Connected healthcare: Medical wearables

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They have long since established themselves in the fitness industry and are now conquering medicine: Wearables have the potential to make sustained improvements in diagnostics, therapy and medication. The electronic assistants measure vital data in clinical quality and play an active role in the healing process.

The world market for medical wearables is growing rapidly: The number of wearable minicomputers is projected to grow from 27 million in 2016 to 94 million in 2022, according to the French market research company Yole Développement. IDC analysts estimate that more than half of the small electronic assistants will be medical wearables by 2020.

According to a Bitkom survey, 90 percent of respondents are willing, in principle, to share the health data captured by the devices with their physicians. In particular, those younger than 30 are interested in early disease detection and health value reading via wearables, according to a Future Health poll by PwC.

Wearables as a driver for digitalization

Medical wearables refer to electronic components that are worn either close to or on the body. The scope of applications ranges from intelligent plasters that can measure blood sugar level and patches that release medication in individual doses, to rehabilitation wearables such as sensor gloves that boost stroke patients’ movement stimuli, through to sensor pills that allow physicians to track if and when patients are taking prescribed medications. Classic assistive devices such as insulin pumps, hearing aids, pacemakers and smart implants also belong to the family of wearables.

Advances in sensor technology, radio technology and power management have enabled the wearables trend to take off. The tiny sensors – they are often made of silicone, polyurethane or polyimide – transmit vital data such as blood pressure, pulse and oxygen saturation. The trend toward miniaturization and the existing ecosystem of smartphones, apps and cloud services provides an additional boost for the wearable, medical-based electronics.

Wearables are getting smaller and smaller, more discreet and more comfortable, and are therefore suitable for long-term monitoring and continuous drug administration. Researchers are also working on new concepts for a reliable power supply over long periods, greater energy efficiency and energy harvesting from motion or body temperature.

Focus on: outpatient follow-up care and chronic conditions

The small digital assistants open up new paths for diagnostics, monitoring and medication in all stages of medical care – from prevention to inpatient and outpatient treatment through to rehabilitation. Industry observers see their key areas of application in outpatient care and remote monitoring, of seniors or infants, for example. In the hospital setting, the wearable devices will likely play a more subordinate role initially due to the existing infrastructure.

Wearables will also improve the care for people with chronic diseases such as diabetes, Alzheimer’s and Parkinson’s in the future: Until now, physicians have had only selective access to their patients’ vital data, but wearables can offer a comprehensive view of their living environments and thus provide the basis for personalized therapies.

The range of wearables available for diabetics, for instance, includes insulin pumps, sensor plasters for blood glucose monitoring, patches and socks with integrated electrodes that can measure pressure and temperature at the foot in order to combat diabetic foot.

Adhesive wearables: Sensor plasters

A number of ultrathin wearables, which can be affixed to the skin like plasters, are available for a variety of medical indications. Among these is the sensor unit RootiRx by Rooticare, which measures cardiac function and transmits to a smartphone via wifi. The sensor plaster for asthmatics, Adamm from Health Care Originals, registers parameters such as breathing sounds, pulse, activity level and temperature, and raises an alarm in the event of abnormal readings.

But wearables of tomorrow should not only measure vital signs, they should also play an active part in the healing process – for instance, through controlled administration of active substances. Scientists at Tufts University in Massachusetts developed a plaster with flexible sensors that monitor the healing process of wounds by measuring pH value and temperature. If infection is detected, the plaster releases medication. The medication is stored in hydrogel cells that, when needed, are warmed by small heating elements and release the substance.

Smart textiles: ECG shirts

Sensor technology for cardiovascular activities, body temperature, breathing rate, sweat production and other vital parameters can also be directly embedded in garments. However, conventional electronics made of rigid silicon wafers are not suitable for this application. Wearables need to be flexible and well tolerated by the skin. Current research is therefore looking into organic electronics that are 3D printed or deposited onto a substrate from a vapor phase. Developers also want to make the electronic components resistant to detergent solutions.

To that end, the FitnessSHIRT from the Fraunhofer Institute for Integrated Circuits (IIS) (electronica, Hall C5 Stand 426) has integrated, conductive textile electrodes that read the ECG. A flexible band in the thorax region that stretches and compresses with the movements of the chest measures breathing rate. The signals are stored in an electronic unit affixed to the t-shirt and are transmitted via radio frequency. The CardioSHIRT from IIS uses textile-integrated sensor technology to read the ECG in medical quality with up to nine measuring channels.

Regulators get ready for wearables

Before wearables can be firmly embedded in day-to-day medical care, there are a few challenges that must be met. These include questions about data validity or measuring accuracy, data protection and data security. Technical aspects such as interfaces and data interoperability also need to be considered. Wearables also have to demonstrate their clinical effectiveness, be well-tolerated by skin and be biocompatible. Before a wearable may be sold as a medical product, it must be approved as a medical device. Regulatory authorities worldwide are just now preparing themselves for this new segment of wearables.

In addition, healthcare systems are based on standardized processes and information. How the information collected from wearables can be integrated in this data landscape still has to be clarified. And: Medical data is not only of interest to physicians and scientists, but to pharmaceutical companies and insurances, too. That makes it even more important to have extensive patient controls for their personal data.

Individualized medicine and big data

Wearables have the potential to replace conventional medical devices such as blood pressure monitors, stethoscopes and thermometers and to become important components of complex care concepts. A key added value of wearable sensors is their ability to not only measure vital data over longer periods, but to register the impact of lifestyle and environmental factors on diseases. The integration of this individual data in clinical and research settings could provide powerful momentum for individualized medicine. The vital data collected by wearables can also enable the early detection and treatment of disease.

Looking at the anonymized healthcare data as big data also allows researchers to derive valuable epidemiological insights. After all, some 61 percent of Germans would be willing to make their data available in an anonymized form for research purposes, according the Smart Health study from the Techniker Krankenkasse.

electronica 2018

You can learn more about medical wearables, new sensor technology, data security, safety, approval and certification of medical electronics at the electronica Medical Electronics Conference and the Medical Electronics Forum.

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