Date: Jan 01, 2007 Source: DARPA Success Stories (
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Technology and Innovation:
Under this DARPA SBIR project, AFrame Digital developed a noninvasive, small, low power, and low cost ambulatory monitoring system. The Mobile Care Monitor system consists of a wearable watch-like device containing various physiological and environmental sensors, a secured wireless data network, and a data storage and analysis system. Sensors monitor the patient's heart rate, temperature, activity, stability, and location, operating 24/7 to provide an active "safety net" for the patient.
The system is primarily to be used for monitoring and alert services for returning soldiers with traumatic brain injuries (TBI), burns, amputations, risk of infection, and posttraumatic stress disorder (PTSD), as well as services for the elderly. Using Bayesian and trend analysis, this integrated system can continuously monitor multiple physiological and environmental data collected by the sensors and analyze the relationships among multiple data streams. It provides immediate patient status, identifies anomalies, and generates and sends real-time alerts to caregivers about important changes in the medical status of a patient.
AFrame has received Phase II funding from DARPA to conduct field trials as part of the Innovative Model of Living (IML) project at Vinson Hall Retirement Community (VHRC), a veteran-focused senior healthcare facility. Rear Admiral
Kathleen Martin (Ret.), CEO of VHRC, said, "The IML comes as a direct response to a clear message from VHRC residents that they want a living environment that allows them to age in place, prolonging their independence and quality of life." The system is also being tested at Brooke Army Medical Center (BAMC) and Walter Reed Army Medical Center (WRAMC) to fully understand the recovery patterns of trauma patients.
Joint Collaborations:
The DARPA SBIR project supported building collaborations with BAMC,
WRAMC, The US Army Institute for Surgical Research and the US Army Medical Research and Material Command for the research studies and validation of the system. In addition, research collaborations were established with a number of universities, including Virginia Tech, University of Virginia, and Virginia Commonwealth University/Medical College of Virginia.
Lessons Learned:
• Obtaining IRB approvals to collaborate with military research organizations under an SBIR is often a lengthy process, especially if the collaboration includes working with human subjects. Start the approval process as early as possible, and also include the approval process as a critical path in the project plan, budget and schedule.
• Conduct field trials as early as possible to obtain feedback from both military and civilian end-user communities (dual use) so that system refinements can be incorporated into the final design. This is a key step to ensuring that the final product will best meet functional and operational requirements in both of these markets.
• Know your regulatory requirements (local, state and federal) and plan for these key compliance efforts as early as possible in the development schedule.
Economic Impact
The DARPA SBIR project provided funding to design and develop an initial prototype of the MobileCare Monitor system and to conduct field tests. This project directly helped the company receive private investments to support additional development activities.
The DARPA SBIR project was also instrumental in securing SBIR funding from
the National Institutes of Health/National Institute on Aging (NIH/NIA) to apply the technology to the Non-intrusive Locomotion and Gait Stability Analysis Monitoring System for the Elderly, a research program focused on developing a system that can accurately detect a fall and, in fact, prevent falls by sending gait instability alerts to care providers.
AFrame Digital currently has a patent pending for the entire MobileCare Monitor
System and has developed additional intellectual property associated with the monitoring and service components of the system. AFrame Digital's business model consists of a multi-year lease for the monitoring device and a monthly subscription fee for monitoring and alert services. AFrame is currently filing for pre-market notification with the FDA (510K clearance) to market the system in the U.S. The FDA 510K application will be submitted in December 2008.
About the Company:
AFrame Digital was founded in 2005 to apply wireless technology and advanced analytics to long-term health monitoring and alerting systems. The company's executives and board bring a combination of experience from Fortune 50 companies and startups in the wireless business—including DHL/Net Express, Freddie Mac, MCI, NYNEX, CyberCash (acquired by VeriSign), and Caspian Networks—and from a range of healthcare and military telemedicine research organizations.
