Interfacing Medical Devices to the Mobile Network
There is no doubt that we are in an amazing and challenging transition period in healthcare. Reform initiatives have demanded an intensive examination of current, accepted methods of care delivery to find more cost-effective, value-based methods of disease management and treatment. The goal is simple: drive better patient outcomes while taking significant costs out of the system.
Across many industries and applications, information technology has proven its ability to deliver increased performance at lower costs. So it is no surprise that remote health monitoring has been gaining momentum across the healthcare value chain. The potential benefits of remote monitoring are being touted in the press. Greater involvement in their own care can improve patients’ compliance; more timely information for physicians can enable better-informed and more effective decisions for disease management; and extending monitoring beyond the hospital or clinic can cut costs through shorter inpatient stays and less-frequent office visits.
With the predicted shortfall of doctors and nurses across the world, the efficiency and time savings of remote monitoring could assist the healthcare industry in providing care outside of the clinical environment. A recent report by PricewaterhouseCooper’s Health Research Institute reported that 40 percent of physicians could eliminate 11-30 percent of office visits via mobile health technologies, which include remote monitoring and email/text communication.1 In addition, according to the Center for Technology and Aging in Oakland, Calif., the use of remote monitoring systems could trim costs by almost $200 billion in the next 25 years.
Although some experts predict an extended period of 8-10 years before remote monitoring solutions become ubiquitous, data shows we might finally be ready for significant initiatives. According to a recent 2010 International Telecommunication Union report, mobile phones are becoming the Internet access platform of choice with an estimated mobile subscriber base of 5.3 billion by the end of 2010, including 940 million using 3G services. Access to mobile networks is now available to 90 percent of the world’s population and 80 percent of populations living in rural areas. According to a 2008 California Healthcare Foundation report, 76 percent of people diagnosed with one chronic condition own a cell phone, while people with more than two conditions reported 70 percent ownership.2 People are mobile, so the devices that monitor our health also should be mobile.
Evidence Starting to Show Positive Results
Evidence is critical in gaining payer acceptance and reimbursement for remote monitoring solutions. We are starting to see evidence of positive results from various ongoing trials around the world. For example, a tuberculosis study in Africa using the SIMpill Medication Adherence System, which combines a pill reminder device with text messages, has shown 94 percent compliance vs. a significantly lower compliance rate without the technology. In addition, results cited from a two-year online e-visit consultation study by the Mayo Clinic Department of Family Medicine showed that only 13 percent of the 2,531 e-visit patients were asked to schedule a face-to-face follow-up visit and 62 percent of the e-visits included an uploaded photograph.3 A U.S. Department of Veterans Administration (VA) telehealth/remote monitoring study conducted with 17,000 veterans showed a 19 percent reduction in hospitalizations and a 25 percent reduction in the average length of stay. The VA states on its website that the value of the solution is a combination of technology and personal involvement by the VA staff in how they use the remote health information to improve care in each specific case.
The Introduction of Unknowns
The use of mobility technology is introducing gray areas and unknown variables into the medical device ecosystem. Until now, the industry has worked in familiar scenarios where evaluation and documentation of issues affecting safety, efficacy and security are more or less contained within the physician/patient/device ecosystem. Using an extended system of communicator devices, mobile networks, and multiple data access and evaluation points opens the possibility for new risks.
Regulatory agencies are hesitant about placing healthcare technology in the hands of patients without clinical supervision. Whether remote technology strictly is used to collect data for forwarding to the provider or the device will make diagnostic or treatment decisions, intended use clearly must be defined and documented.
The topic seems to have hit critical mass. At the joint U.S. Food and Drug Administration (FDA) and Federal Communications Commission meeting in July, FDA Commissioner Margaret Hamburg said the “benefits that wireless technologies can provide to healthcare are very, very clear...But to harness the full power of those benefits, we must navigate a delicate balance between innovation and safety and effectiveness.”4
We are in a transitional period, facing major challenges in identifying and managing the shared regulatory risk across this complex system of devices, networks and data management solutions. Regulatory guidance must identify how the responsibility for hazard management will be distributed across the entire value chain. What alterations will be made to the process for pre-market risk assessment, for the reporting of faults and adverse events during operation, as well as fault analysis and responsibility identification if the adverse event produces a negative patient outcome? Manufacturers need to stay abreast of decisions made within the governing regulatory bodies and use regulatory experts, both internal and external, for guidance.
In addition to meeting evolving regulatory requirements, device manufacturers must address consumer concerns about medical data safety and security. A KMPG study on mobile security and privacy from July 2010 reported that only 16 percent of U.S. consumers are comfortable using their mobile phones to handle banking or credit card transactions. When asked about accessing or sending personal medical information on mobile devices, 40 percent of U.S. said they would not be comfortable doing so. However, the study showed that consumers outside the United States were much more comfortable with accessing sensitive data on their mobile devices.
Mobile Technology Use Across Different Patient Populations
Although the majority of downloaded healthcare applications seem to be centered mainly on wellness and prevention, chronic disease management is where the majority of today’s healthcare costs are generated andmostly likely will be where regulatory bodies, insurance companies and medical device OEMs expend the largest effort in the coming years. When it comes to acceptance of remote monitoring solutions, patients will vary greatly based on many elements including age, overall comfort with technology, disease type, amount of mobility and dexterity, and even the availability of care assistance in the home.
Mobile solutions will vary across different patient populations, with the goal being optimal safety, efficacy and data security at low overall system costs. Some solutions will be aimed at elderly people with more than four chronic illnesses with very limited knowledge of technology; other solutions will be aimed at adults that are technically savvy and extremely active in self-management; and a large majority of patients just want to know whether everything is OK with a simple-to-use technology operating in the background.
Navigating the Introduction of Mobile TechnologyConsidering the huge potential benefits of remote monitoring devices for more-efficient care delivery and the likelihood ofpatient acceptance, medical device manufacturers may want to focus in this emerging area.
However, there are issues and challenges ranging from reimbursement to safety to data security. Of particular concern for manufacturers are the complex electronics involved in a remote monitoring device— technology that may be completely unfamiliar. Medical device manufacturers wishing to take advantage of this market opportunity need access to expertise in the latest mobile electronics technologies. One of the best ways to obtain this expertise—while simultaneously avoiding capital expenditures and shortening time to market—is to partner with a provider with dual experience in consumer electronics and medical device manufacturing. A full-service, global outsourcing provider with substantial presence in medical device design and manufacturing with knowledge in this fast-changing space can fill critical gaps in a device company’s resources and provide regulatory expertise and economies of scale.
Editor’s note: This is the first in a series of three columns examining the issues and challenges that the medical device industry faces in using the mobile network as part of healthcare monitoring systems. Upcoming installments will cover device/communicator and network data management issues.
References:
1 PWC Health Research Institute. Healthcare Unwired. Sept. 2010.
2 California Healthcare Foundation. How Smartphones Are Changing Health Care for Consumers and Providers. April 2010.
3 Steven C. Adamson, MD, and John W. Bachman, MD. “Pilot Study of Providing Online Care in Primary Care Setting.” Mayo Clinic Proceedings. August 2010, 85( 8): 704-710.
4 http://reboot.fcc.gov/workshops/fcc-fda-joint-meeting-on-life-saving-wireless-medical-technology
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.
