Wearable devices are increasingly becoming an integral part of healthcare and wellness industry. Pharmaceutical companies have moved beyond using wearable devices for clinical trials and apart from recording signs and symptoms, ensuring adherence to treatments too can be one of the important objectives. In commercial operations, the use of wearable devices can help drive sales. As a consequence, the pharmaceutical industry has seen increasing growth in partnerships between drug makers, technology companies and patient groups.

The use of wearables is going to shape the future of product sales and marketing. According to a report released by Transparency Market Research, a leading U.S. based market research and analysis firm, the global wearable technology market will make further gains at a CAGR (Compound Annual Growth Rate) of 40.8% from 2012 to 2018. The value of the global wearable technology market in 2018 is expected to be U.S. $5.8 billion, an increase of close to 800% on its 2012 value (U.S. $750 million)

It is interesting to note that wearable technology is increasingly popular with youngsters. Nielsen, a leading global information & measurement company that provides market research, insights & data, states that nearly 48% of wearable owners are between the age group of 18 and 34 years..

What Is Wearable Technology?

Most people think of wearables as devices that are usually worn on the wrists, like a Fitbit that allow continuous monitoring as well as recording of basic health parameters such as number of steps or distance, calories burnt and heart rate. But in reality, wearable devices can and does include items such as glasses (Google Glass), jewelry and clothing worn on or around the body that incorporates sensors and associated electronic technologies.

Also, wearables aren't limited to counting steps or measuring the heartbeat. They are versatile devices that not only track a person's activity levels but can also influence consumer behavior and even motivate them to make healthier lifestyle choices.4 In the disease management space, wearables can provide alerts for dosing times, monitor symptoms for chronic ailments and provide you with a customized fitness goal.

What Role Will Wearables Play In The Pharmaceutical Industry?

As Brian Williams, director at PwC (PricewaterhouseCoopers) puts it, "Some biopharma companies are beginning to realize the potential ramifications to their business that wearables can bring, and they are starting to explore with pilots and new technologies".

Companies are keenly tapping into technology to expedite the expansion or innovation of their business models to seize value beyond varied episodes of care. The aggregated data collected through wearables can bring value to both physicians and care providers. Insurance companies can collect important data and current health trends regarding medications and drug adherence from the data collected from patient wearables.

The disproportionate information that existed traditionally between the doctor and patient is collapsing with increased adoption of wearables. The introduction of these digital technologies is making the patient more engaged and responsible for his/her care and will bring immense value in terms of long-term disease management.

To take advantage of these opportunities, pharmaceutical companies have begun partnering with large and small technology developers since these digital tech innovators are driving the trend for wearables.

A case in point is the table below that lists a few pharma pioneers that have actively adopted wearable tech to design customized solutions for improved patient care.

Company	Wearables and Apps	OS/Platforms	Functions	Implementation
Novartis	ViaOpta Nav App5	Apple iPhone and Android Mobile	Helps persons living with low vision increase mobility and regain independence.	Free download available App store in iTunes & Google Play
Novartis	ViaOpta Daily App5	Apple iPhone and Android Mobile	Personal assistant to help people with low vision with their everyday activities.	Free download available App store in iTunes & Google Play
Novartis	ViaOpta Simulator5	Apple iPhone and Android Mobile	The app provides a first-hand feel of what it is like to live with visual impairment.	Free download available App store in iTunes & Google Play
Novartis	Breezhaler(TM) inhaler6	Inhaler device to treat COPD	Next generation inhaler that provides patients with real time access to their inhalation use.	Launch in 2019.
GlaxoSmithKline	Vital Connect’s HealthPatch® MD 7		Used to continuously measure vital signs, electrocardiogram (ECG) data and activity levels.	Used in clinical trial setting in 2014.
GlaxoSmithKline	ActiGraph’s wGT3X-BT Monitor 7
Johnson and Johnson Health and Wellness Solutions	Intelligent virtual coaching solutions built on Patient Athlete™ program8	iPad® or iPhone®	Holistic virtual coaching and rehabilitation solutions striving to transform the patient experience and healthcare delivery model.	Available in iStore.
Empatica*	Embrace9	Apple iPhone (iOS 8.2 or higher) and Android Mobile (Android 5 or higher)	A consumer-looking, but medical-quality smart watch that helps predict epileptic seizures and measures stress, activity and sleep.	Available for online purchase.

Empatica is not a pharmaceutical company. But since they have developed a wearable that is of medical-quality, it has been included in this list

The Future of Wearables

Gadgets such as Google Glass exhibit great potential in diverse areas from surgery to telehealth. Many health care providers appreciate the idea of collecting and recording information over a period of time through a wearable device as this can provide them with a clearer picture of the patient's health than a single test

If I were to wear the thinking hat of Isaac Asimov, I can easily envision a future where patients walk into a drug store wearing their Google Glass and effortlessly check for dosage regimes, possible side effects and even get visual list of the medicines they need to purchase

In times to come, a wearable won't be merely a fun accessory, but rather a necessity and a healthy lifestyle choice. For example, the iTBraTM by Cyrcadia Health is a smart bra that is able to keep track of breast health.10 Similarly, the Leaf Healthcare Sensor (a wireless, single-use, disposable device that is adhered to a patient's chest) can help prevent bedsores. The Leaf Sensor monitors the patient's position, orientation, movement and activity. Care providers and physicians can remotely monitor the turning and mobility status for all patients through visual notifications

Advances in wearable technology will allow patients to seamlessly pass on health information to their doctors in real-time to discuss their condition and associated treatments. This can give a major boost to telemedicine by facilitating virtual appointments between patients and their health care providers.

Like companion diagnostics, people in the future could have companion wearables/ devices to accompany medicines. One example of this is the development of a match-stick sized mini-pump for the treatment of type 2 diabetes by Intarcia Therapeutics. This mini-pump (ITCA 650) can be placed subdermally in the patient once or twice a year for continual delivery of the diabetes treatment drug Exenatide. This has the potential to become the world's first and only injection-free glucagon-like peptide-1 (GLP-1) agonist.

Current Challenges with Using Wearables

 

Patient Willingness

While the number of people using fitness trackers is increasing, not everyone is tech savvy. There still appears to be some resistance among patients to engage with technology. Technology naive individuals may find it difficult to interpret or operate such digital tech. Consequently, wearable manufacturers would need to focus on making wearable usage as simple and the experience as engaging as possible.

Cost

The cost of wearables plays a vital role in influencing their purchase decisions. Wearable manufacturers would need to keep costs at reasonable levels to influence usage by patients and fitness enthusiasts. An affordable wearable could directly impact its usage in government healthcare plans or pharma business models aimed at improving drug compliance, adoption, and adherence.

Battery-Life

Most wearables that are available to the consumers have limited battery life. While there are a few wearables that have long-life batteries that need to be replaced after a year of use, a majority of the trackers need to be charged. For accurate real-time data collection, medical grade wearables must be capable of operating for prolonged periods without the need for frequent charging.

Privacy

Calculating the return on investment (ROI) of wearable technology is a major challenge that most companies struggle with. However, ensuring data privacy and regulation of the data captured isn't lagging too far behind.

Like with any other piece of technology, privacy and security are prime concerns with any wearable technology. Sensitive personal medical data will be transmitted wirelessly or via device applications to your personal mobile. Can the wearable be protected from malware and viruses? How can the data transmitted through wearables be made secure? These are some tough questions wearable manufacturers need to address.

FDA Approval for Medical Devices

The FDA's Center for Devices and Radiological Health takes keen interest in the advances and convergence of medical devices with connectivity and consumer technology. Does the wearable collect, analyze or share consumer information? Does the wearable diagnose or treat a specific disease of health condition? Patient data is personal information that needs to be protected. In order to safeguard patient data, certain laws have been set in place.

The data generated from the wearable may be subject to the following laws:

a) Health Insurance Portability and Accountability Act (HIPAA)

b) Federal Food, Drug and Cosmetic Act (FD&C Act)

c) Federal Trade Commission Act (FTC Act)

d) FTC's Health Breach Notification Rule

One could visit FDA's Mobile Health Apps Interactive Tool (https://www.ftc.gov/tips-advice/business-center/guidance/mobile-health-apps-interactive-tool) to learn about the different laws that govern patient data collection.

In a draft guidance issued in July 2016, FDA said that it doesn't plan to review low-risk "general wellness products", such as wearables or sleep trackers. The FDA will not require general wellness products to comply with premarket and postmarket regulatory requirements.

As per the guidance document, general wellness products such as wearables are exempt as long as they "are intended for only general wellness use and present a low risk to the safety of users and other persons."

The FDA defines general wellness products to be those with:

1. an intended use that's related to maintaining or encouraging a general state of health or a healthy activity; or,

2. an intended use that relates to the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

References

1. Healthcare and Medical to Remain Most Valuable End-use Segment in Global Wearable Technology Market, says TMR. http://www.transparencymarketresearch.com/pressrelease/wearable-technology-industry.htm (Accessed on 22 Nov 2016)

2. Tech-Styles: Are Consumers Really Interested In Wearing Tech On Their Sleeves? http://www.nielsen.com/us/en/insights/news/2014/tech-styles-are-consumers-really-interested-in-wearing-tech-on-their-sleeves.html (Accessed on 22 Nov 2016)

3. Sungmee Park, Jayaraman S. A transdisciplinary approach to wearables, big data and quality of life. Conf Proc IEEE Eng Med Biol Soc. 2014;2014:4155-8. doi: 10.1109/EMBC.2014.6944539. PubMed PMID: 25570907.

4. Piwek L, Ellis DA, Andrews S, Joinson A. The Rise of Consumer Health Wearables: Promises and Barriers. PLoS Medicine. 2016;13(2):e1001953. doi:10.1371/journal.pmed.1001953.

5. ViaOpta Official Website. http://viaopta-apps.com/ (Accessed on 22 Nov 2016)

6. Novartis Pharmaceuticals collaborates with Qualcomm in digital innovation with the Breezhaler(TM) inhaler device to treat COPD. https://www.novartis.com/news/media-releases/novartis-pharmaceuticals-collaborates-qualcomm-digital-innovation-breezhalertm (Accessed on 22 Nov 2016)

7. GlaxoSmithKline, Medidata partner on mHealth. Joint Initiative Evaluates Impact of mHealth and Cloud-Based Technologies on Patient Engagement, Data Quality and Operational Efficiencies in Clinical Trials. http://www.vitalconnect.com/news/glaxosmithkline-medidata-partner-on-mhealth (Accessed on 22 Nov 2016)

8. Johnson & Johnson Announces Formation of New Health and Wellness Platform Designed to Transform Health Care Delivery and Improve the Patient Experience. https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-formation-of-new-health-and-wellness-platform-designed-to-transform-health-care-delivery-and-improve-the-patient-experience (Accessed on 22 Nov 2016)

9. Empatica Official Website. https://www.empatica.com/about (Accessed on 22 Nov 2016)

10. Cyrcadia Health Official Website. http://cyrcadiahealth.com/ (Accessed on 22 Nov 2016)

11. Leaf Healthcare Official Website. http://leafhealthcare.com/ (Accessed on 22 Nov 2016)

12. ITCA 650. http://www.intarcia.com/pipeline-technology/itca-650.html (Accessed on 22 Nov 2016)