Over the past few years, hospitals and healthcare providers have had their hands full and their wallets busy with ensuring that their businesses are adhering to new legislative provisions. Digitalization of patient and hospital data through electronic health records (EHR) implementations—the main focus of spending—is increasing exponentially across the United States. Cost cutting to counteract lower reimbursements, lower admissions rates and the upcoming move towards pay for value versus payments for transactions is in full swing. Infrastructure and support systems also are being actively implemented across the United States to support data collection and reporting for meaningful use, hospital re-admissions, and patient satisfaction.
This two-part article series will discuss how mobile technology and the medical device market have collided to create exciting and unique opportunities for companies ready to seize them. We will address how collaboration with partners in the value chain can help provide highly desired, differentiated and valued products and services that drive more effective patient outcomes and contribute to lower healthcare costs.
Tablet Uptake in Clinical Administration
With money and resources supporting administration implementations, today’s buzz around eHealth also is centered on the clinical environment. Smartphones and tablets already have taken root in the clinical environment. According to report from New York, N.Y.-based Manhattan Research titled, “Taking the Pulse 2012,” 85 percent of U.S. physicians own or use a smartphone for their profession. Of these, 75 percent favor the simplicity of Apple’s mobile devices and, of the 62 percent of physicians who own tablets, more than half use them at the point of care. Clinicians are a mobile workforce and, like most consumers, have a personal emotional attachment to their smartphones and tablets. They are driving their organizations to implement strategies for using smartphones and tablets, in addition to or as a replacement for previous IT investments both at the patient bedside and in administrative environments.
Hospital IT staff are working through highly complex issues introduced with mobile form factors including interfacing to the EHR system, retooling existing applications to work with the touch-tablet interface without the use of a mouse and keyboard, and privacy and security issues with physicians and nurses bringing their own devices into the workplace, and accessing the network from remote locations.
Effects of Tablet Usage on Clinical Diagnostics & Monitoring
In addition to administration, physicians are using tablet and smartphone form factors to remotely review real-time patient data and images for clinical decision-making. An example is the Airstrip mobility platform, which provides physicians and nurses the ability to remotely access real-time waveforms from a variety of data sources, including the EHR, patient bedside devices or ambulatory medical devices, and view them on approved tablets and smartphones. Solutions tailored to specific conditions include obstetrics, cardiology and patient monitoring. Airstrip is device/vendor neutral, but has announced collaborations with medical device companies including Cardionet Inc. and General Electric. The tablet or smartphone running the AirStrip mobile app (from San Antonio, Texas-based AirStrip Technologies) currently acts as a remote secondary display and has not replaced the primary display on the medical device at the patient bedside.
In time, it is anticipated that with appropriate evidence, the tablet or smartphone could become the primary display and, in combination with the potential migration of diagnostics and analytics from standalone devices into the server and storage infrastructure, this will affect form factors and functionality of future generations of medical devices in the clinical environment. The bedside medical device could be altered dramatically as the infrastructure of the hospital encroaches on functionality that was solely part of the medical device. For example, in the future, some medical devices’ compute and display functionality might be relegated as a backup solution in lieu of interoperability and integration advances within the hospital infrastructure.
To start planning for and responding to the eventuality that consumer platforms and server infrastructure will become a critical part of the medical device ecosystem, medical device companies can work more closely with their value chain partners including design, manufacturing and supply chain vendors to help them develop future generations of new devices and define new services.
Chronic Care: Beyond the Four Walls of the Hospital
According to the Centers for Disease Control and Prevention, more than 75 percent of healthcare costs in the U.S. in 2009 were due to chronic illnesses, including diabetes, heart disease, asthma, obesity, chronic obstructive pulmonary disease, hypertension and obesity. Cost containment of these highly preventable diseases is prompting the industry to implement less expensive methods of care delivery and prevention beyond the four walls of the hospital. Efforts at reduction and prevention of these life style diseases are getting a much more serious look and even some creative monetary motivation by insurers and employers. Development of better methods for engaging patients and employees in their own wellness and healthcare is of upmost importance.
According to Wireless Intelligence, a London, United Kingdom-based source of mobile operator data, analysis and forecasts, there were an estimated 5.9 billion active mobile connections globally in 2012 (excluding mobile-to-mobile) with an average 1.85 subscriber identity module (SIM) cards per user, leading to the conclusion that there are 3.2 billion unique mobile subscribers in the world, or 45 percent of the global population. Many people are comfortable with phones, mobile apps, the Internet and social media. The industry must take advantage of this global embrace of mobility to positively change the way people think and behave regarding their healthcare.
Gaining a deeper understanding of why and how individuals would integrate prevention and care mindfulness into their daily lives is a critical part of designing motivating solutions for the long term. Discrete, easy-to-use sensors will be married with our consumer devices and supplemented with individual motivational elements including competition, games, social media and, most importantly, interpretation of data into specific actions and foreseeable results.
In the book, “The Creative Destruction of Medicine,” Eric Topol, M.D. identifies a disruptive change in medicine that is occurring due to an unprecedented super convergence of critical elements: low-power wireless biosensors, digital imaging, genome sequencing, mobile connectivity, smartphones, the internet, social networking, virtually unlimited computing power/data storage/bandwidth and pervasive health information systems. Both the convergence and maturation of these elements is driving a new connectedness in healthcare, which is resulting in numerous innovative devices for putting healthcare into the hands of the consumer. The ability to leverage familiar—and increasingly ubiquitous—mobile devices as tools in maintaining wellness, driving prevention and monitoring and self-managing chronic diseases is tremendously appealing. Remote monitoring is convenient., cost-effective and ensures closer, more frequent and more accurate oversight by clinicians than is possible through traditional in-person visits.
In Guy Kawasaki’s book, “Rules for Revolutionaries,” he writes that opportunities for real differentiated value can be found on the edges or the interfaces between things. Interfaces are where dissimilar elements come together and conflict and disruption naturally occurs. In healthcare, there are many complex human-to-human interfaces, human-to-machine interfaces and machine-to-machine interfaces. Use of smartphone and tablets with their intuitive user interfaces, easy internet connections, sleek form factors, and engaging downloadable mobile apps, combined with well-designed wireless biologic, physiologic and anatomic sensors might prove to smooth out the bumpy and conflict-ridden terrain of most human to machine interfaces.
Wireless Sensing in Healthcare
Sending health information from devices over a network is nothing new to patients battling chronic heart failure (CHF). For many years, manufacturers of implanted pacemakers and cardiac rhythm management (CRM) devices have developed proprietary systems for sending information from implanted devices to external communicators using non-invasive wireless data transference technologies. Communication to the medical device manufacturer’s server has been via a wired telephone land line. However, recent announcements offer communication under the Global System for Mobile Communications (GSM) standard to the mobile network as an option. Due to the high-risk classification of the implants and associated communicators, the device companies continue to develop proprietary mobile communicators versus using existing consumer devices, such as smartphones and tablets as part of their Class III ecosystem.
According to New York, N.Y.-based technology market research company ABI Research, wearable wireless sensing will reach almost 200 million units in 2016. Topol uses the term “Homo Digitus” in his book to describe the use of miniaturized wireless sensors in a variety of form-factors combining digital imaging and DNA sequencing to digitally quantify a human being. People have been strictly analog beings. This super-convergence and digitization of the human body is catalyzing “the democratization of medicine.” He uses the term “the great inflection of medicine” to describe the move from wasteful and expensive evidence- and population-based medicine to individualized medicine based on our highly digitized selves. We need to create more individualized solutions and treatments integrated with a patient’s daily lives. To do this, the industry will look to a combination of devices, imaging and genetics to more accurately sense, measure and diagnose an individual patient’s proclivity and reception to a specific treatment instead of prescribing based on a “one dose fits all” population methodology.
Ubiquitous sensors and devices are a critical part of the disruption. Sensors that measure a plethora of physiological, biological and anatomical parameters will come in a multitude of form factors including under the skin modules, on-body wearable patches or tattoos, devices that wrap around limbs, wrists or fingers, electronic pills, functional smartphone covers, devices that connect into the phone I/O ports, as well as wireless versions of existing devices such as scales and pill dispensing.
Electro-mechanical miniaturization and ultra-lower power architectures will be required in most of these sensing form factors. Many will benefit from greater flexibility and conformity to the body, which is difficult to achieve with traditional rigid electronics. In many cases, common and pervasive radio frequency (RF) protocols can be used such as NFC, low-power Bluetooth and WiFi, but, due to proven security and privacy issues with hacking and manipulation of medical device data, encryption methodologies and proprietary wireless protocols still are necessary to protect the safety and security of the patient’s data and being.
Health and wellness devices such as the Fitbit Tracker, BodyMedia Patch, Jawbone Up, Nike Fuelband and many others also are gaining momentum in the market. Typically worn on the wrist, as a patch or clipped onto clothing and sporting colorful or sleek metallic consumer-focused designs, their core function is to measure physical activity during the day and sleep patterns at night using miniaturized electronics and sensors such as accelerometers. Small segmented displays and control buttons are included on most models for toggling through display read-outs or indicating functional modes like the start of a sleep pattern. The devices typically use a short-range RF communication or wired universal serial bus (USB) to connect and upload data to the smartphone. A dedicated mobile app displays the data and trending in easy-to-view graphs and connects with proprietary Internet servers to allow individuals to share data with and compete against their friends and family through communities and social media. The device batteries typically are charged via small USB charging stations or directly charged via a mini-USB adapter. Misfit Wearables has announced the introduction of a device that uses a unique charging technology that powers it wirelessly when placed onto the smartphone display.
With doctors starting to prescribe at-home medical monitoring devices and associated mobile apps to patients discharged from hospitals with chronic conditions, the sensing devices will need to be easy and fun to use as well as effortless to connect to the mobile network, and automatic for the upload of patient health information to the Internet server. Since GSM data modules are relatively bulky and too high powered for integration with most sensing devices, smartphones can act as the communication link between the sensor and these cloud servers. The functionality of the smartphone or communicator will vary based on condition-specific requirements for clinical oversight. With conditions such as CHF where intense oversight is the accepted method of care, communicators are proprietary equipment and patients do not have immediate access to their data. Implanted device data transmits to an external GSM communicator via a proprietary short-range wireless protocol. The communicator will provide some feedback to the patient but the protected data is forwarded to the healthcare professional for analysis and treatment alteration.
In contrast, patients with diabetes always have had access to their blood glucose data via handheld blood glucose meters and can make informed, self-managed decisions on their treatment (food, glucose, insulin or medication) without ongoing interaction with a healthcare professional. In these cases, the smartphone can provide a richer user interface by employing a mobile application for patients to self-manage and track their condition. Some manufacturers design the meter as a medical device accessory to existing consumer smartphones, and others choose to develop proprietary communicators for risk management, safety and privacy issues. The smartphone communicator connects the device to the mobile network and sends data to an Internet server on the manufacturer’s premise or in the cloud for further analysis and monitoring. We are getting close to the point where the summarized data can be uploaded to a health information exchange and pulled into healthcare provider’s EHR system to become part of the patient’s digitized medical records.
There is much anticipation that hospital organizations will need to hire nurse or physician’s assistant (PA) technologists to manage patient education for, interaction with and usage of mobile sensing devices. Healthcare providers and device manufacturers actively are funding or partnering with state-of-the-art call centers staffed with PAs, nurses and technologists to support mobile patients as their virtual care team. In addition, as democratization of medicine occurs, more and more patients will want to see and interact with their data, which should prompt them to become more involved in decision-making with their physician or virtual support team. Medical device companies can start to design and plan for this new reality by collaborating and strategizing with their entire value chain.
As circuitry for connecting a sensor directly to the mobile network improves in size and power consumption and, as more diagnostics and data analytics are performed in the cloud by third-party providers, medical sensing no longer may require the smartphone’s computing power or connection to the mobile network. With smaller, low-power GSM modules and antennas, sensors can connect directly to the mobile network. This would create a huge influx of devices requiring global certification on multiple mobile networks, as well as asset management services when deployed in the field. In addition, disease management kits containing loaner devices from the hospital will require individualized set-up, provisioning, programming, validation and monitoring for a specific individual as well as repair services and sterilization and re-purposing for the next patient. Other industries already are prompting the supply chain to establish outsourcing and automation for these mobile management services.
Editor’s note: The second part of this series in the July/August issue of MPO will address additional mobile technology advances and how to leverage the best manufacturing value chain for new product development.
Ralph Hugeneck is the director for medical technology for Jabil HealthCare & Life Sciences. He joined Jabil in 2005 as a business unit manager and was named to the current position in 2009 and is responsible for developing and implementing strategies and technologies to accelerate the growth of Jabil’s medical portable on-/in-body devices. Prior to joining Jabil, Hugeneck spent 14 years with Royal Philips Electronics. His most recent position was director of process development & manufacturing engineering at Philips Creative Display Solutions. Prior to that role, Hugeneck had several management positions in the product development and process development area of Philips Consumer Electronics division. Hugeneck holds a bachelor’s and master’s degree in mechanical engineering from Vienna University of Technology in Austria, including a degree in biomedical engineering.
Donna Fedor is the lead strategist for The Arden Group, which she founded in 2009. During that time, she also was director of strategy for the healthcare industry sector at Jabil Circuit Inc., an $18 billion global electronics design and manufacturing services company. Throughout her career of more than 20 years, Fedor has held numerous strategy, technology, business development and management, channel management, and marketing positions with Flextronics and National Semiconductor. She also founded a Web-based startup company focused on employee services during the early Internet boom. Fedor holds a bachelor’s degree in electrical engineering from Boston University.