As Bluetooth medical devices become more integrated into items that patient can wear, carry around, or even swallow, the opportunity for consumer engagement increases.
We have underwear that monitors vital signs, body bands that record blood flow, bandana that can record epileptic activities and many other health related smart consumer gadgets, thanks to wireless networking made possible by Bluetooth technology. Combined with mobile phone or tablet, the result is personalized pervasive network of connected healthcare devices providing remote patient and medical body area monitoring. These new types of networks hold the key to eHealth – a real time, connected, continuous intelligent care delivery environment. The hard work to realize this future is in the software that supports these devices, an opportunity for device manufacturers to actively partners with specialized software development vendors with domain knowledge.
1 — Exit legacy medical devices
Legacy medical devices are, arguably, monolithic. When they have a user interface, it is usually a built-in terminal with very limited design of the display and is mainly for medical professional use only. They limit the opportunity for software engineers to improve their capabilities, so everyone should be happy to see the go. (see HACKING N’ HEALTHCARE: Are You Experienced? for a funny encounter of a consumer with health care application).
Take, for example, EEG equipment for recording and monitoring brain waves for, say, epileptic activities. The user terminal displays a bunch of waves for medical practitioners with experience with reading EEG tracings. Same goes for other equipment like ECG monitor, sphygmomanometer, oximeter, and many other devices used to perform medical procedures e.g., endoscopes; devices used to dispense medications, at home or in pharmacies e.g., tablet dispensers, inhalers, etc. In the legacy form, if they capture any data, the data remains with the device. These legacy medical devices are data jailhouses, once captured they are never released.
2 — Enter Bluetooth enabled devices
Put a sensor with Bluetooth technology into or onto anything and suddenly you have a smart object. Embedding Bluetooth in objects has been transforming household items and medical devices for the last decade. These new era medical devices are magnitudes better than their legacy counterparts, because we are able to use software to add or extend its functions and features, especially to make the data more meaningful to consumers and users.
These new generations of medical devices are multifunctional, adaptable, portable, self-documenting, self-managing and intelligent. These features are possible because data processing and display is no longer limited to the device hardware or terminal. As these new smart medical devices are being incorporated into items that patients can wear, carry around, or even swallow, the opportunity of consumer interaction increases. This means better usability and presentation of the information to drive appropriate engagement of the consumer in the self-health maintenance. It also means, we can communicate this information to anyone (e.g., physician, case manager, benefit manager) and anywhere (e.g., patient’s medical record system, etc.).
Take another look at Infographic: Are You Ready For Sensors In Healthcare? and imagine the possibilities and opportunities: continuous EEG monitoring with overlay of patient activities that would be triggers to epileptic activities (medical hat), 24 hour vital sign and ECG monitoring coupled with physical activity profile (medical underwear), simultaneous monitoring of airway resistance, environmental pollutants and actual medication delivery (medical inhaler), oximeter capable of adjusting the positive pressure to the changes in carbon dioxide concentration in the exhaled air of the user (medical CPAP), ingestible cameras capable of real time transmission of the images to image processing module, and many others. These devices offer additional data that can be used to care more interactive, and health monitoring an activity of daily living.
3 — The liberation of data from medical devices
Bluetooth technology sets the data gathered by medical devices free or enables the devices to gather data not previously considered. By setting the data free, we can focus on building software for the processing, display and communication of the data, independent of the design of the device. We are no longer limited on how and where this data is displayed. We can, also, apply algorithms and logic to the data to identify events, and to generate notices that consumers can understand.
Instead of tracings and raw numbers that are not meaningful to the end user, we can generate notices of the state of the body part being monitored – normal or abnormal. When it is abnormal, we are able to provide a description of the abnormality and also what intervention may be necessary. We can also present a different more technical picture of the data to medical professionals involved in the care of the patient.
In addition to transmitting measurements, Bluetooth technology also allows the capture and transmission of configuration and administrative data, allowing devices to be remotely controlled. This is useful in two ways: 1) to intermittently waken the devices by time or event, and 2) for programming of the device to respond to changes in status of the user or his/her environment. We can embed processes, in software, to detect the presence of a Bluetooth enabled device and invite consumers to use it.
4 — Collaboration of Bluetooth enabled devices
According to Bluetooth.org, since the advent of Bluetooth technology in 1998, there are already more than 40 million Bluetooth enabled home and professional healthcare devices on the market from leading manufacturers like 3M, A&D, Nonin and Omron. IMS estimates 1 billion Bluetooth Smart devices will be sold every year from this year.
Bluetooth.org notes that it is the fastest adoption rate of any wireless technology. Increasing awareness of the benefits of a healthy, independent lifestyle has created booming market for devices that permit people to monitor their health in the comfort of their home. User experience is becoming a key market differentiator for these devices. The data generated by these devices are mostly in silos, on mobile phones or in tablets, with limited integration. Efforts to integrate this data should not be after-thought, but an integral part of the design the device.
With Bluetooth technology in medical devices, gone are meshes of wires with flashing lights which attended legacy medical devices, and a calmer environment for the care of patients. The extension of medical facility level health monitoring outside the medical facility has also become a reality, and increasingly preferred. We are in a position to coordinate the capture of comprehensive physiological, electrical, chemical data about the body, in sickness and in health, intermittently or continuously.
5 — The rise of secure private health area networks
The emergence of, so-called, Remote Patient Monitoring Networks (RPMN) and Medical Body Area Networks (MBAN) are for organizing the participating devices and the data they generate. RPMN and MBAN solutions are communities of collaborating wireless enabled devices. These specialized health area networks consist of nodes of devices contributing data about the health status of a user and information about the activities and habits of the user.
For example, a user can build a private health network with nodes for monitoring asthma, vital signs, heart rhythm, medication, blood sugar, blood oxygen, activity, temperature and others. Providers can be given access to this network to review the data and design interventions to the data. Also this data as well as any observations from providers can be saved off into the patient’s medical records. When the patient’s medical record system is part of this network, we get automated updates to the medical records, preventing the type of patient alerts in this comic strip (see HACKING N’ HEALTHCARE: Patient Alert?).
What this all means is a new expectation about software’s role in medical devices
This makes the software component of these devices as important as the hardware components. This means the software needs to be subjected to the same level of scrutiny as the hardware in these devices. The software should consistently translate the raw signals from the sensors into useful data. Software errors need to be captured and addressed, and it should not degrade faster than the hardware in error situations. It should also generate messages that would allow users to intervene when necessary.
Since the software component of these medical devices can be completely separated from the hardware, it is not surprising that FDA and EMEA are developing guidelines for medical software of all types.
About Nsikak Akpakpan:
Nsikak Akpakpan is a Physician/Software Architect at mobile health app developer, Pathfinder, LLC. He is passionate about is in software architecture / design, especially data driven (algorithm free), diagnostic / intelligence systems for health care and other industries.
