Wearable Medical Computing and the Amulet Project

Health care is one of the most promising areas for employing wearable devices. Wearable mobile health sensors can track activities (e.g., count steps or caloric expenditure), monitor vital signs including heart rate and blood pressure, measure biometric data (e.g., glucose levels and weight), and provide alerts to medical emergencies including heart failures, falls, and shocks.

Applying wearable computing to support mobile health (mHealth) is promising but involves significant risks. For instance, there are security issues related to the reliability of the devices and sensors employed, the accuracy of the data collected, and the privacy of sensitive information.

The Amulet bracelet-style prototype for developers enables users to control its settings

The Amulet bracelet-style prototype for developers enables users to control its settings

Under the federally funded Amulet project, an interdisciplinary team of Dartmouth College and Clemson University researchers is investigating how wearable devices can effectively address medical problems while ensuring wearability, usability, privacy, and security for mHealth applications. The project aims to develop pieces of “computational jewelry” and a software framework for monitoring them. This computational jewelry set comprises wearable mobile health devices collectively named Amulet. An Amulet device could be worn as a discreet pendant or bracelet that would interact with other wearable health sensors that constitute the wearer’s wireless body-area network (WBAN). The Amulet device would serve as a “hub,” tracking health information from wearable health sensors and securely sending data to other health devices or medical professionals.

The project’s goals are multifold. Regarding the hardware, we’re focusing on designing small and unobtrusive form factors, efficient power sources, and sensing capabilities. With respect to the software, we’re concentrating on processing and interpreting the digital signs coming from the sensors, effectively communicating and synchronizing data with external devices, and managing encrypted data.

Amulet’s multiprocessor hardware architecture includes an application processor that performs computationally intensive tasks and a coprocessor that manages radio communications and internal sensors. Amulet’s current prototypes contain an accelerometer and a gyroscope to monitor the wearer’s motion and physical activities, a magnetometer, a temperature sensor, a light sensor, and a microphone. To save power, the application processor is powered off most of the time, while the coprocessor handles all real-time device interactions.

By employing event-driven software architecture, Amulet enables applications to survive routine processor shutdowns. Amulet is reactive, running only when an event of interest occurs. To handle such events, programmers can define their application as a finite-state machine and set appropriate functions. Amulet’s architecture enables applications to identify the computational states that should be retained between events. Explicitly managing program state (rather than implicitly managing state in a thread’s run-time stack) enables the run-time system to efficiently save the application state to persistent memory and power down the main processor without harming applications.

Amulet provides a secure solution that ensures the accuracy and the integrity of the data sensed and transmitted, continuous availability of the services provided (e.g., data sensing and processing and sending alerts and notifications), and access to the device’s data and services only by authorized parties after their successful authentication. Two key features enable Amulet to provide security in mHealth applications: sandboxing and the authorization manager. The former enforces access control, protects memory, and restricts the execution of event handlers. The latter enables applications to run small tasks until their completion, managing all resources by receiving requests and forwarding them to a corresponding service manager.

Amulet also aims to protect privacy, enabling users to control what is sensed and stored, where it is stored, and how it is shared (with whom). Amulet devices use privacy policies to protect patients’ sensitive information, which ensures confidentiality through authorized access and controlled sharing.

To guarantee easy wearability, the Amulet team focuses on understanding the user’s wishes, needs, and requirements and translating them into appropriate design decisions. Amulet provides a list of principles and guidelines for wearability, which will aid designers in providing high levels of comfort, aesthetics, ergonomics, and discretion in their projects.

Amulet includes a framework to support stakeholders involved in similar projects during all phases of development. It is intended to aid developers and designers from industry or academia. Amulet provides a general-purpose solution for body-area mobile health, complementing the capabilities of a smartphone and facilitating the development of applications that integrate one or more mHealth wearable devices.

Amulet also provides intuitive interfaces and interaction methods for user input and output, employing multimodal approaches that include gestures and haptics. Amulet has developed and continues to refine bracelet-style prototypes with a variety of envisioned applications, including: emergency responders (e.g., providing immediate notifications and quick responses in medical emergencies), stress monitoring, smoking cessation, diet (e.g., bite counting), and physical therapy (e.g., knee sensors).

Dr. Vivian Genaro Motti

Dr. Vivian Genaro Motti

ABOUT THE AUTHOR

Dr. Vivian Genaro Motti holds a PhD in Human Computer Interaction from the Université catholique de Louvain in Belgium. She is a Postdoctoral Research Fellow in the School of Computing at Clemson University in Clemson, SC. She works on the Amulet project, which is funded by a three-year, $1.5 million grant from the National Science Foundation’s Computer Systems Research program. As part of the Amulet project, Vivian is investigating how to properly ensure wearability and privacy in wearable applications for mobile health. Vivian has a BA in Biomedical Informatics and an MS in Human Computer Interaction from University of Sao Paulo in Brazil. Her main research interests are human computer interaction, medical applications, wearable devices and context awareness.

This appears in Circuit Cellar 288, July 2014.

The Future of Open-Source Hardware for Medical Devices

Medical technology is changing at a rapid pace, but regulatory compliance is also becoming increasingly harder. Regulatory compliance can act as a barrier to innovation, but it is a necessary check to ensure quality medical care. For small companies, aligning innovation with regulatory compliance can only help.

Fergus Dixon

When designing any new product, the FDA-recommended process is a great reference. First, the design input requirements must be written down. After the device has been designed and prototyped, verification and validation (V&V) will ensure that the device meets the design input. The device is then documented, creating the design output or device master record (DMR). Each device made is checked against the DMR and documented in the device history record (DHR). So all the details on how to make the device are contained in the DMR, and the results and traceability are recorded in the DHR.

My company recently asked an overseas company to design and manufacture an existing product. After many e-mails, the overseas company managed to build a working unit and immediately requested an order for 1,000. Before ordering even one unit, there was the matter of V&V. So what is V&V? Verification is the act of ensuring that the circuit acts as it should, as the circuit designer intended. This involves testing to a predetermined criteria, where the pass/fail is clearly defined. Testing happens by varying the inputs and checking the outputs to test the device as close to 100% as reasonably possible. When the inputs fall outside a normal range (e.g., a 10-VDC instead of 12-VDC battery voltage), the device must still work or it must provide a message showing why the device will not work (e.g., low battery light). Validation is the act of ensuring the circuit works as the customer or patient requires. This involves field testing, feedback, and rework—lots of it.

Working for medical device companies can be very rewarding. Smaller companies tend to work at the cutting edge. Larger companies are more secure and have stable products, but they can be less agile. With one company, we had a device that used smart batteries. During testing, we discovered that the batteries would not charge below 15ºC. After many meetings and e-mails to the manufacturers, the problem went to management, who decided to change the manual to say: “Do not charge below 15ºC.” Smaller dynamic companies can attract the best scientists, which is great until a connector fails and there is a roomful of highly intelligent people with no soldering iron experience. Every technology company can benefit from having at least one experienced technician or engineer. A few hours spent playing with an Arduino is a great way to get this experience.

What about open-source hardware (OSHW) for medical devices? For home hobbyists and students, OSHW is great. There is free access to working circuits, programs, and sketches. C compilers, which once cost several thousand dollars, are mostly free. For the manufacturers, the benefits are plenty of feedback, which can be used to improve products. There is one roadblock, and that involves the loss of intellectual property (IP), which means anyone can copy the hardware. Creative Commons has addressed this with an agreement that any copies must reference the original work. Closed-source hardware can also be good and present fewer issues with losing IP. Apple is a great example. Rather than use feedback to improve products, it makes smart decisions about future products. The iOS vs. Android battle can be viewed as a closed-source vs. open-source struggle that still hasn’t produced a winner. Medical devices and OSHW will have to meet up sometime.

Fergus Dixon’s embedded DNA sequencer project (Source: F. Dixon)

What about the future of medical devices? Well, the best is yet to come with brighter organic light-emitting diode (OLED) displays, a multitude of wireless connectivity options (all using the serial interface), and 32-bit ARM cores. DNA is gradually being unlocked with even “junk DNA” becoming meaningful. The latest hot topics of 3-D printing and unmanned aerial vehicles (UAVs) have direct medical applications with 3-D printed prosthetic ears and medical nanorobotics ready to benefit from UAV technology. Using a new sensor (e.g., a gyroscope) now means visiting an online seller such as Pololu, which offers ready-built development kits at reasonable prices. A recent design was a manually assisted CPR device project, which was abandoned due to lack of funding. How great would it be to have a device that could not only improve the current 10% survival rate with CPR (5% without CPR) but also could measure a patient’s health to determine whether CPR was helping and, even more importantly, when to stop administering it? Now that would be a good OSHW project.