Preventing and monitoring health problems with wearables

Track your activity, heart rate or sleep duration on one wearable. We think it's the most normal thing in the world medical grade wearables, wearable devices that comply with European medical device regulations, are capable of much more. This makes it possible to obtain ultrasound images or blood pressure via a 'patch' on the skin real time to measure. The potential of wearables is enormous, but this also brings challenges. “We can only solve this by working together integrally within an ecosystem of companies, institutes and hospitals with complementary expertise,” says program manager Dr. Natallia Uzunbajakava of TNO Holst Center. Uzunbajakava will be a plenary speaker during the Medical Electronics event on February 7, 2023 in Leusden.

“During my lecture I want to provide insight into the benefits and challenges of medical grade wearable devices”, says Uzunbajakava enthusiastically. “These are devices that are accurate and precise medical grade data read and which also comply with strict rules of the American FDA and the European MDR. So can nurses and doctors real time view information without the patient having to come to the hospital or treatment center.” Uzunbajakava mentions an ultrasound measurement as an example. “Currently, an ultrasound can only be performed by an experienced medical specialist in this field. The ultrasound device is large and bulky and it only measures a limited surface area of the body. To form a complete picture of the desired area, the specialist must move the device.”

Wafer-thin ultrasound patch
“At TNO we are working on a wafer-thin ultrasound 'patch' that resembles a large plaster and that a doctor applies to the patient's skin,” Uzunbajakava continues. "The patch uses ultrasound electronics to perform the same measurements as a device in the hospital, only for a larger surface area, without the need for a doctor to be present with the patient at all times. The patch is on the skin 24 hours a day and a specialist can view the data at any time while the patient is at home. For example, it is possible to monitor an embryo during pregnancy, or to keep track of the urine level in the bladder.”

Vital signs patch
TNO is also working on one vital signs patch which gives users insight into the status of their health and well-being. Consider: heart rate, heart rate variability, ventilation pattern, blood pressure, SpO2 and so on core body temperature. You can also use the vital signs patch see whether you are at increased risk of health problems and whether, for example, it is desirable to adjust your lifestyle to prevent problems.

Efficient and comfortable
“Wearables arose from the need of patients and practitioners to collect medical data more efficiently outside the hospital environment. The need for wearable devices is increasing due to the aging of the population and the increase in chronic diseases such as cardiovascular disease, diabetes, respiratory diseases, neurodegenerative diseases and mental health problems. These chronic diseases are responsible for approximately 70% of deaths worldwide and also in the Netherlands. Something must be done to reduce this percentage, because the increasing aging population will only increase healthcare costs in the future. The average person doesn't spend half their life in good health,” said Uzunbajakava.

Lifestyle intervention
“Prevention is always best: awareness and prevention through programs aimed at measuring health and well-being, linked to lifestyle intervention. But correct diagnosis at an early stage and therapy or treatment can also prevent bigger problems.” Measuring health data by medical grade wearables plays a central role in this. “If people realize for themselves what effect their lifestyle has on, for example, their heart rate and blood pressure, they are more willing to make lifestyle changes,” says Uzunbajakava. “Medical grade wearables measure precisely and are relatively easy to apply. Of course we also face challenges. Technically, it is important that the sensors measure accurately and also that the data real time and long term is generated. This is only possible if the wearable does not come off by itself while moving or in the shower. In addition, wearing comfort for the patient is of great importance, because the wearable is permanently on the skin and the patient does not want to be bothered by this.”

Modular sensors
The research team at TNO Holst Center works modularly. “Different patient groups have different readouts (signals) are needed,” Uzunbajakava explains. “Developments within the sector are moving rapidly and new and better electronics and materials are becoming available. We want to take advantage of that. When better innovations come onto the market, we want to integrate them into existing ones as quickly as possible wearable platforms. That is why our technology platforms are flexible and easy to adapt.”  

Contribute your own expertise
According to Uzunbajakava, teamwork and integrated collaboration are necessary to improve the quality of the wearable to ensure. “The various modules of such wearable we develop in house, but we don't do this alone. The expertise of TNO Holst Center in the field of hybrid printed electronics and cleanroom manufacturing (a very clean working environment, ed.) makes it possible to integrate flexible and rigid sensors and components into wearable devices. TNO also works with external partners, each of whom contributes their own expertise.

Uzunbajakava: “We work together with research institutions, laboratories, hospitals, universities, foundations and companies here in the Netherlands, such as Philips, LifeSense group, Bambi Medical, Holland HighTech, Erasmus MC. In addition, partners in Europe, the US and Asia, the pacific region, such as Lohmann, DuPont, EmpoHealth and Shin Etsu. We call the entire chain - from idea to end product - the ecosystem of a product. TNO is mainly involved in the first phase of the ecosystem, i.e. from the idea to the working prototype and the preclinical trial.”

Don't miss the boat  
The ultimate goal is that the wearable is approved by the European Medicines Agency or the FDA after which it is placed on the market. During her lecture, Uzunbajakava wants to demonstrate how essential good collaboration is for research and development wearables. “Wearables will only become more important in the future. To develop a good product, the right expertise must be brought together and that is why we at TNO try to connect parties. I hope that visitors to the event will realize at the end of the lecture how widely applicable wearables both for the treatment of diseases and preventatively, and that it is more than worth investing in it.”

Visit presentation
Visit Uzunbajakava's presentation during the Medical Electronics event on February 7 in Leusden. The presentation can be followed free of charge if you register in advance via the website: https://fhi.nl/medischeelektronica/