Modern mobile networks are ubiquitous and accessible virtually everywhere, from remote villages in Africa to deep inside warehouses and hospitals. This universal wireless coverage, combined with new cost-effective and simplified technology, is bringing about some amazing innovations and the medical industry is catching on. Many professional mobile health solutions, commonly known as mHealth, leverage Machine-to-Machine (M2M) technology and mobile networks to improve diagnosis, treatment, and patient outcomes while simultaneously containing healthcare costs. Healthcare providers are realizing the power of mHealth to help solve the challenge of managing chronic diseases such as diabetes or treating heart disease and obesity, which top the list of health threats impacting the greatest number of people and contributing to the high cost of modern healthcare worldwide. Projected to grow 61 percent and reach $26 billion globally by the end of 2017, according to InformationWeek, the mHealth industry is thriving and providing solutions for identifying, managing, and treating disease as well as improving preventive care and health education.
mHealth and M2M Defined
mHealth solutions enhance communication between patients, caregivers, and physicians to improve diagnosis, treatment protocols, and results. They can also enable remote treatment and crisis interventions in the case of emergencies. M2M technology is at the heart of professional mHealth solutions providing reliable, secure connectivity for medical equipment and devices. In addition, relatively new cloud-based M2M Application Enablement Platforms connect devices and data to backend healthcare IT systems. There are a variety of technologies that can be leveraged to enable connectivity including wired line, WiFi, LAN, Bluetooth, RFID, and others. In mHealth solutions, mobile network wireless connectivity provides ubiquity, ease-of-use, anytime-anywhere accessibility, mobility, virtually unlimited communications range, and inherent security. In addition, M2M enables pre-configured devices with integrated wireless modules that work out of the box with little set-up effort and no need for pairing with mobile devices or punching in WiFi keys. (See Figure 1) M2M solutions establish an always-on connection to the mobile network on their own.
mHealth Solutions: Optimizing Healthcare in Real Time
mHealth solutions can be used for a variety of purposes and span a wide range of use cases. For instance, “smart” pillboxes track medication intake and send reminders to patients via text message, phone call, or e-mail. (See Figure 2) They automatically order prescription refills, send alerts when medication is missed, and update care teams and healthcare providers with historical data on patient compliance. Wearable solutions such as M2M-enabled mobile Personal Emergency Response Systems (PERS) help monitor and keep track of elderly and chronic disease patients while providing an additional communication channel that improves independence and peace of mind for users and their loved ones.
Smart glucometers can automatically send blood glucose information to caregivers who are empowered to respond with tips and coaching in a timely fashion to help bring blood sugar levels back to a normal range. mHealth hubs collect data from a variety of medical devices that measure vital signs—blood pressure, heart rate, oxygen saturation, glucose levels, temperature, weight, and respiration—and seamlessly send it all to cloud-based platforms where the data is processed and transformed into standardized, actionable intelligence. Caregivers and consulting physicians can log on to a secure web interface anytime and anywhere to monitor a patient’s status and immediately react in case of emergency— no matter if the patient is at home, traveling, or anywhere in the course of daily life.
Keys to Success
Recent innovations including simplified, all-in-one development tools such as the Cinterion Concept Board and innovative embedded Java application platforms are lowering the barriers for medical device developers to successfully enter the M2M world for the first time. However, for new integrators, implementing mHealth solutions is often more complex than anticipated. Understanding the critical technology bricks and considering the following seven keys to success will help ease development, speed time to market, and, ultimately, improve ROI. (See Figure 3) Seven keys to success are detailed below.
One: Consider Components and Connectivity
Cellular-based mHealth devices rely on two essential components for connectivity: M2M Modules, which provide pre-certified wireless connection in stable form factors; and Machine Identification Modules (MIMs), which securely enable access to mobile networks, encrypt communications, and facilitate native device management. M2M modules are available for a variety of wireless standards including CDMA, 2G, 3G, HSPA, and 4G/LTE. Offered in a variety of different form factors with varying capabilities, certifications, and features, they are optimized for relevant regional target markets.
At the beginning of design, careful consideration must be given to determine the features set required across the entire product lifespan, which is up to 10 years for M2M solutions. Requirements must be matched with a price point that makes sense for the business case. For instance, to design a product that communicates small data bits over European wireless networks, a cost effective 2G or 3G GSM module should be considered.
However, the decision becomes more complex when you intend to introduce a product in one region and expand to other world regions over time. Be sure to select components that support forward evolution through footprint compatibility to eliminate the need for re-designs as technology needs change. A strong technology partner with experience and expertise in your particular vertical market can provide consulting and help navigate the complex M2M component decision tree.
Two: Calculate Total Cost of Ownership
Developing mHealth devices from the ground up requires significant investment of time and money, especially when it comes to approvals, certifications, and potentially clinical trials. Typically, a quick return on investment is desired and Total Cost of Ownership (TCO) over the product lifecycle must be considered. A global multi-mode module that operates on all mobile networks might cost more initially, but it simplifies design, saves time in development, and enables easy scalability to address markets worldwide. In other cases, module footprint compatibility might be all that is needed to enable regionally optimized solutions that leverage differing radio bands without the need to redesign the device.
From module and MIM selection to connectivity provisioning and product lifecycle management, OEMs must always keep TCO top of mind and make decisions that are beneficial in the long run. Expedited design and development with a swift launch can help ensure profitability. A smart migration path to next-generation technologies can help ensure a short-term gain in component price will not end up costing more down the road.
Three: Secure Your Solution from the Ground Up
The same elements that are motivating growth in the M2M and mHealth sectors are also giving rise to a variety of new security threats. In the healthcare sector, where data is highly sensitive and regulated, security is a crucial concern. Hackers and nefarious code can negatively impact a company’s reputation very quickly and even put an end to an mHealth solution. The now famous Sony PlayStation Network hack exposed sensitive data for more than 77 million users worldwide. In addition to the time and effort spent mitigating negative PR, Sony reported that it spent 14 billion yen ($170 million) to cover the costs of shoring up the breech after it occurred.
mHealth application security must be designed by experts with market proven success at the very beginning of the development cycle and not in hindsight. These often invisible measures must consider and ensure the trust of the users first and foremost. Careful engineering of end-to-end security architecture is necessary to protect M2M implementations and leverage passive, reactive and active security measures. Only this type of integrated security approach will be effective to safeguard solutions and ensure their success.
Four: Choose an Open Application Platform for Speed and Simplicity
Java™ is the single most pervasive open standards programming language in the world. Java applications are running on billions of devices and machines ranging from mobile phones and Blu-ray players to medical equipment and supercomputers. As a common thread running through many applications, a Java strategy and embedded systems approach in mHealth application design can simplify design and cut months off development timelines.
An embedded systems approach entails tightly coupling a Java software component to the M2M modules to leverage the ever-increasing processing power in the module’s baseband. This allows OEMs to streamline design and reduce the bill of materials by eliminating the need for extra processors and memory chips.
By adding Java on top of the M2M Embedded System architecture and offering libraries for application and module services, OEMs receive native, “off-the-shelf” integration with cloud-based application platforms, which speeds application development. In addition, by adding processing power to the communications module, data can be easily pre-processed— crunched, analyzed, and consolidated—before it is sent over wireless networks economizing bandwidth for mobile network operators and subscribers alike. It’s a win-win scenario.
Another benefit of leveraging Java application programming interfaces is that OEMs no longer need to worry about heavy protocol handlers or cellular connection management. Instead, they can immediately focus their efforts on developing medical-specific business logic. The complexity of the underlying layer is completely abstracted and application and device development are uncoupled so they can occur simultaneously. This is another huge time saver.
Five: Connect Devices, Data, and Doctors in the Cloud
Transforming disparate sensor data into standardized medical intelligence and integrating it into backend healthcare IT systems has been a longtime barrier to mHealth development and adoption. Until recently, software applications for mHealth solutions were designed from the ground up for each device.
The rise of innovative, agnostic, cloud-based M2M platforms, along with standards as mandated by the Continua Health Alliance, have simplified the process by offering a flexible solution that can be quickly and easily customized for various use cases. When designing your software, consider a cloud-based application platform that collects disparate data bits from devices and sensors and transforms it into standardized actionable intelligence.
Look for a solution that links to a customizable web portal with an intuitive interface. Special consideration should be given to any platform that offers a software element that can be downloaded to the M2M Module to tightly couple the device and platform in order to streamline end-to-end integration.
Six: Plan for Certifications and Approvals
So you’ve designed and prototyped your new M2M solution and you’re ready for market launch. Not so fast! As with smartphones or any wireless device, before your solution can hit the market, it needs to pass a maze of testing and certifications. Any device that radiates energy needs to adhere to strict standards from the FCC, the European Community, and other governing bodies. PTCRB and GCF certifications are the first step followed by individual carrier approvals, such as AT&T or Verizon.
Approvals can be an arduous task that can take months to more than a year to achieve. Independent testing labs including Cetecom, UL, and 7Layers can help facilitate testing and aid entrepreneurs as they navigate the process. Developers can save time and money by selecting trusted, pre-certified M2M Modules and components at the outset to eliminate some (but not all) testing. In this case, the M2M module manufacturers do most of the heavy lifting so that only a delta-type approval is needed.
Seven: Simplify Deployment with On-Demand Connectivity
Until recently, an operator-specific SIM card or MIM was needed to activate mHealth devices for each carrier network. In every country, an OEM would have to work with individual operators to provide technology variants for each network. The logistics of manufacturing, distributing, and deploying carrier-specific products were intimidating enough to keep would-be developers away. Last year, the GSMA wireless governing body published specifications for On-Demand Service Provisioning outlining best practices and protocols for secure, remote, and flexible service provisioning eliminating the need for designs specific to each carrier.
By leveraging On-Demand Connectivity, manufacturers no longer need to create numerous device variants and profiles for specific countries or carriers. Manufacturing and distribution logistics are simplified dramatically, and global rollout is accelerated. This innovative solution as a service removes one of the final barriers to reaching scale and deploying mHealth technology globally.
Make Your Mark and Start Designing Today
The potential mHealth holds to revolutionize and mobilize healthcare is exciting and, whether you are an experienced developer or a first-time entrepreneur, M2M technology provides compelling opportunities to make your mark.
This article was written by Manfred Kube, Director Business Development mHealth, Gemalto, Amsterdam, The Netherlands, and Austin, TX. For more information, Click Here .