The mobile health market is surging, and competition will be intense in the coming years. Companies that embrace interoperability, generate actionable intelligence and design devices that delight users are the most likely to succeed.
Wireless connectivity amongst medical devices is on the rise, as is the use of mobile phones for healthcare applications. The latter has led to the emergence of a new and rapidly growing market segment for mobile health, or m-health, as it is more widely known. In the first half of 2011 alone, m-health start-ups raised US$93 million in venture funds. The iPhone with its simple user interface and open programming platform catalysed the use of smartphones for health applications. More than 6000 health-related applications (or apps) have been developed in the short time since its arrival. The iPad has also made an impact in clinical environments: 30% of US physicians now own an iPad and are using it to simplify their daily routines, according to a survey conducted by Manhattan Research in 2011.
Mobile devices in the hands of physicians provide reference and patient information, but mobile devices in the hands of other caregivers and patients themselves have far greater potential for improving quality of care and reducing healthcare costs. Innovators are seeking ways in which these devices can provide the proverbial ounce of prevention that avoids a pound of cure. Mobile phones and tablets, with their significant computing power and ubiquitous connectivity, can enable real-time, bidirectional data transfer between patients and healthcare providers. They can be used to disseminate messages, gather and store data, and track patient compliance on a continuous basis with minimal disruption in the daily life of the user.
Potential beneficiaries of m-health span from underserved areas in emerging economies to developed countries with a significant medical infrastructure. Mobile phones have proliferated in emerging economies, in many cases well ahead of medical care, so m-health could provide a means for deployment of care to remote areas. In developed countries, m-health could be the catalyst to move from expensive, reactive care toward preventive care, focusing on patient outcomes rather than medical services rendered. Such a change in focus would be nothing short of revolutionary.
The m-health ecosystem
Traditionally, medical devices have been stand-alone or perhaps worked with a couple of other products. m-health, by its nature, is a broad ecosystem and can constitute several devices and client and server software as well as a communications infrastructure.
|A mobile hub and tablet application.|
The home health ecosystem consists of one or more diagnostic/therapeutic devices that are required for a particular condition and a hub or data manager to collect data locally and upload it to a central server, where a dedicated database or electronic medical record (EMR) may reside. The hub may serve as a focal point for delivering telehealth/telemedicine services, or it may simply be a data aggregator. In clinical settings, various devices and monitors hook up to the central hospital network and will be required to send and receive data from the EMR.
When designing m-health solutions, the biggest challenge facing most developers is determining what the hub should be. Options include off-the-shelf mobile phones running an app as well as dedicated devices. A half-way solution that starts with a commercial mobile platform that is then customised is also feasible. The decision must be made based on the particular application, its regulatory path and expected volumes while balancing cost, complexity and scalability.
For m-health solutions that require other hardware such as diagnostic devices and sensors, the choice of a mobile platform becomes critical, as they are not all equally endowed. Operating systems (OS) widely used on mobile phones include Windows Mobile or CE, Android, Symbian and, of course, the iOS on the iPhone. Each OS provides different levels of support for local area wireless communications and, thus, dictates the development effort and timeline to integrate third-party hardware.
As all hardware, software and communications infrastructure will not be provided by a single commercial entity, the m-health ecosystem naturally mandates relationships between various vendors. The obvious ones are between medical device manufacturers and mobile software providers. However, other players such as mobile handset and chip makers, cellular network carriers and enterprise infrastructure providers all have key roles to play if m-health is to be successful. New players such as Big Pharma also have entered the market and are looking for ways to engage consumers. As these players attempt to expand their reach, we are bound to see interesting acquisitions and partnerships begin to form. Such partnerships can help bring together the strengths of different organisations and, more importantly, provide new channels to access the market.
As the m-health ecosystem develops, a number of key factors are likely to shape the market. They are as follows.
Consumerisation of healthcare. As people get more involved in their own care, and especially if they are required to pay for treatment, the focus on user experience will increase. Given a choice, consumers will choose devices and solutions that are easier to use, have a more intuitive interface and are more engaging. Such behaviour is well established in the consumer market; thus, we call this trend the consumerisation of healthcare. Recently, Cambridge Consultants undertook a study to understand factors affecting device choice amongst diabetes patients and found that three-quarters of the survey respondents were willing to pay a small premium for devices that are easier to use.
To gain and maintain a competitive advantage, medical device manufacturers will have to pay attention to the usability of their devices, improving the ergonomics and the overall interface. Over the last few years, both US and European regulatory bodies have increased their demand for human factors validation, especially in drug-delivery devices, where efficacy is dependent on the proper usage of the device. It will not be a surprise to see this expand to other types of devices where proper use affects the end result.
Standards and interoperability. So far, not much attention has been paid to standards or communication protocols to which wireless health devices must adhere. However, as the m-health ecosystem grows, interoperability will become critical to efficiency, and the standardisation of protocols and data formats will be required. In the last five years, the Continua Health Alliance has attempted to build consensus and facilitate development of interoperable systems. They have chosen the IEEE 11073 standard to specify data formats and the Bluetooth Health Device Profile (HDP) as the Personal Area Network transport protocol. They have chosen to use existing standards rather than attempt to develop new standards or set up protected spectra. A separate effort is underway in the United States to have the FCC dedicate a frequency band for Medical Body Area Network (MBAN) similar to what it did with the MedRadio service (MICS) for implantable devices.
When selecting a connectivity option and protocol, every design team is faced with the primary question of whether to choose standards-based solutions or develop a custom proprietary protocol. There are pros and cons to both approaches and the decision must be made bearing in mind the nature of the device being designed. If the device is expected to be part of a larger system that includes other devices, the standards approach can ensure plug-and-play capability. Often, standards-compliant devices take longer to deploy, especially if certification processes are involved. However, there is much good that can come about (for manufacturers and consumers alike) from building interoperable systems rather than silos.
Communications technology. Wireless technology continues to improve and become available at lower cost points. For m-health, both local and wide area communication is required.
Bluetooth has been the most prominent technology for local area communication amongst wireless medical devices, and it promises to continue its leadership. Most mobile phone operating systems provide native Bluetooth stacks, thus making it a convenient technology for m-health. It should be noted that Apple uses its own variant operating system on the iPhone; thus, customised Bluetooth accessories can be developed for the iPhone, iPad and iPod Touch only in cooperation with Apple. Moreover, this involves a nontrivial specialised development unless further support is made available by Apple.
In recent months, the launch of Bluetooth Low Energy (BLE) has created a buzz in the market. BLE was introduced in version 4.0 of the Bluetooth standard. This version allows dual- and single-mode implementation. In dual-mode, BLE functionality is integrated into an existing Classic Bluetooth controller, resulting in a minimal cost increase and the ability to communicate with both Classic Bluetooth (Bluetooth v2.1 + EDR or Bluetooth v3.0 + HS) chips and the new low-energy chips. Single-mode chips feature a lightweight Link Layer providing ultralow-power idle-mode operation, simple device discovery and reliable point-to-multipoint data transfer. Moreover, advanced power-save modes and secure encrypted connections enable highly integrated and compact devices. BLE technology is designed for low peak current consumption, and consequently permits device operation via standard coin-cell batteries and enables battery life lasting up to one year.
BLE is a relatively new standard that was introduced in 2010. Chips have been announced by all major Bluetooth manufacturers and some dual-mode chips have already made it into mobile handsets. It is expected that this market will develop ahead of the accessory market, which is what will drive down cost of the single-mode chipset. Even so, introductory pricing by the major vendors is fairly attractive, thus making single-mode chips better suited for handheld point-of-care or home-use medical devices. While there is every indication that BLE will achieve global uptake similar to Bluetooth, it remains unproven in the market and the risk around new technology should not be ignored.
The other short-range wireless technologies on the market are ZigBee and ANT/ANT+.
ANT is a proprietary 2.4-GHz radio protocol. The upper layers of the stack (ANT+) have been opened up in an attempt to build an ecosystem of interoperable devices; several fitness products based on this protocol recently have been launched. However, the future of ANT for clinical applications remains uncertain. The Continua Health Alliance considered ANT for the low power link before choosing BLE.
ZigBee is another low-data-rate transmission protocol that has been around for some years and also supports a specialised healthcare profile. Unlike Bluetooth, however, ZigBee has not proliferated widely. There are no ZigBee hubs on the medical market yet, and attachment to mobile phones is absent.
In the wide area network space, recent months have seen single-chip cellular modules starting to make their appearance. Qualcomm’s Wearable Mobile Device, which is available in both GSM and CDMA versions, was first to market but several others are due to hit soon. While the price point of these modules remains high at the moment, increased competition will drive down cost. Bandwidth availability and carrier costs notwithstanding, direct data push from medical devices to the cloud thus becomes feasible without the need for an actual mobile phone in the communication chain.
Wi-Fi technology is a strong alternative to cellular networks, and has been gaining popularity. Given its seemingly ubiquitous presence in homes, offices, hospitals and even city blocks, as well as the range of chipsets available at a reasonable price, Wi-Fi can be built into devices relatively easily. A recent report by ABI research suggests that the market for Wi-Fi healthcare services is likely to reach US$1.34 billion by 2016.
Sensors. Sensing technology has advanced significantly in the past few years. Sensors are becoming smaller, cheaper and smarter at the same time. Measuring activity, temperature, impedance and even electrical signals such as ECG is becoming possible in small form factor devices that can run for a reasonable period of time on disposable batteries. Appropriate application of such sensors can enable collection of highly relevant data. Combine that with wireless connectivity and you have a complete toolkit that enables continuous, real-time monitoring of various physiological and environmental parameters essential to diagnose and treat chronic diseases.
Regulatory environment. The other challenge faced by m-health today is an evolving regulatory environment. Until US FDA released draft guidance in July 2011 describing its approach toward m-health regulation, there was no clarity around what might be regulated. Everyone wondered whether a smartphone could be considered a medical device. US FDA guidance clearly differentiates between applications that use built-in or attached sensors on a smartphone, thus turning it into a medical device, from those that simply use the phone to collect, transfer and display data. This risk-based approach is quite sensible and will create the necessary framework to ensure that smartphone-based health applications go through the appropriate level of scrutiny. Many expect the EU to take a similar approach. Regardless of the regulation, m-health players are advised to pay attention to the end use (and risk profile) of their application and follow proper development and verification and validation processes to ensure the safety of their systems.
The road ahead for m-health
As the m-health market continues to grow, competition will be fierce amongst device makers and solution providers alike. Three elements likely will separate the winners from the losers:
CTIA, the association for the wireless telecommunications industry, recently estimated that the wireless home health market, which represented about US$304 million in 2009, will grow to US$4.4 billion by 2013. M-health based solutions will continue to rise and become increasingly vital to care delivery. The initial uptake is likely to be driven by conscientious individuals interested in taking care of loved ones or themselves as well as by large employers facing the burden of rising healthcare costs. However, critical mass will be reached only when payers recognise the benefits of deploying mobile applications for monitoring chronic diseases and promoting healthy living habits.
is Group Manager, Medical Technology, at Cambridge Consultants, 101 Main Street, Cambridge, MA 02142, USA
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