.

“It’s a proof of concept that they can generate enough power to meet the requirements,” says Oweiss, adding that the next step will be to demonstrate that it can work in a living animal.

A team of researchers at Brown University, Massachusetts General Hospital and other institutions recently demonstrated that paralysed patients could use a brainmachine interface to move a robotic arm; those implants have to be plugged into a wall outlet.

Mimicking Biology with Microelectronics

Sarpeshkar’s group is a leader in the field of ultra-low-power electronics, having pioneered such designs for cochlear implants and brain implants. “The glucose fuel cell, when combined with such ultra-low-power electronics, can enable brain implants or other implants to be completely self-powered,” says Sarpeshkar, author of the book “Ultra Low Power Bioelectronics.” This book discusses how the combination of ultra-lowpower and energy-harvesting design can enable self-powered devices for medical, bio-inspired and portable applications.

Sarpeshkar’s group has worked on all aspects of implantable brain-machine interfaces and neural prosthetics, including recording from nerves, stimulating nerves, decoding nerve signals and communicating wirelessly with implants.

One such neural prosthetic is designed to record electrical activity from hundreds of neurons in the brain’s motor cortex, which is responsible for controlling movement. That data is amplified and converted into a digital signal so that computers—or in the Sarpeshkar team’s work, brain-implanted microchips—can analyse it and determine which patterns of brain activity produce movement.

The fabrication of the glucose fuel cell was done in collaboration with Jakub Kedzierski at MIT’s Lincoln Laboratory.

SPECIAL REPORT: Powering Future Medical Devices “This collaboration with Lincoln Lab helped make a long-term goal of mine— to create glucose-powered bioelectronics—a reality,” Sarpeshkar says. Although he has just begun working on bringing

ultra-low-power and medical technology to market, he cautions that glucose-powered implantable medical devices are still many years away.

The original article from MIT News can be read online at: www.newsoffice.mit. edu/2012/glucose-fuel-cell-0612 n

Prototype Batteries that Dissolve Safely in the Body Could Power Ingested Devices Batteries made from pigments found in cuttlefish ink may lead to edible, dissolvable power sources for new kinds of medical devices.

Researchers led by Carnegie Mellon University (CMU) materials scientist Christopher Bettinger demonstrated the new battery.

“Instead of lithium and toxic electrolytes that work really well but aren’t biocompatible, we chose simple materials of biological origin,” Bettinger says.

Conventional battery materials are not safe inside the body unless they’re encased in bulky protective cases that must eventually be surgically removed. Electronics that can either be swallowed or implanted in the body without causing harm could monitor wound healing and disease progression, release drugs, and enable more sensitive neural and cardiovascular sensors and stimulators.

The prototype sodium-ion battery from the CMU researchers uses melanin from cuttlefish ink for the anode and manganese oxide as the cathode. All the materials in the battery break down into nontoxic components in the body.

The CMU group developed the battery as part of its work with edible electronics that can be swallowed like pills. These elec-

tronic medicines could let doctors deliver sensitive protein drugs - which are ordinarily destroyed in the stomach - orally rather than by injection. This could make therapies such as arthritis drugs that currently have to be given intravenously at the hospital much easier to take. Smart pills, says Bettinger, could carry sensors and circuits and release drugs only after they’ve passed the harsh environment of the stomach and reached the intestine, where the drugs would be absorbed into the body. Edible electronics could also be used by athletes to monitor their core body temperature and other body metrics.

By incorporating edible, biodegradable power sources the scope for this type of technology is considerably widened. The melanin batteries don’t match the performance of lithium-ion batteries, but they don’t have to in order to be useful, says Bettinger. The prototypes, described in the journal Proceedings of the National Academy of Sciences, currently provide enough power to run simple sensors. Bettinger says they’re working to improve their power output and storage capacity by experimenting with different forms of melanin.

The original article can be viewed online at: www.technologyreview. com/news/522581/biodegradable-batteries-to-power-smart-medicaldevices n

Battery-Free Energy Harvesting Chips Medical device components that complement energy-harvesting processes can effectively improve the capacity and efficiency of a solution.

In 2013 Texas Instruments (TI) introduced five new next-generation power management integrated circuits (PMICs) that efficiently acquire and manage microwatts (uW) to milliwatts (mW) of power harvested from ambient light, heat or mechanical energy sources. The components maintain the industry's lowest levels of active quiescent current to enable battery-free operation of wireless sensor networks, monitoring systems, wearable medical devices, mobile accessories and other applications with limited access to power.

PMICs are integrated circuits (or a system block in a system-on-a-chip device) for managing power requirements of the host system. A PMIC is often included in battery operated devices such as mobile phones.

These components include a boost charger with integrated buck converter which features maximum power point tracking to extract and manage power from photovoltaic cells and thermoelectric generators, and supports any energy storage element, such as a rechargeable Li-ion battery, thin film battery, supercapacitor or conventional capacitor. The device is designed to consume just 488nA of quiescent current and achieve greater than 90% efficiency at output currents lower than 10uA.

These PMICs also feature an autonomous power multiplexor gate drive that enables faultless system operation from energy-harvesting sources and the primary battery, ensuring constant power is available when the system needs to operate, even when no energy is available from the harvester.

The ability to incorporate advanced complementary components that support energy-harvesting methods, allows designers to develop devices that optimise the levels of available ambient energy capture. This ultimately results in devices that operate with greater efficiency and reduced dependency upon alternative energy sources. n

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SPECIAL REPORT: Powering Future Medical Devices

Body Heat as a Plausible Power Source for Wearable and Medical Devices Embedding a thermoelectric generator (TEG) in a biological body is a promising way to supply electronic power in the long term for an implantable medical device (IMD). It can resolve the service life mismatch between the IMD and its battery.

Exploiting body heat to power electronic devices is an obvious candidate for energy-harvesting. Miniature thermoelectric generators (TEGs), that produce energy from the temperature differential between the skin and the outside air, are already being used to run e-health devices such as blood sugar monitors, and to power sports and fitness equipment. For medical implants, the challenge is to generate energy internally.

Chip-based TEGs are now envisioned that can be inserted under the skin, or in the skull, exploiting the small temperature differences between the brain and skin tissue. In theory, enough energy can be produced to power neurotechnological implants.

In a recent paper published in The Journal of Medical Devices (Dec, 2013)[1] researcher Yang Yang demonstrated a working prototype, which consists of an implanted TEG and a specified boosted circuit. Two implanted TEG modules were constructed and a boosted circuit with a highly integrated DC/DC converter was fabricated to stabilise the energy output and improve the voltage output for the implanted TEG.

systems, also has to be considered.

Whilst the use of TEGs for in vivo applications is still in the early phases of development, the use of TEGs for wearable sensors and devices is becoming more commonplace. A number of commercial solutions are currently available that can be incorporated into the design of wearable monitoring devices.

Laird Technology produces a device that is not much bigger than a piece of confetti. In low-grade thermal environments, the eTEG generates micro-watts of power - enough thermal energy conversion to power remote sensors and other distributed devices. The thin film thermoelectric material delivers a miniaturised thermoelectric generator (eTEG) with a high output power density. Five to twenty times thinner than conventional bulk thermoelectrics, Laird’s thin-film thermoelectric materials can convert waste heat into electrical power using a thin, nanoscale material which enables it to be used in situations where standard bulk thermoelectric devices and other energy scavenging or energy reclamation systems cannot be applied.

1 Yang, et al, 2013. A Prototype of an Implantable Thermoelectric Generator for Permanent Power supply to Body Inside a Medical Device. Journal of Medical Devices 8 (1) 014507. n

According to the experiments, such a device combination was capable of supporting a clock circuit in an in vivo rabbit where the power consumption is much higher than an ordinary cardiac pacemaker. This study is expected to serve as a valuable reference for future designs of the implanted TEG and its boosted circuit.

Practical issues such as tissue heating, biocompatibility, hygiene, safety, and reliability are critical considerations in this field, and significant additional work is required to test the feasibility of such components. Compatibility, or at least non-interference with medical equipment such as MRI scanners and radiotherapy

Energy Harvesting from Jaw Movement to Power Hearing Aids As alternatives to batteries, energy harvesting technologies are increasingly gaining interest. Energy harvesters, which are able to recover small amounts of energy from external sources such as solar power, thermal energy, or the human body, are usually suitable for low power portable or wearable devices.

Hearing aids are among wearable medical devices which have been substantially modified in recent years and are

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becoming less energy consuming.

Therefore, energy harvesting could be successfully applied to them. In addition to hearing aids, other types of inear devices such as electronic hearing protectors and communication earpieces could also benefit from energy harvesting technologies.

Researchers at École de Technologie

SupĂŠrieure are investigating energy harvesting to power hearing aids.

This research project to replace hearing aid batteries by energy harvesting technologies is important for Dr. Aidin Delnavaz, a postdoc researcher working on this project. It reminds him of his grandmother who suffers from hearing loss and hardly goes anywhere without her hearing aids. "She always complained

SPECIAL REPORT: Powering Future Medical Devices about her unit because of problems caused by batteries. Sometimes these hearing aids fail at parties, family evenings or during telephone conversation" explains Dr. Delnavaz.

cation significantly restricts their widespread use.

Energy harvesting technologies for hearing aids

The challenge of this project was to find a source of energy close to the ear canal to recharge the hearing aid. The ear canal is a dynamic environment. Indeed, opening the mouth contracts the face muscles and pulls the lower jaw down.

Since the lower jaw is articulated to the head very close to the ear canal, its displacement deforms the soft tissue of the ear canal wall. Therefore, in each cycle of opening and closing the mouth, the ear canal deforms and then returns to its pre-deformed shape. This cycle occurs thousands of times during a day while chewing, eating or speaking and can be considered as a source of energy for hearing aids. The magnitude of ear canal deformation varies among individuals.

We could measure it by comparing 3D images of ear impressions at two extents of the jaw excursion: open jaw and closed jaw.

The researchers have started by considering different sources of energy. Since the user wears the hearing aid, one possible power source would be the user and another would be the user's environment. Several innovative ideas have been recently proposed to use energy harvesting to power hearing aids. Light, body heat, electromagnetic waves, speaker vibrations, and radio frequency waves are sources of energy which have been already proposed for this application.

Among the patented technologies, a solar charging system is the only commercially available product on the market. It is composed of a charger unit with photovoltaic panels for recharging hearing aid batteries. The solar recharging system is very useful for the people who live in the areas where access to electric power is limited or expensive.

While the hearing aid solar charger is an improvement, its battery power capacity is still limited and users must always rely on a solar charger, which is cumbersome and inconvenient. Some disadvantages can be assumed for other above-mentioned inventions that place them in an unfavorable position. For example, using photosensitive surfaces directly on the shell of the hearing aid requires more exposed external sections in order for the photocell to produce electrical current when exposed to ambient light. In practice however, hearing-aid users frequently request that the device be completely in the ear canal (CIC), that is, not visible from the outside: this reduces sunlight exposure to the point of discouraging the use of solar power for hearing aids. The main drawback of the thermoelectric system is that its thermal efficiency is highly influenced by ambient temperatures and radically drops in warmer environment. In case of energy harvesting from ambient radiations such as electromagnetic or infrared, their fundamental dependency upon the amount of energy available in the area of appli-

Ear canal dynamic motion

An experimental setup has been subsequently developed to measure the energy capacity of the ear canal dynamic motion and its capability to power hearing aids. The instantaneous power and the total energy produced by the ear canal dynamic motion during eating a medium size hamburger was measured.

It is estimated that approximately 7mJ of energy per day is available from ear canal dynamic motions. This amount of energy can power a 1mW-hearing aid for more than 2 hours.

Energy harvester The objective of the invention is to provide an in-ear technology for harvesting energy from the ear canal dynamic motions in order to power electronic circuits of hearing aids. Therefore, the desirable hearing device must be capable of being adapted to be placed inside the ear canal and having the contour of the ear canal wall.

Fortunately, Sonomax Technologies Inc., a Quebec company specialised in hearing protection technologies and the industrial partner of the laboratory at ÉTS, has a patented technology based on inflatable earpieces to make a pair of custom-

fitted ear plugs only in 5 minutes. An advantage of our invention is integrating the energy harvesting module into this custom-fitted earpiece to provide a platform in which the required electronic components (for example a microphone, a digital signal processor and a speaker in case of the hearing aid) can be added to form a custom-fitted self-powered in-ear device. Another advantage is that the energy harvesting module is essentially transparent to the user of the in-ear device, that is, there is no electrical connection extending out from the in-ear device, no battery to periodically replace, no significant weight added to the in-ear device, etc. Also, the energy harvester device allows the electronic components to be powered on purpose by a jaw-joint activity, such as chewing gum, eating a solid meal, etc.

In one embodiment of this invention, the energy harvesting module consists of a flexible piezoelectric film. It is formed in a hollow cylindrical shape and is adapted for being embedded inside the settable area of the in-ear device between a rigid core and the sheath. The settable area receives silicon medical rubber that remains generally flexible once set so as to transmit the dynamic motion of the ear canal wall to the energy harvesting module. The film electrodes are connected to a power management unit which is responsible to receive produced charges, store them and supply the power demanded by the electronic components.

Read more at www.energyharvestingjournal. com n

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SPECIAL REPORT: Powering Future Medical Devices

New Thermoelectric Generator Could Power Wearables in the Future “For our case, the glass fabric itself serves as the upper and lower substrates of a TE generator, keeping the inorganic TE materials in between. This is quite a revolutionary approach to the design of a generator. In so doing, we were able to significantly reduce the weight of our generator (~0.13g/cm2), which is an essential element for wearable electronics.”

A newly developed thin, flexible patch that converts body heat into electricity, has the possibility to provide wearable electronic devices with self-generating capabilities to significantly improve battery-life in the future, or potentially negate the need for them entirely.

Patches that generate power from heat have been developed in the past, but this newest version from the Korea Advanced Institute of Science and Technology (KAIST) combines the essential features necessary to create a patch that maximises power output while still remaining thin and flexible. Both of these characteristics are critical for a patch meant to be worn on the skin.

The patch is made from glass fibers woven together to form a sheet. Pastes that can convert heat into electricity by exploiting the temperature difference between a person’s skin and surrounding air are pressed down into the fabric. The glass fabric is much lighter than materials like ceramics and alumina that are more traditionally used to hold the pastes.

For electronics to be worn by a user, they must be light, flexible, and equipped with a power source, which could be a portable, long-lasting battery, or no battery at all, but a generator. How to supply power in a stable and reliable man-

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ner is an essential practicality for commercial wearable devices.

A team of KAIST researchers headed

by Byung Jin Cho, a professor of electrical engineering, proposed a solution to this problem by developing a glass fabric-based thermoelectric (TE) generator that is extremely light and flexible and produces electricity from the heat of the human body. In fact, it is so flexible that the allowable bending radius of the generator is as low as 20 mm. There are no changes in performance even if the generator bends upward and downward for up to 120 cycles.

Professor Cho comments on the new concept and design technique to build a flexible TE generator that minimises thermal energy loss but maximises power output.

When using KAIST’s TE generator (with a size of 10 cm x 10 cm) for a wearable wristband device, it will produce around 40 mW electric power based on the temperature difference of 31 °F between human skin and the surrounding air.

Battery-life and power sources are often the ‘achilles heel’ of many wearable medical devices. The wearable electronics industry is in pursuit of battery and power technology that can vastly extend the life of personal electronics. Right now, it is impossible to build a sophisticated mobile device that can remain on and under a heavy computing load without draining the battery before the day is up. As a result, devices like Google Glass need to switch between “on” and “idle,” diminishing their usefulness. Developments like this patch and other selfgenerating technologies could someday reduce devices’ reliance on batteries or eliminate it altogether.

More information on this research can be found on the KAIST website at: http://www.kaist.edu/html/en/ n

SPECIAL REPORT: Powering Future Medical Devices

Innovative Method to Transfer Energy to Medical Chips Deep in the Body A Stanford electrical engineer has invented a way to wirelessly transfer power deep inside the body, and then use this power to run tiny electronic medical devices such as pacemakers, nerve stimulators or new sensors yet to be developed.

The discoveries reported in the May 19th edition of the Proceedings of the National Academy of Sciences culminate years of efforts by Ada Poon, assistant professor of electrical engineering, to eliminate the bulky batteries and clumsy recharging systems that prevent medical devices from being more widely used.

The technology could provide a path toward a new type of medicine that allows physicians to treat diseases with electronics rather than drugs.

“We need to make these devices as small as possible to more easily implant them deep in the body and create new ways to treat illness and alleviate pain,” said Poon.

Poon’s team built an electronic device smaller than a grain of rice that acts as a pacemaker. It can be powered or recharged wirelessly by holding a power source about the size of a credit card above the device, outside the body.

New generation of sensors The central discovery is an engineering breakthrough that creates a new type of wireless power transfer – using roughly the same power as a cell phone – that can safely penetrate deep inside the body. As Poon writes, an independent laboratory that tests cell phones found that her system fell well below the danger exposure levels for human safety.

Her lab has tested this wireless charging

system in a pig and used it to power a tiny pacemaker in a rabbit. She is currently preparing the system for testing in humans. Should such tests be approved and prove successful, it would still take several years to satisfy the safety and efficacy requirements for using this wireless charging system in commercial medical devices.

Poon believes this discovery will spawn a new generation of programmable microimplants – sensors to monitor vital functions deep inside the body; electrostimulators to change neural signals in the brain; and drug delivery systems to apply medicines directly to affected areas.

Drug therapy alternatives William Newsome, director of the Stanford Neurosciences Institute, said Poon’s work created the potential to develop “electroceutical” treatments as alternatives to drug therapies. Newsome, who was not involved in Poon’s experiments but is familiar with her work, said such treatments could be more effective than drugs for some disorders because electroceutical approaches would use implantable devices to directly modulate Continued on page 46

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SPECIAL REPORT: Powering Future Medical Devices Continued from page 45

activity in specific brain circuits. Drugs, by comparison, act globally throughout the brain.

“To make electroceuticals practical, devices must be miniaturised, and ways must be found to power them wirelessly, deep in the brain, many centimeters from the surface,” said Newsome, the Harman Family Provostial Professor and professor of neurobiology at Stanford.

He added, “The Poon lab has solved a significant piece of the puzzle for safely powering implantable microdevices, paving the way for new innovation in this field.”

How it works The article describes the work of Poon’s interdisciplinary research team that included John Ho and Alexander Yeh, electrical engineering graduate students in Poon’s lab; Yuji Tanabe, a visiting scholar; and Ramin Beygui, associate professor of cardiothoracic surgery at Stanford University Medical Center.

The crux of the discovery involves a new way to control electromagnetic waves inside the body.

Electromagnetic waves pervade the universe. We use them every day when we broadcast signals from giant radio towers, cook in microwave ovens or use an electric toothbrush that recharges wirelessly in a special cradle next to the bathroom sink.

Before Poon’s discovery, there was a clear divide between the two main types of electromagnetic waves in everyday use, called far-field and near-field waves.

Far-field waves, like those broadcast from radio towers, can travel over long distances. But when they encounter biological tissue, they either reflect off the body harmlessly or get absorbed by the skin as heat. Either way, far-field electromagnetic waves have been ignored as a potential wireless power source for medical devices.

Near-field waves can be safely used in wireless power systems. Some current medical devices like hearing implants use near-field technology. But their lim-

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itation is implied by the name: They can transfer power only over short distances, limiting their usefulness deep inside the body.

What Poon did was to blend the safety of near-field waves with the reach of far-field waves. She accomplished this by taking advantage of a simple fact–waves travel differently when they come into contact with different materials such as air, water or biological tissue.

For instance, when you put your ear on a railroad track, you can hear the vibration of the wheels long before the train itself because sound waves travel faster and further through metal than they do through air.

With this principle in mind, Poon designed a power source that generated a special type of near-field wave. When this special wave moved from air to skin, it changed its characteristics in a way that

enabled it to propagate – just like the sound waves through the train track.

She called this new method mid-field wireless transfer.

In the experiment, Poon used her midfield transfer system to send power directly to tiny medical implants. But it is possible to build tiny batteries into microimplants, and then recharge these batteries wirelessly using the mid-field system. This is not possible with today’s technologies.

Co-author Ho noted, “With this method, we can safely transmit power to tiny implants in organs like the heart or brain, well beyond the range of current nearfield systems.”

Further details are available online at: www.pnas.org/content/ early/2014/05/14/1403002111.abstract n

SPECIAL REPORT: Powering Future Medical Devices

Energy Harvesting Materials for Wearables and Smart-Textiles Targeted by Ground-breaking European Study

Micro devices which can harvest, conduct and store energy within a strong, flexible, wearable material are being developed in a study led by German applied and industrial contract research specialist institute Fraunhofer IZM, which includes Imperial College London among its partners.

The EU funded project is called MATFLEXEND (MATerials for FLEXible ENergy harvesting Devices) and is developing integrated micro batteries and tiny “capacitive harvesters” which

convert energy from mechanical to electric form. They can be turned into printable inks and easily manufactured as integrated, energy harvesting devices, combining energy conversion and storage in a single unit.

There are countless application areas for the technology, including wearables and medical sensing.

The technology’s USP is likely to be its innovative capacitive converter which exploits “deformation” and so permits converting mechanical energy into

usable electricity. Its energy storage is also enhanced by a flexibly designed lithium-ion battery design.

The team are busy optimising superior energy conversion efficiency and mechanical compliance. They're also working hard to minimise production costs, with the aim of making the technology suitable for mass-market manufacturing.

For more information visit www.matflexend.eu n

Superelastic Battery Research Lithium ion batteries that can be stretched by 600% have been unveiled by scientists in China. In the future, the fibre shaped batteries could be woven into textiles to satisfy the ever-growing requirement for wearable devices.

for small, lightweight, wearable electronics. ‘Our fibre-shaped batteries can easily be scaled-up to an appropriate length and woven into clothing that can adapt to the body’s movement,’ says Peng.

Huisheng Peng and colleagues at Fudan University made the superelastic batteries by winding two carbon nanotubes–lithium oxide composites yarns, which served as the positive and negative electrodes, onto an elastomer substrate and covering this with a layer of gel electrolyte. The batteries owe their stable electrochemical performance under stretching to the twisted structure of the fibre electrodes and the stretchability of the substrate and gel electrolyte, with the latter also acting as an anchor.

When the batteries were stretched, the spring-like structure of the two electrodes was maintained.

The battery recorded a specific capacity of 91.3mAh/g and this was maintained at over 88% after stretching by 600%.

Previous stretchable batteries have generally been produced in a planar format, which has been an obstacle for their development

Ray Baughman, an electrochemical device expert at the University of Texas at Dallas, US, says the superelasticity achieved for the operating battery is fascinating. ‘A future challenge will be to dramatically increase the volume fraction of energy-storing material in the total elastomeric structure and to the decrease overall diameter to those conventionally used for weaving, while still maintaining a useful degree of rubber-like elasticity.’

Source: Royal Society of Chemistry n

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Innovative Initiative Opens Door to Wealth of FDA's Publicly Available Data

Innovative Initiative Opens Door to Wealth of FDA’s Publicly Available Data OpenFDA is the recently launched initiative from the FDA Office of Informatics and Technology Innovation (OITI), which has been specifically designed to make it easier for developers, researchers, and the public to access and use the many large, important, health datasets collected by the agency.

These publicly available datasets, once successfully integrated and analysed, can provide knowledge and insights that cannot be gained from any other single source.

The platform has been developed to provide API and raw download access to a number of high-value structured datasets. Currently in public beta the platform at this time features just the one dataset, based upon the extensive FDA’s publicly available drug adverse event reports. The database contains millions of adverse event and medication error reports submitted to the FDA, covering all regulated drugs.

by the FDA and a place for the community to interact with each other and FDA domain experts, with the goal of spurring innovation around FDA data.

Researchers, scientists, software developers, and other technically-focused individuals in both the private and public sectors have always been invited to mine the publicly available datasets to educate consumers, which in turn can further regulatory or scientific missions, and ultimately, save lives. But obtaining this information hasn’t always been easy.

Future datasets will include:

In the past, these vast datasets could be difficult for industry to access and to use.

Pharmaceutical companies, for example, send hundreds of Freedom of Information Act (FOIA) requests to FDA every year because that has been one of the ways they could get this data. Other methods called for downloading large amounts of files encoded in a variety of formats or not fully documented, or using a website to point-and-click and browse through a database – all slow and labour-intensive processes.

Recalls - Enforcement Report and Product Recalls Data, containing information gathered from public notices about certain recalls of FDA-regulated products Documentation - Structured Product Labeling Data, containing detailed product label information on many FDAregulated product

OpenFDA makes the data publicly available, in a structured, computer-readable, format. It provides a “search-based” Application Programming Interface - the set of requirements that govern how one software application can talk to another – that makes it possible to find both structured and unstructured content online.

It is hoped that the project will provide a platform for public challenges issued

Software developers can now build their own applications (such as a mobile

phone app or an interactive website) that can quickly search, query or pull massive amounts of public information instantaneously and directly from FDA datasets in real-time on an “as-needed” basis.

Additionally, with this approach, applications can be built on one common platform that is free and open to use.

Drug adverse events is the first dataset – with reports submitted from 2004 through 2013 available now.

Using this data, a mobile developer could create a search app for a smartphone, for example, a consumer could then use to determine whether anyone else has experienced the same adverse event they did after taking a certain drug.

As the FDA focus on making existing public data more easily accessible, and providing appropriate documentation and examples to developers, they have emphasised the importance that they will not release any data that could be used to identify individuals or reveal other private information.

OpenFDA is deployed on FDA’s new Public Cloud Computing infrastructure enabled by OITI, and will serve as a pilot for how the FDA can interact internally and with external stakeholders, spur innovation, and develop or use novel applications securely and efficiently.

For more information and to gain access to the datasets visit: www.open.fda.gov n

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Global Reach Our readers come from all around the world, although the majority are based in the UK, North American and European markets.

Targeted Professional Audience

Our current subscriber base is representative of the whole mHealth and Digital Health industries with readers including: Doctors, Healthcare professionals, Government, Business professionals, NGO's and many others.

Advertising

Marketing Opportunities Let us help you to deliver information on your product and solutions to a global audience of digital healthcare professionals.

We have a whole range of advertising formats available across our publications and online channels, with prices to suit all budgets. Please contact us for more information.

Content Publishing Program We can publish your educational white papers, case studies, and research reports in The Journal of mHealth. We can work with you to develop engaging, creative, and informative content that will help promote the results of your work, to a targeted audience of industry professionals.

Our readers appreciate thought-provoking white papers that educate and inform in order to expedite their decision-making process. Publishing credible, quality white papers in The Journal of mHealth will ensure that your potential clients will refer to them frequently as valued resources.

Our publishing programs all include an integrated marketing plan to ensure that your content gets high exposure.

Please contact us for more information.

We regularly work with digital health solution providers to develop marketing packages that can help significantly raise awareness of a solution and provide targeted industry coverage.

To discuss how we can help you, please get in touch.

Report Sponsorship We aim to provide a variety of library resources for our readers, and our report program is very well respected and followed within the industry. We publish a range of reports throughout the year on topics relating to many different aspects of the mHealth and Digital Health sectors.

We often collaborate with commerical partners on these reports, to gain additional insight and expertise.

A number of our reports are available for sponsorship. Please contact us for more information.

The

Journal of mHealth The Global Voice of mHealth