The world appears to have shrunk into a virtual ball. People are getting connected through devices; machines are getting connected; and today, even homes are getting connected. Everything in the world is getting connected. So, what about medical devices? Well, they too are.
The world of healthcare is also on the threshold of disruptive changes, happening due to the proliferation of mobile devices and the ever-increasing connectivity between them. Technological advancements in networking and telecommunications have led to the emergence of new products, services, business avenues and models that were hitherto unheard or unthought of. The latest addition to this ecosystem of connectivity is machine-to-machine communication also called, in short, M2M communication.
WHAT IS M2M COMMUNICATION?
Machine-to-machine (M2M) communication is an umbrella term used for any technology that enables two machines to transfer data and information between them without human intervention. Medical devices can be connected and made to talk with each other, enabling the transmission of vital data between them. This transmission results in new and exciting possibilities in healthcare, especially in areas such as patient care, patient monitoring, medical device maintenance, manufacturing and making an efficient medical supply chain.
This whitepaper provides an overview of the various factors that are now influencing the direction of medical devices toward M2M, and the elements that are driving its growth, evolution, adoption and proliferation. It will also look at some of the challenges involved and provide a few exciting use cases.
WHY SHOULD WE STOP AND TAKE NOTICE OF THE M2M WAVE?
According to IDC, there were 9.1 billion connected Internet of Things (IoT) units in 2013. Cisco estimated that in 2003, there were nearly 500 million connected devices: In 2012, this number rose to 8.7 billion. It projects that by 2020 there will be 50 billion connected devices, showcasing the exponential growth of the M2M ecosystem.
This includes medical devices, hospital equipment, cars, electric and lighting poles and a variety of household equipment such as televisions, refrigerators, washing machines, doors, air conditioners, heaters, manufacturing equipment, trucks and pallets the list is literally endless. Take into account all the associated data, interfaces, platforms, frameworks and services that grow with it, and this would be a gargantuan growth of an entire ecosystem at an astonishing pace. Undoubtedly, the world has to take advantage of it. Data generated and communicated through connected machines can be considered to be more reliable, accurate, structured and cleaner when compared to other data pools like the unstructured data of social media or human-generated data. Thus, data flowing from connected machinery is more preferable for building robust and secure applications.
The figure above shows that IoT would majorly rely on M2M communication in the future. We are going to witness a network that is dominated by machines, and M2M data traffic will overtake all other data streams on the internet. Machines, not humans, would be the major data generators and consumers on networks. Hence, M2M is being used synonymously with IoT and is being seen as the next big thing with the potential to create new revenue-generating streams for product manufacturers, system integrators, IT vendors, Cloud vendors, among others.
WHAT IS MAKING THIS HAPPEN NOW?
Wireless Connectivity Boom
With the exponential rise of wireless technologies and standards like Wi-Fi, Bluetooth, ZigBee and Z-Wave, several efficient network-connectivity topologies, which were previously infeasible, can now be implemented economically because using a wire that incurs cost is unnecessary. Wireless connections can be achieved with more redundancy and lesser latency, thus making them more reliable and robust than wired networks. They are designed to use bandwidth efficiently, consume minimal power and get easily configured within a demarcated area, irrespective of the deviceâ€™s exact physical location. Such designing makes these connections an ideal choice over wired networks and ensures wire-free, cost-effective, hassle-free additions of machines to the network.
Advanced Sensor Technology
New technologies and advancements in the design and miniaturization have made, and are making sensors cheaper, smaller, faster and more responsive. There is a ubiquitous range of sensors currently available, including the temperature sensor, pressure sensor and ambient light sensor that can be incorporated easily into the devices.
The emergence of IPv6 the latest Internet Protocol (IP) versionâ€”is paving the way for IoT. Unlike IPv5, the latest version ensures that there is a limitless number of IP addresses made available. With IPv6, an IP address can be made available for each and every machine that can be connected to the network.
The emergence of the Cloud technology has ensured a high availability and uptime of data round the clock. Devices can remain connected, generate and consume data and provide analysis, alerts and actions at all times. The technology is undoubtedly the major enabler for this, and all the subsequent layers of interfaces, applications and analysis are built on top of the machine-data layer on the Cloud. Moreover, many chipset manufacturers have come up with intelligent operating systems within the embedded chips, which can provide seamless data integration with the external Cloud.
The age of data and analytics
Keeping pace with the rise in the data generated, there are competing developments in data science and analytics to handle humongous data. New technologies aimed at handling and analyzing big data not only manage huge amounts of data, but also seek them as a source of hidden insights for adding value. It would not make sense to have a rapidly growing data footprint without these technological augmentations to support, enable and derive value out of it.
WHAT NEW CHANGES CAN WE EXPECT IN MEDICAL DEVICES?
M2M communications have profound effect on the medical device field, as connected medical devices can bring in revolutionary changes. This can add a whole new dimension to patient care, physician interaction, medical device usability and maintenance. Umpteen avenues in services, innovation and business can be opened up. A few such use cases have been detailed below.
Predictive Maintenance of Medical Devices
The medical devices that are used to treat or diagnose life-threatening conditions are quite complex and expensive. They need to be operated by highly skilled personnel and need to be in the best of conditions at all times for giving accurate results. Error tolerance in such devices is near zero: This is a very difficult feat to achieve, given the wear and tear involved. The best way to do this is through their proactive maintenance, and M2M is the best that technology has to offer for this purpose. Connected medical devices can continuously stream data regarding their usage, which can be stored on a secure Cloud. Monitoring and collecting usage data can be done round the clock and can be analyzed in real time to check the need for scheduled maintenance. Based on the real-time analysis, future faults or failures can be predicted and averted beforehand, and the required parts or spares that are worn out or damaged can easily be found and replaced. This would greatly reduce the maintenance costs for hospitals or device owners.
Imagine a scenario where all the medical devices are connected, and M2M data is available in real-time. Device usage statistics can be analyzed to establish usage patterns and can be integrated with the manufacturing department of a medical devices company, providing it the insights into which parts are getting frequently worn out, which ones need more inventory and which ones need less. Based on prolonged and historical usage patterns, insights can be drawn into design changes that are required to make the devices more efficient and less prone to error or repair. These inputs, received in advance due to the integration of M2M data with the ERP, would help streamline production and reduce inventory costs, thereby enabling the organization to maintain a lean and agile supply chain.
In the current scenario, hospitals are the sole operators and owners of medical devices. In the future, where these devices will not merely be machines but data generators and recorders in a connected network, both the hospitals and the device manufacturing and assembling plants would have a view or access. Hospitals can pass on some of the burden of monitoring and maintaining the devices to their manufacturers or third-party organizations assigned for this purpose. Hospitals or medical practitioners can concern themselves with only using these devices rather than spending valuable time on their maintenance. More advancements can even lead to medical devices being offered as a service rather than being sold as a device. In this case, hospitals or medical practitioners will not own the device, but only pay for its usage while the device would be owned by its manufacturer or product vendor. This can usher in rapid changes in developing countries owing to the economic feasibilities.
Automatic Alerting Systems
Smart medicine dispensers can record the time and date when the medication is taken and can alert the patient when she/he forgets to take it. GPS-enabled, smart medical devices can be worn as a watch and provide continuous location details of patients, suffering from Alzheimer’s disease, sleep walking, epilepsy, to name a few. These devices can send alerts or warnings to the concerned medical practitioner or caregiver whenever the patient moves out of the safety confines or when found to be suspiciously stationary.
Emergency Medical Services (EMS)
In case of emergencies, even before patients arrive at the hospital, their information can be sent remotely to the hospital so that it can be ready with the necessary equipment for initiating treatment.
Remote vital sign monitoring from a hospital environment
Wirelessly enabled miniature devices can be embedded into patients with chronic illnesses like diabetes, hypertension and Alzheimerâ€™s disease so that their vital signs can be remotely monitored by physicians without the patients actually visiting the hospital. This can be made possible with the continuous data stream that is broadcasted by these wireless-embedded devices that can be built according to a wide number of wireless protocols currently available such as ZigBee and Z-Wave.
Post-marketing Surveillance of Medical Devices
The devices can be monitored for their safety and efficacy even after they are approved for use. The data generated and streamed by the embedded chips in these devices is far more accurate and reliable than human input data. Apart from the above scenarios, there are several other areas such as medical imaging, image-guided surgeries, operating room logistics and smart ICUs in hospitals that can take advantage of this wave to bring in better planning, more efficiency and differentiated service.
WHAT WILL BE THE ROLE OF IT VENDORS?
IT vendors will play a significant role in the entire IoT ecosystem. The humongous data that would be generated by the machines would need to be managed, analyzed and used by end users.
This would be possible only with the help of intelligent applications that have to be built on top of the machine communication layers. New business models can be enabled with an entirely new set of applications for both the industry and end users or consumers. Application development in this area is still in its nascent stage, but there is potential for an exponential rise. The fragmented landscape of the current standards translates to more opportunities before consolidation takes place. IT vendors/system integrators or application developers can provide multileveled service. They can start with the application development on top of the machine data layer or the Cloud API, or provide the application development platform with API management, or they can start right from providing the Cloud platform to delivering the final applications.
M2M is a multidisciplinary ecosystem, and there can be no single best way of doing things. There are several approaches to harness and leverage the power of M2M communications. Several point solutions right from the realm of device connectivity to data analysis and visualization can come together to provide innovative business solutions. Alternately, there can be integrated platforms offered by several vendors that can offer better bases to build robust applications quickly.
EXAMPLE OF A PLATFORM & THE COMPNAY APROACH?
One such company providing M2M platform is HCL. HCL has invested in a framework that provides an integrated approach for standardizing data collection across medical devices, managing the data securely and provisioning for several services.
At a high level, the major components of such a system with its activities, devices, infrastructure and supporting services are presented below.
HCL’s M2M platform offers common shared services to the application layers. The integrated approach brings the required tools and platforms together. All the necessary features like data storage, real-time event collection and correlation, API management and analytics will be exposed as services to the higher order applications. The platform is based on SOA principles and delivers containerized capabilities/services to internal and external integration points. Key facets of the platform are as follows:
- Offered as a completely managed Cloud-based solution
- Comes with most of the utilities and components that are configurable or customizable, significantly reducing the time to market and the cost
- Has unique capabilities to aggregate and harmonize data to industry standards such as BRIDG, enables the customers with a wider usage of the information and sharing across departments.
- Can be further co-developed/customized with partners
HCL’s M2M platform architecture
Major components of the framework also follow the plug-and-play mechanism to make the integration much easier. It offers several secure APIs, which allow integration with third-party applications. HCL’s M2M Gateway, AEGIS, extends the reach of an M2M service provider into device networks in healthcare provider settings or patientsâ€™ homes. The platform provides for options like real-time data processing and analysis of large volumes of data. It contains a big data-based data syndication and analytics engine, which helps drive the continuous analysis of myriad sets of data from different sources/feeds.
The platform also contains a Mobile App Kit that enables application development in multiple mobile devices/operating systems.
Impediments and Challenges on the road ahead
At present, medical device adoption of M2M communication is very low as the technology is relatively new and immature. For better adoption, the following challenges need to be addressed:
Fragmented Technology Landscape
Technologically, there are still certain gaps that need to be bridged to complement the emerging ecosystem. No one standard exists for data interoperability. The presence of disparate standards for data is a major roadblock. Even if we look at only wireless connectivity, there are plenty of network protocols like ZigBee, Z-Wave, INSTEON and EnOcean, each optimized for a specific purpose, but is not interoperable. However, more standards are ensuring optimum and energy-efficient network topologies, which might increase the efficiency of connected devices in the future while at the same time keeping a check on energy consumption. An ideal M2M data communication environment would be agnostic to the underlying technology and should be plug and play. We definitely have a long way to go before we get to that point.
Disparate Device Data Formats
There are a host of instruments and devices that need to communicate with each other and their number keeps increasing day by day. Several devices like CT scans, X-ray machines, ECG monitors, wearable medical devices and pacemakers have their own formats and file extensions for the output. Images like DICOM files that are heavy due to their high-image resolution might need to be integrated with lightweight applications, which require building several custom interfaces. It is a fact that there is no common standard of data exchange, which only multiplies the number of interfaces for each of the protocols; thus bringing in a lot of complexity and cost.
Security and Compliance
Data collected from the medical devices can be extremely sensitive and needs to be protected from unauthorized access. Several data security standards and policies like HIPPA should be adhered to, but in contrast, the ever-evolving and changing technology landscape makes it very difficult to comply with them. Also, government regulations are not comprehensive and are evolving with the technology, which only makes for a larger gray area.
Scalability and Cost Constraints
Different types of data are generated by medical devices. The data comes in several types, formats and sizes and so the storage needs differ. Some medical devices generate high-resolution images for which there would be a particular storage architecture. Some may warrant high network and data availability and synchronous operations for which the storage architecture may differ; for others, a low network availability might suffice. Hence, storage architecture could differ with devices. However, with all the devices in connection and all their data accumulating at the backend, it would be challenging to make devices nimble and provide for flexible storage systems and architectures for the backend while ensuring optimum cost and performance.
It is clear by now that the healthcare segment is set to ride on the technology wave enabled by connected devices that can seamlessly share data with each other. Medical device companies should brace themselves to catch up with this wave. It would be a multidisciplinary ecosystem and stakeholders will be many. The new streams of data that can be generated hold incisive insights and drive the future of medical device maintenance, patient care, manufacturing processes, lean supply chains and much more. The possibilities are limited only by imagination. IT vendors and system integrators are going to be the key enablers of an empowered ecosystem with a maze of data streams. Boundaries between hospitals, clinics and homes will become blurred, and care will get more personalized and customized. The ever-increasing range of sensors, decreasing cost of data hosting, innovations in network technologies, emerging frameworks on big data, data analysis and visualization will come together for an exciting and new breed of medical devices and services.
HCL LIFE SCIENCES & HEALTHCARE
HCL is a leading provider of Life Sciences and Healthcare Business and Technology services. HCL are the chosen service provider for enabling new growth drivers for our clients, providing them with industry leading best practices, taking care of their compliance needs and ensuring gold standard process cycle times. HCL clientele includes seven of the top ten global pharmaceutical companies, seven of the top ten medical devices companies, six of the top ten health plans, three of the top five CRO’s and two of the top three data providers. Equipped with certified technology experts and domain specialists, HCL offers services in critical areas of the life sciences and healthcare eco system such as drug discovery, clinical development, drug safety, regulatory compliance, manufacturing and plant automation, commercial, Healthcare analytics, Population Health Management [PHM], mHealth, member experience management [MEM], fraud, waste and abuse management [FWA].