Interfacing Medical Devices to the Mobile Network, Part Three
With the use of mobile technology for remote monitoring, gray areas and unknown variables are being introduced into the medical device ecosystem. Until now, the industry has worked under relatively controlled scenarios where evaluation and documentation of issues affecting safety, efficacy, and security are more or less contained within the physician/patient/device ecosystem. The emerging scenario of using an extended system of communicator devices, mobile networks, and multiple data access and evaluation points could impact safety, efficacy and security.
Our discussion of issues and challenges continues with a deeper look at the mobile network. Current remote health monitoring solutions have been using landlines for years. By replacing a wired network connection with a mobile one, we are introducing some potential unknowns into the medical device system.
First, since many mobile networks utilize different operating parameters, the communicator device will have to be certified, tested and validated on each specific network. If the device will be operating on multiple networks in multiple countries, managing the different technical requirements for validation and certification on each network may be extremely time-consuming and tedious. Each certification can cost tens of thousands of dollars, not to mention the global support structure required for supporting many networks across the globe. As discussed in the last column, one answer is to design the medical device with pre-certified wireless modules that can limit upfront licensing fees, indemnification against specific intellectual property, and elements of certification on the network.
There are many mobile network operators that want to benefit from the anticipated large volumes of healthcare data and images soon to be zooming across the wireless network. In the past year, many of these operators have joined platform providers to develop simpler solutions for machine-to-machine (M2M) mobile connectivity so more devices can be certified and operational on their networks more quickly and cost-effectively. Partnerships such as the ones announced in 2010 between Verizon Wireless and nPhase with Vodafone and Qualcomm, as well as the alliance between Jasper Wireless and AT&T, Telefonica, and others, aim to make it easier for medical devices to be certified and operate on multiple networks around the world. However, questions still exist.
The mobile network can introduce operational risks for wireless medical devices, such as a patient being out of range or the network going down for an unspecified period. If the mobile function went away, would the device still operate for its intended use? Is the addition of wireless technology driving new and potentially hazardous behaviors in the patient that must be acknowledged and mitigated? How can all of the technical and operational hazards that arise when using a mobile network be identified and mitigated? What U.S. Food and Drug Administration guidance exists for regulating the medical device interface and data over the mobile network? Does your labeling detail the processes required for backup operation?
What are the shared regulatory liabilities between the network operators and the device manufacturers if the network goes down while delivering critical medical data? Do the network operators have existing mechanisms and infrastructure to ensure priority delivery of critical healthcare data? Will companies set up a new entity to separate any increased regulatory risks from their core consumer business?
If the network experiences a period when it is non-functional, some examples of mitigation techniques could include a clearly documented and easy-to-implement secondary back-up process via the Internet or a traditional landline phone. It also is possible for a tertiary backup process to develop a path back to the patient via a phone call from the healthcare provider and/or a warning light, alarm or message on the device itself instructing the patient to take action due to a problem. Note that proper reporting of any adverse events experienced is a critical part of the overall regulatory system.
Managing Vast Amounts of Patient Data
Now, how will we manage the potentially massive amount of data that is to be collected from patients? How can the data effectively be filtered for out-of-range parameters and presented to the physician or other healthcare provider, or directly to the patient so that they can make a decision on health and treatment options? Third-party disease management companies with medical professionals on staff to view and manage the uploaded data have been showing up on the radar screen. Certain medical device OEMs have been making some acquisitions in the disease management services space. In addition, economic pressures have been driving some analysis of online data to healthcare professionals located in countries where the costs significantly could be less than in the United States. There even is early research discussing the possibility of using artificial intelligence for first-pass analysis of certain medical images in the future.
There also may be legal concerns regarding the availability of data. If data that shows an issue with a patient is available on the server or in a queue but the physician is delayed in viewing it and responding in a timely manner, can the physician’s malpractice liabilities increase? How can physicians effectively manage the analysis and follow-up of online data for all of their patients? Can they use third parties, technicians, or nurses to filter critical parameters and prioritize follow-up? Can they use a software application on their own mobile device, such as a tablet or smart phone, to maintain constant oversight of patients?
Data Privacy and Security
With their sensitive medical data sitting on the network, patients need to be confident about privacy and security across theentire mobile system. The system must be complaint with HIPAA (the Health Insurance Portability and Accountability legislation was enacted to, among other objectives, protect the security and privacy of health information) with the proper paper paths in place for tracking access and secured passwords for access to the data.
Devices should use data encryption in the short-range wireless network, embedded in the device platform architecture and within the data network. Network operators should have security procedures as well as the ability to strictly limit access to the data on their servers.
In addition, the possibility of data corruption, leading to uploading of incorrect information into the electronic medical record of a patient, must be considered.
Costs Savings and Business Models
Knowing that the overall healthcare system will experience savings, what types of business models might work? How can we get these models up and running to spur new investment from venture funds in this space? Reimbursement rules must be altered so that device manufacturers can be reimbursed properly for mobile devices and healthcare providers and physicians can be reimbursed for diagnosis, monitoring, and treatment outside of a standard, face-to-face office visit.
Some market research data has already shown that some customers might be willing to pay for remote management services and others might not. Without new reimbursement rules, flexible business models along the value chain must be developed. One possible business model for device manufacturers could be embedding the cost of the device into a subscription price including service, device, and network costs. Some devices might be considered an accessory and therefore managed as a cost. An ongoing trial that was presented at last year’s AdvaMed conference was able to take advantage of the shared savings provision in the Patient Protection and Affordable Care Act as well as grants to help pay for staff, point-of-care devices, and support required by the program. Early results from the study indicate that remote monitoring of elderly people with multiple chronic illnesses might be more effective when there is a holistic care delivery approach combining technology, at-home support and healthcare provider support. More evidencesoon will tell us whether healthcare providers need to alter their support and cost structure for delivering these services.
On Our Way to Remote Monitoring
Clearly, some significant changes have to be made within the healthcare industry to enable remote monitoring technologies to drive better patient outcomes at lower costs. Even with all of the issues that exist, it is commonly accepted that mobile devices operating across existing wireless standards and mobile networks will become a significant part of the medical device solution. Anticipation that the industry will provide more positive, evidence-based results from global studies and trials is very high.
To the patient, remote monitoring adds the convenience of fewer devices to carry, a better ability to self-manage, and less-frequent hospital or doctor visits. To the physician, remote monitoring provides more timely data to provide better care to patients and possibly frees up more time for higher-acuity patients. To the healthcare system, remote monitoring is expected to deliver better patient outcomes at lower costs. To the medical device manufacturer, remote monitoring potentially can lower the development cost of capital equipment, extend services into disease management and provide more timely insight into individuals living with their device therapies.
The industry has a long road ahead in identifying and mitigating all of the issues, challenges, and obstacles that are limiting greater acceptance of remote monitoring.Some changes are rapid and others are glacial. Everyone along the value chain must be extremely flexible in the transitional environment.
Interestingly enough, a new question is arising: With increased use of consumer devices and platforms in the medical devices ecosystem, what will be the new face of the medical device in the future? With the device’s display, storage, and communication functions and a much larger portion of its financial value potentially being provided by existing consumer devices, is the real value of the medical device OEM in the front-end patient interface or the sensing and treatment element?
Industry changes are appearing on the horizon and medical device manufacturers must embrace this new reality and deftly manage the inevitable shift infuture business models.
Editor’s note: This is the third and final installment in a series aimed at examining the issues and challenges that the medical device industry faces in using the mobile network as part of the healthcare monitoring system. The first column introduced the topic and the second columnfocused on the device/communicator function. This final installment covers the remainingissues introduced by the mobile network and data management/security.
Donna Fedor has been the director of strategy for Jabil’s Healthcare & Life Sciences sector since 2009. She is responsible for developing unique strategies to build deeper knowledge and expertise in the global healthcare industry, specific conditions and disease states, and medical products and technologies. Fedor holds a bachelor’s degree in electrical engineering from Boston University.