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Designing a home health care monitoring device

09 May 2016  | Gwyneth Saldanha

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A Nuvation Engineering client in the tele-health industry was seeking assistance upgrading a health monitoring device used by patients who are managing their care at home. The device collects data from various personal health monitoring devices (PHM) and uploads it to a central monitoring station manned by live agents. The client was primarily a health monitoring services provider and developing electronic devices was not their core business.



They needed the assistance of an engineering firm that could:

 • Work with an RFP that was based on functional requirements and not complex technical specifications
 • Provide up-front visibility of the entire project effort and costs from initial design to market-ready product
 • Possess the diverse skill sets needed to execute both software and hardware development
 • Manage all the complexities of medical and electronic device product testing and regulatory certification
 • Manage the project until ready-to-ship products were rolling off the production line.

Figure 1: Personal health monitoring (PHM) devices being used in the home are connected to a device that collects and transmits the customer's health status to a central monitoring station.


Requirements
The current device was several years old and some components had reached parts obsolescence. The device could also only support a single PHM device and needed to support multiple devices simultaneously. Support also needed to be added for newer communication technologies since the device was currently limited to plain old telephone service (POTS) as the only mode of data transfer to the cloud.

The new device needed to:

 • Collect health information via USB and Bluetooth from multiple PHM devices simultaneously (e.g. blood-glucose monitors, blood pressure monitors, pulse oximeters, etc.)
 • Upload PHM device data to the cloud via Internet, cellular networks, and home phone line
 • Be designed to meet North American and European EMC and Electrical Safety standards
 • Use components with lifecycles that exceeded the planned product life
 • Be manufactured at a price point that was well within the average home-care patient's budget
 • PHM device connectivity standards
 • 

Standards for connected health monitoring devices used in the home are governed in part through collaboration between IEEE and the Continua Health Alliance, whose mandate is "to establish an eco-system [sic] of interoperable personal health systems that empower people and organisations to better manage their health and wellness." [1] Nuvation provided hardware and firmware solutions to help make the device compliant with Continua's special USB standard for PHM devices.


Regulatory compliance
The device had to undergo testing to ensure compliance with a range of medical and information technology equipment regulatory standards including:

 • IEC 60601-01, 3rd Edition ("IEC 60601" in North America, "EN 60601" in Europe [2] ) – an internationally recognised standard for medical equipment performance, managed by the International Electrotechnical Commission (IEC)
 • IEC 60950 – governs the safety of "information technology equipment"
 • FCC Part 68 – a U.S. regulation that governs device connectivity to telephone lines [3]
 • CS-03 – an Industry Canada guideline governing the operation of devices that connect to the telecommunications equipment of Canadian carriers [4]
 • TBR21 – a European telecommunications standard published by ETSI and which applies to all telephone equipment being connected to Europe's public switched telephone network [5]
 • CISPR-11, 22 – an IEC-managed standard governing how a device manages radio interference [6]

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