Get Ready for mHealth to Revolutionize the Device Market

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Applied Clinical Trials

Mobile health devices are poised to transform medical care-and with it the medical device market.

Mobile health devices are poised to transform medical care-and with it the medical device market.

mHealth devices including motion sensors, wearable heart and blood sugar monitors, and patient-reported outcome apps can provide a wealth of real-time patient data previously unavailable. When networked with electronic health records (EHR), advanced analytics, call centers, and telemedicine technologies, mHealth devices are making possible a complete redesign of patient care, an emerging model known as the continuous safety monitoring paradigm.

Instead of relying on periodic clinic checkups, mHealth allows continuous monitoring of patient vital signs, symptoms, and activity in the real world. The data can be used to adjust treatment for chronic conditions such as diabetes, heart failure and COPD, and monitor patients after surgery. This enables highly personalized care that is more responsive to patient needs, resulting in better clinical and functional outcomes. It also gives patients more control over their lives and their health.

The continuous safety monitoring care model will be a bonanza for medical device manufacturers. According to BCC Research, global mHealth revenues from mHealth devices will reach $46.2 billion by 2021.

Savvy medical device manufacturers have an opportunity to benefit by positioning themselves as early pioneers. However, mHealth device development involves many technical and economic challenges, and these must be addressed early in the development cycle. Among them:

Demonstrating value-Payers and regulators increasingly require device developers to demonstrate the benefits of their products in terms of how they improve patients’ lives, and their effect on patients’ need for other services. To address these requirements, device developers must think early in the development process about how they can demonstrate the value of mHealth products.

For example, payers might ask for evidence that a mobile network-connected spirometer not only accurately measures lung capacity, but also ensure that its use helps improve COPD or cystic fibrosis patients’ ability to do daily tasks such as walking to the grocery store, or that it reduces the need for emergency room or hospital treatment. In response, mobile device and app developers must think of their products in terms of how they can promote positive patient outcomes alone, and in combination with systems that enable continuous safety monitoring.

Validating new outcome measures-Realizing the promise of mHealth will require developing new outcome measures that quantify meaningful real-world benefits. One challenge will be proving the accuracy of devices or mobile apps in measuring the target outcome under real-world conditions. For example, demonstrating the reliability and concurrent validity of a pedometer for measuring the daily activity of COPD or heart failure patients could require months of field testing under a wide range of conditions, especially for devices that are connected to or installed on patients’ existing smartphones, tablets or other consumer electronics.

A second challenge will be demonstrating that the measured clinical outcome relates to meaningful aspects of how patients feel, function or survive or related economic outcomes. For example, it won’t be enough to arbitrarily set, say, walking 1,000 steps daily as a clinically desirable endpoint. You may also need to show that walking a specific distance daily provides a measurable and meaningful change for patients, for example making patients more independent in activities of daily living, or reducing emergency room visits, which will require extensive validation and economic modeling studies.

Combining data from wearable devices with clinical measures and patient perceptions of how their progress affects their lives makes it possible to determine thresholds for change that can be used to construct robust, statistically validated, and patient-centered endpoints. An industry group, the Critical Path Institute’s Electronic Patient-Reported Outcome Consortium, has developed guidelines for ensuring the validity and reliability of new patient-centered outcome measures and endpoints derived from wearables data [1].

Ensuring cybersecurity-Many mHealth devices and apps depend heavily on electronic communication-between mobile sensors and apps; apps and central servers; servers and EHR systems; and among physician offices and support centers, and patients’ apps and devices. Safety and privacy requires that these communication channels are secure at every step from both known and emerging cybersecurity threats including:

●     Ransomware, in which hackers threaten to interrupt a device or app’s function unless a ransom is paid

●     General malware, such as viruses or bots for launching denial-of-service attacks, interfering with device or app function

●     Privacy breaches, in which protected patient data is exposed

●     Device takeovers, in which a cardiac pacemaker or other device is taken over

●     Financial blackmail, in which the vulnerability of a device is exposed by parties trying to manipulate stock prices


Protections against these threats must be built in from the earliest design stage and updated for the life of the device or app as part of an overall risk management approach. It involves continuously monitoring emerging threats, assessing device vulnerabilities, developing and deploying countermeasures such as software patches, and backing up data to restore devices that have been compromised. This requires technical expertise and experience that exceed the capabilities of individual device developers. Collaborating with device industry coalitions and commercial IT security firms are essential for success.

Developing patient-friendly mHealth devices

As with any therapeutic product, developing effective mHealth devices requires a clear understanding of patient needs and preferences. Beyond addressing clinical needs, a successful device also must be patient-friendly, provide value to the patient and be engaging.

For example, a heart failure mHealth solution may include a passive heart monitor, a wireless link to a connected scale, an active patient-reported outcomes app, a medication and exercise reminder system, a telemedicine link to an on-call nurse, and an app to schedule office visits. However, patients will not tolerate five or six separate log-ins, so these all must be integrated into a single easy-to-use interface. Coordinating multiple developers to create such integrated solutions may be as big a challenge as developing the devices and apps themselves. Providing data to the patient in simple, understandable and (where appropriate) actionable formats is important to ensure ongoing value and engagement.

In addition, many mHealth devices take advantage of existing mobile platforms, including smartphones and laptops using Mac, Android, and Microsoft operating systems. Patient preferences for these platforms also must be considered, and this may vary considerably by the condition and patient population to be treated. For example, a solution appropriate for managing diabetes will be very different from one for monitoring a cardiac pacemaker or recovery from pneumonia. The goal is always to engage the patient to meet their needs.

Involving patients in program design through social media, patient and stakeholder interviews, analysis of real-world data from patient records, pharmacy and claims history, and reviews of literature and existing treatment guidelines and pathways is a good place to start. From these, potential channels for engaging and serving patients can be identified. These include mobile devices and sensors, and more conventional approaches such as call centers and educational brochures.

Advantages of building an ecosystem

Multiple mHealth and related products can be integrated into a product ecosystem, linking patients, providers, and device developers through integrated apps. In addition to providing patients with a seamless array of services, establishing a coordinated ecosystem can generate many strategic and financial benefits-notably, a more reliable and potentially larger, long-term revenue stream. Furthermore, an established ecosystem with dedicated customers creates a platform for seamlessly introducing new products and services, giving manufacturers an edge in competitive markets.

The ecosystem concept is also flexible, presenting many opportunities to participate.

One way is to develop all the parts needed to build an ecosystem that addresses a specific condition, such as cardiac arrhythmia. These might include a treatment device integrated with mobile sensors to communicate with clinicians about symptoms and device performance, and a smartphone app that informs patients when they need an appointment, connects them to call centers when they have questions, and provides information on what they need to do to stay healthy.

Another way to participate in a digital health ecosystem is through partnerships. Many mHealth and other technologies that were developed separately can and are being connected. A mobile device that tracks a body function or symptoms might be combined with an app that shares the information with patients or alerts healthcare professionals. Apps that connect with many devices and incorporate analytics could help patients and clinicians choose the best option among a wide range of therapies, or alert when a better option might be available as a patient’s condition changes. This could create a powerful system for improving healthcare awareness and delivery, while opening up opportunities for developers of every size and type to participate.

By participating in and contributing to a digital health ecosystem, manufacturers can gain a competitive edge though building stronger partnerships with providers and patients, and demonstrating real-world value to regulators and payers. However, making the most of the market opportunities mHealth presents will take planning and significant expertise.

A robust EHR-centered infrastructure and patient engagement strategy is needed to successfully integrate mHealth into product development. Extensive experience with incorporating real-world evidence into clinical trials, including developing and validating new outcome measures, also is needed. And making the case for value-based reimbursement purposes, requires expertise in analyzing claims and service-use data. Collaborating with partners experienced in medical device development, use and commercialization, as well as in IT development and security, may be the best place to start.


[1] Byrom B, Watson C, Doll H, Coons SJ et al. Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium. Value in Health (in press)

Vicki Anastasi, Vice President and Global Head, Medical Device and Diagnostics Research, ICON plc